When an investigational anticancer drug is being tested, demonstration of improvement in overall survival (OS) will generally lead to regulatory approval. However, the value that improvement in OS adds to patients’ lives is guided largely by the context of the improvement and accompanying trade-offs. For example, when a patient’s life expectancy is less than 6 months, many oncologists will not embark on any active cancer treatments. However, multiple new anticancer drugs have been approved recently after being tested in end-stage cancer patients and demonstrating median OS in the experimental arm close to 6 months. Such practice, particularly when the treatment is also accompanied by serious toxicities and cost, can undermine a peaceful life-death transition. In this commentary, we review regulatory approvals in the last 5 years and the ethical considerations involved in testing active cancer treatment in terminal cancer patients.
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