Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer

A Hoosier Oncology Group and Fox Chase Network Phase III Trial

Gary Hudes, Lawrence Einhorn, Eric Ross, Andrew Balsham, Patrick Loehrer, Harry Ramsey, John Sprandio, Michael Entmacher, William Dugan, Rafat Ansari, Frank Monaco, Mark Hanna, Bruce Roth

Research output: Contribution to journalArticle

201 Citations (Scopus)

Abstract

Purpose: To compare vinblastine versus the combination of vinblastine plus estramustine as treatment for patients with hormone-refractory prostate cancer (HRPC). Patients and Methods: A total of 201 patients with metastatic prostate cancer, progressive after hormonal therapy and antiandrogen withdrawal (if prior antiandrogen treatment), were randomized to receive vinblastine (V) 4 mg/m2 by intravenous bolus weekly for 6 weeks followed by 2 weeks off, either alone or together with estramustine phosphate (EM-V) 600 mg/m2 PO days 1 through 42, repeated every 8 weeks. Of 193 eligible patients, 98 received V, and 95 received EM-V. Results: Overall survival trended in favor of EM-V but was not significantly different as determined by Kaplan-Meier analysis (P = .08). Median survival was 11.9 months for EM-V and 9.2 months for V. EM-V was superior to V for secondary end points of time to progression (P < .001, stratified log rank test; median 3.7 v 2.2 months, respectively) and for proportion of patients with ≥ 50% prostate-specific antigen (PSA) decline sustained for at least 3 monthly measurements (25.2% v 3.2%, respectively; P < .0001). Granulocytopenia was significantly less for EM-V compared with V (grade 2, 3, and 4 = 7%, 7%, and 1% v 27%, 18% and 9%, respectively; P < .0001); however, grade 2 or worse nausea (26% v 7%, respectively; P = .0002) and extremity edema (22% v 8%, respectively; P = .005) were more frequent for EM-V. Conclusion: Although overall survival was not significantly greater for the combination, EM-V was superior to V for time to progression and PSA improvement. These results encourage further study of estramustine-based antimicrotubule drug combinations in HRPC.

Original languageEnglish
Pages (from-to)3160-3166
Number of pages7
JournalJournal of Clinical Oncology
Volume17
Issue number10
StatePublished - Oct 1999

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Estramustine
Vinblastine
Prostatic Neoplasms
Phosphates
Hormones
Androgen Antagonists
Prostate-Specific Antigen
Survival
Agranulocytosis
Kaplan-Meier Estimate
Drug Combinations
Nausea
Edema
Therapeutics
Extremities

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer : A Hoosier Oncology Group and Fox Chase Network Phase III Trial. / Hudes, Gary; Einhorn, Lawrence; Ross, Eric; Balsham, Andrew; Loehrer, Patrick; Ramsey, Harry; Sprandio, John; Entmacher, Michael; Dugan, William; Ansari, Rafat; Monaco, Frank; Hanna, Mark; Roth, Bruce.

In: Journal of Clinical Oncology, Vol. 17, No. 10, 10.1999, p. 3160-3166.

Research output: Contribution to journalArticle

Hudes, G, Einhorn, L, Ross, E, Balsham, A, Loehrer, P, Ramsey, H, Sprandio, J, Entmacher, M, Dugan, W, Ansari, R, Monaco, F, Hanna, M & Roth, B 1999, 'Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer: A Hoosier Oncology Group and Fox Chase Network Phase III Trial', Journal of Clinical Oncology, vol. 17, no. 10, pp. 3160-3166.
Hudes, Gary ; Einhorn, Lawrence ; Ross, Eric ; Balsham, Andrew ; Loehrer, Patrick ; Ramsey, Harry ; Sprandio, John ; Entmacher, Michael ; Dugan, William ; Ansari, Rafat ; Monaco, Frank ; Hanna, Mark ; Roth, Bruce. / Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer : A Hoosier Oncology Group and Fox Chase Network Phase III Trial. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 10. pp. 3160-3166.
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title = "Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer: A Hoosier Oncology Group and Fox Chase Network Phase III Trial",
abstract = "Purpose: To compare vinblastine versus the combination of vinblastine plus estramustine as treatment for patients with hormone-refractory prostate cancer (HRPC). Patients and Methods: A total of 201 patients with metastatic prostate cancer, progressive after hormonal therapy and antiandrogen withdrawal (if prior antiandrogen treatment), were randomized to receive vinblastine (V) 4 mg/m2 by intravenous bolus weekly for 6 weeks followed by 2 weeks off, either alone or together with estramustine phosphate (EM-V) 600 mg/m2 PO days 1 through 42, repeated every 8 weeks. Of 193 eligible patients, 98 received V, and 95 received EM-V. Results: Overall survival trended in favor of EM-V but was not significantly different as determined by Kaplan-Meier analysis (P = .08). Median survival was 11.9 months for EM-V and 9.2 months for V. EM-V was superior to V for secondary end points of time to progression (P < .001, stratified log rank test; median 3.7 v 2.2 months, respectively) and for proportion of patients with ≥ 50{\%} prostate-specific antigen (PSA) decline sustained for at least 3 monthly measurements (25.2{\%} v 3.2{\%}, respectively; P < .0001). Granulocytopenia was significantly less for EM-V compared with V (grade 2, 3, and 4 = 7{\%}, 7{\%}, and 1{\%} v 27{\%}, 18{\%} and 9{\%}, respectively; P < .0001); however, grade 2 or worse nausea (26{\%} v 7{\%}, respectively; P = .0002) and extremity edema (22{\%} v 8{\%}, respectively; P = .005) were more frequent for EM-V. Conclusion: Although overall survival was not significantly greater for the combination, EM-V was superior to V for time to progression and PSA improvement. These results encourage further study of estramustine-based antimicrotubule drug combinations in HRPC.",
author = "Gary Hudes and Lawrence Einhorn and Eric Ross and Andrew Balsham and Patrick Loehrer and Harry Ramsey and John Sprandio and Michael Entmacher and William Dugan and Rafat Ansari and Frank Monaco and Mark Hanna and Bruce Roth",
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T1 - Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer

