Beyond the Drama: the Beautiful Life in News Feeds on Cancer

Abstract

Facebook is one of the main communication tools in the world nowadays. In Brazil, it is used for almost half of the population. Knowing what is conveyed about cancer by this social network can be an important step for the development of efficient health communication strategies. We evaluate Facebook user's comments on pages about cancer; verify if there is a pattern of public awareness on the disease and compare it with results from other studies. Three pages about cancer on Facebook were selected among those with more followers in Brazil. For 6 months, from January to June 2014, all posts were selected and evaluated, and we created eight categories. On each page, the categories that generated most comments were elected for the second analysis. The behavior of empowered citizens by new communication tools is the target of this study. Similarities and differences between 12,926 comments coming from 1243 posts in three different Facebook pages on cancer were analyzed. Four new categories were identified: "religion," "positive," "negative," and "information." Despite the differences among the three pages selected for this study, we observed the predominance of positive speeches associated with religious terms. Following public perceptions on cancer is an important step for the development of efficient health communication strategies.

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Overexpression of Histone Deacetylase and Amyloid Precursor Protein in Hepatocellular Carcinoma

Epigenetic modifications are involved in the pathogenesis of cancer, and histone deacetylase inhibitors are considered potential therapeutic agents. Histone tails undergo acetylation at lysine residues, which is associated with transcriptional activation. However, previous studies indicated that as histone deacetylase inhibitors, both (–)-epigallocatechin-3-gallate and valproic acid presented the effects of downregulation of amyloid precursor protein expression, which resulted in the induction of apoptosis. The downregulation of amyloid precursor protein, instead of conventionally activating gene expression as histone deacetylase inhibitor, was attractive. However, there was no relevant report on the correlation of the expression of amyloid precursor protein and histone deacetylase 1 in cancer. In the present study, we detected the expression of amyloid precursor protein and histone deacetylase 1 in hepatocellular carcinoma and adjacent tissues, as well as the correlations among histone deacetylase 1, amyloid precursor protein, and tumor stage. The results showed that the expressions of amyloid precursor protein and histone deacetylase 1 were significantly higher in hepatocellular carcinoma tissues than that in adjacent tissues (P < .05), however, there was no statistical difference between amyloid precursor protein and histone deacetylase 1 with tumor stages. The present findings provided more foundation for the study on amyloid precursor protein metabolism in cancer, especially on the regulation of amyloid precursor protein by histone deacetylases.

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Short- and long-term results of radial artery and saphenous vein grafts in the right coronary system: a propensity-matched study

Abstract

Purpose

The selection of optimal grafts for the right coronary artery remains controversial. This study aims to evaluate the short- and long-term results of radial artery (RA) grafts and saphenous vein grafts (SVGs) to the right coronary artery.

Methods

We reviewed, retrospectively, isolated coronary artery bypass grafts, placed between 1997 and 2007, and compared the long-term results of patients who received RA (n = 110) grafts with those of patients who received SVGs (n = 264) using propensity-score matching for risk. The preoperative predictors of graft occlusion were investigated on a per case basis.

Results

Superior survival was noted in the unmatched RA group, but late outcomes after propensity-score matching yielded 91 patient pairs that were similar in the two groups. Graft failure was not correlated with mortality, but showed strong correlation with cardiac events in all patients. The predictors of graft occlusion in the RA group were mild proximal stenosis and low indexing glomerular filtration rates for body surface area, whereas those in the SVG were female gender and off-pump coronary artery bypass grafting.

Conclusions

There were no significant differences in long-term outcomes between the RA and SVG groups. Predictors of graft occlusion differed between the groups. Notably, renal dysfunction impaired radial patency, emphasizing the importance of careful graft selection.

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A novel transanal tube designed to prevent anastomotic leakage after rectal cancer surgery: the WING DRAIN

Abstract

Purpose

We introduce a novel transanal tube (TAT), named the "WING DRAIN", designed to prevent anastomotic leakage after rectal cancer surgery, and report the fundamental experiments that led to its development.

Materials and methods

We performed the basic experiments to evaluate the effect of TATs on intestinal decompression, the changes they make in patterns of watery fluid drainage, the changes in their decompression effect when the extension tube connecting the TAT to the collection bag fills with watery drainage fluid, and the variations in intestinal contact and crushing pressure made by some types of TAT.

Results

Any type of TAT contributed to decompression in the intestinal tract. Watery drainage commenced from when the water level first rose to the hole in the tip of drain. The intestinal pressure increased with the length of the vertical twist in an extension tube. The crushing pressures of most types of TAT were high enough to cause injury to the intestine.

Conclusions

We resolved the problems using an existing TAT for the purpose of intestinal decompression and by creating the first specialized TAT designed to prevent anastomotic leakage after rectal cancer surgery in Japan.

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Association between the age and the development of colorectal cancer in patients with familial adenomatous polyposis: a multi-institutional study

Abstract

Purpose

To investigate the incidence of colorectal cancer among familial adenomatous polyposis (FAP) patients by phenotype using the latest modalities.

Methods

We collected data on 303 patients who underwent surgery for FAP at one of 23 institutions between 2000 and 2012. The incidence of colorectal cancer was investigated by phenotype.

Results

Colorectal cancer was diagnosed in 115 (38.0 %) of the 303 patients. Overall, colorectal cancer with the attenuated, sparse, and profuse phenotypes was diagnosed at 30, 31, and 28 years of age, respectively, in 10 % of the patients and at 59, 48, and 41 years of age, respectively, in 50 % of the patients (P = 0.013). The patients with colorectal cancer were older than those without colorectal cancer for all phenotypes. The optimal cut-off age for predicting the development of colorectal cancer in the attenuated, sparse, and profuse phenotypes was 46, 31, and 27 years, respectively.

Conclusions

Patients with profuse and sparse phenotypes should undergo prophylactic proctocolectomy before their mid-to-late 20 s. On the other hand, the timing and type of surgery for patients with attenuated FAP (AFAP) should be decided individually with reference to the colonoscopic findings.

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The HB22.7–vcMMAE antibody–drug conjugate has efficacy against non-Hodgkin lymphoma mouse xenografts with minimal systemic toxicity

Abstract

In this study, HB22.7, an anti-CD22 monoclonal antibody, was used for specific, targeted delivery of monomethyl auristatin E (MMAE) to non-Hodgkin lymphoma (NHL). MMAE was covalently coupled to HB22.7 through a valine–citrulline peptide linker (vc). Maleimide-functionalized vcMMAE (mal-vcMMAE) was reacted with thiols of the partially reduced mAb. Approximately 4 molecules of MMAE were conjugated to HB22.7 as determined by residual thiol measurement and hydrophobic interaction chromatography–HPLC (HIC-HPLC). HB22.7–vcMMAE antibody–drug conjugate (ADC) retained its binding to Ramos NHL cells and also exhibited potent and specific in vitro cytotoxicity on a panel of B cell NHL cell lines with IC₅₀s of 20–284 ng/ml. HB22.7–vcMMAE also showed potent efficacy in vivo against established NHL xenografts using the DoHH2 and Granta 519 cell lines. One dose of the ADC induced complete and persistent response in all DoHH2 xenografts and 90 % of Granta xenografts. Minimal toxicity was observed. In summary, HB22.7–vcMMAE is an effective ADC that should be evaluated for clinical translation.

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A review of the infection-associated cancers in North African countries

Abstract

Cancer is typically classified as a leading non-communicable disease; however, infectious agents, such as Helicobacter pylori (H. pylori), hepatitis B virus (HBV), hepatitis C virus (HCV) and human papilloma virus (HPV), contribute significantly to the pathogenesis of various cancers. Less developed countries, including countries of the North African (NA) region, endure the highest burden of infection-related cancers. The five most common infection-associated cancers in NA in order of incidence are bladder cancer, cervical cancer, liver cancer, stomach cancer, and nasopharyngeal carcinoma. This review aims to outline the epidemiologic pattern of infection-associated cancers in five NA countries (namely: Morocco, Algeria, Tunisia, Libya and Egypt) highlighting the similarities and differences across the region. The present study employed an initial literature review of peer-reviewed articles selected from PubMed, ScienceDirect and World Health Organization (WHO) databases based on key word searches without restriction on publication dates. Original research articles and reports written in French, as well as data from institutional reports and regional meeting abstracts were also included in this extensive review. Egypt, Libya, Tunisia, Algeria and Morocco were selected to be the focus of this review.

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Impact of Diabetes on Outcomes of Sorafenib Therapy for Hepatocellular Carcinoma

Abstract

Background

Patients with diabetes are at increased risk of developing hepatocellular carcinoma (HCC) and have a poorer prognosis as compared to non-diabetics when HCC occurs. Diabetics with non-HCC cancers are at higher risk of toxicity related to systemic therapy, but data on HCC are lacking.

Objective

The aim of this study was to evaluate safety and effectiveness of sorafenib in HCC patients according to the presence/absence of diabetes.

Patients and Methods

From October 2008 to June 2014, 313 patients with HCC treated with sorafenib were enrolled. The patients were staged according to the BCLC system. Treatment response was evaluated according to the mRECIST criteria. The main evaluated outcomes were the overall survival and the safety in the two groups.

