Originally published as JCO Early Release 10.1200/JCO.2008.18.9159 on April 20 2009

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Progression-Free Survival as a Predictor of Overall Survival in Men With Castrate-Resistant Prostate Cancer

From the Department of Biostatistics and Bioinformatics, Duke University; Cancer and Leukemia Group B Statistical Center, Durham, NC; Nevada Cancer Institute, Las Vegas, NV; Fred Hutchinson Cancer Research Center, Seattle, WA; and University of California, San Francisco, CA.

Corresponding author: Susan Halabi, PhD, Department of Biostatistics and Bioinformatics, Duke University Medical Center, 2424 Erwin Rd, Durham, NC 27705; e-mail: susan.halabi{at}duke.edu.

Purpose To explore whether progression-free survival (PFS) or biochemical PFS can be used as a predictor of overall survival (OS) and to investigate the dependence between PFS and OS in men with castrate-resistant prostate cancer.

Patients and Methods Data from nine Cancer and Leukemia Group B trials that enrolled 1,296 men from 1991 to 2004 were pooled. Men were eligible if they had prostate cancer that had progressed during androgen deprivation therapy and did not receive prior treatment with chemotherapy, immunotherapy, or other nonhormonal therapy. Landmark analyses of PFS at 3 and 6 months from randomization/registration were performed to minimize lead time bias. The proportional hazards model was used to assess the significance effect of PFS rate at 3 and at 6 months in predicting OS. In addition, biochemical progression using the definitions of Prostate-Specific Antigen Working Group (PSAW) Criteria PSAWG1 and PSAWG2 were analyzed as time-dependent covariates in predicting OS.

Results The median survival time among men who experienced progression at 3 months was 9.2 months (95% CI, 8.0 to 10.0 months) compared with 17.8 months in men who did not experience progression at 3 months (95% CI, 16.2 to 20.4 months; P < .0001). Compared with men who did not progress at 3 and at 6 months, the adjusted hazard ratios for death were 2.0 (95% CI, 1.7 to 2.4; P < .001) and 1.9 (95% CI, 1.6 to 2.4; P < .001) for men who experienced progression at 3 and 6 months, respectively. In addition, biochemical progression at 3 months predicted OS. The association between PFS and OS was 0.30 (95% confidence limits = 0.26, 0.32).

Conclusion PFS at 3 and 6 months and biochemical progression at 3 months predict OS. These observations require prospective validation.

Supported in part by grants from the United States Department of Defense Grants No. DAMD 17-03-1-0112 and W81XWH-06-1-0032 and the National Cancer Institute (Grant No. CA 36601).

Presented in part in abstract format at the American Society of Clinical Oncology Genitourinary Symposium, San Francisco, CA, February 14-16, 2008

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

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