Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 24, Issue 24, Pages 3871-3879Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2005.04.6979
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Funding
- NCI NIH HHS [CA-52352, CA-37404, CA-35448, CA-15083, CA-25224, CA-37417, CA-35090, CA-60276, CA-35101, CA-35103, CA-63826, CA-35431, CA-63844, CA-63848, CA-35113, CA-63849, CA-35269, CA-35195, CA-35272, CA-35415, CA-45450] Funding Source: Medline
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Purpose In patients with newly diagnosed glioblastoma multiforme, to determine whether cisplatin plus carmustine (BCNU) administered before and concurrently with radiation therapy (RT) improves survival compared with BCNU and RT and whether survival using accelerated RT (ART) is equivalent to survival using standard RT (SRT). Patients and Methods After surgery, patients were stratified by age, performance score, extent of surgical resection, and histology (glioblastoma v gliosarcoma) and then randomly assigned to arm A (BCNU plus SRT), arm B (BCNU plus ART), arm C (cisplatin plus BCNU plus SRT), or arm D (cisplatin plus BCNU plus ART). Results Four hundred fifty-one patients were randomly assigned, and 401 were eligible. Frequent toxicities included myelosuppression, vomiting, sensory neuropathy, and ototoxicity and were worse with cisplatin. There was no difference in toxicity between SRT and ART. Median survival times and 2-year survival rates for patients who received BCNU plus RT (arms A and B) compared with cisplatin, BCNU, and RT (arms C and D) were 10.1 v 11.5 months, respectively, and 11.5% v 13.7%, respectively (P=.19). Median survival times and 2-year survival rates for patients who received SRT (arms A and C) compared with ART (arms B and D) were 11.2 v 10.5 months, respectively, and 13.8% v 11.4%, respectively (P=.33). Conclusion Cisplatin administered concurrently with BCNU and RT resulted in more toxicity but provided no significant improvement in survival. SRT and ART produced similar toxicity and survival.
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