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A Multi-institutional Pooled Analysis

William U. Shipley, MD; Howard D. Thames, PhD; Howard M. Sandler, MD; Gerald E. Hanks, MD; Anthony L. Zietman, MD; Carlos A. Perez, MD; Deborah A. Kuban, MD; Steven L. Hancock, MD; Cyndi D. Smith

JAMA. 1999;281:1598-1604.

Context  Prostate-specific antigen (PSA) evaluation leads to the early detection of both prostate cancer and recurrences following primary treatment. Prostate-specific antigen outcome information on patients 5 or more years following treatment is limited and available mainly as single-institution reports.

Objectives  To assess the likelihood and durability of tumor control using PSA evaluation 5 or more years after radical external beam radiation therapy and to identify pretreatment prognostic factors in men with early prostate cancer treated since 1988, the PSA era.

Design and Setting  Retrospective, nonrandomized, multi-institutional pooled analysis of patients treated with external beam radiation therapy alone between 1988 and 1995 at 6 US medical centers. Follow-up lasted up to a maximum of 9 years. Outcome data were analyzed using Cox regression and recursive partitioning techniques.

Patients  A total of 1765 men with stage T1b, T1c, and T2 tumors treated between 1988 and 1995 with external beam radiation. The majority (58%) of patients were older than 70 years and 24.2% had initial PSA values of 20 ng/mL or higher. A minimum of 2 years of subsequent follow-up was required for participation.

Main Outcome Measure  Actuarial estimates of freedom from biochemical failure.

Results  The 5-year estimates of overall survival, disease-specific survival, and the freedom from biochemical failure are 85.0% (95% confidence interval [CI], 82.5%-87.6%), 95.1% (95% CI, 94.0%-96.2%), and 65.8% (95% CI, 62.8%-68.0%), respectively. The PSA failure-free rates 5 and 7 years after treatment for patients presenting with a PSA of less than 10 ng/mL were 77.8% (95% CI, 74.5%-81.3%), and 72.9% (95% CI, 67.9%-78.2%). Recursive partitioning analysis of initial PSA level, palpation stage, and the Gleason score groupings yielded 4 separate prognostic groups: group 1, included patients with a PSA level of less than 9.2 ng/mL; group 2, PSA level of at least 9.2 but less than 19.7 ng/mL; group 3, PSA level at least 19.7 ng/mL and a Gleason score of 2 to 6; and group 4, PSA level of at least 19.7 ng/mL and a Gleason score of 7 to 10. The estimated rates of survival free of biochemical failure at 5 years are 81% for group 1, 69% for group 2, 47% for group 3, and 29% for group 4. Of the 302 patients followed up beyond 5 years who were free of biochemical disease, 5.0% relapsed from the fifth to the eighth year.

Conclusions  Estimated PSA control rates in this pooled analysis are similar to those of single institutions. These rates indicate the probability of success for subsets of patients with tumors of several prognostic category groupings. These results represent a multi-institutional benchmark for evidence-based counseling of prostate cancer patients about radiation treatment.

Author Affiliations: Department of Radiation Oncology, Massachusetts General Hospital, Boston (Drs Shipley and Zietman); Department of Biomathematics, MD Anderson Cancer Center, University of Texas, Houston (Dr Thames and Ms Smith); Department of Radiation Oncology, University of Michigan Medical Center, Ann Arbor (Dr Sandler); Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pa (Dr Hanks); Mallinckrodt Institute of Radiology, Washington University, St Louis, Mo (Dr Perez); Department of Radiation Oncology, Eastern Virginia Medical School, Norfolk (Dr Kuban); and Department of Radiation Oncology, Stanford University Medical Center, Palo Alto, Calif (Dr Hancock).

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