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Clinical Investigations |
Department of Neurological Surgery, University of California San Francisco, San Francisco, CA (K.R.L., S.M.C., M.D.P.); Department of Neuro-Oncology (W.K.A.Y., M.R.G., K.D.A.) and Data Management Center (J.H., P.M.P.), The University of Texas M. D. Anderson Cancer Center, Houston, TX; Dana-Farber Cancer Institute, Boston, MA (P.Y.W.); Department of Neurosurgery, University of California Los Angeles, Los Angeles, CA (T.F.C.); Memorial Sloan-Kettering Cancer Center, New York, NY (L.M.D., L.A.); University of Wisconsin Hospital, Madison, WI (H.I.R., M.M.); Division of Neuro-Oncology, University of Pittsburgh Medical Center Cancer Pavilion, Pittsburgh, PA (F.S.L.); Neuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD (H.A.F.); Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX (K.L.F.); Department of Neurology, University of Michigan Hospital, Ann Arbor, MI (L.J.); Pharmacotherapy Education and Research Center, The University of Texas Health Science Center, San Antonio, TX (J.G.K.); USA
Address correspondence to Kathleen R. Lamborn, Department of Neurological Surgery, University of California San Francisco, 400 Parnassus Ave., UC Clinics 808, San Francisco, CA 94143-0372 (lambornk{at}neurosurg.ucsf.edu).
The North American Brain Tumor Consortium (NABTC) uses 6-month progression-free survival (6moPFS) as the efficacy end point of therapy trials for adult patients with recurrent high-grade gliomas. In this study, we investigated whether progression status at 6 months predicts survival from that time, implying the potential for prolonged survival if progression could be delayed. We also evaluated earlier time points to determine whether the time of progression assessment alters the strength of the prediction. Data were from 596 patient enrollments (159 with grade III gliomas and 437 with grade IV tumors) in NABTC phase II protocols between February 1998 and December 2002. Outcome was assessed statistically using Kaplan-Meier curves and Cox proportional hazards models. Median survivals were 39 and 30 weeks for patients with grade III and grade IV tumors, respectively. Twenty-eight percent of patients with grade III and 16% of patients with grade IV tumors had progression-free survival of >26 weeks. Progression status at 9, 18, and 26 weeks predicted survival from those times for patients with grade III or grade IV tumors (p < 0.001 and hazard ratios < 0.5 in all cases). Including KPS, age, number of prior chemotherapies, and response in a multivariate model did not substantively change the results. Progression status at 6 months is a strong predictor of survival, and 6moPFS is a valid end point for trials of therapy for recurrent malignant glioma. Earlier assessments of progression status also predicted survival and may be incorporated in the design of future clinical trials.
Key Words: brain tumors • clinical trial end points • glioma • progression-free survival
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  S. M. Chang, K. R. Lamborn, J. G. Kuhn, W.K. A. Yung, M. R. Gilbert, P. Y. Wen, H. A. Fine, M. P. Mehta, L. M. DeAngelis, F. S. Lieberman, et al. Neurooncology clinical trial design for targeted therapies: Lessons learned from the North American Brain Tumor Consortium Neuro-oncol, August 1, 2008; 10(4): 631 - 642. [Abstract] [Full Text] [PDF]
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