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Comparison
of survival of patients in the phase I study of motexafin gadolinium (MGd) with
radiation therapy (RT) for glioblastoma multiforme (GBM), with a matched cohort
of patients from the RTOG RPA glioma database
J. M. Ford, W. Seiferheld, M. Mehta, S. Phan, W.
Curran
UCLA,
Los Angeles, CA; Radiation Therapy Oncology Group, Philadelphia, PA; University
of Wisconsin, Madison, WI; Pharmacyclics Inc., Sunnyvale, CA; Thomas Jefferson
University, Philadelphia, PA
Aim. To compare the survival of patients with
GBM treated in the phase I study of motexafin gadolinium in combination with
radiation, with a matched cohort of patients from the RTOG Recursive
Partitioning Analysis (RPA) glioma database.
Methods. Data were available for 33 cases
treated on the phase I trial.
These were matched with 33 cases from the RTOG database according to the
following prognostic factors: Karnofsky Performance Status, extent of surgery,
histology, and age (within 5 years).
Kaplan-Meier survival curves were generated.
A matched pair Cox analysis of overall survival was done and the generalized
Wilcoxon (Peto-Prentice) test was used for a nonparametric comparison.
Results. Kaplan-Meier estimate of median
survival time for the RTOG cases was 12.0 months compared to 17.6 months for the
cases treated with motexafin gadolinium.
The Cox analysis of overall survival yielded a hazard ratio of 2.0 in favor of
the motexafin gadolinium treated cases (p=0.07).
The generalized Wilcoxon test also resulted in a one-sided p-value of 0.07.
Discussion. Studies of chemotherapy for GBM
suggest at best a median survival benefit in the range of 3 months, yet
chemotherapy is routinely given to many patients; therefore, a survival benefit
of 5.6 months is of interest.
The numbers of patients are small, but they were well matched for the major
prognostic factors.
Conclusion.
The results of this well matched
case control comparison showed a potential survival benefit of 5 to 6 months
from the use of motexafin gadolinium in combination with standard radiation
therapy for Glioblastoma Multiforme.
This result should be further investigated with either a larger phase II trial
or a randomized trial in a multi-center setting.
© Copyright 2003
American Society of Clinical Oncology All rights
reserved worldwide
Source:
http://www.asco.org/ac/1,1003,_12-002489-00_18-002003-00_19-00102399-00_29-00A,00.asp?cat=CNS+Tumors&parent=
Central+Nervous+System+Tumors&returnpid=2325&SubCat_ID=4 |