Results

Patients were divided in two groups: 80 diabetics (DIAB) and 233 nondiabetics (nDIAB). The median treatment duration was 4 months in DIAB and 3 months in nDIAB. Main adverse events occurred with comparable frequency in both groups, with the exception of rash, that was more frequent among DIAB than in nDIAB: 27.5 % vs 17.6 % (P = .047). The median overall survival was 9 months in nDIAB and 10 months in DIAB group (P = .535). Median time-to-progression (TTP) was longer the in DIAB than the nDIAB group (P = .038).

Conclusions

Sorafenib was as safe as effective in DIAB and in nDIAB patients. The longer TTP observed among DIAB than in nDIAB patients might suggest a better anticancer effect of sorafenib in patients with diabetes.

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mTOR Inhibitors in Castration-Resistant Prostate Cancer: A Systematic Review

Abstract

Background

The progression of prostate cancer to castration-resistant prostate cancer (CRPC) is often a result of somatic alterations in the PI3K/Akt/mTOR (mammalian target of rapamycin) pathway, suggesting that therapies targeting this pathway might lead to improved survival and efficacy. Here, we systematically evaluate the results of clinical trials investigating mTOR inhibition in CRPC and utilize preclinical data to predict clinical outcomes.

Methods

Trials included in the study were identified through PubMed and via review of conference abstracts cited by relevant review articles. The eligibility of trials was independent of sample size, clinical setting, or date.

Results

A total of 14 studies were eligible for qualitative analysis. The clinical setting was variable among studies, and all utilized an allosteric mTOR inhibitor as either a monotherapy or in combination. Molecular criteria were evaluated in three trials. Among most studies, the prostate-specific antigen level declined during treatment, but often increased shortly thereafter. Partial responses to treatment were minimal, and no complete responses were reported. Two studies exploring therapy with an mTOR inhibitor in combination with bicalutamide resulted in minimal efficacy. Overall, allosteric mTOR inhibition was deemed to be inadequate for the treatment of CRPC.

Conclusion

Preclinical data suggest that a reciprocal feedback mechanism between PI3K and androgen receptor signaling is a potential mechanism behind the clinical inefficacy of mTOR inhibitors in CRPC, indicating combinatorial targeting of PI3K, mTORC1/2, and the androgen receptor might be more effective. Comprehensive analysis of preclinical data to assess clinical trial targets and efficacy may reduce the number of unproductive trials and identify potentially beneficial combinatorial therapies for resistant disease.

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Surgical spacer placement prior carbon ion radiotherapy (CIRT): an effective feasible strategy to improve the treatment for sacral chordoma

Abstract

Background

Sacral chordoma (SC) is a neoplasm arising from residual notochordal cells degeneration. SC is difficult to manage mainly because of anatomic location and tendency to extensive spread. Carbon ion radiotherapy (CIRT) is highly precise to selectively deliver high biological effective dose to the tumor target sparing the anatomical structure on its path even if when SC is contiguous to the intestine, and a surgical spacer might be an advantageous tool to create a distance around the target volume allowing radical curative dose delivery with a safe dose gradient to the surrounding organs. This paper describes a double approach—open and hand-assisted laparoscopic—for a silicon spacer placement in patients affected by sacral chordoma undergoing carbon ion radiotherapy.

Methods

Six consecutive patients have been enrolled for surgical spacer placement—open (three) or hand-assisted (three)—prior carbon ion radiotherapy treatment in order to increase efficacy of carbon ion radiotherapy minimizing its side effects.

Results

Results showed that silicon spacer placement for SC treatment is feasible both via laparoscopic and laparotomic approach.

Conclusions

Its use might improve CIRT safety and thus efficacy for SC treatment.

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NKD1 correlates with a poor prognosis and inhibits cell proliferation by inducing p53 expression in hepatocellular carcinoma

Abstract

Naked cuticle 1 (NKD1), a negative regulator of the Wnt signaling pathway, is abnormally expressed in many types of malignant tumors. Yet the role and mechanism of NKD1 in hepatocellular carcinoma (HCC) cell proliferation and its relationship with HCC patients' prognosis have been poorly characterized. In the present study, real-time polymerase chain reaction (PCR) was used to examine the mRNA expression patterns of NKD1 in the tissues of 60 patients with HCC and corresponding adjacent non-tumor tissues and found that NKD1 mRNA expression in HCC tissues was relatively lower than that in non-tumor tissues and negatively correlated with tumor size. Kaplan–Meier survival curves uncovered that patients with lower NKD1 expression had a poorer post-operative prognosis than those with higher expression. In addition, over-expression of NKD1 inhibited the HCC cell proliferation ability, whereas knockdown of NKD1 had the opposite effect. In vivo assays showed that mice injected with SMMC-7721 + control cells had bigger tumor nodules than those injected with SMMC-7721 + NKD1. Mechanism studies demonstrated that NKD1 repressed HCC cell proliferation by inducing p53 expression. Taken together, our study revealed that NKD1 mRNA expression was downregulated in HCC tissues and correlated with a poor prognosis. NKD1 inhibited HCC cell proliferation by inducing p53 expression.

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Characterization of cancer stem cells from different grades of human colorectal cancer

Abstract

Colorectal cancer (CRC) is one of the most common solid tumors worldwide. Recent evidence suggests that a population of cancer cells, called cancer stem cells (CSCs), is responsible for tumor heterogeneity, invasion, metastasis, therapeutic resistance, and recurrence of CRC. The isolation and characterization of CSCs using cell surface markers have been reported previously with varying results. In this study, we investigated a panel of four putative CSC markers, CD44, CD24, CD166, and EpCAM, to define CRC-CSC. Paraffin embedded tissue samples from different grades of primary, untreated CRC were analyzed for the expression of four CSC markers CD44, CD326, CD24, and CD166, using immunohistochemistry. Flow cytometric analysis of CRC-CSC from HT29 (low grade) and HCT116 (high grade) human colorectal cancer cell lines was done. Marker-based isolation of CSC and non-CSC-bulk-tumor cells from HT29 was done using FACS, and tumor sphere assay was performed. There was a statistically significant difference (p < 0.05) in the expression of CD44, CD326, and CD166 between cases and controls. A novel cutoff distribution of CD44 and CD166 was suggested to help for better immunohistochemical analysis of CRC. Higher prevalence of CSC was seen in high-grade CRC as compared to low-grade CRC. Sorted and cultured CD44 + CD166+ cells formed tumor spheres, suggesting that these cells, having properties of self renewal and anchorage independent proliferation, were in fact CSC. Hence, CD44 and CD166 may serve as good CRC-CSC markers when used together with novel cutoff immunohistochemistry (IHC) expression levels.

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Préface

Publication date: Available online 9 August 2016
Source:Cancer/Radiothérapie





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Chapitre commun à la prise en charge et à la procédure de préparation des traitements des cancers de la tête et du cou

Publication date: Available online 9 August 2016
Source:Cancer/Radiothérapie
Author(s): P. Maingon, P. Giraud, Y. Pointreau
La radiothérapie, avec ou sans chimiothérapie ou thérapie ciblée, nécessite une préparation du malade rigoureuse, parfois complexe, souvent chronophage, mais indispensable pour garantir au malade de réduire autant que possible les risques d'intolérance aiguë et les complications tardives. Elles s'appliquent quelle que soit la localisation dans la sphère maxillo-faciale avec quelques adaptations anatomiques. L'acquisition des volumes d'intérêts, tumoraux ou tissus sains, obéit aux mêmes règles. La radiothérapie avec modulation d'intensité et les principes qui régissent son utilisation sont devenus des standards pour cette localisation tumorale. Les règles de surveillance des patients en cours de traitement sont identiques.The treatment of head and neck carcinoma by radiotherapy with or without chemotherapy or targeted agents requires a rigorous preparation, sometimes complex, frequently time consuming to guaranty to the patient to reduce as much as possible acute toxicity as well as late complications. These rules are valuable whatever the location of the primary with some anatomic variations. Intensity modulated radiotherapy and its rules are currently the standard of care for this disease. The follow-up of the patients during their treatment is similar.



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Global or Granulosa Cell-Specific Pten Mutations in Combination with Elevated FSH Levels Fail to Cause Ovarian Tumours in Mice

Abstract

Phosphatase and tensin homologue (PTEN) is a known tumour suppressor. To explore the role of Pten in ovarian tumorigenesis, we used transgenic (Tg) SOX2. Cre and AMH. Cre mouse models to direct global Pten haploinsufficiency (Pten ^+/−) or ovary-specific granulosa cell (GC) Pten disruption (Pten ^GC ). Pten mutant models were combined with progressively rising Tg-follicle-stimulating hormone (TgFSH) levels to study the tumorigenic potential of combined genetic/endocrine modification in vivo. Global Pten ^+/− mice exhibited grossly detectable tumours in multiple organs including uterine and mammary tissue and displayed reduced survival. Despite extra-ovarian tumorigenesis, Pten ^+/− females had no detectable ovarian tumours, although elevated corpus luteum numbers increased ovary size and estrous cycling was altered. Combined TgFSH/Pten ^+/− mice also had no ovarian tumours, but early survival was reduced in the presence of TgFSH. Ovary-specific Pten ^GC  ± TgFSH females exhibited no detectable ovarian or uterine tumours, and corpus luteum numbers and estrous cycling remained unchanged. The non-tumorigenic ovarian phenotypes in Pten ^+/− and Pten ^GC  ± TgFSH mice support the proposal that multi-hit genetic mutations (including ovarian and extra-ovarian tissue) initiate ovarian tumours. Our findings suggest that elevated FSH may reduce early cancer survival; however, the ovary remains remarkably resistant to Pten-induced tumorigenic changes even in the presence of uterine and reproductive cancers.

