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The Brain Tumor Cooperative Group NIH Trial 87-01: A Randomized
Comparison of Surgery, External Radiotherapy, and Carmustine versus
Surgery, Interstitial Radiotherapy Boost, External Radiation Therapy, and
Carmustine
The Brain Tumor Cooperative Group; Robert G. Selker, M.D.; William
R. Shapiro, M.D.; Peter Burger, M.D.; Margaret S. Blackwood, M.S.; Melvin
Deutsch, M.D.; Vincent C. Arena, Ph.D.; John C. Van Gilder, M.D.;
Julian Wu, M.D.; Mark G. Malkin, M.D.; John Mealey, Jr., M.D.; John
H. Neal, M.D.; Jeffrey Olson, M.D.; James T. Robertson, M.D.; Gene H. Barnett,
M.D.; Stephen Bloomfield, M.D.; Robert Albright, M.D.; Fred H. Hochberg, M.D.;
Emile Hiesiger, M.D.; Sylvan Green, M.D.
Objective.
The objective of the Brain Tumor Cooperative Group NIH Trial
87-01 trial was to investigate the effect of additional
implanted radiation therapy in newly diagnosed patients with
pathologically confirmed malignant gliomas.
Methods. The study involved a randomized comparison of
surgery, external beam radiotherapy, and carmustine (BCNU) versus
surgery, external beam therapy, interstitial radiotherapy boost, and
BCNU in newly diagnosed malignant gliomas.
125I was chosen as best suited for this effort
because it allowed preimplantation planning and postimplantation
quality assurance review.
Two hundred ninety-nine patients met the eligibility criteria
and were randomized into the two arms of the study between
December 1987 and April 1994.
Follow-up continued for an additional 3 years.
Twenty-nine patients were identified as having committed protocol
violations and were excluded, resulting in 270 subjects in the
Valid Study Group.
One hundred thirty-seven patients received external beam radiation
and BCNU, and 133 underwent the 125I implantation
plus external beam radiation and BCNU therapy.
Results. The overall median survival for the Valid Study
Group was 64.3 weeks.
The median survival for patients receiving additional therapy of 125I
was 68.1 weeks, and median survival for those receiving only
external beam radiation and BCNU was 58.8 weeks.
The cumulative proportion surviving between the two treatment
groups was not statistically significantly different (log-rank test,
P = 0.101).
As in other studies in the literature, age, Karnofsky score, and
pathology were predictors of mortality.
Additional analyses incorporating an adjustment for these prognostic
variables, either in a stratified analysis or Cox proportional
hazards model, did not result in statistically significant differences
in the cumulative proportion of patients surviving between the two
treatment groups.
Conclusion.We conclude that there is no long-term
survival advantage of increased radiation dose with 125I
seeds in newly diagnosed glioma patients.
Key words: Chemotherapy; Interstitial radiation; Malignant glioma;
Quality assurance
Copyright © by the Congress of Neurological Surgeons.
All Rights Reserved.
Source: http://www.neurosurgery-online.com/abstracts/5102/NURO51020343_abs.html
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