Evaluating Adaptation of a Cancer Clinical Trial Decision Aid for Rural Cancer Patients: A Mixed-Methods Approach

Abstract

Rural-residing cancer patients often do not participate in clinical trials. Many patients misunderstand cancer clinical trials and their rights as participant. The purpose of this study is to modify a previously developed cancer clinical trials decision aid (DA), incorporating the unique needs of rural populations, and test its impact on knowledge and decision outcomes. The study was conducted in two phases. Phase I recruited 15 rural-residing cancer survivors in a qualitative usability study. Participants navigated the original DA and provided feedback regarding usability and implementation in rural settings. Phase II recruited 31 newly diagnosed rural-residing cancer patients. Patients completed a survey before and after using the revised DA, R-CHOICES. Primary outcomes included decisional conflict, decision self-efficacy, knowledge, communication self-efficacy, and attitudes towards and willingness to consider joining a trial. In phase I, the DA was viewed positively by rural-residing cancer survivors. Participants provided important feedback about factors rural-residing patients consider when thinking about trial participation. In phase II, after using R-CHOICES, participants had higher certainty about their choice (mean post-test = 3.10 vs. pre-test = 2.67; P = 0.025) and higher trial knowledge (mean percentage correct at post-test = 73.58 vs. pre-test = 57.77; P < 0.001). There was no significant change in decision self-efficacy, communication self-efficacy, and attitudes towards or willingness to join trials. The R-CHOICES improved rural-residing patients' knowledge of cancer clinical trials and reduced conflict about making a trial decision. More research is needed on ways to further support decisions about trial participation among this population.

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Risk of operating on the wrong site: how to avoid a never event

Joy C Edlin<br />May 7, 2018; 2018:bcr-2017-223704-bcr-2017-223704<br />Images in...

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Correlation of IDH1 and B7H3 expression with prognosis of CRC patients

Publication date: Available online 2 June 2018
Source:European Journal of Surgical Oncology
Author(s): Jingyi Wu, Fang Wang, Xingxiang Liu, Ting Zhang, Fen Liu, Xiaosong Ge, Yong Mao, Dong Hua
BackgroundB7H3 is an immuno-stimulatory glycoprotein that is overexpressed in cancer. However, its functional contributions to cancer development and progression are not well understood. In several reports, it was demonstrated that B7H3 reprograms lipid metabolism and regulates glucose metabolism. Isocitrate dehydrogenase 1 (IDH1), a metabolic enzyme in the TCA cycle, its reaction product is involved in lipid synthesis. Thus, we aimed to identify a novel marker to predict the prognosis of CRC patients and to investigate the relationship between IDH1 and B7H3.MethodsWe analyzed IDH1 and B7H3 expression levels in 225 CRC specimens by immunochemistry. Moreover, in vitro studies were performed to demonstrate the correlation between IDH1 and B7H3.ResultsAmong 225 tissues, the positive rates of IDH1 and B7H3 were 37.8% (85/225) and 87.6% (197/225), respectively. In CRC samples, IDH1 significantly correlated with B7H3 expression (P = 0.044). Moreover, multivariate analyses revealed that high expression of both B7H3 and IDH1 and a high tumor grade were related to the prognosis of CRC patients. Kaplan-Meier survival analysis revealed that patients with co-expression of IDH1 and B7H3 had a poor overall survival. In SW480B7H3-EGFP cells, which highly express B7H3, IDH1 was up-regulated. Similarly, knockdown of B7H3 expression in Caco-2-shB7-H3 contributed to reduced IDH1 levels.ConclusionsAlthough IDH1 and B7H3 cannot be used as independent prognostic factors, co-expression of IDH1 and B7H3 significantly correlated with the prognosis of CRC patients and may serve as a combined predictive marker. Thus, the correlation between IDH1 and B7H3 has been proven in vivo and in vitro.



