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A Mumbai trial that added about one-twentieth of the usual dose of the immunotherapy nivolumab to cheap oral chemotherapy and nearly tripled the share of patients alive at one year.
151 patients were randomised to triple metronomic chemotherapy (methotrexate, celecoxib and erlotinib) alone or with nivolumab at a flat 20 mg every 3 weeks, a small fraction of the standard 240 mg dose. One-year overall survival rose from 16.3% (95% CI 8.0-27.4) to 43.4% (30.8-55.3) and median overall survival from 6.7 to 10.1 months (hazard ratio 0.545; 95% CI 0.362-0.820; P=0.0036), with no increase in grade 3 or worse adverse events (50% versus 46.1%). The authors proposed the combination as an alternative standard for patients who cannot access full-dose checkpoint inhibitors, which is most of the world. It is the leading example of dose-optimisation trials that make immunotherapy affordable.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
151 enrolled.
Shares Vanita Noronha, Vijay Patil, Kumar Prabhash, Buccal mucosa and gingivobuccal cancer (oral cancer in India).
Shares Vijay Patil, Kumar Prabhash, Tata Memorial Centre, Wrong doses.
Shares Buccal mucosa and gingivobuccal cancer (oral cancer in India), Tata Memorial Centre, Recurrent or metastatic head and neck squamous cell carcinoma, Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs.
Shares Vanita Noronha, Kumar Prabhash, Tata Memorial Centre, Prices and value.
Shares Tata Memorial Centre, Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Most of the world has almost no cancer care.
Shares Project Optimus, Tata Memorial Centre, Wrong doses, Prices and value.
Shares Tata Memorial Centre, Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Most of the world has almost no cancer care.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Prices and value, Most of the world has almost no cancer care, Nivolumab.