Low-dose nivolumab plus metronomic chemotherapy (Tata Memorial)
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.
Overview
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.
- 43.4 vs 16.3 out of 100 alive at 1 year with Metronomic chemotherapy + low-dose nivolumab compared with Metronomic chemotherapy; 27.1 more per 100.
- Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 45 percent lower chance of the event at any given time (hazard ratio 0.545, likely range 0.362 to 0.82).
- Median 10.1 vs 6.7 months with Metronomic chemotherapy + low-dose nivolumab compared with Metronomic chemotherapy; about 3.4 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Recurrent or newly diagnosed advanced head and neck squamous cell carcinoma, palliative intent: triple oral metronomic chemotherapy with or without nivolumab 20 mg every 3 weeks. People in a different situation may not see the same effect.
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 participants enrolled.
Pages like this
not linked directly; found by shared links- IdeaConfirm ultra-low-dose immunotherapy so it can be afforded where most patients live
Shares Vijay Patil, Kumar Prabhash, Tata Memorial Centre, Wrong doses.
- TrialOral metronomic chemotherapy vs intravenous cisplatin (Tata Memorial)
Shares Vanita Noronha, Vijay Patil, Kumar Prabhash, Methotrexate.
- IdeaTest one-tenth-dose immunotherapy where the full dose is unaffordable
Shares Tata Memorial Centre, Wrong doses, Prices and value, Nivolumab.
- TrialGefitinib vs gefitinib plus pemetrexed-carboplatin in EGFR-mutant lung cancer (Tata Memorial)
Shares Vanita Noronha, Kumar Prabhash, Tata Memorial Centre, Prices and value.
- IdeaAn advance market commitment for PD-1 biosimilars for lower-income countries
Shares Prices and value, Nivolumab, Most of the world has almost no cancer care, PD-1.
- IdeaRestore weight-based dosing and vial sharing for immunotherapy in the label
Shares Wrong doses, Prices and value, Nivolumab, Immune checkpoint inhibitors.
- IdeaExtended-interval immunotherapy: give checkpoint inhibitors every 8-12 weeks once stable
Shares Wrong doses, Prices and value, Nivolumab, PD-1.
- TrialMETRO PLUS (Tata Memorial Centre, Varanasi)
Shares Methotrexate, Tata Memorial Centre, Most of the world has almost no cancer care, Cytotoxic chemotherapy.