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Outcome of gastrointestinal graft-versus-host disease according to the treatment response

Abstract

The optimal treatment strategy for gastrointestinal graft-versus-host disease (GI-GVHD) after allogeneic hematopoietic cell transplantation remains to be established. We retrospectively analyzed 68 cases of GI-GVHD at our institution between 2007 and 2017. The survival outcomes were significantly inferior in patients who did not respond to the first-line treatment (1-year overall survival 27.3 vs 69.2%, P = 0.0017; non-relapse mortality 50.0 vs 18.6%, P = 0.026). After subsequent treatments, 18 patients were refractory to all steroid-based treatments such as steroid pulse therapy and oral beclomethasone dipropionate (BDP). However, these steroid-refractory cases showed a gradual increase in the response rate after the initial diagnosis of steroid refractoriness. This result may be explained by the problem of evaluating the response based solely on the volume of diarrhea, i.e., severe mucosal damage due to refractory GI-GVHD may require a long recovery and sometimes be complicated with other diseases. In conclusion, patients with GI-GVHD who failed to respond to the first-line treatment had inferior survival. However, later improvement may be observed without additional immunosuppressant other than steroid among patients who initially do not respond to steroid therapy. It is important to repeat colonoscopy in patients with refractory GI-GVHD to monitor the activity of GVHD.

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Thromboelastometry-guided hemostatic therapy for hemorrhagic shock in the postoperative period of vascular surgery: a case report

Hemorrhagic shock is a medical emergency that often complicates vascular surgery and can lead to death. Hemorrhagic shock is characterized by hypoperfusion and hemodynamic abnormalities leading to the collapse...

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Carcinosarcoma of the parotid gland with abdominal metastasis: a case report and review of literature

Abstract

Background

Carcinosarcoma of the salivary gland is a rare aggressive malignant tumor, composed of a mixture of carcinomatous and sarcomatous components. The most common metastatic sites include the lungs, bones, and central nervous system.

Case presentation

This report describes a rare case of carcinosarcoma of the parotid gland with an osteosarcoma as sarcomatous component in a 72-year-old man who had a history of low anterior resection for rectal cancer. Six months after parotidectomy, he presented abdominal pain as a symptom of abdominal metastasis by the sarcomatous component. At that time, the possibility of abdominal metastasis was overlooked because of the history of abdominal surgery. After several days of conservative treatment, emergency laparotomy was done. However, he died of acute respiratory distress syndrome.

Conclusions

Awareness of the possibility of abdominal metastasis by salivary carcinosarcoma may help in managing patients with a history of abdominal surgery.

https://ift.tt/2JqjfS2

Super-resolution T2-weighted 4D MRI for image guided radiotherapy

The superior soft-tissue contrast of 4D-T2w MRI motivates its use for delineation in radiotherapy treatment planning. We address current limitations of slice-selective implementations, including thick slices and artefacts originating from data incompleteness and variable breathing.

https://ift.tt/2JosNwP

Potential of memory T cells in bridging preoperative chemoradiation and immunotherapy in rectal cancer

The management of locally advanced rectal cancer has passed a long way of developments, where total mesorectal excision and preoperative radiotherapy are crucial to secure clinical outcome. These and other aspects of multidisciplinary strategies are in-depth summarized in the literature, while our mini-review pursues a different goal. From an ethical and medical standpoint, we witness a delayed implementation of novel therapies given the cost/time consuming process of organizing randomized trials that would bridge an already excellent local control in cT3-4 node-positive disease with long-term survival.

https://ift.tt/2Len0aI

Outcomes of radiosensitisation in elderly patients with advanced bladder cancer

There is little evidence to guide treatment in elderly patients with muscle invasive bladder cancer (MIBC). We evaluated the efficacy and tolerability of concurrent radical radiotherapy with gemcitabine radiosensitisation (GemX) in elderly patients with MIBC and compared outcomes to those from the bladder carbogen and nicotinamide (BCON) phase III trial.

https://ift.tt/2Jj1xA7

Molecular classification of patients with grade II/III glioma using quantitative MRI characteristics

Abstract

Background

Molecular markers of WHO grade II/III glioma are known to have important prognostic and predictive implications and may be associated with unique imaging phenotypes. The purpose of this study is to determine whether three clinically relevant molecular markers identified in gliomas—IDH, 1p/19q, and MGMT status—show distinct quantitative MRI characteristics on FLAIR imaging.