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Early clinical experience utilizing scintillator with optical fiber (SOF) detector in clinical boron neutron capture therapy: its issues and solutions

Abstract

Background

Real-time measurement of thermal neutrons in the tumor region is essential for proper evaluation of the absorbed dose in boron neutron capture therapy (BNCT) treatment. The gold wire activation method has been routinely used to measure the neutron flux distribution in BNCT irradiation, but a real-time measurement using gold wire is not possible. To overcome this issue, the scintillator with optical fiber (SOF) detector has been developed. The purpose of this study is to demonstrate the feasibility of the SOF detector as a real-time thermal neutron monitor in clinical BNCT treatment and also to report issues in the use of SOF detectors in clinical practice and their solutions.

Material and methods

Clinical measurements using the SOF detector were carried out in 16 BNCT clinical trial patients from December 2002 until end of 2006 at the Japanese Atomic Energy Agency (JAEA) and Kyoto University Research Reactor Institute (KURRI).

Results

The SOF detector worked effectively as a real-time thermal neutron monitor. The neutron fluence obtained by the gold wire activation method was found to differ from that obtained by the SOF detector. The neutron fluence obtained by the SOF detector was in better agreement with the expected fluence than with gold wire activation. The estimation error for the SOF detector was small in comparison to the gold wire measurement. In addition, real-time monitoring suggested that the neutron flux distribution and intensity at the region of interest (ROI) may vary due to the reactor condition, patient motion and dislocation of the SOF detector.

Conclusion

Clinical measurements using the SOF detector to measure thermal neutron flux during BNCT confirmed that SOF detectors are effective as a real-time thermal neutron monitor. To minimize the estimation error due to the displacement of the SOF probe during treatment, a loop-type SOF probe was developed.

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Overweight/obese status associates with favorable outcome in patients with metastatic nasopharyngeal carcinoma: a 10-year retrospective study

Abstract

Background

Although the prognostic impact of body mass index (BMI) in patients with non-metastatic nasopharyngeal carcinoma (NPC) had been extensively studied, its effect among metastatic NPC patients remains unknown. The purpose of this study was to evaluate the prognostic effect of BMI in patients with metastatic NPC.

Methods

We retrospectively studied 819 patients who were diagnosed with distant metastasis from NPC and received treatment between 1998 and 2007. The patients were divided into three subgroups according to the World Health Organization classifications for Asian populations: underweight (BMI <18.5 kg/m²), normal weight (BMI 18.5–22.9 kg/m²), and overweight/obese (BMI ≥23.0 kg/m²). The associations of BMI with overall survival (OS) and progression-free survival (PFS) were determined by Cox regression analysis.

Results

Of the 819 patients, 168 (20.5%) were underweight, 431 (52.6%) were normal weight, and 220 (26.9%) were overweight/obese. Multivariate analysis adjusted for covariates showed that overweight/obese patients had a longer OS than underweight patients [hazard ratio (HR), 0.64; 95% confidence interval (CI), 0.49–0.84] and normal weight patients (HR, 0.72; 95% CI, 0.57–0.90); no significant difference in PFS was observed among these three groups (P = 0.407). Moreover, in stratified analysis, no statistically significant differences in the effect of overweight/obese status among different subgroups were observed.

Conclusion

For patients with metastatic NPC, overweight/obese status was associated with longer OS but not longer PFS compared with underweight or normal weight status.

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A Randomized Controlled Trial of a Nurse-Led Supportive Care Package (SurvivorCare) for Survivors of Colorectal Cancer

Introduction.

Colorectal cancer (CRC) and its treatments can cause distressing sequelae. We conducted a multicenter randomized controlled trial aiming to improve psychological distress, supportive care needs (SCNs), and quality of life (QOL) of patients with CRC. The intervention, called SurvivorCare (SC), comprised educational materials, needs assessment, survivorship care plan, end-of-treatment session, and three follow-up telephone calls.

Methods.

At the end of treatment for stage I–III CRC, eligible patients were randomized 1:1 to usual care (UC) or to UC plus SC. Distress (Brief Symptom Inventory 18), SCNs (Cancer Survivors' Unmet Needs measure), and QOL (European Organization for Research and Treatment of Cancer [EORTC] QOL questionnaires C30 and EORTC CRC module CR29) were assessed at baseline and at 2 and 6 months (follow-up 1 [FU1] and FU2, respectively). The primary hypothesis was that SC would have a beneficial effect on distress at FU1. The secondary hypotheses were that SC would have a beneficial effect on (a) SCN and QOL at FU1 and on (b) distress, SCNs, and QOL at FU2. A total of 15 items assessed experience of care.

Results.

Of 221 patients randomly assigned, 4 were ineligible for the study and 1 was lost to FU, leaving 110 in the UC group and 106 in the SC group. Patients' characteristics included the following: median age, 64 years; men, 52%; colon cancer, 56%; rectal cancer, 35%; overlapping sites of disease, 10%; stage I disease, 7%; stage II, 22%; stage III, 71%. Baseline distress and QOL scores were similar to population norms. Between-group differences in distress at FU1 (primary outcome) and at FU2, and SCNs and QOL at FU1 and FU2 were small and nonsignificant. Patients in the SC group were more satisfied with survivorship care than those in the UC group (significant differences on 10 of 15 items).

Conclusion.

The addition of SC to UC did not have a beneficial effect on distress, SCNs, or QOL outcomes, but patients in the SC group were more satisfied with care.

Implications for Practice:

Some survivors of colorectal cancer report distressing effects after completing treatment. Strategies to identify and respond to survivors' issues are needed. In a randomized controlled trial, the addition of a nurse-led supportive care package (SurvivorCare) to usual post-treatment care did not impact survivors' distress, quality of life, or unmet needs. However, patients receiving the SurvivorCare intervention were more satisfied with survivorship care. Factors for consideration in the design of subsequent studies are discussed.

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Efficacy and Safety of Methadone as a Second-Line Opioid for Cancer Pain in an Outpatient Clinic: A Prospective Open-Label Study

Introduction.

Most clinical reports on methadone rotation describe outcomes in hospitalized patients. The few studies that have included outpatients are retrospective. The aim of this study was to assess the efficacy and safety of methadone as a second-line opioid in adult patients with advanced cancer after rotation in routine clinical practice at a palliative care outpatient clinic.

Patients and Methods.

This was a prospective, open-label study of 145 patients whose treatment was rotated from other opioids to methadone. Informed consent was obtained in all cases. The main outcome measure was change in the variable "worst pain" at day 28. Pain and pain interference were assessed with the Brief Pain Inventory, with side effects evaluated according to the Common Terminology Criteria for Adverse Events version 3.0. Pain levels were evaluated at study entry and at days 3, 7, 9, 14, 21, and 28.

Results.

Rotation to methadone was performed for the following reasons: poor pain control (77.9%), opioid side effects (2.1%), or both (20%). The mean daily oral morphine equivalent dose before rotation was 193.7 mg. The median worst and average pain scores decreased significantly (p < .0001) from baseline to day 28: The median worst pain score decreased from 9 (interquartile range [IQR]: 8–10) to 6 (IQR: 3–8), and the median average pain score decreased from 6 (IQR: 5–7) to 4 (IQR: 2–5). The proportions of patients with moderate to severe worst and average pain decreased by 30.3% and 47.5%, respectively, by day 28. No increase in opioid toxicity was observed during the study.

Conclusion.

In outpatients with advanced cancer, rotation to methadone as a second-line opioid was efficacious and safe when using a tiered scheme with close follow-up by experienced health professionals.

Implications for Practice:

The results of this study, conducted prospectively under real clinical conditions, support the efficacy and safety of oral methadone as a second-line opioid in ambulatory patients with cancer. Moreover, these findings corroborate previously reported outcomes in retrospective outpatient studies and prospective studies that evaluated inpatient populations. Although more research into methadone rotation strategies is still needed, this study describes a successful tiered scheme of oral methadone rotation that was proven safe and effective during follow-up.

