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•Missing data in quality of life are adequately reported in 7.4% of oncology trials.•Articles specifically reporting quality of life are more likely to meet guidelines.•Informative censoring in quality of life cannot be excluded in most oncology trials. [Display omitted] Objective We aimed to systematically characterize reporting missing quality of life (QoL) data in oncology randomized controlled trials (RCTs) and to estimate prevalence of adequate reporting according to existing guidelines. Study Design and Setting This cross-sectional analysis includes all articles on anti-cancer drugs tested in RCTs in six high impact medical/oncology journals, published between January 2015 and May 2020, that reported QoL outcomes. From 1942 identified articles, 215 (11%) met inclusion criteria. Data abstracted included whether compliance for QoL assessment were reported, whether results from a missing data statistical analysis were reported, whether articles met current recommendations for reporting missing data in QoL assessments. Results The results from a missing data statistical analysis were available in 22 trials (10.2%). Overall, 16 trials (7.4%) met current recommendations for reporting missing data in QoL assessments. Articles specifically reporting on QoL or patient reported outcomes were more likely to meet recommendations than other reports (P < 0.0001). Conclusion This systematic cross-sectional study found that most oncology RCTs reporting on QoL do not report adequately on missing data in QoL, with only 7.4% of trials meeting current reporting guidelines. The possibility of informative censoring, therefore, cannot be assessed in most of trials.

Purpose To examine the benefit of telehealth over current delivery options in oncology practices without genetic counselors. Methods Participants meeting cancer genetic testing guidelines were recruited to this multi‐center, randomized trial comparing uptake of genetic services with remote services (telephone or videoconference) to usual care in six predominantly community practices without genetic counselors. The primary outcome was the composite uptake of genetic counseling or testing. Secondary outcomes compare telephone versus videoconference services. Results 147 participants enrolled and 119 were randomized. Eighty percent of participants in the telehealth arm had genetic services as compared to 16% in the usual care arm (OR 30.52, p < 0.001). Five genetic mutation carriers (6.7%) were identified in the telehealth arm, compared to none in the usual care arm. In secondary analyses, factors associated with uptake were lower anxiety (6.77 vs. 8.07, p = 0.04) and lower depression (3.38 vs. 5.06, p = 0.04) among those who had genetic services. There were no significant differences in change in cognitive or affective outcomes immediately post‐counseling and at 6 and 12 months between telephone and videoconference arms. Conclusion Telehealth increases uptake of genetic counseling and testing at oncology practices without genetic counselors and could significantly improve identification of genetic carriers and cancer prevention outcomes. Providing remote telehealth genetic services increases uptake of genetic counseling and testing at oncology practices without genetic counselors. These data highlight the value of telehealth strategies to significantly improve identification of genetic carriers and cancer prevention outcomes.

BackgroundTumor treating fields (TTF) harness magnetic fields to induce apoptosis in targeted regions. A 2015 landmark randomized phase III trial of newly diagnosed glioblastoma (GBM) patients demonstrated TTF + temozolomide to be superior to temozolomide alone. Given these results, we sought to assess practice patterns of providers in TTF utilization for GBM.MethodsA survey was administered to practices in the United States self-identifying as specializing in radiation oncology, medical oncology, neuro-oncology, neurosurgery, and/or neurology. Responses were collected anonymously; analysis was performed using Fisher’s exact test.ResultsA total of 106 providers responded; a minority (36%) were in private practice. Regarding case volume, 82% treated at least six high-grade gliomas/year. The provider most commonly certified to offer TTF therapy to GBM patients was the neuro-oncologist (40%), followed by the radiation oncologist (34%); 31% reported no TTF-certified physician in their practice. TTF users were more likely to have high volume, and be aware of TTF inclusion in National Comprehensive Cancer Network (NCCN) guidelines (p < 0.05).ConclusionsMore than 80% of TTF for GBM in the United States is performed by groups who treat at least six high-grade gliomas per year; unfortunately more than 30% were in practices bereft of anyone certified to offer TTF therapy. These results indicate that there remains fertile soil for TTF therapy nationwide to be introduced into practices for GBM treatment. Providers seeking to refer newly diagnosed GBM patients for TTF should seek out practices with TTF user-associated characteristics to ensure optimal access for their patients.

This cross-sectional study examines the prevalence of restricted choice of treatment in control groups among physicians and investigators conducting oncology randomized clinical trials (RCTs).

[...]hospitals might have postponed diagnostic evaluation or have longer turnaround times for diagnostic evaluation because many hospital-based resources are being allocated to tackle COVID-19. [...]national screening programmes for breast, colorectal, and cervical cancer are temporarily halted as of March 16, 2020, to alleviate the demand on the health-care system due to COVID-19. [...]misconceptions were eliminated about a heightened risk of contracting COVID-19 in a health-care setting because of inadequate policies for infection control at the institutional level and resource constraints in the delivery of essential oncological care.