Methods

Sixty-one patients with grade II/III gliomas who had molecular data and MRI available prior to radiation were included. Quantitative MRI features were extracted that measured tissue heterogeneity (homogeneity and pixel correlation) and FLAIR border distinctiveness (edge contrast; EC). T-tests were conducted to determine whether patients with different genotypes differ across the features. Logistic regression with LASSO regularization was used to determine the optimal combination of MRI and clinical features for predicting molecular subtypes.

Results

Patients with IDH wildtype tumors showed greater signal heterogeneity (p = 0.001) and lower EC (p = 0.008) within the FLAIR region compared to IDH mutant tumors. Among patients with IDH mutant tumors, 1p/19q co-deleted tumors had greater signal heterogeneity (p = 0.002) and lower EC (p = 0.005) compared to 1p/19q intact tumors. MGMT methylated tumors showed lower EC (p = 0.03) compared to the unmethylated group. The combination of FLAIR border distinctness, heterogeneity, and pixel correlation optimally classified tumors by IDH status.

Conclusion

Quantitative imaging characteristics of FLAIR heterogeneity and border pattern in grade II/III gliomas may provide unique information for determining molecular status at time of initial diagnostic imaging, which may then guide subsequent surgical and medical management.

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Hyperfibrinogenemia is a poor prognostic factor in diffuse large B cell lymphoma

Abstract

Diffuse large B cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphomas worldwide. Previous studies indicated that hyperfibrinogenemia was a poor predictor in various tumors. The purpose of our study was to evaluate the prognostic effect of hyperfibrinogenemia in DLBCL. Data of 228 patients, who were diagnosed with DLBCL in our hospital between May 2009 and February 2016, were analyzed retrospectively. The Kaplan-Meier method and Cox regression were performed to find prognostic factors associated with progression-free survival (PFS) and overall survival (OS). Receiver operator characteristic (ROC) curve and the areas under the curve were used to evaluate the predictive accuracy of predictors. Comparison of characters between groups indicated that patients with high National Comprehensive Cancer Network-International Prognostic Index (NCCN-IPI) score (4–8) and advanced stage (III–IV) were more likely to suffer from hyperfibrinogenemia. The Kaplan-Meier method revealed that patients with hyperfibrinogenemia showed inferior PFS (P < 0.001) and OS (P < 0.001) than those without hyperfibrinogenemia. Multivariate analysis showed that hyperfibrinogenemia was an independent prognostic factor associated with poor outcomes (HR = 1.90, 95% CI: 1.15–3.16 for PFS, P = 0.013; HR = 2.65, 95% CI: 1.46–4.79 for OS, P = 0.001). We combined hyperfibrinogenemia and NCCN-IPI to build a new prognostic index (NPI). The NPI was demonstrated to have a superior predictive effect on prognosis (P = 0.0194 for PFS, P = 0.0034 for OS). Hyperfibrinogenemia was demonstrated to be able to predict poor outcome in DLBCL, especially for patients with advanced stage and high NCCN-IPI score. Adding hyperfibrinogenemia to NCCN-IPI could significantly improve the predictive effect of NCCN-IPI.

https://ift.tt/2HfQoe3

Cancers, Vol. 10, Pages 177: Frequency of EBV LMP-1 Promoter and Coding Variations in Burkitt Lymphoma Samples in Africa and South America and Peripheral Blood in Uganda

Cancers, Vol. 10, Pages 177: Frequency of EBV LMP-1 Promoter and Coding Variations in Burkitt Lymphoma Samples in Africa and South America and Peripheral Blood in Uganda

Cancers doi: 10.3390/cancers10060177

Authors: Liao Liu Lei Li Chin Tsai Bhatia Gutierrez Epelman Biggar Nkrumah Neequaye Ogwang Reynolds Lo Mbulaiteye

