{"entity":{"id":"paper-petrylak-swog-9916-docetaxel-estramustine-nejm-2004","kind":"paper","name":"SWOG 9916: docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer","aka":["SWOG 9916","Petrylak 2004 docetaxel estramustine"],"tldr":"Published in the same issue as TAX 327 and reaching the same conclusion by a different route: docetaxel extends life in advanced prostate cancer. The extra drug it was paired with, estramustine, brought enough side effects that it was dropped from practice.","summary":"Daniel Petrylak and the Southwest Oncology Group randomised 770 men with metastatic androgen-independent prostate cancer to docetaxel with estramustine or to mitoxantrone with prednisone; 674 were eligible for analysis. Overall survival was the primary endpoint.\n\nThe pair of trials published in the New England Journal of Medicine on 7 October 2004 is the reason docetaxel became standard. TAX 327 gave the better toxicity profile and the schedule that survived; SWOG 9916 gave the independent replication. The estramustine combination produced more febrile neutropenia, more nausea and vomiting and more cardiovascular events, and did not deliver a better survival result, so the simpler regimen won.","asOf":"2026-09-25","links":[{"label":"N Engl J Med 2004","url":"https://doi.org/10.1056/nejmoa041318"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/15470214/"}],"tags":["prostate-evidence"],"related":["paper-tannock-tax-327-docetaxel-prednisone-nejm-2004","chemotherapy-roadmap","prostate-roadmap"],"cancers":["prostate","prostate-mcrpc"],"sections":["chemotherapy"],"technologies":[],"targets":[],"drugs":["docetaxel","mitoxantrone","estramustine","prednisone"],"companies":[],"institutions":[],"pathways":[],"terms":["castration-resistance","psa"],"trials":[],"people":[],"bottlenecks":["b-toxicity-qol","b-resistance"],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2004,"doi":"10.1056/nejmoa041318","pmid":"15470214","authors":"Petrylak DP, Tangen CM, Hussain MH, et al.","paperType":"rct","findings":["Median overall survival 17.5 months with docetaxel and estramustine against 15.6 months with mitoxantrone and prednisone (P equals 0.02; hazard ratio for death 0.80, 95 percent confidence interval 0.67 to 0.97).","Median time to progression 6.3 months against 3.2 months (P less than 0.001).","Declines in prostate-specific antigen of at least 50 percent in 50 percent against 27 percent (P less than 0.001).","Objective tumour responses in 17 percent against 11 percent of patients with bidimensionally measurable disease (P equals 0.30).","Grade 3 or 4 neutropenic fevers (P equals 0.01), nausea and vomiting (P less than 0.001) and cardiovascular events (P equals 0.001) were more common with docetaxel and estramustine; pain relief was similar in both groups."],"whatItMeans":"The confirmatory half of the 2004 result. Two independent trials, two different docetaxel regimens, the same direction of effect: this is why docetaxel was adopted quickly and why it survived the move into hormone-sensitive disease a decade later.","caveats":["The comparison bundles docetaxel with estramustine, so the trial cannot say how much of the benefit or the harm each drug contributed; TAX 327 answered that by omitting estramustine.","96 of 770 randomised men were ineligible, and the analysis is of the 674 eligible.","Cardiovascular events were significantly more common in the experimental arm, which is why estramustine is no longer used."],"changedPractice":true,"participants":770},"route":"/key-papers/paper-petrylak-swog-9916-docetaxel-estramustine-nejm-2004/","neighbours":{"paper":[{"id":"paper-tannock-tax-327-docetaxel-prednisone-nejm-2004","kind":"paper","name":"TAX 327: docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer","route":"/key-papers/paper-tannock-tax-327-docetaxel-prednisone-nejm-2004/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"},{"id":"prostate-roadmap","kind":"roadmap","name":"Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch","route":"/roadmaps/prostate-roadmap/"}],"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"}],"drug":[{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"estramustine","kind":"drug","name":"Estramustine","route":"/drugs/estramustine/"},{"id":"mitoxantrone","kind":"drug","name":"Mitoxantrone","route":"/drugs/mitoxantrone/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"term":[{"id":"castration-resistance","kind":"term","name":"Castration-resistant prostate cancer (CRPC)","route":"/terms/castration-resistance/"},{"id":"psa","kind":"term","name":"PSA (prostate-specific antigen)","route":"/terms/psa/"}],"bottleneck":[{"id":"b-resistance","kind":"bottleneck","name":"Acquired resistance to every therapy","route":"/bottlenecks/b-resistance/"},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}