OnCo
ideasIdea

Validate low-cost metronomic oral regimens in phase 3 and carry them into guidelines

Indian trials have shown that tiny daily doses of old oral chemotherapy drugs can help patients with head and neck cancer at a cost of a few dollars a month. These regimens should be proven and adopted worldwide.

Tata Memorial Centre's randomised trials of low-dose oral metronomic chemotherapy (methotrexate plus celecoxib, later triple metronomic therapy) in head and neck cancer reported survival comparable or superior to intravenous cisplatin in palliative settings at a fraction of the cost, and low-dose nivolumab added to metronomic therapy improved survival in another trial. These results have had limited uptake outside India. The proposal is a coordinated programme of confirmatory phase 3 trials in several LMICs across common cancers (head and neck, cervical, breast), with an explicit path to WHO essential medicines listing and guideline inclusion.

Hypothesis
Metronomic regimens confirmed in multinational phase 3 trials are non-inferior in overall survival to standard intravenous regimens in defined palliative settings at less than a tenth of the drug cost, and are adopted into WHO and national guidelines within two years of publication.
Rationale
The Indian trials are the most cost-effective oncology results of the past decade and were possible only because a public institution ran them; replication is the step that will make them global practice.
What would test it
Fund two multinational phase 3 trials in head and neck and cervical cancer across five LMICs with OS primary endpoints and cost-effectiveness analyses, with WHO involvement from the outset.
Maturity
early clinical
Who has to act
research
Cost to try
Medium ($1M to $50M)
Years to first evidence
5
Bottlenecks it attacks

Connected

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