Epstein-Barr virus (EBV) is linked to several cancers, including endemic Burkitt lymphoma (eBL), but causal variants are unknown. We recently reported novel sequence variants in the LMP-1 gene and promoter in EBV genomes sequenced from 13 of 14 BL biopsies. Alignments of the novel sequence variants for 114 published EBV genomes, including 27 from BL cases, revealed four LMP-1 variant patterns, designated A to D. Pattern A variant was found in 48% of BL EBV genomes. Here, we used PCR-Sanger sequencing to evaluate 50 additional BL biopsies from Ghana, Brazil, and Argentina, and peripheral blood samples from 113 eBL cases and 115 controls in Uganda. Pattern A was found in 60.9% of 64 BL biopsies evaluated. Compared to PCR-negative subjects in Uganda, detection of Pattern A in peripheral blood was associated with eBL case status (odds ratio [OR] 31.7, 95% confidence interval: 6.8&ndash;149), controlling for relevant confounders. Variant Pattern A and Pattern D were associated with eBL case status, but with lower ORs (9.7 and 13.6, respectively). Our results support the hypothesis that EBV LMP-1 Pattern A may be associated with eBL, but it is not the sole associated variant. Further research is needed to replicate and elucidate our findings.

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Localized myxofibrosarcomas: roles of surgical margins and adjuvant radiotherapy

Publication date: Available online 2 June 2018
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Raoudha Boughzala-Bennadji, Eberhard Stoeckle, Cécile Le Péchoux, Pierre Méeus, Charles Honoré, Justine Attal, Florence Duffaud, Gonzague De Pinieux, Emmanuelle Bompas, Juliette Thariat, Agnès Leroux, François Bertucci, Nicolas Isambert, Corinne Delcambre, Jean-Yves Blay, Marie-Pierre Sunyach, Jean-Michel Coindre, Paul Sargos, Nicolas Penel, Sylvie Bonvalot
BackgroundThe objective of this study was to describe the outcome and prognostic factors of adults treated for localized myxofibrosarcoma.MethodsWe conducted a retrospective multicenter study of 425 non-metastatic patients (pts) operated between January 1996 and December 2015 in X national Group and were enrolled in the "Conticabase." Pathological diagnosis was systematically reviewed by expert pathologists. The endpoints were relapse-free and metastasis-free survival. Log-rank tests and Cox models have been used to identified prognostic factors.ResultsMedian age was 66, 53% were males, 85% of cases occurred in limbs or superficial trunk, median size was 60 mm, 47%/39% had grade 2/3, 66% R0 resection and 34% R1 resection. Adjuvant radiotherapy was given to 65% of patients, neoadjuvant radiotherapy in 3%, neoadjuvant chemotherapy in 7% and adjuvant chemotherapy in 13%. The median follow-up was 51 months. The 5-year local relapse free-survival was 67%; independent prognostic factors for local relapse were R1 resection (HR=1.26; p=0.001) and adjuvant radiotherapy (HR= 0.35; p=0.0001) [i.e. R1 resection and no adjuvant radiotherapy increase the hazard ratio]. In stratified analysis, adjuvant radiotherapy was beneficial after R0 resection (p=0.0020) as well as after R1 resection (p=0.0001). The 5-year overall survival was 80%. The 5-year metastasis-free survival was 83%. Independent prognostic factors for metastatic relapse were: grade 3 (HR=1.975; p=0.0001) and size (HR=1.006; p=0.001).ConclusionsThis large series of myxofibrosarcoma confirms the high rate of local relapse. Combination of R0 resection and adjuvant radiotherapy provided the best local control. In parallel with increasing rate of R0 resection and adjuvant radiotherapy, during the study we have observed a constant improvement of both metastatic and local relapse free survivals.

Teaser

After R0 or R1 resection of limb or superificial trunk myxofibrosarcoma, the 5-year local relapse free survival was only 67%.Three independent prognostic factors influenced the local control: age, R0 resection and adjuvant radiotherapy


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Validating a predictive atlas of tumor shrinkage for adaptive radiotherapy of locally advanced lung cancer

