Randomized Comparisons of Radiotherapy and Nitrosoureas for the Treatment of Malignant Glioma after Surgery

1980 New England Journal of Medicine 1,618 citations

Abstract

Within three weeks of definitive surgical intervention, 467 patients with histologically proved malignant glioma were randomized to receive one of four treatment regimens: semustine (MeCCNU), radiotherapy, carmustine (BCNU) plus radiotherapy, or semustine plus radiotherapy. We analyzed the data for the total randomized population and for the 358 patients in whom the initial protocol specifications were met (the valid study group). Observed toxicity included acceptable skin reactions secondary to radiotherapy and reversible leukopenia and thrombocytopenia due to chemotherapy. Radiotherapy used alone or in combination with a nitrosourea significantly improved survival in comparison with semustine alone. The group receiving carmustine plus radiotherapy had the best survival, but the difference in survival between the groups receiving carmustine plus radiotherapy and semustine plus radiotherapy was not statistically significant. The combination of carmustine plus radiotherapy produced a modest benefit in long-term (18-month) survival as compared with radiotherapy alone, although the difference between survival curves was not significiant at the 0.05 level. This study suggests that it is best to use radiotherapy in the post-surgical treatment of malignant glioma and to continue the search for an effective chemotherapeutic regimen to use in addition to radiotherapy.

Keywords

CarmustineMedicineRadiation therapyLomustineGliomaRandomized controlled trialChemotherapyRegimenSurgeryOncologyVincristineCyclophosphamide

MeSH Terms

AgedBrain NeoplasmsCarmustineClinical Trials as TopicDrug Administration ScheduleGliomaHumansMiddle AgedNitrosourea CompoundsPrognosisRadiotherapy DosageRandom AllocationSemustine

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Publication Info

Year
1980
Type
article
Volume
303
Issue
23
Pages
1323-1329
Citations
1618
Access
Closed

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1618
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30
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1282
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Cite This

Michael Walker, Sylvan B. Green, David P. Byar et al. (1980). Randomized Comparisons of Radiotherapy and Nitrosoureas for the Treatment of Malignant Glioma after Surgery. New England Journal of Medicine , 303 (23) , 1323-1329. https://doi.org/10.1056/nejm198012043032303

Identifiers

DOI
10.1056/nejm198012043032303
PMID
7001230

Data Quality

Data completeness: 81%