Negative trials in ovarian cancer: is there such a thing as too much optimism?
Recently, two clinical trials of novel agents in metastatic ovarian cancer were published: a phase 3 study of nintedanib and a phase 2 study of volasertib. There seemed to be discordance between the results and conclusions in the publication of both these trials. Despite not very optimistic results, the studies concluded optimistically in favor of the new agents under study. Using these examples, we point out the discrepancies and the risks of concluding optimistically based on statistical significance when the actual benefit is minimal. We also appeal against conducting large phase 3 trials that require significant resources without good phase 2 evidence for doing so.
Department of Hemato-Oncology, Nobel Hospital, Sinamangal, Kathmandu 21034, Nepal.
Bishal
B
Gyawali
Division of Hematology Oncology, Knight Cancer Institute, Oregon Health and Science University, USA; Department of Public Health and Preventive Medicine, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Portland, Oregon, USA; Center for Health Care Ethics, Oregon Health and Science University, Portland, Oregon 97239, USA.
Vinay
V
Prasad
angiogenesis inhibitor; clinical trials; nintedanib; ovarian cancer; statistical significance; volasertib