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url: https://fevir.net/resources/Citation/179631

identifier: FEvIR Object Identifier/179631, https://pubmed.ncbi.nlm.nih.gov/19029421

title: 19029421 Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer.

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Titles

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Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer.

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PURPOSE: We conducted a phase III trial in patients with previously untreated metastatic prostate cancer to test the hypothesis that three 8-week cycles of ketoconazole and doxorubicin alternating with vinblastine and estramustine, given in addition to standard androgen deprivation, would delay the appearance of castrate-resistant disease.\nPATIENTS AND METHODS: Eligible patients had metastatic prostate cancer threatening enough to justify sustained androgen ablation and were fit enough for chemotherapy. The primary end point was time to castrate-resistant progression as shown by increasing prostate-specific antigen, new radiographic lesions, worsening cancer-related symptoms, or receipt of any other systemic therapy.\nRESULTS: Three hundred six patients were registered; 286 are reported. Median time to progression was 24 months (95% CI, 18 to 39 months) in the standard therapy arm, and 35 months (95% CI, 26 to 44 months) in the chemohormonal group (P = .39). At median follow-up of 6.4 years, overall survival was 5.4 years (95% CI, 4.7 to 7.8 years) in the standard therapy arm versus 6.1 years (95% CI, 5.1 to 10.1 years; P = .41). Prostate-specific antigen kinetics at the time of androgen ablation and the nadir after hormone treatment were strongly correlated with survival. Chemotherapy significantly increased the burden of therapy, with 51% of patients experiencing an adverse event of grade 3 or worse, especially thromboembolic events.\nCONCLUSION: There is no role for ketoconazole and doxorubicin alternating with vinblastine and estramustine before emergence of a castrate-resistant phenotype.

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Smith DC, Esper P, Strawderman M, et al: Phase II trial of oral estramustine, oral etoposide, and intravenous paclitaxel in hormone-refractory prostate cancer. J Clin Oncol 17:1664-1671, 1999

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"https://www.ncbi.nlm.nih.gov/pmc/", "value" : "PMC3864402" }, { "system" : "https://doi.org", "value" : "10.1200/JCO.2007.15.9830" }, { "type" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v2-0203", "code" : "ACSN", "display" : "Accession ID" }], "text" : "pii" }, "value" : "JCO.2007.15.9830" }], "title" : [{ "type" : [{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/title-type", "code" : "primary", "display" : "Primary title" }] }], "text" : "Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer." }], "abstract" : [{ "type" : [{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/cited-artifact-abstract-type", "code" : "primary-human-use", "display" : "Primary human use" }] }], "text" : "**PURPOSE:** We conducted a phase III trial in patients with previously untreated metastatic prostate cancer to test the hypothesis that three 8-week cycles of ketoconazole and doxorubicin alternating with vinblastine and estramustine, given in addition to standard androgen deprivation, would delay the appearance of castrate-resistant disease.\n**PATIENTS AND METHODS:** Eligible patients had metastatic prostate cancer threatening enough to justify sustained androgen ablation and were fit enough for chemotherapy. The primary end point was time to castrate-resistant progression as shown by increasing prostate-specific antigen, new radiographic lesions, worsening cancer-related symptoms, or receipt of any other systemic therapy.\n**RESULTS:** Three hundred six patients were registered; 286 are reported. Median time to progression was 24 months (95% CI, 18 to 39 months) in the standard therapy arm, and 35 months (95% CI, 26 to 44 months) in the chemohormonal group (P = .39). At median follow-up of 6.4 years, overall survival was 5.4 years (95% CI, 4.7 to 7.8 years) in the standard therapy arm versus 6.1 years (95% CI, 5.1 to 10.1 years; P = .41). Prostate-specific antigen kinetics at the time of androgen ablation and the nadir after hormone treatment were strongly correlated with survival. Chemotherapy significantly increased the burden of therapy, with 51% of patients experiencing an adverse event of grade 3 or worse, especially thromboembolic events.\n**CONCLUSION:** There is no role for ketoconazole and doxorubicin alternating with vinblastine and estramustine before emergence of a castrate-resistant phenotype." }], "relatesTo" : [{ "type" : "cites", "classifier" : [{ "coding" : [{ "system" : "http://hl7.org/fhir/citation-artifact-classifier", "code" : "D016428", "display" : "Journal Article" }] }], "citation" : "Jemal A, Siegel R, Ward E, et al: Cancer Statistics, 2007. 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