Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Low-Dose Immunotherapy in Head and Neck Cancer: A Randomized Study.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 96 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
96 citing papers in PubMed, 5 syntheses or guidelines pooled it, 187 citations in OpenAlex.
- Efficacy and safety of immunotherapy in head and neck tumors: a systematic review and meta-analysis of clinical outcomes and survival benefits.Frontiers in oncology · 2026Pooled it
- Efficacy of Immune Checkpoint Inhibitors in the Treatment for Head and Neck Cancer Patients: A Systematic Review and Network Meta-Analysis.Oncology research · 2025Pooled it
- Efficacy of oral metronomic chemotherapy in the management of head and neck squamous cell carcinoma-a systematic review.Frontiers in oral health · 2025Pooled it
- Efficacy and safety of immunotherapy for head and neck squamous cell carcinoma: a meta-analysis of randomized clinical trials.Frontiers in oncology · 2024Pooled it
- Efficacy and safety of immune checkpoint inhibitors in recurrent or metastatic head and neck squamous cell carcinoma: A systematic review and meta-analysis of randomized clinical trials.Cancer medicine · 2023Pooled it
- Metronomic chemotherapy plus anti-PD-1 in metastatic breast cancer: a Bayesian adaptive randomized phase 2 trial.Nature medicine · 2024Trial
- Repurposing pantoprazole in combination with systemic therapy in advanced head and neck squamous cell carcinoma: a phase I/II randomized study.Medical oncology (Northwood, London, England) · 2023Trial
- Article
- The Immune Checkpoint Inhibitors Journey: From Early Promise to Lasting Impact.Journal of immunotherapy and precision oncology · 2026Review
- Evidence for Dose Optimization of Immune Checkpoint Inhibitors.Journal of immunotherapy and precision oncology · 2026Article
- Head and neck squamous cell carcinoma: current and emerging therapeutic strategies.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- Neoadjuvant chemotherapy in women with triple-negative breast cancer: real world results from Western Kenya.The oncologist · 2026Article
- Translational modelling challenges receptor‑occupancy‑based dosing of PD‑1 inhibitors like pembrolizumab.British journal of cancer · 2026Article
- Carbon Footprint of Antibody-Based Drugs and Biologics Using Hybrid Life Cycle Assessment.Clinical pharmacology and therapeutics · 2026Article
- Article
- Remarkable response to personalized combination immunotherapy of nivolumab plus ipilimumab in an 84-year-old patient with locally advanced squamous cell carcinoma: a case report.Translational lung cancer research · 2026Article
- A real-world study of the effectiveness and safety of low-dose immunotherapy in addition to oral metronomic chemotherapy in recurrent and metastatic head and neck squamous cell carcinoma.Journal of the Egyptian National Cancer Institute · 2026Observational
- Asiatic acid promotes CD8Acta pharmacologica Sinica · 2026Article
- Article
- Article
36 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
27 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe regimens approved for the treatment of advanced head and neck squamous cell carcinoma are accessible to only 1%-3% of patients in low- and middle-income countries because of their cost. In our previous study, metronomic chemotherapy improved survival in this setting. Retrospective data suggest that a low dose of nivolumab may be efficacious. Hence, we aimed to assess whether the addition of low-dose nivolumab to triple metronomic chemotherapy (TMC) improved overall survival (OS).
methodsThis was a randomized phase III superiority study. Adult patients with recurrent or newly diagnosed advanced head and neck squamous cell carcinoma being treated with palliative intent with an Eastern Cooperative Oncology Group performance status of 0-1 were eligible. Patients were randomly assigned 1:1 to TMC consisting of oral methotrexate 9 mg/m
resultsOne hundred fifty-one patients were randomly assigned, 75 in TMC and 76 in the TMC-I arm. The addition of low-dose nivolumab led to an improvement in the 1-year OS from 16.3% (95% CI, 8.0 to 27.4) to 43.4% (95% CI, 30.8 to 55.3; hazard ratio, 0.545; 95% CI, 0.362 to 0.820;
conclusionTo our knowledge, this is the first-ever randomized study to demonstrate that the addition of low-dose nivolumab to metronomic chemotherapy improved OS and is an alternative standard of care for those who cannot access full-dose checkpoint inhibitors.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.