Phase II evaluation of early oral estramustine, oral etoposide, and intravenous paclitaxel combined with hormonal therapy in patients with high-risk metastatic prostate adenocarcinoma: Southwest Oncology Group S0032

David C. Smith, Cathy M. Tangen, Peter J. Van Veldhuizen, Grant W. Harrer, Ali Golshayan, Glenn M. Mills, Nicholas J. Vogelzang, Ian M. Thompson, Maha H A Hussain

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Objectives: To assess the efficacy of a multiagent taxane-based chemotherapy combined with hormonal therapy in men with metastatic androgen-dependent prostate cancer in a multicenter, cooperative group, single-arm trial. Methods: A total of 41 patients with newly diagnosed metastatic prostate cancer involving both the axial and the appendicular skeletons or viscera were enrolled. Of the 41 patients, 35 were treated with combined androgen blockade and ≤4 cycles of oral estramustine (280 mg orally 3 times daily) and etoposide (50 mg/m2 daily) for 14 days of each 21-day cycle, with paclitaxel (135 mg/m2 intravenously within 1 hour) on day 2 of each cycle. Chemotherapy was started within 30 days of the initiation of hormonal therapy. The patients were followed up to determine the progression-free survival. Results: The 35 patients received a total of 126 cycles of chemotherapy, with 30 receiving all 4 cycles. The median progression-free survival for the evaluable population was 13 months (95% confidence interval 10-16), with a median overall survival of 38 months (95% confidence interval 28-49). The main toxicities were myelosuppression, with 9 patients experiencing grade 3 or greater neutropenia and 1 developing grade 4 thrombocytopenia. One patient died of neutropenic infection. Thrombosis embolism occurred 4 times (3 of grade 4 and 1 of grade 3), with 1 episode of grade 4 cardiac ischemia. Conclusions: The results of our study have shown that the administration of chemotherapy to this population is feasible, with moderate toxicity. Taxane-based chemotherapy did not demonstrate significant efficacy in this high-risk population of patients with a poor prognosis.

Original languageEnglish (US)
Pages (from-to)1172-1176
Number of pages5
JournalUrology
Volume77
Issue number5
DOIs
StatePublished - May 2011
Externally publishedYes

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Estramustine
Etoposide
Paclitaxel
Prostate
Adenocarcinoma
Drug Therapy
Therapeutics
Androgens
Disease-Free Survival
Prostatic Neoplasms
Embolism and Thrombosis
Confidence Intervals
Population
Viscera
Neutropenia
Skeleton
Ischemia
Survival

ASJC Scopus subject areas

  • Urology

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Phase II evaluation of early oral estramustine, oral etoposide, and intravenous paclitaxel combined with hormonal therapy in patients with high-risk metastatic prostate adenocarcinoma : Southwest Oncology Group S0032. / Smith, David C.; Tangen, Cathy M.; Van Veldhuizen, Peter J.; Harrer, Grant W.; Golshayan, Ali; Mills, Glenn M.; Vogelzang, Nicholas J.; Thompson, Ian M.; Hussain, Maha H A.

In: Urology, Vol. 77, No. 5, 05.2011, p. 1172-1176.

Research output: Contribution to journalArticle

Smith, David C. ; Tangen, Cathy M. ; Van Veldhuizen, Peter J. ; Harrer, Grant W. ; Golshayan, Ali ; Mills, Glenn M. ; Vogelzang, Nicholas J. ; Thompson, Ian M. ; Hussain, Maha H A. / Phase II evaluation of early oral estramustine, oral etoposide, and intravenous paclitaxel combined with hormonal therapy in patients with high-risk metastatic prostate adenocarcinoma : Southwest Oncology Group S0032. In: Urology. 2011 ; Vol. 77, No. 5. pp. 1172-1176.
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abstract = "Objectives: To assess the efficacy of a multiagent taxane-based chemotherapy combined with hormonal therapy in men with metastatic androgen-dependent prostate cancer in a multicenter, cooperative group, single-arm trial. Methods: A total of 41 patients with newly diagnosed metastatic prostate cancer involving both the axial and the appendicular skeletons or viscera were enrolled. Of the 41 patients, 35 were treated with combined androgen blockade and ≤4 cycles of oral estramustine (280 mg orally 3 times daily) and etoposide (50 mg/m2 daily) for 14 days of each 21-day cycle, with paclitaxel (135 mg/m2 intravenously within 1 hour) on day 2 of each cycle. Chemotherapy was started within 30 days of the initiation of hormonal therapy. The patients were followed up to determine the progression-free survival. Results: The 35 patients received a total of 126 cycles of chemotherapy, with 30 receiving all 4 cycles. The median progression-free survival for the evaluable population was 13 months (95{\%} confidence interval 10-16), with a median overall survival of 38 months (95{\%} confidence interval 28-49). The main toxicities were myelosuppression, with 9 patients experiencing grade 3 or greater neutropenia and 1 developing grade 4 thrombocytopenia. One patient died of neutropenic infection. Thrombosis embolism occurred 4 times (3 of grade 4 and 1 of grade 3), with 1 episode of grade 4 cardiac ischemia. Conclusions: The results of our study have shown that the administration of chemotherapy to this population is feasible, with moderate toxicity. Taxane-based chemotherapy did not demonstrate significant efficacy in this high-risk population of patients with a poor prognosis.",
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T1 - Phase II evaluation of early oral estramustine, oral etoposide, and intravenous paclitaxel combined with hormonal therapy in patients with high-risk metastatic prostate adenocarcinoma

