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Clinical Therapy TrialsOutcomes |
Departments of Neuro-Oncology (E.T.W., K.A.J., A.P.K., V.A.L., W.K.A.Y.) and Biomathematics (K.R.H.), The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030; and the Department of Neurological Surgery, University of California, San Francisco, CA 94143 (M.D.P.)
2 Address correspondence and reprint requests to Kenneth R. Hess, Ph.D., Department of Biomathematics, Box 237, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030.
Abstract
In this article we report the results of a study of the relationship between response and progression in 375 patients with recurrent glioma enrolled in phase II chemotherapy trials. We reviewed the records of patients from 8 consecutive phase II trials, including 225 patients with recurrent glioblastoma multiforme and 150 with recurrent anaplastic astrocytoma. Median age was 45 years (range, 1582) and median Karnofsky performance score was 80 (range, 60100). Forty-one patients (11%) had more than two prior resections and/or more than two prior chemotherapy regimens. Best response was complete (n = 1) or partial (n = 33) in 34 patients (9%). Median time to response was 14 weeks, and median response duration was 44 weeks. Simon-Makuch estimates for 52-week progression-free survival for patients progression-free at 13 weeks were 48% for response and 28% for nonresponse. When response was treated as a time-dependent covariate in a Cox proportional hazards regression analysis, response was associated with significantly lower failure rates (hazard ratio 0.5; 95% confidence interval 0.30.8; P = 0.0016). This study showed that response in recurrent glioma is associated with a significant reduction in progression rates.
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