Single-injection depot progesterone before surgery and survival in operable breast cancer
A single cheap hormone injection given days before breast surgery did not help every patient, but among women whose cancer had spread to lymph nodes it improved five-year survival, a result that seeded twenty years of low-cost perioperative trials in India.
Overview
976 women with operable breast cancer at Tata Memorial were randomised to one intramuscular injection of depot hydroxyprogesterone 5 to 14 days before surgery or to surgery alone, with a median follow-up of 65 months. Disease-free and overall survival were not significantly different overall. In node-positive women, 5-year disease-free survival was 65.3% versus 54.7% (hazard ratio 0.72; 95% CI 0.54-0.97; P=0.02) and overall survival 75.7% versus 66.8% (hazard ratio 0.70; 95% CI 0.49-0.99; P=0.04).
- No significant overall improvement in disease-free or overall survival.
- Node-positive subgroup: 5-year disease-free survival 65.3% versus 54.7% (HR 0.72).
- Node-positive subgroup: 5-year overall survival 75.7% versus 66.8% (HR 0.70).
- Intervention cost is a single injection of a generic hormone.
The trial did not change practice, but it established the idea that the days around surgery are a window in which cheap interventions might reduce metastasis, a line the same group pursued to a positive result with peritumoral lidocaine in 2023. It is a reminder that subgroup findings need confirmation, which is still awaited.
- The benefit is a subgroup finding in a trial whose primary analysis was negative.
- Mechanism (progesterone-driven changes in tumour gene expression) is plausible but unproven in humans.
- No confirmatory trial has yet reported.
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