Fund trials that test shorter courses of the most expensive adjuvant drugs
The PERSEPHONE trial showed six months of trastuzumab after surgery is as good as twelve, halving the drug cost; no company will run such trials, so public funders and charities must.
Overview
PERSEPHONE (Earl et al., Lancet 2019) randomised 4,089 women with HER2-positive early breast cancer to six or twelve months of adjuvant trastuzumab and found four-year disease-free survival of 89.4% versus 89.8%, meeting non-inferiority, with less cardiotoxicity. Adjuvant durations for checkpoint inhibitors (one year), CDK4/6 inhibitors (two to three years) and PARP inhibitors (one year) were set without duration-finding studies. A dedicated de-escalation trial fund, on the model of the UK National Institute for Health and Care Research that paid for PERSEPHONE, would test the highest-spend adjuvant regimens.
- Wrong doses · Most drug doses were chosen as the highest a person can tolerate, which is often more than they need.
- Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
- Incentives reward me-too drugs and marginal gains · The system pays the same for a drug that adds two months as for a cure, so companies race to copy rather than to cure.
Pages like this
not linked directly; found by shared links- IdeaA public fund for trials that test less treatment
Shares Trastuzumab, Cancer Research UK, Incentives reward me-too drugs and marginal gains, Trial design, endpoints and cost.
- IdeaDisclose R&D and manufacturing costs of publicly funded cancer drugs to get coverage
Shares Cancer Research UK, Incentives reward me-too drugs and marginal gains, National Cancer Institute (NIH), Prices and value.
- PersonHelena Earl
Shares PERSEPHONE, Trastuzumab, HER2-positive breast cancer.
- PersonAndrew Wardley
Shares PERSEPHONE, Trastuzumab, HER2-positive breast cancer.
- IdeaAn abbreviated approval path for follow-on antibodies within a validated class
Shares Trastuzumab, Incentives reward me-too drugs and marginal gains, Trial design, endpoints and cost, Prices and value.
- IdeaPublicly funded dose-reduction trials of expensive approved drugs
Shares Wrong doses, Incentives reward me-too drugs and marginal gains, Prices and value, Pembrolizumab.
- TermTrastuzumab cardiotoxicity
Shares PERSEPHONE, Trastuzumab, HER2-positive breast cancer.
- IdeaPublish per-patient trial cost benchmarks and target halving them
Shares Cancer Research UK, National Cancer Institute (NIH), Trial design, endpoints and cost.