{"entity":{"id":"metronomic-vs-cisplatin-tmh","kind":"trial","name":"Oral metronomic chemotherapy vs intravenous cisplatin (Tata Memorial)","aka":[],"tldr":"Two cheap tablets taken at home matched, and in fact beat, intravenous cisplatin for advanced head and neck cancer in a 422-patient Indian trial, with fewer side effects.","summary":"An open-label non-inferiority phase 3 randomised 422 patients (213 oral metronomic, 209 cisplatin). Median overall survival was 7.5 months with oral metronomic chemotherapy versus 6.1 months with cisplatin (hazard ratio 0.773; 95% CI 0.615-0.97; P=0.026), meeting non-inferiority and favouring the oral regimen, with grade 3 or worse adverse events in 19% versus 30%. The authors noted that NCCN-recommended options apply to fewer than 3% of patients in low- and middle-income settings because of cost. The regimen became the backbone for the later low-dose nivolumab trial and for METRO PLUS.","status":"positive","asOf":"2026-09-10","links":[{"label":"Patil et al., Lancet Global Health 2020","url":"https://doi.org/10.1016/S2214-109X(20)30275-8"}],"tags":[],"related":[],"cancers":["head-and-neck","oral-cavity-cancer","recurrent-metastatic-hnscc","buccal-mucosa-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["methotrexate","cisplatin","celecoxib"],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":[],"trials":[],"people":["patil-vijay","prabhash-kumar","noronha-vanita"],"bottlenecks":["b-generic-repurposing","b-drug-pricing","b-global-access"],"keyPapers":["paper-patil-lancet-glob-health"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Recurrent, metastatic or inoperable head and neck carcinoma, palliative intent: oral methotrexate 15 mg/m2 weekly plus celecoxib 200 mg twice daily vs intravenous cisplatin","sponsor":"Tata Memorial Centre","result":"Median OS 7.5 vs 6.1 months, HR 0.773; grade 3+ adverse events 19% vs 30%.","yearReported":2020,"enrolled":422,"enrolledBasis":"registry","outcomes":[{"endpoint":"Median overall survival","primary":true,"unit":"months","arms":[{"name":"Oral metronomic (methotrexate + celecoxib)","n":213,"value":7.5},{"name":"IV cisplatin","n":209,"value":6.1}],"hr":0.773,"ci":[0.615,0.97],"p":"0.026","source":"https://doi.org/10.1016/S2214-109X(20)30275-8"}]},"route":"/trials/metronomic-vs-cisplatin-tmh/","neighbours":{"cancer":[{"id":"buccal-mucosa-cancer","kind":"cancer","name":"Buccal mucosa and gingivobuccal cancer (oral cancer in India)","route":"/cancers/buccal-mucosa-cancer/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-negative-head-and-neck-cancer","kind":"cancer","name":"HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)","route":"/cancers/hpv-negative-head-and-neck-cancer/"},{"id":"oral-cavity-cancer","kind":"cancer","name":"Oral cavity cancer (mouth and tongue)","route":"/cancers/oral-cavity-cancer/"},{"id":"oral-tongue-cancer","kind":"cancer","name":"Oral tongue and floor of mouth cancer","route":"/cancers/oral-tongue-cancer/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"celecoxib","kind":"drug","name":"Celecoxib","route":"/drugs/celecoxib/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"methotrexate","kind":"drug","name":"Methotrexate","route":"/drugs/methotrexate/"}],"institution":[{"id":"tata-memorial","kind":"institution","name":"Tata Memorial Centre","route":"/institutions/tata-memorial/"}],"person":[{"id":"prabhash-kumar","kind":"person","name":"Kumar Prabhash","route":"/people/prabhash-kumar/"},{"id":"noronha-vanita","kind":"person","name":"Vanita Noronha","route":"/people/noronha-vanita/"},{"id":"patil-vijay","kind":"person","name":"Vijay Patil","route":"/people/patil-vijay/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-generic-repurposing","kind":"bottleneck","name":"No incentive to repurpose cheap drugs","route":"/bottlenecks/b-generic-repurposing/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"}],"paper":[{"id":"paper-patil-lancet-glob-health","kind":"paper","name":"Low-cost oral metronomic chemotherapy versus intravenous cisplatin in patients with recurrent, metastatic, inoperable head and neck carcinoma: an open-label, parallel-group, non-inferiority, randomised, phase 3 trial","route":"/key-papers/paper-patil-lancet-glob-health/"}],"trial":[{"id":"metro-plus-varanasi","kind":"trial","name":"METRO PLUS (Tata Memorial Centre, Varanasi)","route":"/trials/metro-plus-varanasi/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"},{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}