Showing papers by "Laurence Collette published in 2017"

Prognostic Factors for Local Control in Breast Cancer After Long-term Follow-up in the EORTC Boost vs No Boost Trial: A Randomized Clinical Trial.

Abstract: Importance Prognostic factors of ipsilateral breast tumor recurrence (IBTR) may change over time following breast-conserving therapy. Objective The EORTC “boost no boost” trial showed that young age and high-grade invasive carcinoma were the most important risk factors for IBTR. This study reanalyses pathological prognostic factors related to IBTR using long-term follow-up. Design, Setting, and Participants Participants included 5569 early-stage breast cancer patients, treated with breast-conserving surgery (BCS) and whole-breast irradiation (WBI), who were randomized between no boost and a 16-Gy boost in the EORTC phase III “boost no boost” trial (1989-1996). A total of 1616 patients with a microscopically complete resection (according to local pathologists), included in the central pathology review, have been analyzed in this study. Median follow-up was 18.2 years. Interventions No further treatment or 16-Gy boost, after BCS and 50-Gy WBI. Main Outcomes and Measures Time to ipsilateral breast tumor recurrence (IBTR) as first event. Results The 20-year cumulative incidence of IBTR in 1616 patients (160 events observed) was 15% (95% CI, 12%-17%). Young age ( P P = .001) were associated with an increased risk of IBTR in multivariable analysis. The cumulative incidence of IBTR at 20 years was 34% (95% CI, 25%-41%), 14% (95% CI, 10%-18%), and 11% (95% CI, 8%-15%), in patients 40 years or younger, 41 to 50 years and 50 years or older, respectively ( P P P Conclusions and Relevance The association of high-grade invasive tumor with IBTR diminished during follow-up, while the effect of DCIS adjacent to invasive tumor seemed to remain stable. Therefore, patients with high-grade invasive tumors should be monitored closely, especially in the first 5 years, while additional DCIS is an indication for longer follow-up, emphasizing the importance of long-term trial follow-up to estimate absolute effects accurately. Trial Registration clinicaltrials.gov Identifier:NCT02295033

International evaluation of the psychometrics of health-related quality of life questionnaires for use among long-term survivors of testicular and prostate cancer

Abstract: Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors. In this study we evaluated, in an international context, the psychometrics of HRQoL questionnaires for use among long-term, disease-free, survivors of testicular and prostate cancer. In this cross-sectional study, we recruited long-term survivors of testicular and prostate cancer from Northern and Southern Europe and from the United Kingdom who had participated in two phase III EORTC clinical trials. Participants completed the SF-36 Health Survey, the EORTC QLQ-C30 questionnaire, the QLQ-PR25 (for prostate cancer) or the QLQ-TC26 (for testicular cancer) questionnaires, and the Impact of Cancer questionnaire. Testicular cancer survivors also completed subscales from the Nordic Questionnaire for Monitoring the Age Diverse Workforce. Two hundred forty-two men (66% response rate) were recruited into the study. The average time since treatment was more than 10 years. Overall, there were few missing questionnaire data, although scales related to sexuality, satisfaction with care and relationship concerns of men without partners were missing in more than 10% of cases. Debriefing showed that in general the questionnaires were accepted well. Many of the survivors scored at the upper extremes of the questionnaires, resulting in floor and ceiling effects in 64% of the scales. All of the questionnaires investigated met the threshold of 0.70 for group level reliability, with the exception of the QLQ-TC26 (mean reliability .64) and the QLQ-PR25 (mean reliability .69). The questionnaires were able to discriminate clearly between patients with and without comorbid conditions. The currently available HRQoL questionnaires exhibit acceptable psychometric properties and were well received by patients, but additional efforts are needed to ensure that the full range of survivor-specific issues is assessed.

Comment on the “TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions”

Abstract: The purpose of this correspondence is to discuss the TrialsTracker, presented by Powell-Smith and Goldacre in their article ‘TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions’ (2016) as a tool to discover publication bias in clinical trial results. The findings from one specific organization (European Organization for Research and Treatment of Cancer; EORTC) are compared with the actual publication history of the trials in question. We also present shortcomings of the method being used and suggestions for improvement to the proposed algorithm.

Dose-Finding Methods: Moving Away from the 3 + 3 to Include Richer Outcomes.

Abstract: The most commonly used method for dose finding, the 3 + 3, has poor performance. New adaptive designs are more efficient. Nevertheless, they have reached a maximum performance level, and further improvement requires either larger sample sizes or outcomes measures richer than the simplistic severe toxicity measured at cycle 1. Clin Cancer Res; 23(15); 3977–9. ©2017 AACR. See related article by Yan et al., p. 3994

How to Interpret Numeric Results in Publications

Abstract: Massive amounts of new literature are published each year, providing varied levels of evidence to the medical urology community. Despite the peer-review processes in place with most journals and congresses and in spite of the widespread adoption of international reporting guidelines such as CONSORT, the new evidence is unfortunately not always objectively and unbiasedly presented. Intentional or more often, unintentional misuse or misinterpretation of statistical evidence, inadequate trial methodology, the natural tendency of humans to seek confirmation of their prior beliefs and to give more focus to the more statistically significant findings are the most common flaws in the medical literature. In this chapter, we will illustrate some of these pitfalls, with the aim to exercise the reader to using their critical thinking when appraising published research findings. We will use published reports comparing therapeutic interventions against prostate cancer as examples because modern clinical trials are becoming increasingly complex and therefore more difficult to appraise for the non-statistically trained reader.

EORTC1527/JCOG1609INT: Diffusion-weighted MRI (DW-MRI) assessment of liver metastasis to improve surgical planning (DREAM).

Abstract: TPS3633Background: For patients with initially unresectable colorectal liver metastases (CRLM) with good clinical response to chemotherapy, the presence of disappearing liver metastases (DLMs) diag...