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Multicenter phase 2 study of neoadjuvant paclitaxel, estramustine phosphate, and carboplatin plus androgen deprivation before radiation therapy in patients with unfavorable-risk localized prostate cancer: results of Cancer and Leukemia Group B 99811.

Publication ,  Journal Article
Kelly, WK; Halabi, S; Elfiky, A; Ou, S-S; Bogart, J; Zelefsky, M; Small, E; Cancer Leukemia Group B,
Published in: Cancer
December 1, 2008

BACKGROUND: A multicenter phase 2 trial was conducted to evaluate the safety and feasibility of radiotherapy after paclitaxel, estramustine phosphate, and carboplatin (TEC) plus androgen deprivation therapy in previously untreated unfavorable-risk localized prostate cancer patients. METHODS: Patients with localized high-risk prostate cancer were treated with 4 cycles (16 weeks) of continuous weekly paclitaxel at 80 mg/m(2) intravenously with estramustine at 280 mg orally 3 times a day for 5 days a week and carboplatin (area under the curve of 6) on Day 1 of every cycle followed by 3-dimensional conformal or intensity-modulated radiotherapy (total dose of 77.4 gray [Gy] in 1.8-Gy fractions). All patients received androgen deprivation therapy with either goserelin acetate at 3.6 mg subcutaneously or leuprolide acetate at 7.5 mg intramuscularly monthly for 6 months starting at Day 1 of therapy. Patients were evaluated for acute and late toxicities along with progression-free survival and time to prostate-specific antigen (PSA) failure associated with the multimodality therapy. RESULTS: Twenty-seven of 34 patients completed therapy and were evaluable for safety and feasibility. There was 1 patient with grade 3 nausea during chemotherapy. No other grade 3 or 4 gastrointestinal, cardiovascular, or genitourinary acute or late toxicities were reported. The most common grade 1 to 2 late toxicities were proctitis (11%), dysuria (11%), and urinary frequency/urgency (33%). Two deaths due to prostate cancer were observed. Median follow-up was 38 months among 24 surviving patients; median PSA progression-free survival was 12.1 months (95% confidence interval, 13.3-25.9). CONCLUSIONS: Neoadjuvant chemohormonal therapy with TEC followed by high-dose radiation therapy is safe and feasible in a multicenter setting.

Duke Scholars

Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

December 1, 2008

Volume

113

Issue

11

Start / End Page

3137 / 3145

Location

United States

Related Subject Headings

  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Neoadjuvant Therapy
  • Middle Aged
  • Male
  • Humans
  • Feasibility Studies
  • Estramustine
 

Citation

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Kelly, W. K., Halabi, S., Elfiky, A., Ou, S.-S., Bogart, J., Zelefsky, M., … Cancer Leukemia Group B, . (2008). Multicenter phase 2 study of neoadjuvant paclitaxel, estramustine phosphate, and carboplatin plus androgen deprivation before radiation therapy in patients with unfavorable-risk localized prostate cancer: results of Cancer and Leukemia Group B 99811. Cancer, 113(11), 3137–3145. https://doi.org/10.1002/cncr.23910
Kelly, William Kevin, Susan Halabi, Aymen Elfiky, San-San Ou, Jeff Bogart, Michael Zelefsky, Eric Small, and Eric Cancer Leukemia Group B. “Multicenter phase 2 study of neoadjuvant paclitaxel, estramustine phosphate, and carboplatin plus androgen deprivation before radiation therapy in patients with unfavorable-risk localized prostate cancer: results of Cancer and Leukemia Group B 99811.Cancer 113, no. 11 (December 1, 2008): 3137–45. https://doi.org/10.1002/cncr.23910.
Journal cover image

Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

December 1, 2008

Volume

113

Issue

11

Start / End Page

3137 / 3145

Location

United States

Related Subject Headings

  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Neoadjuvant Therapy
  • Middle Aged
  • Male
  • Humans
  • Feasibility Studies
  • Estramustine