Publication date: Available online 2 June 2018
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Pengpeng Zhang, Ellen Yorke, Gig Mageras, Andreas Rimner, Jan-Jakob Sonke, Joseph O. Deasy
PurposeTo cross-validate and expand a predictive atlas that can estimate geometric patterns of lung tumor shrinkage during radiotherapy using data from two independent institutions, and model its integration into adaptive radiotherapy (ART) for enhanced dose escalation.MethodsData from 22 patients at a collaborating institution were obtained to cross-validate an atlas originally created with 12 patients for predicting patterns of tumor shrinkage during radiotherapy. Subsequently, the atlas was expanded by integrating all 34 patients. Each study patient was selected via a leave-one-out scheme and matched with a subgroup in the remaining 33 patients based on similarity measures of tumor volume and surroundings. The spatial distribution of residual tumor was estimated by thresholding the superimposed shrinkage patterns in the subgroup. A Bayesian method was also developed to recalibrate the prediction using the tumor observed on the mid-course images. Finally, in a retrospective predictive treatment planning (PTP) study, at the initial planning stage, the predicted residual tumors were escalated to the highest achievable dose, while maintaining the original prescription dose to the remainder of the tumor. The PTP approach was compared isotoxically to ART that replans with mid-course imaging, and to PTP-ART with the recalibrated prediction.ResultsPredictive accuracy (true positive plus true negative ratios based on predicted and actual residual tumor) were comparable across institutions, 0.71 vs 0.73, and improved to 0.74 with an expanded atlas including two institutions. Recalibration further improved accuracy to 0.76. PTP increased the mean dose to the actual residual tumor by an averaged 6.3Gy compared to ART.ConclusionA predictive atlas found to perform well across institutions, and benefit from more diversified shrinkage patterns and tumor locations. Elevating tumoricidal dose to the predicted residual tumor throughout the entire treatment course, could potentially improve the efficacy and efficiency compared to ART with mid-course replanning.

Teaser

We generated a predictive atlas that can estimate the spatial distribution of residual tumor in response to radiotherapy, and validated the atlas across independent institutions. Treatment planning guided by the prediction as well as recalibration of the prediction based on imaging surveillance can provide relevant dose escalation to the actual residual tumor, and improve the efficacy compared to the adaptive mid-course replanning approach.


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Combining Perfusion and High B-value Diffusion MRI to Inform Prognosis and Predict Failure Patterns in Glioblastoma

Publication date: Available online 2 June 2018
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Daniel R. Wahl, Michelle M. Kim, Madhava P. Aryal, Holly Hartman, Theodore S. Lawrence, Matthew J. Schipper, Hemant A. Parmar, Yue Cao
BackgroundAdvanced imaging modalities such as high b-value diffusion and dynamic contrast enhancement (DCE) MRI have the potential to improve the clinical management of glioblastoma by informing prognosis, predicting sites of progression and guiding dose-escalated radiation to maximize tumor control while minimizing toxicity.MethodsFifty-two patients with de novo GBM underwent MRI scanning prior to chemoradiation. Enhanced tumor volumes excluding surgical cavity (TVGdNoCavity), hypercellularity (TVHCV) and increased cerebral blood volume (TVCBV) were defined using conventional post-gadolinium T1 images, high b-value (3000 s/mm²) diffusion-weighted images and CBV maps from T1-weighted DCE images, respectively. The image-phenotype TVs were analyzed for prediction of progression-free survival (PSF) (Cox proportional hazard models), and sites of progression (TVPOF).ResultsThe median PFS of the cohort was 13 months. TVCBV and TVHCV were spatially distinct with a mean overlap of only 21%. Univariate analysis showed that increasing age, decreasing radiation dose, larger TVHCV and larger overlap of TVHCV and TVCBV (TVoverlap) were significantly associated with inferior PFS, while multivariate analysis identified that TVHCV was the most adversely prognostic imaging-defined variable. TVGdNoCavity as well as the union of TVHCV and TVCBV had a high likelihood of containing the TVPOF, while the volume comprised of the intersection of TVHCV and TVCBV had an especially high likelihood of progressing.ConclusionsTVHCV and TVoverlap are prognostic for PFS. Combinations of TVGd, TVCBV and TVHCV could predict tumor progression locations better than individual subvolumes. Radiation dose escalation to these subvolumes could be a promising therapeutic strategy.