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Cancer Drug Pricing and Reimbursement: Lessons for the United States From Around the World

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Value-Based Care in Lung Cancer

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The Future of Immunotherapy in the Treatment of Small Cell Lung Cancer

Small cell lung cancer (SCLC), which accounts for 10%–15% of lung cancer cases, is an aggressive disease characterized by rapid growth and early widespread metastasis. Although up to 80% of patients respond to first-line chemotherapy, most eventually relapse, and there are no approved agents beyond the second line. Despite the high incidence of mutations in SCLC, to date no targeted therapy has shown a benefit for this patient population, and systemic treatment has not changed significantly during the past 3 decades. Given that extensive-stage SCLC has a 5-year survival rate of only 1%–2%, novel therapies are desperately needed. Recent evidence shows that the immune system is capable of generating antitumor responses against various tumors, including lung cancer, suggesting that immunotherapy may be a viable therapeutic approach to the treatment of patients with SCLC. Of the immunotherapies being investigated for patients with SCLC, antibodies that target the programmed cell death protein-1 (nivolumab and pembrolizumab) and cytotoxic T-lymphocyte antigen-4 (ipilimumab) immune checkpoint pathways are perhaps the most promising. Because these immune checkpoint pathways, which under normal circumstances function to protect healthy tissues from damage during inflammatory responses and maintain self-tolerance, can help tumor cells evade elimination by the immune system, they represent potential therapeutic targets. This review discusses the rationale for immunotherapy and the early clinical results of immunotherapeutic agents being investigated in SCLC.

Implications for Practice:

Small cell lung cancer (SCLC) is an aggressive lung cancer subtype. Despite sensitivity to first-line chemotherapy, SCLC has high recurrence rates, and responses to second-line treatments are poor. Recent evidence shows that the immune system is capable of generating responses against various tumors, including lung cancer, suggesting that immunotherapy may be a viable approach for patients with SCLC. Of several immunotherapies being investigated, antibodies that target the programmed cell death protein-1 (nivolumab and pembrolizumab) and cytotoxic T-lymphocyte antigen-4 (ipilimumab) immune checkpoint pathways are among the most promising for patients with SCLC and are the focus of this review.

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Bleomycin-Induced Pulmonary Changes on Restaging Computed Tomography Scans in Two Thirds of Testicular Cancer Patients Show No Correlation With Fibrosis Markers

Background.

In metastatic testicular cancer patients treated with bleomycin, etoposide, and cisplatin (BEP) chemotherapy, bleomycin-induced pneumonitis is a well-known and potentially fatal side effect. We sought to determine the prevalence of lesions as signs of bleomycin-induced pulmonary changes on restaging computed tomography (CT) scans after treatment and to ascertain whether fibrosis markers were predictive of these changes.

Patients and Methods.

This prospective nonrandomized cohort study included metastatic testicular cancer patients, 18–50 years of age, treated with BEP chemotherapy. Restaging CT scans were examined for lesions as signs of bleomycin-induced pulmonary changes by two independent radiologists and graded as minor, moderate, or severe. Plasma samples were collected before, during, and after treatment and were quantified for transforming growth factor-β1 (TGF-β1), growth differentiation factor-15 (GDF-15), and high-sensitivity C-reactive protein (hs-CRP).

Results.

In total, 66 patients were included: forty-five (68%) showed signs of bleomycin-induced pulmonary changes on the restaging CT scan, 37 of which were classified as minor and 8 as moderate. No differences in TGF-β1, GDF-15, or hs-CRP plasma levels were found between these groups.

Conclusion.

Bleomycin-induced pulmonary changes are common on restaging CT scans after BEP chemotherapy for metastatic testicular cancer. Changes in TGF-β1, GDF-15, and hs-CRP plasma levels do not differ between patients with and without radiological lesions as signs of bleomycin-induced pulmonary changes and are therefore not helpful as predictive biomarkers.

Implications for Practice:

Bleomycin-induced pneumonitis (BIP) is a well-known and potentially fatal side effect in metastatic testicular cancer patients treated with bleomycin, etoposide, and cisplatin chemotherapy. Currently, the decision to discontinue bleomycin administration is made during treatment and is based on clinical signs. An upfront or early marker or biomarker that identifies patients likely to develop BIP would be preferable. This study found that bleomycin-induced pulmonary changes are common on restaging computed tomography scans and mostly resolve. No correlation was seen between these changes and fibrosis or inflammation markers (transforming growth factor-β1, growth differentiation factor-15, and high-sensitivity C-reactive protein).

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Clinical Implications of the Progression-Free Survival Endpoint for Treatment of Hormone Receptor-Positive Advanced Breast Cancer

Hormonal therapy for advanced breast cancer (ABC) has evolved significantly since the introduction of tamoxifen more than 40 years ago. The availability of selective antiestrogen therapies has further improved treatment options for women with hormone receptor-positive (HR+) ABC. However, with the development of resistance to hormonal therapies, a new treatment paradigm has emerged based on our understanding of biological pathways involved in HR+ breast cancer and mechanisms of resistance to hormonal therapy. Recent drug development efforts have focused on combining hormonal treatment with agents that target mammalian target of rapamycin serine-threonine kinases and cyclin-dependent kinases. In parallel with the evolution of hormonal and targeted therapies, our understanding of the utility of clinical endpoints has deepened. Progression-free survival (PFS) is a primary endpoint well-understood by clinicians and is increasingly accepted as a surrogate for overall survival (OS) by the U.S. Food and Drug Administration. Yet the perceived clinical benefit of PFS to patients is less well understood. Patients may not grasp the implications of prolonged PFS, highlighting the reality that patient preference in treatment selection encompasses factors that extend beyond drug activity. This presents an opportunity for clinicians to discuss PFS with patients in the context of their treatment plans, clinical outcomes, and quality-of-life measures. The objective of this review is to explore the clinical validity of the PFS and OS endpoints and the clinical relevance of PFS and OS to patients, especially in light of drivers that led to a range of treatment options for patients with HR+ ABC.

Implications for Practice:

Advances in drug development during the past two decades have provided numerous options for treatment of advanced breast cancer that include monotherapy with endocrine modulating agents and dual therapy that combines endocrine therapy with an inhibitor targeting the mammalian target of rapamycin serine-threonine kinase or cyclin-dependent kinase pathways known to be involved with resistance. Clinical trial endpoints for breast cancer have evolved as well. Communication of progression-free survival, overall survival, and other outcomes with patients should incorporate the context of the individual's treatment plan and include discussion of response rate, side effects, and quality of life.

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Urine 2-Hydroxyglutarate in Glioma

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FDG-PET/CT and MRI for Evaluation of Pathologic Response to Neoadjuvant Chemotherapy in Patients With Breast Cancer: A Meta-Analysis of Diagnostic Accuracy Studies

Introduction.

This study compared the diagnostic test accuracy of magnetic resonance imaging (MRI) with that of ¹⁸F-fluoro-2-glucose-positron emission tomography/computed tomography (FDG-PET/CT) imaging in assessment of response to neoadjuvant chemotherapy (NAC) in breast cancer.

Methods.

A systematic search was performed in PubMed and EMBASE (last updated in June 2015). Studies investigating the performance of MRI and FDG-PET or FDG-PET/CT imaging during or after completion of NAC in patients with histologically proven breast cancer were eligible for inclusion. We considered only studies reporting a direct comparison between these imaging modalities to establish precise summary estimates in the same setting of patients. Pathologic response was considered as the reference standard. Two authors independently screened and selected studies that met the inclusion criteria and extracted the data.

Results.

A total of 10 studies were included. The pooled estimates of sensitivity and specificity across all included studies were 0.71 and 0.77 for FDG-PET/CT (n = 535) and 0.88 and 0.55 for MRI (n = 492), respectively. Studies were subgrouped according to the time of therapy assessment. In the intra-NAC setting, FDG-PET/CT imaging outperformed MRI with fairly similar pooled sensitivity (0.91 vs. 0.89) and higher specificity (0.69 vs. 0.42). However, MRI appeared to have higher diagnostic accuracy than FDG-PET/CT imaging when performed after the completion of NAC, with significantly higher sensitivity (0.88 vs. 0.57).

Conclusion.

Analysis of the available studies of patients with breast cancer indicates that the timing of imaging for NAC-response assessment exerts a major influence on the estimates of diagnostic accuracy. FDG-PET/CT imaging outperformed MRI in intra-NAC assessment, whereas the overall performance of MRI was higher after completion of NAC, before surgery.

Implications for Practice:

The timing of therapy assessment imaging exerts a major influence on overall estimates of diagnostic accuracy. ¹⁸F-fluoro-2-glucose-positron emission tomography (FDG-PET)/computed tomography (CT) imaging outperformed magnetic resonance imaging (MRI) in intra-neoadjuvant chemotherapy assessment with fairly similar pooled sensitivity and higher specificity. However, MRI appeared to be more accurate than FDG-PET/CT in predicting pathologic response when used in the post-therapy setting.

