Pilot Trial of Adjuvant Paclitaxel Plus Estramustine in Resected High-Risk Prostate Cancer

Jeremy Cetnar, S. Bruce Malkowicz, Steven C. Palmer, Alan J. Wein, David J. Vaughn

Research output: Contribution to journalArticle

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Abstract

Objectives: To determine the feasibility and toxicity of adjuvant paclitaxel plus estramustine in prostate cancer patients at high risk of a 2-year PSA failure after prostatectomy. Methods: Patients with prostate adenocarcinoma who underwent radical prostatectomy with at least a 50% probability of PSA failure at 2 years postprostatectomy received 4 cycles of paclitaxel 90 mg/m2 by 1-hour infusion, weekly for 3 weeks, followed by a 1-week treatment rest. Patients received estramustine phosphate 140 mg orally 3 times daily on the day before, the day of, and the day after paclitaxel administration. Patients received warfarin 1 mg daily to prevent thromboembolism. Serum PSA was measured monthly during adjuvant therapy, then every 3 months for a minimum of 2 years. Results: Between December 2001 and September 2004, 17 patients underwent radical prostatectomy and received protocol treatment at the University of Pennsylvania. The median risk of a 2-year PSA failure was 70%. Five (30%) patients had PSA failure develop after radical prostatectomy. The median time to PSA failure was 19 months. A statistically significant difference (P = 0.001) was noted between the expected rate of PSA failure (0.70) and the actual rate of PSA failure (0.30). Grade 3 to 4 toxicities were uncommon and included thromboembolism (6%) and neutropenia (6%). All patients completed 4 cycles of therapy and there were no treatment related deaths. Conclusions: The adjuvant use of paclitaxel and estramustine in resected high-risk prostate cancer patients is feasible and well tolerated. Adjuvant cytotoxic chemotherapy deserves further investigation with randomized studies.

Original languageEnglish (US)
Pages (from-to)942-946
Number of pages5
JournalUrology
Volume71
Issue number5
DOIs
StatePublished - May 2008
Externally publishedYes

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Estramustine
Paclitaxel
Prostatic Neoplasms
Prostatectomy
Thromboembolism
Warfarin
Therapeutics
Adjuvant Chemotherapy
Clinical Protocols
Neutropenia
Prostate
Adenocarcinoma
Phosphates

ASJC Scopus subject areas

  • Urology

Cite this

Pilot Trial of Adjuvant Paclitaxel Plus Estramustine in Resected High-Risk Prostate Cancer. / Cetnar, Jeremy; Malkowicz, S. Bruce; Palmer, Steven C.; Wein, Alan J.; Vaughn, David J.

In: Urology, Vol. 71, No. 5, 05.2008, p. 942-946.

