Trends in phase III randomized controlled clinical trials on the treatment of advanced non-small-cell lung cancer

Abstract

The objective of this review was to analyze trends in outcomes and in the quality of phase III randomized controlled trials on advanced NSCLC published between 2000 and 2012, selecting 76 trials from a total of 122 retrieved in a structured search. Over the study period, the number of randomized patients per trial increased by 14 per year (P = 0.178). The sample size significantly increased between 2000 and 2012 in trials of targeted agents (460.1 vs. 740.8 patients, P = 0.009), trials of >1 drug (360.4 vs. 584.8, P = 0.014), and those including patients with good performance status (675.3 vs. 425.6; P = 0.003). Quality of life was assessed in 46 trials (60.5%), and significant improvements were reported in 10 of these (21.7%). Platinum-based regimens were the most frequently investigated (86.8% of trials). Molecular-targeted agents were studied in 25.0% of chemotherapy arms, and the percentage of trials including these agents increased each year. The median (interquartile range) overall survival (MOS) was 9.90 (3.5) months with an increase of 0.384 months per year of publication (P < 0.001). A statistically significant improvement in MOS was obtained in only 13 (18.8%) trials. The median progression-free survival was 4.9 (1.9) months, with a nonsignificant increase of 0.026 months per year (P > 0.05). There has been a continuous but modest improvement in the survival of patients with advanced NSCLC over the past 12 years. Nevertheless, the quality of clinical trials and the benefit in outcomes should be carefully considered before the incorporation of novel approaches into clinical practice.

Constant but moderate improvement in efficacy outcomes in advanced NSCLC until 2012. Critical analysis of the published results of phase III clinical trials in NSCLC is required.

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Cancer Screening Perception Scale: Development and Construct Validation

Abstract

The aim of this study was to demonstrate the construct validity of a newly developed cancer screening perception scale as a measure of the perception of cancer screening in general among high-risk but healthy asymptomatic groups.

The cancer screening perception scale (CSPS) was developed based on extensive literature reviews guided by The Health Belief Model. Fifty-five written items were initially pooled, reviewed by experts for face validity, pretested by 25 healthcare workers and translated into Malay using simple back translation. The scale was then distributed to 300 respondents from two health clinics for construct validation purposes. The obtained data were analyzed using the varimax rotation method for exploratory factor analysis (EFA). The data was submitted for further confirmatory factor analysis using AMOS software.

Based on EFA, the results produced five constructs as predicted: perceived severity, perceived susceptibility, perceived benefits, perceived barriers, and cues for action. Two items with low factor loading and unrelated to the recovered domains were removed. Perceived barriers and cues for action had three and two sub-domains respectively which were further confirmed to fit the measurement and structural models. CFA demonstrated the scale fitted GFI = 0.936, CFI = 0.935, RMSEA = 0.076, NORMEDCHISQ = 2.162. The scale discriminated between the domains. Cronbach's alpha for perceived severity, perceived susceptibility, perceived benefits, perceived barrier, and cues for action were 0.907, 0.877, 0.940, 0.864 and 0.938, respectively.

The cancer screening perception scale with its promising psychometric properties is now available to measure risks to high-risk but healthy, asymptomatic groups aged 18 and above and can also be used for larger scale study purposes.

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Readability and Coherence of Department/Ministry of Health HPV Information

Abstract

Background

Human papilloma virus (HPV) is a prime factor in the development of many cancers and genital warts in Canada. A majority of sexually active Canadians are likely to have an HPV infection during their lifetime. Information provided online by each specific provincial department/ministry of health in regard to HPV and vaccination may not be at an ideal standard for the lay population to understand and should be evaluated.

Purpose

The purpose of this study is to assess the readability and coherence of provincial department/ministry of health HPV information to determine if it is adequate for the Canadian lay population to understand.

Methods and Results

Seven of ten Canadian provincial department/ministry of health's HPV information websites were evaluated for readability and coherence. The readability tools Gunning-Fog index and Simple Measure of Gobbledygook (SMOG) both found that approximately 60 % of the population for each of the provinces evaluated may be able to understand the information. The coherence measures of latent semantic analysis (LSA) and computerized propositional idea density rater (CPIDR) both concluded that relative to the benchmark that represents the lay population, the coherence level is not appropriate (LSA, p < 0.001and CPIDR, p < 0.001).

Interpretation

HPV information provided by the Canadian provincial department/ministry of health websites may not be adequate for the lay population to understand. Readability and coherence are important factors that should be considered to improve the quality and adequacy of the information provided so the message reaches the Canadian population.