Cancer is a disease of aging and, as the world's population ages, the number of older persons with cancer is increasing and will make up a growing share of the oncology population in virtually every country. Despite this, older patients remain vastly underrepresented in research that sets the standards for cancer treatments. Consequently, most of what we know about cancer therapeutics is based on clinical trials conducted in younger, healthier patients, and effective strategies to improve clinical trial participation of older adults with cancer remain sparse. For this systematic review, the authors evaluated published studies regarding barriers to participation and interventions to improve participation of older adults in cancer trials. The quality of the available evidence was low and, despite a literature describing multifaceted barriers, only one intervention study aimed to increase enrollment of older adults in trials. The findings starkly amplify the paucity of evidence-based, effective strategies to improve participation of this underrepresented population in cancer trials. Within these limitations, the authors provide their opinion on how the current cancer research infrastructure must be modified to accommodate the needs of older patients. Several underused solutions are offered to expand clinical trials to include older adults with cancer. However, as currently constructed, these recommendations alone will not solve the evidence gap in geriatric oncology, and efforts are needed to meet older and frail adults where they are by expanding clinical trials designed specifically for this population and leveraging real-world data.

Only 3.4% of cancer drugs evaluated in phase 1 trials are approved by the US Food and Drug Administration, with most failing in phase 3 trials. To investigate whether an association exists between the sponsorship and conduct of a negative phase 3 randomized clinical trial (RCT) investigating a cancer drug that lacked supporting phase 2 trial evidence for that drug, and to evaluate the association with overall survival among patients randomized to the experimental arm of such phase 3 trials. Articles in the Lancet, Lancet Oncology, JAMA, JAMA Oncology, and Journal of Clinical Oncology published between January 2016 and June 2018 were searched. Phase 3 RCTs of cancer drugs that failed to improve the primary end point were selected and any prior phase 2 trial of the same drug that supported the phase 3 trial was selected without any date or journal restrictions. Percentages of negative phase 3 RCTs of cancer drugs that lacked any phase 2 evidence, had a negative phase 2 trial, or had a positive phase 2 study were extracted. Associations were assessed using the Fisher exact test. Pooled hazard ratios and 95% CIs for the overall survival of patients enrolled in these negative phase 3 RCTs were estimated using a random-effects model. Negative phase 3 RCTs with a lack of a phase 2 trial or the presence of a negative phase 2 trial and overall survival of enrolled patients in the phase 3 RCTs. In this meta-epidemiological study, 67 negative phase 3 RCTs on cancer drugs, which included 64 600 patients, met the criteria of being sponsored by industry or academic groups, of which 42 RCTs (63%) were industry sponsored and the remaining 25 RCTs (37%) were academic. A phase 2 trial was not available for 28 of these trials (42%). Of 29 trials (43%) with a phase 2 trial available, 8 trials (28%) failed to meet their primary end points and 5 of those were industry sponsored. There was no association with overall survival for patients participating in these negative phase 3 RCTs (pooled hazard ratio, 0.99; 95% CI, 0.96-1.02). When the pooled analysis was limited to the 27 RCTs with a hazard ratio above 1.00, the overall pooled hazard ratio for overall survival was 1.11 (95% CI, 1.06-1.16). No association between having a negative or undefined phase 2 trial and trial sponsorship was found using the Fisher exact test. More than 40% of the negative phase 3 RCTs in oncology published in these 5 journals were conducted without a supporting phase 2 trial and were sponsored by both academia and industry. Running such trials not only may risk loss of resources owing to a failed trial but also may be associated with decreased patient survival. Further research and regulations in this area appear warranted.

Objective To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe.Design Retrospective cohort study.Setting Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013.Main outcome measures Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs.Results From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years’ follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%).Conclusions This systematic evaluation of oncology approvals by the EMA in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality of life. At a minimum of 3.3 years after market entry, there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications. When there were survival gains over existing treatment options or placebo, they were often marginal.

Background An increasing number of qualitative evidence syntheses papers are found in health care literature. Many of these syntheses use a strictly exhaustive search strategy to collect articles, mirroring the standard template developed by major review organizations such as the Cochrane and Campbell Collaboration. The hegemonic idea behind it is that non-comprehensive samples in systematic reviews may introduce selection bias. However, exhaustive sampling in a qualitative evidence synthesis has been questioned, and a more purposeful way of sampling papers has been proposed as an alternative, although there is a lack of transparency on how these purposeful sampling strategies might be applied to a qualitative evidence synthesis. We discuss in our paper why and how we used purposeful sampling in a qualitative evidence synthesis about ‘sexual adjustment to a cancer trajectory’, by giving a worked example. Methods We have chosen a mixed purposeful sampling, combining three different strategies that we considered the most consistent with our research purpose: intensity sampling, maximum variation sampling and confirming/disconfirming case sampling. Results The concept of purposeful sampling on the meta-level could not readily been borrowed from the logic applied in basic research projects. It also demands a considerable amount of flexibility, and is labour-intensive, which goes against the argument of many authors that using purposeful sampling provides a pragmatic solution or a short cut for researchers, compared with exhaustive sampling. Opportunities of purposeful sampling were the possible inclusion of new perspectives to the line-of-argument and the enhancement of the theoretical diversity of the papers being included, which could make the results more conceptually aligned with the synthesis purpose. Conclusions This paper helps researchers to make decisions related to purposeful sampling in a more systematic and transparent way. Future research could confirm or disconfirm the hypothesis of conceptual enhancement by comparing the findings of a purposefully sampled qualitative evidence synthesis with those drawing on an exhaustive sample of the literature.