Research output: Contribution to journalArticle

Cetnar, Jeremy ; Malkowicz, S. Bruce ; Palmer, Steven C. ; Wein, Alan J. ; Vaughn, David J. / Pilot Trial of Adjuvant Paclitaxel Plus Estramustine in Resected High-Risk Prostate Cancer. In: Urology. 2008 ; Vol. 71, No. 5. pp. 942-946.
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abstract = "Objectives: To determine the feasibility and toxicity of adjuvant paclitaxel plus estramustine in prostate cancer patients at high risk of a 2-year PSA failure after prostatectomy. Methods: Patients with prostate adenocarcinoma who underwent radical prostatectomy with at least a 50{\%} probability of PSA failure at 2 years postprostatectomy received 4 cycles of paclitaxel 90 mg/m2 by 1-hour infusion, weekly for 3 weeks, followed by a 1-week treatment rest. Patients received estramustine phosphate 140 mg orally 3 times daily on the day before, the day of, and the day after paclitaxel administration. Patients received warfarin 1 mg daily to prevent thromboembolism. Serum PSA was measured monthly during adjuvant therapy, then every 3 months for a minimum of 2 years. Results: Between December 2001 and September 2004, 17 patients underwent radical prostatectomy and received protocol treatment at the University of Pennsylvania. The median risk of a 2-year PSA failure was 70{\%}. Five (30{\%}) patients had PSA failure develop after radical prostatectomy. The median time to PSA failure was 19 months. A statistically significant difference (P = 0.001) was noted between the expected rate of PSA failure (0.70) and the actual rate of PSA failure (0.30). Grade 3 to 4 toxicities were uncommon and included thromboembolism (6{\%}) and neutropenia (6{\%}). All patients completed 4 cycles of therapy and there were no treatment related deaths. Conclusions: The adjuvant use of paclitaxel and estramustine in resected high-risk prostate cancer patients is feasible and well tolerated. Adjuvant cytotoxic chemotherapy deserves further investigation with randomized studies.",
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N2 - Objectives: To determine the feasibility and toxicity of adjuvant paclitaxel plus estramustine in prostate cancer patients at high risk of a 2-year PSA failure after prostatectomy. Methods: Patients with prostate adenocarcinoma who underwent radical prostatectomy with at least a 50% probability of PSA failure at 2 years postprostatectomy received 4 cycles of paclitaxel 90 mg/m2 by 1-hour infusion, weekly for 3 weeks, followed by a 1-week treatment rest. Patients received estramustine phosphate 140 mg orally 3 times daily on the day before, the day of, and the day after paclitaxel administration. Patients received warfarin 1 mg daily to prevent thromboembolism. Serum PSA was measured monthly during adjuvant therapy, then every 3 months for a minimum of 2 years. Results: Between December 2001 and September 2004, 17 patients underwent radical prostatectomy and received protocol treatment at the University of Pennsylvania. The median risk of a 2-year PSA failure was 70%. Five (30%) patients had PSA failure develop after radical prostatectomy. The median time to PSA failure was 19 months. A statistically significant difference (P = 0.001) was noted between the expected rate of PSA failure (0.70) and the actual rate of PSA failure (0.30). Grade 3 to 4 toxicities were uncommon and included thromboembolism (6%) and neutropenia (6%). All patients completed 4 cycles of therapy and there were no treatment related deaths. Conclusions: The adjuvant use of paclitaxel and estramustine in resected high-risk prostate cancer patients is feasible and well tolerated. Adjuvant cytotoxic chemotherapy deserves further investigation with randomized studies.

AB - Objectives: To determine the feasibility and toxicity of adjuvant paclitaxel plus estramustine in prostate cancer patients at high risk of a 2-year PSA failure after prostatectomy. Methods: Patients with prostate adenocarcinoma who underwent radical prostatectomy with at least a 50% probability of PSA failure at 2 years postprostatectomy received 4 cycles of paclitaxel 90 mg/m2 by 1-hour infusion, weekly for 3 weeks, followed by a 1-week treatment rest. Patients received estramustine phosphate 140 mg orally 3 times daily on the day before, the day of, and the day after paclitaxel administration. Patients received warfarin 1 mg daily to prevent thromboembolism. Serum PSA was measured monthly during adjuvant therapy, then every 3 months for a minimum of 2 years. Results: Between December 2001 and September 2004, 17 patients underwent radical prostatectomy and received protocol treatment at the University of Pennsylvania. The median risk of a 2-year PSA failure was 70%. Five (30%) patients had PSA failure develop after radical prostatectomy. The median time to PSA failure was 19 months. A statistically significant difference (P = 0.001) was noted between the expected rate of PSA failure (0.70) and the actual rate of PSA failure (0.30). Grade 3 to 4 toxicities were uncommon and included thromboembolism (6%) and neutropenia (6%). All patients completed 4 cycles of therapy and there were no treatment related deaths. Conclusions: The adjuvant use of paclitaxel and estramustine in resected high-risk prostate cancer patients is feasible and well tolerated. Adjuvant cytotoxic chemotherapy deserves further investigation with randomized studies.

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