T2 - A Hoosier Oncology Group and Fox Chase Network Phase III Trial

AU - Hudes, Gary

AU - Einhorn, Lawrence

AU - Ross, Eric

AU - Balsham, Andrew

AU - Loehrer, Patrick

AU - Ramsey, Harry

AU - Sprandio, John

AU - Entmacher, Michael

AU - Dugan, William

AU - Ansari, Rafat

AU - Monaco, Frank

AU - Hanna, Mark

AU - Roth, Bruce

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N2 - Purpose: To compare vinblastine versus the combination of vinblastine plus estramustine as treatment for patients with hormone-refractory prostate cancer (HRPC). Patients and Methods: A total of 201 patients with metastatic prostate cancer, progressive after hormonal therapy and antiandrogen withdrawal (if prior antiandrogen treatment), were randomized to receive vinblastine (V) 4 mg/m2 by intravenous bolus weekly for 6 weeks followed by 2 weeks off, either alone or together with estramustine phosphate (EM-V) 600 mg/m2 PO days 1 through 42, repeated every 8 weeks. Of 193 eligible patients, 98 received V, and 95 received EM-V. Results: Overall survival trended in favor of EM-V but was not significantly different as determined by Kaplan-Meier analysis (P = .08). Median survival was 11.9 months for EM-V and 9.2 months for V. EM-V was superior to V for secondary end points of time to progression (P < .001, stratified log rank test; median 3.7 v 2.2 months, respectively) and for proportion of patients with ≥ 50% prostate-specific antigen (PSA) decline sustained for at least 3 monthly measurements (25.2% v 3.2%, respectively; P < .0001). Granulocytopenia was significantly less for EM-V compared with V (grade 2, 3, and 4 = 7%, 7%, and 1% v 27%, 18% and 9%, respectively; P < .0001); however, grade 2 or worse nausea (26% v 7%, respectively; P = .0002) and extremity edema (22% v 8%, respectively; P = .005) were more frequent for EM-V. Conclusion: Although overall survival was not significantly greater for the combination, EM-V was superior to V for time to progression and PSA improvement. These results encourage further study of estramustine-based antimicrotubule drug combinations in HRPC.

AB - Purpose: To compare vinblastine versus the combination of vinblastine plus estramustine as treatment for patients with hormone-refractory prostate cancer (HRPC). Patients and Methods: A total of 201 patients with metastatic prostate cancer, progressive after hormonal therapy and antiandrogen withdrawal (if prior antiandrogen treatment), were randomized to receive vinblastine (V) 4 mg/m2 by intravenous bolus weekly for 6 weeks followed by 2 weeks off, either alone or together with estramustine phosphate (EM-V) 600 mg/m2 PO days 1 through 42, repeated every 8 weeks. Of 193 eligible patients, 98 received V, and 95 received EM-V. Results: Overall survival trended in favor of EM-V but was not significantly different as determined by Kaplan-Meier analysis (P = .08). Median survival was 11.9 months for EM-V and 9.2 months for V. EM-V was superior to V for secondary end points of time to progression (P < .001, stratified log rank test; median 3.7 v 2.2 months, respectively) and for proportion of patients with ≥ 50% prostate-specific antigen (PSA) decline sustained for at least 3 monthly measurements (25.2% v 3.2%, respectively; P < .0001). Granulocytopenia was significantly less for EM-V compared with V (grade 2, 3, and 4 = 7%, 7%, and 1% v 27%, 18% and 9%, respectively; P < .0001); however, grade 2 or worse nausea (26% v 7%, respectively; P = .0002) and extremity edema (22% v 8%, respectively; P = .005) were more frequent for EM-V. Conclusion: Although overall survival was not significantly greater for the combination, EM-V was superior to V for time to progression and PSA improvement. These results encourage further study of estramustine-based antimicrotubule drug combinations in HRPC.

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