Do experts agree on how to assess disease progression (DP) and progression-free survival (PFS) in phase III trials? A survey with experts in breast cancer research.

作者: E. D. Saad , A. Katz , L. Pusztai , P. M. Hoff , M. E. Buyse

DOI: 10.1200/JCO.2010.28.15_SUPPL.1084

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摘要: 1084 Background: Endpoints based on DP, such as PFS, are currently the most frequently used primary efficacy parameters in advanced breast cancer. We conducted a survey with principal investigators (PIs) of recent phase III trials this setting. Methods: Trial selection has been described (Saad, Ann Oncol 2009). PIs for each study were sent questionnaire 6 hypothetical cases (12 questions) assessing type evidence and choice dates declaring DP. Results: Among 51 58 eligible trials, there 5 contact failures, declined. Of remaining 41 (48 trials), 20 ultimately participated (21 21 never responded, participation rate 21/53=39.6%. There was considerable lack agreement 12 questions, some which illustrated follows. In patient bone lung disease at baseline developing low back pain positive scan, 11 would declare whereas 9 not or sure; 16 believed additional stu...

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