Evidence Based Medicine on FHIR Implementation Guide
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Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

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

Active as of 2024-12-19

Generated Narrative: Citation 179631

version: 9; Last updated: 2024-11-22 19:14:41+0000

Profile: JournalArticleCitation

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/https://fevir.net/FOI/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

version: 2.0.0-ballot

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

status: Active

date: 2024-12-19 14:29:51+0000

publisher: HL7 International / Clinical Decision Support

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

description:

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

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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.

Abstracts

-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. 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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type: cites

classifier: Journal Article

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Yagoda A, Petrylak D: Cytotoxic chemotherapy for advanced hormone-resistant prostate cancer. Cancer 71:1098-1109, 1993

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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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Kelly WK, Curley T, Slovin S, et al: Paclitaxel, estramustine phosphate, and carboplatin in patients with advanced prostate cancer. J Clin Oncol 19:44-53, 2001

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citation:

Millikan RE, Thall PF, Lee SJ, et al: Randomized multicenter phase II trial of two multicomponent regimens in androgen independent prostate cancer. J Clin Oncol 21:878-883, 2003

Documents

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Petrylak DP, Tangen CM, Hussain MH, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004

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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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Murphy GP, Huben RP, Priore R: Results of another trial of chemotherapy with and without hormones in patients with newly diagnosed metastatic prostate cancer. Urology 28:36-40, 1986

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Osborne CK, Blumenstein B, Crawford ED, et al: Combined versus sequential chemo-endocrine therapy in advanced prostate cancer: Final results of a randomized Southwest Oncology Group study. J Clin Oncol 8:1675-1682, 1990

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Pummer K, Lehnert M, Stettner H, et al: Randomized comparison of total androgen blockade alone versus combined with weekly epirubicin in advanced prostate cancer. Eur Urol 32:81-85, 1997. (suppl)

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Janknegt RA, Boon TA, van de Beek C, et al: Combined hormono/chemotherapy as primary treatment for metastatic prostate cancer: A randomized, multicenter study of orchiectomy alone versus orchiectomy plus estramustine phosphate. Urology 49:411-420, 1997

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Fontana D, Bertetto O, Fasolis G, et al: Randomized comparison of goserelin acetate versus mitomycin C plus goserelin acetate in previously untreated prostate cancer patients with bone metastases. Tumori 84:39-44, 1998

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Boel K, Van Poppel H, Goethuys H, et al: Mitomycin C for metastatic prostate cancer: Final analysis of a randomized trial. Anticancer Res 19:2157-2161, 1999

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de Reijke TM, Keuppens FI, Whelan P, et al: Orchiectomy and orchiectomy plus mitomycin C for metastatic prostate cancer in patients with poor prognosis: The final results of a European organization for research in cancer therapy genitourinary group trial. J Urol 162:1658-1664, 1999

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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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Hussain M, Tangen CM, Higano C, et al: Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: Data from the Southwest Oncology Group trial 9346 (INT-0162). J Clin Oncol 24:3984-3990, 2006

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Stewart AJ, Scher HI, Chen M-H, et al: Prostate-specific antigen nadir and cancer-specific mortality following hormonal therapy for prostate-specific antigen failure. J Clin Oncol 23:6556-6560, 2005

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Friedman J, Dunn RL, Wood D, et al: Neoadjuvant docetaxel and capecitabine in patients with high risk prostate cancer. J Urol 179:911-916, 2008

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

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