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In randomized controlled trials in oncology, changes in quality of life are usually reported together with a description of the differences considered a priori to be clinically important, but overall survival outcomes are rarely provided together with information of what constitutes a clinically meaningful threshold. In this Comment, we propose the benefits that could be derived from reporting overall survival in a similar way to quality of life.
Median overall survival for patients with newly diagnosed multiple myeloma may surpass ten years. Nonetheless, many patients face considerable treatment-related morbidity and relapsed disease. Owing to this typically long overall survival, most multiple myeloma trials now use progression-free survival as their primary end point. In this Comment, we highlight circumstances in which this end point does not best answer the questions that various trials seek to investigate.
Timely and comprehensive updating of treatment guidelines remains a challenge and necessity in medical oncology. Herein we discuss our assessment of how trial results with four off-patent drugs have been considered for integration into major guidelines in the absence of a commercial sponsor, in which we found reasons for concern.