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Benefit-Risk Summary of Crizotinib for the Treatment of Patients With ROS1 Alteration-Positive, Metastatic Non-Small Cell Lung Cancer

On March 11, 2016, after an expedited 5-month review, the U.S. Food and Drug Administration expanded the crizotinib metastatic non-small cell lung cancer (mNSCLC) indication to include the treatment of patients whose tumors harbor a ROS1 rearrangement. The approval was based on a clinically meaningful, durable objective response rate (ORR) in a multicenter, single-arm clinical trial (ROS1 cohort of Trial PROFILE 1001) in patients with ROS1-positive mNSCLC. The trial enrolled 50 patients (age range: 25–77 years) whose tumors were prospectively determined to have a ROS1 gene rearrangement by break-apart fluorescence in situ hybridization (96%) or reverse transcriptase polymerase chain reaction (4%) clinical trial assays. Crizotinib demonstrated an ORR of 66% (95% confidence interval [CI]: 51%–79%) with a median duration of response of 18.3 months by independent radiology review and 72% (95% CI: 58%–84%) by investigator review. Patients received crizotinib 250 mg twice daily and had a median duration of exposure of 34.4 months. The toxicity profile in ROS1-positive patients was generally consistent with the randomized safety data in the U.S. Product Insert from two ALK-positive mNSCLC trials. The most common (≥25%) adverse reactions and laboratory test abnormalities included vision disorders, elevation of alanine transaminase and aspartate transaminase levels, nausea, hypophosphatemia, diarrhea, edema, vomiting, constipation, neutropenia, and fatigue. There were no treatment-related deaths. A favorable benefit-to-risk evaluation led to the traditional approval of crizotinib for this new supplemental indication.

Implications for Practice:

Given the results from the ROS1 cohort of the clinical trial PROFILE 1001, crizotinib represents a new treatment option and the first approved therapy for patients with metastatic non-small cell lung cancer whose tumors are ROS1 positive. Crizotinib demonstrated efficacy irrespective of prior treatment status.

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DNA Repair Deficiency Is Common in Advanced Prostate Cancer: New Therapeutic Opportunities

Advances in DNA sequencing technology have created a wealth of information regarding the genomic landscape of prostate cancer. It had been thought that BRCA1 and BRCA2 mutations were associated with only a small fraction of prostate cancer cases. However, recent genomic analysis has revealed that germline or somatic inactivating mutations in BRCA1 or BRCA2, or other genes involved in the homologous recombination (HR) pathway of DNA repair collectively occur in as much as 20%–25% of advanced prostate cancers. A synthetic lethal therapeutic approach using poly(ADP-ribose) polymerase inhibitor therapy has been developed for BRCA mutant- and HR deficient-related cancers (those with "BRCAness") and is being studied in multiple clinical trials. This article discusses the current understanding of the genomic landscape of prostate cancer, focusing on the occurrence of DNA repair mutations and the therapeutic opportunities that this presents.

Implications for Practice:

This review aims to update oncologists about the increased understanding of the genomes of prostate cancers and, in particular, the prevalence of mutations in DNA repair genes. These observations provide potential new therapeutic opportunities for the use of poly(ADP-ribose) polymerase inhibitors and other therapies, especially in advanced forms of the disease. Of note is the recent U.S. Food and Drug Administration breakthrough therapy designation of olaparib for the treatment of BRCA1/2- or ATM-mutated metastatic castration-resistant prostate cancer. The implications of this new knowledge for clinical practice now and in the future are discussed.

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Location of Primary Tumor and Benefit From Anti-Epidermal Growth Factor Receptor Monoclonal Antibodies in Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer

Introduction.

Right- and left-sided colorectal cancers (CRCs) differ in clinical and molecular characteristics. Some retrospective analyses suggested that patients with right-sided tumors derive less benefit from anti-epidermal growth factor receptor (EGFR) antibodies; however, molecular selection in those studies was not extensive.

Patients and Methods.

Patients with RAS and BRAF wild-type metastatic CRC (mCRC) who were treated with single-agent anti-EGFRs or with cetuximab-irinotecan (if refractory to previous irinotecan) were included in the study. Differences in outcome between patients with right- and left-sided tumors were investigated.

Results.

Of 75 patients, 14 and 61 had right- and left-sided tumors, respectively. None of the right-sided tumors responded according to RECIST, compared with 24 left-sided tumors (overall response rate: 0% vs. 41%; p = .0032), and only 2 patients with right-sided tumors (15%) versus 47 patients with left-sided tumors (80%) achieved disease control (p < .0001). The median duration of progression-free survival was 2.3 and 6.6 months in patients with right-sided and left-sided tumors, respectively (hazard ratio: 3.97; 95% confidence interval: 2.09–7.53; p < .0001).

Conclusion.

Patients with right-sided RAS and BRAF wild-type mCRC seemed to derive no benefit from single-agent anti-EGFRs.

Implications for Practice:

Right- and left-sided colorectal tumors have peculiar epidemiological and clinicopathological characteristics, distinct gene expression profiles and genetic alterations, and different prognoses. This study assessed the potential predictive impact of primary tumor site with regard to anti-epidermal growth factor receptor (EGFR) monoclonal antibody treatment in patients with RAS and BRAF wild-type metastatic colorectal cancer. The results demonstrated the lack of activity of anti-EGFRs in RAS and BRAF wild-type, right-sided tumors, thus suggesting a potential role for primary tumor location in driving treatment choices.

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Physical Functioning in Older Patients With Breast Cancer: A Prospective Cohort Study in the TEAM Trial

Background.

Previous retrospective studies have shown that physical functioning in older cancer survivors is affected after treatment, yet prospective data are lacking. The aim of this study was to assess change in physical functioning in different age groups of patients with hormone receptor-positive breast cancer who were enrolled in the Tamoxifen Exemestane Adjuvant Multinational (TEAM) phase III trial.

Methods.

Two physical parameters were assessed. Physical functioning was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire 1 year (T1) and 2 years (T2) after diagnosis. Physical activity was measured in metabolic equivalent of task (MET) hours/week at T1 and T2. Physical activity before diagnosis (T0) was assessed retrospectively at the T1 questionnaire. Patients were divided into three age groups: <60, 60–69, and ≥70 years. Decline in physical functioning was assessed using linear regression analysis. Differences in mean values of physical activity levels were calculated using repeated-measures one-way analysis of variance.

Results.

A total of 431 patients were included for analysis. In all age groups, physical activity levels at T1 and T2 were significantly lower than prediagnostic physical activity levels (T0) (p < .001 for all age groups). Age ≥70 years was independently associated with decline in physical functioning between T1 and T2 (β = –4.62, 95% confidence interval –8.73 to –0.51, p = .028).

Conclusion.

Patients aged 70 years or older treated with breast surgery and adjuvant hormonal therapy did not improve between years 1 and 2 after diagnosis to the same extent as did younger patients.

Implications for Practice:

Although older patients constitute a large share of the breast cancer population, little is known about the effect and consequences of treatment of breast cancer in this specific age group. This study revealed that, unlike younger patients, older patients do not regain their physical abilities after surgical and adjuvant treatment for breast cancer. In older adults, the effect of treatment on physical functioning and independency could be more relevant than survival outcomes. Clinicians and older patients should be aware of the impact of treatment on physical functioning and prevent older patients from experiencing physical decline, which could lead to institutionalization and loss of independence. There is a need for age-specific guidelines that take into account the heterogeneity of the older population and for evidence-based treatment that focuses not only on cancer-specific outcomes but also on the consequences of treatment for physical and cognitive functioning and quality of life.

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Sarcomas Associated With Genetic Cancer Predisposition Syndromes: A Review

Sarcomas are rare mesenchymal malignancies that demonstrate great clinical and biological heterogeneity. A variety of sarcomas develop in the context of well-defined heritable cancer predisposition syndromes, associations that are often overlooked, given the rarity and diversity of sarcomas and the equivalent relative infrequency of cancer genetic syndromes. This review describes in detail selected heritable cancer predisposition syndromes that are known to be associated with sarcomas. Beyond the molecular and clinical features that define each syndrome, disparities in clinical presentation, natural history, and treatment of syndrome-associated compared with otherwise histologically identical sporadic sarcomas will be described. The clinical approach to selected sarcoma subsets with a view to identifying possible associations with these syndromes will then be described. Although the treatment of the majority of sarcomas will not differ significantly between sporadic cases and those associated with predisposition syndromes, knowledge of features such as unique anatomic sites of affliction or excess toxicities with particular cytotoxic therapies can facilitate alterations in therapeutic strategies to maximize efficacy and minimize toxicity. In addition, recognition of cancer genetic predisposition syndrome will allow patients and their relatives to undertake appropriate genetic counseling and testing, as well as screening, surveillance, and interventional measures, as needed. Situating sarcomas within the genetic endowment of particular patients—specifically that which confers a higher risk of malignancy—will enable clinicians to better manage the patient as a whole, complementing the great efforts currently routinely undertaken to genomically characterize somatic tumor changes with a view to achieving the dream of personalized medicine.

Implications for Practice:

Sarcomas are uncommon malignancies that often occur sporadically but can also arise in the setting of a recognized heritable cancer predisposition syndrome. Identification of such associations when present can facilitate refinement and optimization of treatment strategies for the sarcoma so as to minimize toxicity and maximize efficacy. Discerning genetic predisposition can also facilitate institution of genetic counseling, as well as screening or surveillance schema for both the patient and his or her relatives, if required. Vigilance for these syndromes has the potential to significantly enhance the quality and comprehensiveness of sarcoma clinical management.

