# Low-dose immunotherapy in head and neck cancer: a randomised study (Tata Memorial)

Source: https://onco.cc/key-papers/paper-patil-low-dose-nivolumab-jco-2023/  
OnCo record `paper-patil-low-dose-nivolumab-jco-2023` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Giving about one-twentieth of the standard dose of nivolumab alongside cheap oral chemotherapy nearly tripled one-year survival in advanced head and neck cancer, showing that immunotherapy can be made affordable without losing its effect.

## Summary

Open-label phase 3 randomising 151 patients with advanced head and neck squamous cell carcinoma being treated with palliative intent to triple oral metronomic chemotherapy with or without nivolumab 20 mg flat every 3 weeks. One-year overall survival was 43.4% (95% CI 30.8-55.3) with nivolumab versus 16.3% (8.0-27.4) without; median overall survival 10.1 versus 6.7 months (hazard ratio 0.545; 95% CI 0.362-0.820; P=0.0036); grade 3 or worse adverse events 46.1% versus 50%.

The dose is roughly 6% of the approved flat dose and the drug cost correspondingly small. The trial has become the reference case for dose-optimisation in immuno-oncology and for pragmatic trials in low- and middle-income countries.

## Fields

- Kind: Key paper
- Last checked: 2026-09-10
- Journal: Journal of Clinical Oncology
- Year: 2023
- DOI: 10.1200/JCO.22.01015
- Authors: Patil VM, Noronha V, Menon N, et al.
- Findings: One-year overall survival 43.4% with low-dose nivolumab versus 16.3% without.; Median overall survival 10.1 versus 6.7 months; hazard ratio 0.545 (95% CI 0.362-0.820).; No increase in grade 3 or worse adverse events (46.1% versus 50%).; Nivolumab dose was a flat 20 mg every 3 weeks, a small fraction of the licensed dose.
- What it means: For the majority of the world's head and neck cancer patients who cannot afford full-dose checkpoint inhibitors, a low dose added to oral metronomic chemotherapy is a tested alternative that improves survival. It also challenges the assumption that approved doses are the necessary doses: pharmacology had long suggested receptor saturation at far lower exposures.
- Caveats: Single-centre and open-label; the comparator was metronomic chemotherapy rather than the standard-dose immunotherapy used in high-income settings.; Whether low-dose nivolumab matches full-dose nivolumab head to head is untested.; Patients were mostly tobacco-related, HPV-negative oral cancers, so applicability to oropharyngeal HPV-positive disease is unknown.

## Sources

- JCO 2023: https://doi.org/10.1200/JCO.22.01015

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/)
- institutions: [Tata Memorial Centre](https://onco.cc/institutions/tata-memorial/)
- trials: [Low-dose nivolumab plus metronomic chemotherapy (Tata Memorial)](https://onco.cc/trials/low-dose-nivolumab-tmh/)
- people: [Kumar Prabhash](https://onco.cc/people/prabhash-kumar/), [Vanita Noronha](https://onco.cc/people/noronha-vanita/), [Vijay Patil](https://onco.cc/people/patil-vijay/)
- bottlenecks: [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/paper-patil-low-dose-nivolumab-jco-2023.json