# Oral metronomic chemotherapy vs intravenous cisplatin (Tata Memorial)

Source: https://onco.cc/trials/metronomic-vs-cisplatin-tmh/  
OnCo record `metronomic-vs-cisplatin-tmh` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- 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
- Enrolled: 422
- Result: Median OS 7.5 vs 6.1 months, HR 0.773; grade 3+ adverse events 19% vs 30%.
- Outcomes: Median overall survival: Oral metronomic (methotrexate + celecoxib) 7.5 months vs IV cisplatin 6.1 months, HR 0.773

## Sources

- Patil et al., Lancet Global Health 2020: https://doi.org/10.1016/S2214-109X(20)30275-8

## Connected records

- cancers: [Buccal mucosa and gingivobuccal cancer (oral cancer in India)](https://onco.cc/cancers/buccal-mucosa-cancer/), [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)](https://onco.cc/cancers/hpv-negative-head-and-neck-cancer/), [Oral cavity cancer (mouth and tongue)](https://onco.cc/cancers/oral-cavity-cancer/), [Oral tongue and floor of mouth cancer](https://onco.cc/cancers/oral-tongue-cancer/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Celecoxib](https://onco.cc/drugs/celecoxib/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Methotrexate](https://onco.cc/drugs/methotrexate/)
- institutions: [Tata Memorial Centre](https://onco.cc/institutions/tata-memorial/)
- 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: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [No incentive to repurpose cheap drugs](https://onco.cc/bottlenecks/b-generic-repurposing/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)
- key papers: [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](https://onco.cc/key-papers/paper-patil-lancet-glob-health/)
- trials: [METRO PLUS (Tata Memorial Centre, Varanasi)](https://onco.cc/trials/metro-plus-varanasi/)
- roadmaps: [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/), [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/)

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