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Patient Counseling and Management of Symptoms During Olaparib Therapy for Recurrent Ovarian Cancer

Our primary objective is to review the safety and tolerability profile of olaparib, a novel anticancer therapy, and to discuss key considerations for symptom management in patients with advanced ovarian cancer. Olaparib is the first of a new class of anticancer therapies, poly (ADP-ribose) polymerase (PARP) inhibitors that target tumors that have deficits in homologous recombination repair (such as BRCA mutations) by a process known as synthetic lethality. Through this process, neither the deficiency in homologous recombination repair nor PARP inhibition alone is cytotoxic, but the combination of these two conditions leads to cell death. In December 2014, olaparib received accelerated approval by the U.S. Food and Drug Administration (FDA) as monotherapy for patients with known or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who had been treated with at least three lines of chemotherapy. Most adverse events (AEs) reported during olaparib clinical trials conducted in patients with recurrent ovarian cancer and measurable disease were of grade 2 or less severity according to the National Cancer Institute's Common Terminology Criteria for Adverse Events. Fatigue and gastrointestinal AEs are among the most common in ovarian cancer clinical trials and can be particularly bothersome to patients. We focus on interventions to address these AEs in patients who are candidates for treatment with olaparib and allow them to remain on therapy for as long as clinically indicated.

Implications for Practice:

Olaparib therapy represents a new approach to treating recurrent ovarian cancer. Some associated adverse events can have a substantial effect on quality of life. It is therefore important for patients, caregivers, and health care providers to have realistic expectations and a thorough understanding of the safety and tolerability profile of olaparib to prevent or alleviate key symptoms so that therapy can continue uninterrupted if possible. This report summarizes a practical approach to supportive care for patients receiving olaparib therapy.

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When the Patient Says No

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Integration of Stereotactic Body Radiation Therapy With Tyrosine Kinase Inhibitors in Stage IV Oncogene-Driven Lung Cancer

Genotype-based selection of patients for targeted therapies has had a substantial impact on the treatment of non-small cell lung cancers (NSCLCs). Tyrosine kinase inhibitors (TKIs) directed at cancers driven by oncogenes, such as epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, often achieve dramatic responses and result in prolonged survival compared with chemotherapy. However, TKI resistance invariably develops. Disease progression can be limited to only one or a few sites and might not be symptomatic, raising the important question of whether this type of oligoprogression warrants a change in systemic therapy or consideration of local treatment. Recent clinical observations suggest a growing role for stereotactic body radiation therapy (SBRT) in the treatment of oligoprogressive and perhaps even oligopersistent disease (primary and/or metastases) in oncogene-driven NSCLC. SBRT might allow patients to continue with existing TKI treatments longer and delay the need to switch to other systemic options. We review the current data with regard to the use of SBRT for metastatic NSCLC and particularly oncogene-driven disease. Although there is great promise in the marriage of targeted therapies with SBRT, prospective data are urgently needed. In the meantime, such strategies are being used in carefully selected patients, with risk-adapted SBRT dose-fractionation regimens used to optimize the therapeutic index.

Implications for Practice:

Stereotactic body radiation therapy (SBRT) or SBRT-like treatments are increasingly being used for oligoprogression in patients with oncogene-driven non-small cell lung cancer. This approach allows patients to extend the duration of tyrosine kinase inhibitor therapy and has the potential to prolong survival times. Careful patient selection and risk-adapted radiation dosing is of critical importance to minimize toxicity and preserve patient quality of life.

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In Reply

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The HB22.7–vcMMAE antibody–drug conjugate has efficacy against non-Hodgkin lymphoma mouse xenografts with minimal systemic toxicity

Abstract

In this study, HB22.7, an anti-CD22 monoclonal antibody, was used for specific, targeted delivery of monomethyl auristatin E (MMAE) to non-Hodgkin lymphoma (NHL). MMAE was covalently coupled to HB22.7 through a valine–citrulline peptide linker (vc). Maleimide-functionalized vcMMAE (mal-vcMMAE) was reacted with thiols of the partially reduced mAb. Approximately 4 molecules of MMAE were conjugated to HB22.7 as determined by residual thiol measurement and hydrophobic interaction chromatography–HPLC (HIC-HPLC). HB22.7–vcMMAE antibody–drug conjugate (ADC) retained its binding to Ramos NHL cells and also exhibited potent and specific in vitro cytotoxicity on a panel of B cell NHL cell lines with IC₅₀s of 20–284 ng/ml. HB22.7–vcMMAE also showed potent efficacy in vivo against established NHL xenografts using the DoHH2 and Granta 519 cell lines. One dose of the ADC induced complete and persistent response in all DoHH2 xenografts and 90 % of Granta xenografts. Minimal toxicity was observed. In summary, HB22.7–vcMMAE is an effective ADC that should be evaluated for clinical translation.

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Lack of pharmacokinetic drug–drug interaction between ramucirumab and irinotecan in patients with advanced solid tumors

Abstract

Purpose

The objective of this phase II study was to evaluate the potential of pharmacokinetic (PK) drug–drug interactions between ramucirumab and irinotecan or its metabolite, SN-38, when administered with folinic acid and 5-fluorouracil (FOLFIRI).

Methods

Patients received intravenous infusions of FOLFIRI and ramucirumab 8 mg/kg on Day 1 of a 2-week cycle. FOLFIRI was administered alone in Cycle 1; ramucirumab followed by FOLFIRI was administered in all subsequent cycles. Blood was collected at regular intervals after infusions in Cycles 1 and 2 to determine irinotecan, SN-38, and ramucirumab concentrations. PK parameters were derived by noncompartmental analysis.

Results

Twenty-nine patients received treatment. The dose-normalized area under the concentration versus time curve from zero to infinity [AUC_(0–∞)] and the maximum observed concentration (C _max) of irinotecan and SN-38 were comparable between Cycle 1 (FOLFIRI alone) and Cycle 2 (ramucirumab + FOLFIRI). The ratios of geometric least squares (LS) means for irinotecan were 0.93 (90 % CI 0.83–1.05) for AUC_(0–∞) and 1.04 (90 % CI 0.97–1.12) for C _max. The ratios of geometric LS means for SN-38 were 0.95 (90 % CI 0.88–1.04) for AUC_(0–∞) and 0.97 (90 % CI 0.85–1.12) for C _max. The most common treatment-emergent adverse events, regardless of grade, were fatigue (19 patients, 65.5 %), diarrhea, (16 patients, 55.2 %), and neutropenia (15 patients, 51.7 %). Grade ≥3 neutropenia was reported in 7 (24.1 %) patients.

Conclusions

There was no PK drug–drug interaction between ramucirumab and irinotecan or its metabolite, SN-38. Ramucirumab with FOLFIRI was well tolerated in this study, with no new safety concerns.

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Beyond the Drama: the Beautiful Life in News Feeds on Cancer

Abstract

Facebook is one of the main communication tools in the world nowadays. In Brazil, it is used for almost half of the population. Knowing what is conveyed about cancer by this social network can be an important step for the development of efficient health communication strategies. We evaluate Facebook user's comments on pages about cancer; verify if there is a pattern of public awareness on the disease and compare it with results from other studies. Three pages about cancer on Facebook were selected among those with more followers in Brazil. For 6 months, from January to June 2014, all posts were selected and evaluated, and we created eight categories. On each page, the categories that generated most comments were elected for the second analysis. The behavior of empowered citizens by new communication tools is the target of this study. Similarities and differences between 12,926 comments coming from 1243 posts in three different Facebook pages on cancer were analyzed. Four new categories were identified: "religion," "positive," "negative," and "information." Despite the differences among the three pages selected for this study, we observed the predominance of positive speeches associated with religious terms. Following public perceptions on cancer is an important step for the development of efficient health communication strategies.

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Postoperative surveillance of pediatric cerebellar pilocytic astrocytoma

Abstract

The purpose of this study was to identify the optimal frequency and duration of magnetic resonance imaging follow-up in children who had gross totally resected cerebellar pilocytic astrocytomas (CPAs). Our hypothesis was that following two MR examinations, separated by at least 3 months, showing no evidence of tumor, gross totally resected CPAs did not recur and no further imaging follow-up was necessary. Retrospective review of Neuro-Oncology database from 1/2000 to 7/2013 yielded 53 patients with CPAs that had preoperative imaging and >2 years post-operative imaging follow-up available. Pilocytic astrocytomas with brainstem involvement and patients with neurofibromatosis type I were excluded. Preoperative tumor volumes were calculated. The dates and reports of the examinations were tabulated. The median number of follow-up examinations was 9 over a median follow-up time of 6.05 years (2.07–12.28 years). Two consecutive MR examinations over at least a 3 month span demonstrated the smallest negative likelihood ratio of future recurrence (0.15). There was no association of recurrence with preoperative tumor volume. Among the 35 patients with gross total resection of their tumor and greater than two negative follow-up examinations, one recurrence (2.9 %) was identified, occurring 6.4 years after initial resection. Gross totally resected pediatric CPAs can recur, but this is exceedingly rare. Frequent surveillance (every 3–6 months) is suggested in patients with CPAs until absence of tumor is concluded on imaging and documented on two consecutive studies spaced at least 3 months apart. The likelihood of recurrence thereafter is low.