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Severe PTCH1 deficiency in cancer-prone Gorlin patient cells results in intrinsic radiosensitivity

Publication date: Available online 2 June 2018
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Adeline Vulin, Melissa Sedkaoui, Sandra Moratille, Nicolas Sevenet, Pascal Soularue, Odile Rigaud, Laure Guibbal, Joshua Dulong, Penny Jeggo, J.F. Deleuze, Jérôme Lamartine, Michèle T. Martin
PurposeGorlin syndrome (or basal-cell nevus syndrome: BCNS) is a cancer-prone genetic disease in which hyper-susceptibility to secondary cancer and tissue reaction after radiotherapy is debated, as well as increased radiosensitivity at cellular level. It results from heterozygous mutations in the PTCH1 gene for 60% of patients, and we therefore aimed to highlight correlations between intrinsic radiosensitivity and PTCH1 gene expression in fibroblasts from adult Gorlin patients.Materials and MethodsThe radiosensitivity of fibroblasts from 6 Gorlin patients was determined by cell-survival assay after high (0.5-3.5 Gy) and low (50-250 mGy) γ-ray doses. PTCH1 and DNA damage response (DDR) gene expression was characterized by real-time PCR and western blotting. DNA damage and repair were investigated by γH2AX and 53BP1 foci assay. PTCH1 knockdown was performed in cells from healthy donors by stable RNA interference. Gorlin cells were genotyped by two complementary sequencing methods.ResultsOnly cells from Gorlin patients presenting severe deficiency in PATCHED1 protein exhibited a significant increase in cellular radiosensitivity, affecting cell responses to both high and low radiation doses. For two of the radiosensitive cell strains, heterozygous mutations in the 5'end of PTCH1 gene explain PATCHED1 protein deficiency. In all sensitive cells, DDR pathways (ATM, CHK2 and P53 levels and activation by phosphorylation) were deregulated after irradiation, whereas DSB repair recognition was unimpaired. Furthermore, normal cells with RNA interference-mediated PTCH1 deficiency showed reduced survival after irradiation, directly linking this gene to high and low-dose radiosensitivity.ConclusionsIn the present study, we show an inverse correlation between PTCH1 expression level and cellular radiosensitivity, suggesting an explanation for the conflicting results previously reported for Gorlin syndrome, and possibly providing a basis for prognostic screens for radiosensitive Gorlin patients with PTCH1 mutations.

Teaser

Gorlin syndrome is a typical case of debated hyper-sensitivity to radiation, although it is well-recognized as a cancer-prone disorder. The present data reveal that only Gorlin cells presenting severe deficiency in PTCH1 gene expression exhibited significantly increased cellular radiosensitivity, and that the PATCHED1 protein had a direct role in regulating intrinsic radiosensitivity, after both high and low radiation doses. This may provide a basis for prognostic screens for radiosensitive Gorlin patients with PTCH1 mutations.


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Tumor-infiltrating Treg, MDSC, and IDO expression associated with outcomes of neoadjuvant chemotherapy of breast cancer

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Relationships between sunitinib plasma concentration and clinical outcomes in Japanese patients with metastatic renal cell carcinoma

Abstract

Background

The aim was to investigate the relationships between total sunitinib plasma concentrations (sunitinib plus its active metabolite; N-desethyl sunitinib) and clinical outcomes in Japanese patients with metastatic renal cell carcinoma (mRCC).

Methods

Twenty patients with mRCC were enrolled following treatment with sunitinib. To assess safety, the total sunitinib concentration range up to discontinuation of treatment and dosage reduction associated with adverse events within 6 weeks from initiating administration were analyzed. The longest administered sunitinib dosage was defined as the maintenance dose, and the relationship between total sunitinib concentration at the maintenance dosage and sunitinib efficacy was investigated.

Results

Total sunitinib concentration was significantly higher in patients who discontinued treatment or had dosage reduction due to adverse events within 6 weeks after initiation of sunitinib than in patients who continued treatment with the initial dosage. The time to treatment failure, progression-free survival, and overall survival were better in patients with total sunitinib concentrations < 50 ng/mL than in those with concentrations ≥ 50 ng/mL.

Conclusions

The present study demonstrated that the effective range of total sunitinib concentration in Japanese patients with mRCC was lower than 50–100 ng/mL which was previously reported. These results indicate that therapeutic drug monitoring could maintain the therapeutic effect of sunitinib while minimizing adverse events by personalizing sunitinib dosages for Japanese patients with mRCC.

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A new apatinib microcrystal formulation enhances the effect of radiofrequency ablation treatment on hepatocellular carcinoma

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Association of VDR gene TaqI polymorphism with the susceptibility to prostate cancer in Asian population evaluated by an updated systematic meta-analysis

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