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Quality of Life and Pain in Advanced Stage Prostate Cancer: Results of a Southwest Oncology Group Randomized Trial Comparing Docetaxel and Estramustine to Mitoxantrone and Prednisone

Donna L. Berry, Carol M. Moinpour, Caroline S. Jiang, Donna Pauler Ankerst, Daniel P. Petrylak, Lynne V. Vinson, Primo N. Lara, Sharon Jones, Mary E. Taplin, Patrick A. Burch, Maha H.A. Hussain, E. David Crawford

From the University of Washington; Southwest Oncology Group Statistical Center/Fred Hutchinson Cancer Research Center, Seattle, WA; Columbia Presbyterian Medical Center, New York, NY; Central Arkansas Veterans’ Affairs Healthcare System, Little Rock, AR; University of California Davis Cancer Center, Sacramento, CA; Southeastern Medical Oncology Center, Goldsboro, NC; Dana-Farber Cancer Institute, Boston, MA; Mayo Clinic, Rochester, MN; University of Michigan, Ann Arbor, MI; and the University of Colorado Cancer Center, Denver, CO

Address reprint requests to Donna L. Berry, PhD, Box 357266, University of Washington, Seattle, WA 98195-7266; e-mail: donnalb{at}u.washington.edu

PURPOSE: Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms.

METHODS: Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions.

RESULTS: Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms.

CONCLUSION: DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.

Presented in part in poster format at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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