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Pedigree based DNA sequencing pipeline for germline genomes of cancer families

Abstract

Background

In the course of our whole-genome sequencing efforts, we have developed a pipeline for analyzing germline genomes from Mendelian types of cancer pedigrees (familial cancer variant prioritization pipeline, FCVPP).

Results

The variant calling step distinguishes two types of genomic variants: single nucleotide variants (SNVs) and indels, which undergo technical quality control. Mendelian types of variants are assumed to be rare and variants with frequencies higher that 0.1 % are screened out using human 1000 Genomes (Phase 3) and non-TCGA ExAC population data. Segregation in the pedigree allows variants to be present in affected family members and not in old, unaffected ones. The effectiveness of variant segregation depends on the number and relatedness of the family members: if over 5 third-degree (or more distant) relatives are available, the experience has shown that the number of likely variants is reduced from many hundreds to a few tens. These are then subjected to bioinformatics analysis, starting with the combined annotation dependent depletion (CADD) tool, which predicts the likelihood of the variant being deleterious. Different sets of individual tools are used for further evaluation of the deleteriousness of coding variants, 5' and 3' untranslated regions (UTRs), and intergenic variants.

Conlusions

The likelihood of success of the present genomic pipeline in finding novel high- or medium-penetrant genes depends on many steps but first and foremost, the pedigree needs to be reasonably large and the assignments and diagnoses among the members need to be correct.

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Current Status and Future Direction of Nanomedicine: Focus on Advanced Biological and Medical Applications

Abstract

Nanotechnology is the engineering and manipulation of materials and devices with sizes in the nanometer range. Colloidal gold, iron oxide nanoparticles and quantum dot semiconductor nanocrystals are examples of nanoparticles, with sizes generally ranging from 1 to 20 nm. These nanotechnologies have been researched tremendously in the last decade and this has led to a new area of "nanomedicine" which is the application of nanotechnology to human health-care for diagnosis, monitoring, treatment, prediction and prevention of diseases. Recently progress has been made in overcoming some of the difficulties in the human use of nanomedicines. In the mid-1990s, Doxil was approved by the FDA, and now various nanoconstructs are on the market and in clinical trials. However, there are many obstacles in the human application of nanomaterials. For translation to clinical use, a detailed understanding is needed of the chemical and physical properties of particles and their pharmacokinetic behavior in the body, including their biodistribution, toxicity, and biocompatibility. In this review, we provide a broad introduction to nanomedicines and discuss the preclinical and clinical trials in which they have been evaluated.

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Trends in the characteristics, dose-limiting toxicities and efficacy of phase I oncology trials: The Cancer Research UK experience

Publication date: October 2016
Source:European Journal of Cancer, Volume 66
Author(s): Han Hsi Wong, Claire Barton, Gary Acton, Robert McLeod, Sarah Halford
IntroductionPhase I oncology trials have evolved over the years, and these changes could have implications for future studies and patients.MethodsAdult trials sponsored by Cancer Research UK Centre for Drug Development between 1995 and 2013 were analysed. Forty-nine trials were divided into two groups based on the starting date for recruitment: 1995–2003 (24 trials, n = 603) and 2004–2013 (25 trials, n = 750) for comparative purposes.ResultsFrom 1995–2003 to 2004–2013, there was a shift towards studying non-cytotoxic agents that are administered orally. In later trials, patients tended to have better performance status, were older, had greater disease burden, and were more likely to have received prior treatment. In 2004–2013, wider variety of dose escalation designs were used, and studies were more likely to be multicentre, target/disease specific, conducted in first-/any-line setting and to require tumour biopsy. The overall incidence of dose-limiting toxicities (DLTs) was unchanged (10.9%; risk of death 0.4%), but DLTs such as neuropathy, stomatitis and thrombocytopaenia were less frequent in the more recent trials, while elevated liver enzymes were more frequent. Non-classical DLTs emerged in the later trials, including hypertension, hypophosphataemia, cardiac and ophthalmic toxicities. Disease control rate (DCR) increased from 27.9% (1995–2003) to 36.0% (2004–2013; P = 0.0033) due to higher rates of disease stabilisation.ConclusionChanges in trial designs, therapeutic agents, patient characteristics and DLTs were observed. Although the nature of DLTs changed, the incidence was similar in the two time periods and DCR improved, suggesting that the benefit-risk balance for patients participating in early-phase trials remains acceptable.



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Optimizing the process of fertility preservation in pediatric female cancer patients – a multidisciplinary program

Abstract

Background

Current evidence indicates sub-optimal incidence of fertility preservation (FP) in eligible patients. We present herein our designated multidisciplinary program for FP in pediatric and adolescent population and present our data on FP in female patients.

Methods

Pediatric patients (age 0–18) who were candidate for highly gonadotoxic treatments were referred to FP program for a multidisciplinary discussion and gonadal risk-assessment followed by either oocyte cryopreservation or ovarian cryopreservation (OCP) for female patients, and sperm banking for male patients. The OCP protocol consists of aspiration of oocytes from small antral follicles and in-vitro maturation followed by cryopreservation, as well as ovarian tissue cryopreservation.

Results

The establishment of a designated FP program resulted in a significant increase in referral and subsequent FP procedures of all eligible patients. Sixty-two female patients were referred for FP discussion during a period of 36 months; 41 underwent OCP; 11 underwent oocyte cryopreservation and six were declined due to parental decision. The median age was 13.2y (range 18 months-18y). Thirty-two (51.6 %) were chemotherapy-naïve. Seventeen patients (27 %) had sarcoma, 16 patients (26 %) had acute leukemia. The mean number of mature oocytes that were eventually vitrified was significantly higher in chemotherapy-naïve patients compared with chemotherapy-exposed patients (mean 12 oocytes (1–42) versus 2 (0–7)).

Conclusion

Multidisciplinary programs that encompass experts of all relevant fields, skilled laboratory resources and a facilitated path appear to maximize the yield. We observed a considerable higher referral rates following launching a designated program and earlier OCP in chemo-naïve patients that culminated in a better fertility preservation procedure.

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Some hematological reference values estimated by the reference values advisor in the Iraqi Awassi sheep

Abstract

The hematological parameters in domestic animal can be affected by several factors such as the sex, age, breed, and nutrition. There is a few published data on hematological reference values of the Iraqi Awassi sheep. Hence, the study aimed to determine hematological reference interval (RI) for the Awassi sheep to establish a basis for clinical interpretation. In the present study, a total 130 healthy Awassi sheep for both sex with two ages (2–5 years) were selected randomly from five regions (Shula, Abu-Ghraib, Mahmoudia, Yousifia, and Alameel) West and South of Baghdad during the period from December to February 2015–2016. Hematological parameters were measured by parametric and nonparametric methods using Reference Value Advisor. The RI of hematological parameters obtained in this study includes the following: the white blood cell count (WBC) (6.00–12.41 × 103/μl), mean corpuscular hemoglobin concentration (MCHC) (25.70–41.03 g/dl), mean corpuscular hemoglobin (MCH) (6.65–15.48 pg), mean corpuscular volume (MCV) (21.14–43.83 fl), red blood cells (RBC) (4.44–11.95 × 106/μl), hemoglobin (Hb) (7.08–11.04 g/dl), and packed cell volume (PCV) (19.53–20.43 %). The results also revealed that the low limits reference intervals of the hematological parameters in the Awassi sheep were lower than lower limits of the general reference values for all parameters except the WBC, while the upper limits were within the general reference values in three parameters (RBC, Hb, and PCV). The statistical analysis confirmed that the effect of age was not significant on all parameters whereas the effect of sex was significant (P < 0.05) on RBC and Hb where the estimations in males (8.33 × 106/μl, 11.09 g/dl) superior to females (7.19 × 106/μl, 8.89 g/dl). In conclusion, the results of this study indicated a considerable difference between reference interval of Awassi sheep and general reference values, besides the results confirmed the importance of establishing a local reference interval to be a more accurate guide to assess the animal status and to assist the clinician to reach a definitive diagnosis.

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Diffuse type testicular seminoma in a stallion

Abstract

A 7-year-old stallion with progressive left testicular enlargement was presented. Grossly, the excised testicle measured 25 × 15 × 12 cm and weighed 3.7 kg. It was multinodular with a gray-white surface; however, the right testis was normal. Histologically, the neoplastic cells were disseminated diffusely in the tumoral stroma with a minimal fibrovascular stroma. Neoplastic cells were round to polygonal with abundant eosinophilic cytoplasm and large round to oval vesicular or hyperchromatic nucleous with a single prominent nucleolus. Immunohistochemically, the neoplastic cells were positive nuclear immunostaining for C-KIT and negative for OCT3/4. According to gross, histopathological, and immunohistochemical characteristics, the diffuse type of seminoma was diagnosed. Nine months later, the follow-up observation of the case showed that the tumor had no recurrence and metastasis.