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Orthopedic Oncology Caseload Among Orthopedic Surgery Residents

Abstract

Despite educational focus regarding orthopedic oncology during residency, assessment of resident orthopedic oncology caseload has not been performed. The purpose of this study was to evaluate orthopedic oncology caseload trends and variation among residents. The Accreditation Council for Graduate Medical Education case log reports for orthopedic surgery residents were reviewed for graduating years 2007 to 2013. Trends in orthopedic oncology cases and variation in the median number of cases performed by residents in the 90th, 50th, and 10th percentiles of caseload were evaluated. The proportion of orthopedic oncology caseload among all cases performed by residents increased significantly (P = 0.005) from 2007 to 2013. Likewise, the mean number of adult (P = 0.002), pediatric (P = 0.003), and total orthopedic oncology cases increased significantly (P = 0.002). On average, residents in the 90th, 50th, and 10th percentiles performed 83, 28, and 3 cases, respectively. The current study demonstrates a significant increase in adult, pediatric, and total orthopedic oncology caseload. There is also evidence of substantial caseload variation among residents. Caseload variation may influence the education and technical proficiency of orthopedic residents.

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Knowledgeability, Attitude and Behavior of Primary Care Providers Towards Oral Cancer: a Pilot Study

Abstract

The objective of this study was to assess current knowledgeability, attitudes, and practice behaviors of primary care providers (PCPs) towards oral cancer screening. Applying a cross-sectional design, a 14-question survey was emailed to 307 PCPs practicing at a large, multi-specialty, rurally based healthcare system. Survey data were collected and managed using REDCap and analyzed applying descriptive statistics. A 20 % response rate (n = 61/307) was achieved for survey completion. Approximately 70 % of respondents were physicians, 16 % were nurse practitioners, and 13 % were physician assistants. Nearly 60 % of respondents were family medicine practitioners. Limited training surrounding oral cancer screening during medical training was reported by 64 %. Although 78 % of respondents reported never performing oral cancer screening on patients in their practice, >90 % answered knowledge-based questions correctly. Frequency rate for specialist referral for suspicious lesions by PCPs was 56 % "frequently". Optimal periodicity for oral cancer screening on all patients selected by respondents was 61 % "annually", 3 % "every 6 months", 3 % "every visit", 2 % "not at all", and 31 % "unsure". This study established a baseline surrounding current knowledgeability, practice patterns, and opinions of PCPs towards oral cancer screening at a single, large, regional healthcare system. In the absence of evidence-based support for population-based cancer screening, this study result suggests a need for better integration of oral cancer surveillance into the medical setting, supplemented by education and training with emphasis on assessment of high-risk patients to achieve early detection. Prospectively, larger studies are needed to validate these findings.

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Clinicopathological analysis of UHRF1 expression in medulloblastoma tissues and its regulation on tumor cell proliferation

Abstract

Studies have showed the involvement of ubiquitin-like with PHD and RING finger domains 1 (UHRF1) in tumorigenesis and progression. This study focused on the relationships between UHRF1 and medulloblastoma (MB). Immunostaining and western blotting demonstrated differential expression of UHRF1 in MB tissues and no UHRF1 expression in normal cerebellum tissues. Univariate survival analysis revealed MB patients with high UHRF1 expression had significantly shorter OS and PFS than patients with low UHRF1 (OS p = 0.009, PFS p = 0.003). Multivariate analysis illustrated that UHRF1 expression level is an independent prognostic factor influencing the OS and PFS (OS p = 0.038, PFS p = 0.014). UHRF1 expression levels were significantly different among molecular subgroups of MB (p = 0.003). Down-regulation of UHRF1 by RNAi inhibited proliferation and clonogenic ability of MB cell lines with cell cycle arrest in G1/G2-phase. Meanwhile, cells transfected with lenti-shUHRF1 showed increased p16 expression and location shift of CDK4 in MB cells. These findings indicate UHRF1 may promote cell proliferation and be a potential biomarker that can be used as a prognostic parameter and a therapeutic target for MB.

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Profiling gene mutations, translocations, and multidrug resistance in pediatric acute lymphoblastic leukemia: a step forward to personalizing medicine

Abstract

Precise risk stratification and tailored therapy in acute lymphoblastic leukemia (ALL) can lead to enhanced survival rates among children. Translocations and mutations along with multidrug resistance markers are important factors that determine therapeutic efficacy. Gene mutation profiling of patients at the time of diagnosis can offer accurate clinical decision-making. Multiplex PCR was used to screen for various translocations, mutations, and P-glycoprotein (P-gp) status in pediatric ALL samples. The roles of P-gp were analyzed at the transcriptional and translational levels by using real-time PCR and immunoblotting, respectively. ALL specific cell line Jurkat was used to validate the functional role of P-gp in imparting drug resistance by siRNA knockdown studies. Co-occurrence of translocations and mutations contributes to cellular drug resistance. Presence of any translocation in addition to FLT3/ITD hints for overactive P-gp. Co-occurrence of E2A/PBX and TEL/AML has also been positively correlated with P-gp status. Multiplex PCR provides a rapid and cost effective technique for profiling translocations, mutations, and multidrug resistance status that determines what therapy patients could be administered. Mutation profiling in patients for analyzing genetic lesions along with drug resistance profiling will help improve risk stratification and personalized medicine, thereby increasing the treatment success rates among pediatric patients with leukemia.

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