{"entity":{"id":"paper-badwe-progesterone-jco-2011","kind":"paper","name":"Single-injection depot progesterone before surgery and survival in operable breast cancer","aka":[],"tldr":"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.","summary":"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).","asOf":"2026-09-10","links":[{"label":"JCO 2011","url":"https://doi.org/10.1200/JCO.2010.33.0738"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":[],"trials":["progesterone-preop-tmh","lidocaine-peritumoral-tmh"],"people":["badwe-rajendra"],"bottlenecks":["b-generic-repurposing"],"keyPapers":[],"journals":["jco"],"dependsOn":[],"notes":[],"journal":"Journal of Clinical Oncology","year":2011,"doi":"10.1200/JCO.2010.33.0738","authors":"Badwe R, Hawaldar R, Parmar V, et al.","paperType":"rct","findings":["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."],"whatItMeans":"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.","caveats":["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."],"changedPractice":false,"participants":976},"route":"/key-papers/paper-badwe-progesterone-jco-2011/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"}],"institution":[{"id":"tata-memorial","kind":"institution","name":"Tata Memorial Centre","route":"/institutions/tata-memorial/"}],"trial":[{"id":"lidocaine-peritumoral-tmh","kind":"trial","name":"Peritumoral lidocaine before breast cancer surgery (Tata Memorial)","route":"/trials/lidocaine-peritumoral-tmh/"},{"id":"progesterone-preop-tmh","kind":"trial","name":"Single-injection depot progesterone before breast surgery (Tata Memorial)","route":"/trials/progesterone-preop-tmh/"}],"person":[{"id":"badwe-rajendra","kind":"person","name":"Rajendra Badwe","route":"/people/badwe-rajendra/"}],"bottleneck":[{"id":"b-generic-repurposing","kind":"bottleneck","name":"No incentive to repurpose cheap drugs","route":"/bottlenecks/b-generic-repurposing/"}],"journal":[{"id":"jco","kind":"journal","name":"Journal of Clinical Oncology","route":"/journals/jco/"}]}}