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Use of systemic therapy with definitive radiotherapy for elderly patients with head and neck cancer: A National Cancer Data Base analysis

BACKGROUND

The purpose of this study was to investigate the use of systemic therapy along with definitive radiotherapy for elderly patients with head and neck cancer.

METHODS

Patients who were 71 years old or older with stage III to IVB squamous cell carcinoma of the nasopharynx, oropharynx, larynx, or hypopharynx treated with definitive radiotherapy with or without systemic therapy were identified from the National Cancer Data Base. Patterns of systemic therapy use before or during definitive radiotherapy were investigated. The association between systemic therapy use and overall survival was investigated with a multivariate, inverse probability–weighted propensity score–adjusted Cox proportional hazards model.

RESULTS

Elderly patients treated between 2004 and 2012 (n = 4165) were identified, and 80.4% received systemic therapy. The median follow-up was 26 months (range, 1.8-125 months), and the 3-year overall survival rate was 51.6% (95% confidence interval, 50.0%-53.2%). During the study period, there was an increase in the frequency of systemic therapy use from 64% in 2004 to 86% in 2012. The use of systemic therapy was associated with improved overall survival in the multivariate model (hazard ratio, 1.456; 95% confidence interval, 1.308-1.620; P < .0001). A threshold age above which the use of systemic therapy was not associated with improved overall survival in select patients was not identified.

CONCLUSIONS

In contrast to the available prospective evidence, the majority of elderly patients with locoregionally advanced head and neck cancer treated with definitive radiotherapy also receive systemic therapy. The use of systemic therapy is associated with improved overall survival and should be a patient-specific decision in all age groups. Cancer 2016. © 2016 American Cancer Society.

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Race does not predict the development of metastases in men with nonmetastatic castration-resistant prostate cancer

BACKGROUND

Although race is associated with prostate cancer progression in early stage disease, once men have advanced disease, it is unclear whether race continues to predict a poor outcome. The authors hypothesized that, in an equal-access setting among patients with castration-resistant prostate cancer (CRPC) and no known metastases (M0/Mx), black men would receive imaging tests at similar rates as nonblack men (ie, there would be an equal opportunity to detect metastases) but would have a higher risk of metastatic disease.

METHODS

In total, 837 men who were diagnosed with M0/Mx CRPC during 2000 through 2014 from 5 Veterans Affairs hospitals in the SEARCH (Shared Equal Access Regional Cancer Hospital) database were analyzed. Data on all imaging tests after CRPC diagnosis were collected, including date, type, and outcome. Multivariable Cox models were used to test associations between race and the time to first metastasis, first bone metastasis, first bone scan, second bone scan among men who had a negative first bone scan, and overall survival.

RESULTS

Black men (n = 306) were equally as likely as nonblack men (n = 531) to receive a first and second bone scan after a diagnosis of CRPC. There were no significant differences in the risk of developing any metastases, bone metastases, time to bone scans, or overall survival between black men and nonblack men (all P > .2).

CONCLUSIONS

The lack of racial differences in the development of metastases and scanning practices observed in this study suggests that, once men have a diagnosis of M0/Mx CRPC, race may not be a prognostic factor. Efforts to understand prostate cancer racial disparities may derive greater benefit by focusing on the risk of developing prostate cancer and on the outcomes of men who have early stage disease. Cancer 2016. © 2016 American Cancer Society.

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Risk and impact of pulmonary complications in survivors of childhood cancer: A report from the Childhood Cancer Survivor Study

BACKGROUND

Pulmonary complications after cancer therapy are varied. This study describes pulmonary outcomes among childhood cancer survivors and evaluates their impact on daily activities.

METHODS

The incidence of pulmonary outcomes (asthma, chronic cough, emphysema, lung fibrosis, oxygen need, and recurrent pneumonia) reported among 5-year cancer survivors (n = 14,316) and the incidence of death due to pulmonary causes among all eligible survivors (n = 20,690) in the Childhood Cancer Survivor Study were compared with those for sibling controls (n = 4027) with cumulative incidence, standardized mortality ratio (SMR), and piecewise exponential models. Logistic regression with random effects was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for activity limitations with pulmonary complications.

RESULTS

By the age of 45 years, the cumulative incidence of any pulmonary condition was 29.6% (95% CI, 29.1%-30.0%) for cancer survivors and 26.5% (95% CI, 24.9%-28.0%) for siblings. Fewer survivors reported ever smoking (23.6% vs 36.4%, P < .001), but survivors were more likely to report chronic cough (rate ratio [RR], 1.6; 95% CI, 1.4-1.9), oxygen need (RR, 1.8; 95% CI, 1.5-2.2), lung fibrosis (RR, 3.5; 95% CI, 2.3-5.4), and recurrent pneumonia (RR, 2.0; 95% CI, 1.4-3.0). The SMR for death due to pulmonary causes was 5.9 (95% CI, 4.2-8.1), and it was associated with platinum exposure and lung radiation (P < .01). The impact of chronic cough on daily activities for survivors (OR vs survivors without chronic cough, 2.7) was greater than that for siblings (OR, 2.0; P = .04).

CONCLUSIONS

Pulmonary complications are substantial among adult survivors of childhood cancer and can affect daily activities. Cancer 2016. © 2016 American Cancer Society.

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Burden of cancer attributable to tobacco smoking in member countries of the Association of Southeast Asian Nations (ASEAN), 2012

Publication date: October 2016
Source:Cancer Epidemiology, Volume 44
Author(s): Susi Ari Kristina, Dwi Endarti, Montarat Thavorncharoensap
BackgroundCancer is an increasing problem in ASEAN (Association of Southeast Asian Nations). Tobacco use is a well-established risk factor for many types of cancers. Evidence on burden of cancer attributable to tobacco is essential to raise public and political awareness of the negative effects of tobacco on cancer and to be used to stimulate political action aims at reducing smoking prevalence in ASEAN member countries. The objective of this study was to estimate burden of cancer attributable to tobacco smoking in ASEAN, 2012.MethodsIn this study, smoking prevalence was combined with Relative Risks (RRs) of cancer to obtain Smoking Attributable Fractions (SAFs). Cancer incidence and mortality data among individuals aged 15 years and older were derived from GLOBOCAN 2012. Fourteen types of cancer were included in the analysis. Sensitivity analyses were conducted to examine the impact of the use of alternative RRs and the use of alternative prevalence of smoking in some countries.ResultsThe findings showed that tobacco smoking was responsible for 131,502 cancer incidence and 105,830 cancer mortality in ASEAN countries in 2012. In other words, tobacco smoking was accounted for 28.4% (43.3% in male and 8.5% in female) of cancer incidence and 30.5% (44.2% in male and 9.4% in female) of cancer mortality in ASEAN. When looking at the types of cancer, lung cancer showed the strongest association with tobacco smoking. Incidence of cancer and cancer mortality attributable to tobacco smoking varied by countries due to the differences in size of population, background risk of cancer, and prevalence of smoking in each country. According to the sensitivity analyses, RRs of lung cancer, pharynx cancer, and larynx cancer used in the estimates have significant impact on the estimates.ConclusionsAs about one-third of cancer incidence and mortality in ASEAN are attributable to tobacco smoking ASEAN member countries are strongly encouraged to put in place stronger tobacco control policies and to strengthen the existing tobacco control measure in order to effectively control cancer.



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Prevalence and survival benefit of adjuvant chemotherapy in stage III colon cancer patients: Comparison of overall and age-stratified results by multivariable modeling and propensity score methodology in a population-based cohort

Publication date: October 2016
Source:Cancer Epidemiology, Volume 44
Author(s): Robert B. Hines, Milan Bimali, Asal M. Johnson, A. Rana Bayakly, Tracie C. Collins
BackgroundFew population-based studies have assessed the effectiveness of adjuvant chemotherapy (ACT) in stage III colon cancer patients according to age. We sought to quantify the prevalence of ACT use and the absolute and relative survival benefit of ACT overall and by age in a population-based cohort.MethodsStage III patients with adenocarcinoma of the colon identified by the Georgia Comprehensive Cancer Registry for the years 2000–07 were eligible (final N=3057). We utilized Poisson regression to obtain adjusted mortality rates (MR) and Cox proportional hazards models to obtain adjusted hazard ratios (HRs) for 5-year overall survival. We evaluated control of confounding by comparing HRs obtained via multivariable modeling (MM), propensity score weighting (PSW), and propensity score matching (PSM).ResultsJust over one-third of colon cancer patients did not receive ACT, and the proportion increased with age. Overall, receipt of ACT conferred an absolute (MR difference [No ACT rate–ACT rate] 25.4 deaths/1000 person-years [py], 95% confidence interval [CI]: 19.1–32.7 deaths/1000 py) and relative (MM HR=0.67, 95% CI: 0.59–0.76) survival benefit. The survival benefit was demonstrated across age groups. MM and propensity score methods yielded highly similar HRs.ConclusionUnless contraindicated, efforts to ensure receipt of ACT for stage III colon cancer patients up to 84 years of age are needed to improve the prognosis of patients with node-positive disease.



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