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Evaluating the value of continuing docetaxel and prednisone (DP) beyond 10 cycles in men with metastatic castration-resistant prostate cancer (mCRPC).

Publication ,  Journal Article
Pond, GR; Armstrong, AJ; Wood, BA; Brookes, M; Leopold, LH; Berry, WR; De Wit, R; Eisenberger, MA; Tannock, I; Sonpavde, G
Published in: J Clin Oncol
May 20, 2011

4582 Background: The optimal number of cycles of 3-weekly DP therapy for mCRPC has not been ascertained. An exploratory analysis was conducted comparing results of 335 men on the DP arm of the TAX-327 study, which limited chemotherapy to 10 cycles, and a recently completed randomized clinical trial of 221 men allocated to either DP+AT-101 (bcl-2 inhibitor) versus DP+placebo, which allowed up to 17 cycles of DP. METHODS: Patients who initiated cycle 10 of therapy without progression in both studies were included. Per protocol, men on the TAX-327 study received 1 additional cycle, while men on the AT-101 study received up to cycle 17. Men in both arms of the AT-101 study were combined for analysis, as no significant differences in outcomes were observed. Overall survival (OS) was estimated from the cycle 10 D infusion date, using the Kaplan-Meier method. RESULTS: The number of men receiving cycle 10 cycle was similar (Fisher's exact test p-value=0.60) between the two studies (166 or 49.6% in the TAX-327 study versus 99 or 44.8% in the AT-101 study), though of these men, death date information was more complete due to longer follow-up in TAX-327 (79.5% versus 34.4%). Six- and 12-month estimated survival from cycle 10 was 92.2% (95% CI: 86.9-95.4%) and 74.6% (CI: 67.2-80.5%) for TAX-327 patients, compared with 92.8% (CI: 85.5-96.5) and 63.4% (CI: 51.8-72.9%) for those on AT-101. Survival statistics were similar beyond cycle 10 within good, intermediate and poor risk groups. 38 (38.4%) men on the AT-101 study completed all 17 cycles. Of men on the AT-101 study, 24 and 13 had consistently declining PSA through cycles 13 and 17. CONCLUSIONS: A survival benefit was not detected with more than 10 cycles of DP chemotherapy in men with mCRPC in this hypothesis-generating exploratory analysis. A subset of men with mCRPC continue to have declines in PSA up to cycle 17 and thus may have ongoing benefit to continued chemotherapy administration. However, a randomized clinical trial is necessary to establish the optimal duration of therapy.

Duke Scholars

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

May 20, 2011

Volume

29

Issue

15_suppl

Start / End Page

4582

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

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Pond, G. R., Armstrong, A. J., Wood, B. A., Brookes, M., Leopold, L. H., Berry, W. R., … Sonpavde, G. (2011). Evaluating the value of continuing docetaxel and prednisone (DP) beyond 10 cycles in men with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol, 29(15_suppl), 4582.
Pond, G. R., A. J. Armstrong, B. A. Wood, M. Brookes, L. H. Leopold, W. R. Berry, R. De Wit, M. A. Eisenberger, I. Tannock, and G. Sonpavde. “Evaluating the value of continuing docetaxel and prednisone (DP) beyond 10 cycles in men with metastatic castration-resistant prostate cancer (mCRPC).J Clin Oncol 29, no. 15_suppl (May 20, 2011): 4582.
Pond GR, Armstrong AJ, Wood BA, Brookes M, Leopold LH, Berry WR, et al. Evaluating the value of continuing docetaxel and prednisone (DP) beyond 10 cycles in men with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2011 May 20;29(15_suppl):4582.
Pond GR, Armstrong AJ, Wood BA, Brookes M, Leopold LH, Berry WR, De Wit R, Eisenberger MA, Tannock I, Sonpavde G. Evaluating the value of continuing docetaxel and prednisone (DP) beyond 10 cycles in men with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2011 May 20;29(15_suppl):4582.

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

May 20, 2011

Volume

29

Issue

15_suppl

Start / End Page

4582

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences