Randomised trials of stopping immunotherapy after one year versus continuing
Immunotherapy is often given for two years or until it stops working, but responses can last long after stopping. Trials that randomly assign responders to stop or continue would show whether the extra year is needed.
Non-inferiority trials randomising patients with response or stable disease after 12 months of PD-1/PD-L1 therapy to discontinuation with surveillance and retreatment at progression versus continuation to 24 months or beyond, with a 'treatment-free interval' and cumulative drug exposure as secondary endpoints. Several academic trials (e.g., in melanoma and NSCLC) are under way; the proposal is to make stop-versus-continue a standard post-approval requirement for durable-response agents.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
- Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.
- Toxicity and quality of life are undervalued · Trials measure how long people live, not how they live. Side-effects are under-reported and under-treated.
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