T2 - Southwest Oncology Group S0032

AU - Smith, David C.

AU - Tangen, Cathy M.

AU - Van Veldhuizen, Peter J.

AU - Harrer, Grant W.

AU - Golshayan, Ali

AU - Mills, Glenn M.

AU - Vogelzang, Nicholas J.

AU - Thompson, Ian M.

AU - Hussain, Maha H A

PY - 2011/5

Y1 - 2011/5

N2 - Objectives: To assess the efficacy of a multiagent taxane-based chemotherapy combined with hormonal therapy in men with metastatic androgen-dependent prostate cancer in a multicenter, cooperative group, single-arm trial. Methods: A total of 41 patients with newly diagnosed metastatic prostate cancer involving both the axial and the appendicular skeletons or viscera were enrolled. Of the 41 patients, 35 were treated with combined androgen blockade and ≤4 cycles of oral estramustine (280 mg orally 3 times daily) and etoposide (50 mg/m2 daily) for 14 days of each 21-day cycle, with paclitaxel (135 mg/m2 intravenously within 1 hour) on day 2 of each cycle. Chemotherapy was started within 30 days of the initiation of hormonal therapy. The patients were followed up to determine the progression-free survival. Results: The 35 patients received a total of 126 cycles of chemotherapy, with 30 receiving all 4 cycles. The median progression-free survival for the evaluable population was 13 months (95% confidence interval 10-16), with a median overall survival of 38 months (95% confidence interval 28-49). The main toxicities were myelosuppression, with 9 patients experiencing grade 3 or greater neutropenia and 1 developing grade 4 thrombocytopenia. One patient died of neutropenic infection. Thrombosis embolism occurred 4 times (3 of grade 4 and 1 of grade 3), with 1 episode of grade 4 cardiac ischemia. Conclusions: The results of our study have shown that the administration of chemotherapy to this population is feasible, with moderate toxicity. Taxane-based chemotherapy did not demonstrate significant efficacy in this high-risk population of patients with a poor prognosis.

AB - Objectives: To assess the efficacy of a multiagent taxane-based chemotherapy combined with hormonal therapy in men with metastatic androgen-dependent prostate cancer in a multicenter, cooperative group, single-arm trial. Methods: A total of 41 patients with newly diagnosed metastatic prostate cancer involving both the axial and the appendicular skeletons or viscera were enrolled. Of the 41 patients, 35 were treated with combined androgen blockade and ≤4 cycles of oral estramustine (280 mg orally 3 times daily) and etoposide (50 mg/m2 daily) for 14 days of each 21-day cycle, with paclitaxel (135 mg/m2 intravenously within 1 hour) on day 2 of each cycle. Chemotherapy was started within 30 days of the initiation of hormonal therapy. The patients were followed up to determine the progression-free survival. Results: The 35 patients received a total of 126 cycles of chemotherapy, with 30 receiving all 4 cycles. The median progression-free survival for the evaluable population was 13 months (95% confidence interval 10-16), with a median overall survival of 38 months (95% confidence interval 28-49). The main toxicities were myelosuppression, with 9 patients experiencing grade 3 or greater neutropenia and 1 developing grade 4 thrombocytopenia. One patient died of neutropenic infection. Thrombosis embolism occurred 4 times (3 of grade 4 and 1 of grade 3), with 1 episode of grade 4 cardiac ischemia. Conclusions: The results of our study have shown that the administration of chemotherapy to this population is feasible, with moderate toxicity. Taxane-based chemotherapy did not demonstrate significant efficacy in this high-risk population of patients with a poor prognosis.

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