19029421 Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer. - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot

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

Active as of 2023-12-17

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Resource Citation "179631" Version "1" Updated "2023-11-26 22:35:32+0000"

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

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* Primary title (Title Type#primary) English (Tags for the Identification of Languages#en) 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. **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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citation: Yagoda A, Petrylak D: Cytotoxic chemotherapy for advanced hormone-resistant prostate cancer. Cancer 71:1098-1109, 1993
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citation: 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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citation: 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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citation: 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: 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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citation: 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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citation: 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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freeToShare: true
Components
- Type Classifier
* qualifier () is not a major topic ()
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Middle Aged (#D008875)
freeToShare: true
Components
- Type Classifier
* qualifier () is not a major topic ()
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Neoplasm Metastasis (#D009362)
freeToShare: true
Components
- Type Classifier
* qualifier () is not a major topic ()
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Prostatic Neoplasms (#D011471)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: drug therapy (#Q000188)
component
component
type: qualifier ()
classifier: mortality (#Q000401)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Vinblastine (#D014747)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: administration & dosage (#Q000008)
component