Single-injection depot progesterone before breast surgery (Tata Memorial)
A single cheap hormone injection before breast surgery did not help every woman, but in those whose cancer had reached the lymph nodes it improved survival at five years, a finding still being tested.
Overview
976 women with operable breast cancer were randomised to a single preoperative injection of depot hydroxyprogesterone or no injection, with a median follow-up of 65 months. Disease-free survival and overall survival were not significantly improved overall, but in node-positive patients 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). Badwe and colleagues concluded that a simple, inexpensive intervention deserved confirmation; the same group's later randomised trial of peritumoral lidocaine at surgery (1,583 women) did show a survival gain, keeping the perioperative window a live research theme in India.
- 65.3 vs 54.7 out of 100 alive without the cancer coming back at 5 years with Progesterone compared with Control; 10.6 more per 100.
- Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 28 percent lower chance of the event at any given time (hazard ratio 0.72, likely range 0.54 to 0.97).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Operable breast cancer: one intramuscular injection of hydroxyprogesterone 5 to 14 days before surgery vs no injection. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
976 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 5-year disease-free survival, node-positive subgroup | Progesterone | — | 65.3% | 0.72 (0.54–0.97) | 0.02 | link |
| Control | — | 54.7% |
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