Randomized Controlled Trials in Lung, Gastrointestinal, and Breast Cancers: An Overview of Global Research Activity

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Randomized Controlled Trials in Lung, Gastrointestinal, and Breast Cancers: An Overview of Global Research Activity


JournalCurrent Oncology
Article typeJournal research article – Literature review
Publication date – Apr – 2022
Authors – J. Connor Wells, Adam Fundytus, Shubham Sharma, Wilma M. Hopman, Joseph C. Del Paggio, Bishal Gyawali, Deborah Mukherji, Nazik Hammad, C. S. Pramesh, Ajay Aggarwal, Richard Sullivan, Christopher M. Booth
Keywordsbreast, cancer, design, Gastrointestinal, lung, outcomes, randomized controlled trial
Open access – Yes
SpecialityGeneral surgery, Surgical oncology
World region Global

Language – English
Submitted to the One Surgery Index on April 20, 2022 at 6:59 am
Abstract:

Background: In this study, we compared and contrasted design characteristics, results, and publications of randomized controlled trials (RCTs) in gastrointestinal (GI), lung, and breast cancer. Methods: A PUBMED search identified phase III RCTs of anticancer therapy in GI, lung, and breast cancer published globally during the period 2014–2017. Descriptive statistics, chi-square tests, and the Kruskal–Wallis test were used to compare RCT design, results, and output across the cancer sites. Results: A total of 352 RCTs were conducted on GI (36%), lung (29%), and breast (35%) cancer. Surrogate endpoints were used in 55% of trials; this was most common in breast trials (72%) compared to GI (47%) and lung trials (43%, p < 0.001). Breast trials more often met their primary endpoint (54%) than GI (41%) and lung trials (41%) (p = 0.024). When graded with the ESMO-MCBS, lung cancer trials (50%, 15/30) were more likely to meet the threshold for substantial benefit. GI trials were published in journals with a substantially lower impact factor (IF; median IF 13) than lung (median IF 21) and breast cancer trials (median IF 21) (p = 0.038). Conclusions: Important differences in RCT design and output exist between the three major cancer sites. Use of surrogate endpoints and the magnitude of benefit associated with new treatments vary substantially across cancer sites.

OSI Number – 21567

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