Generated Narrative: Citation 179631

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

identifier: FEvIR Object Identifier/179631, https://pubmed.ncbi.nlm.nih.gov/19029421, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.42

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

status: Active

date: 2024-11-21 14:09:14+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

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approvalDate: 2009-01-13

lastReviewDate: 2023-02-02

author: Computable Publishing®: MEDLINE-to-FEvIR Converter:

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citedArtifact

identifier: https://pubmed.ncbi.nlm.nih.gov/19029421, https://www.ncbi.nlm.nih.gov/pmc//PMC3864402, https://doi.org/10.1200/JCO.2007.15.9830, pii/JCO.2007.15.9830

Titles

-	Type	Language	Text
*	Primary title	English	Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer.

Abstracts

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Text

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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. 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. 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. CONCLUSION: There is no role for ketoconazole and doxorubicin alternating with vinblastine and estramustine before emergence of a castrate-resistant phenotype.

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Beer T, Raghavan D: Chemotherapy for hormone-refractory prostate cancer: Beauty is in the eye of the beholder. Prostate 45:184-193, 2000

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Ellerhorst JA, Tu SM, Amato RJ, et al: Phase II trial of alternating weekly chemohormonal therapy for patients with androgen-independent prostate cancer. Clin Cancer Res 3:2371-2376, 1997

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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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Tannock IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004

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Murphy GP, Beckley S, Brady MF, et al: Treatment of newly diagnosed metastatic prostate cancer patients with chemotherapy agents in combination with hormones versus hormones alone. Cancer 51:1264-1272, 1983

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Noguchi M, Noda Shinshi, Yoshida M, et al: Chemohormonal therapy as primary treatment for metastatic prostate cancer: A randomized study of estramustine phosphate plus luteinizing hormone-releasing hormone agonist versus flutamide plus luteinizing hormone-releasing hormone agonist. Int J Urol 11:103-109, 2004

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identifier: Electronic ISSN Type/1527-7755, ISOAbbreviation/J Clin Oncol, ISSN Linking/0732-183X, Medline Title Abbreviation/J Clin Oncol, NLM Unique ID/8309333

title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology

publisherLocation: United States

citedMedium: Internet

volume: 26

issue: 36

articleDate: 2008-12-20

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classifier: Androgen Antagonists, Antibiotics, Antineoplastic, Antineoplastic Agents, Alkylating, Antineoplastic Agents, Phytogenic, Estramustine, Vinblastine, Doxorubicin, Ketoconazole

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affiliation: Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, 1155 Pressler, CPB7.3462, Houston, TX 77030, USA. rmillika@mdanderson.org

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

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