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Age is one of the strongest risk factors for cancer and also affects tumour biology, treatment recommendations and response to therapy. Although clinical oncology guidelines advocate against classifying patients on the basis of chronological age alone, most studies and published guidelines use discrete age cutoffs, often heterogeneously. Herein, we discuss age cutoffs from a historical and biological perspective, focusing on breast cancer.
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.
Randomized controlled trials (RCTs) are conducted when clinical equipoise between treatment options exists. However, some RCTs in patients with non-small-cell lung cancer continue to use chemotherapy as the control arm several years after chemotherapy was proven inferior to anti-PD-1 antibodies. Here, we highlight why the justifications for using an inferior treatment in the control arm are invalid and offer solutions that are applicable across tumour types.
In 2021, policy areas of focus for FDA Oncology included the Accelerated Approval programme, expanding eligibility criteria, dose optimization and patient-reported outcomes. The FDA continued to be active with approvals of both new drugs and supplementary applications, including three new chimeric antigen receptor T cell products, two antibody–drug conjugates and several new targeted agents.
Gynaecological cancer diagnosis and treatment can affect reproductive function. Fertility preservation is a complex issue for women with these cancers but one that needs to be addressed during cancer management as it can restore not only fertility but also a threatened or lost sense of femininity. In this Comment, we discuss the importance of fertility counselling to provide optimal cancer care.
