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Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma.
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- Author(s): Perry, James R.; Laperriere, Normand; O'Callaghan, Christopher J.; Brandes, Alba A.; Menten, Johan; Phillips, Claire; Fay, Michael; Ryo Nishikawa; Cairncross, J. Gregory; Roa, Wilson; Osoba, David; Rossiter, John P.; Sahgal, Arjun; Hirte, Hal; Laigle-Donadey, Florence; Franceschi, Enrico; Chinot, Olivier; Golfinopoulos, Vassilis; Fariselli, Laura; Wick, Antje
- Source:
New England Journal of Medicine. 3/16/2017, Vol. 376 Issue 11, p1027-1037. 11p. - Source:
- Additional Information
- Subject Terms: TEMOZOLOMIDE; RADIOTHERAPY; OLDER patients; GLIOBLASTOMA multiforme treatment; DRUG therapy; MEDICAL care; CENTRAL nervous system tumors; COMPARATIVE studies; GLIOMAS; RESEARCH methodology; MEDICAL cooperation; QUALITY of life; RESEARCH; SURVIVAL analysis (Biometry); EVALUATION research; RANDOMIZED controlled trials; DISEASE progression; DACARBAZINE; THERAPEUTICS
- Abstract:
Background: Glioblastoma is associated with a poor prognosis in the elderly. Survival has been shown to increase among patients 70 years of age or younger when temozolomide chemotherapy is added to standard radiotherapy (60 Gy over a period of 6 weeks). In elderly patients, more convenient shorter courses of radiotherapy are commonly used, but the benefit of adding temozolomide to a shorter course of radiotherapy is unknown.Methods: We conducted a trial involving patients 65 years of age or older with newly diagnosed glioblastoma. Patients were randomly assigned to receive either radiotherapy alone (40 Gy in 15 fractions) or radiotherapy with concomitant and adjuvant temozolomide.Results: A total of 562 patients underwent randomization, 281 to each group. The median age was 73 years (range, 65 to 90). The median overall survival was longer with radiotherapy plus temozolomide than with radiotherapy alone (9.3 months vs. 7.6 months; hazard ratio for death, 0.67; 95% confidence interval [CI], 0.56 to 0.80; P<0.001), as was the median progression-free survival (5.3 months vs. 3.9 months; hazard ratio for disease progression or death, 0.50; 95% CI, 0.41 to 0.60; P<0.001). Among 165 patients with methylated O6-methylguanine-DNA methyltransferase (MGMT) status, the median overall survival was 13.5 months with radiotherapy plus temozolomide and 7.7 months with radiotherapy alone (hazard ratio for death, 0.53; 95% CI, 0.38 to 0.73; P<0.001). Among 189 patients with unmethylated MGMT status, the median overall survival was 10.0 months with radiotherapy plus temozolomide and 7.9 months with radiotherapy alone (hazard ratio for death, 0.75; 95% CI, 0.56 to 1.01; P=0.055; P=0.08 for interaction). Quality of life was similar in the two trial groups.Conclusions: In elderly patients with glioblastoma, the addition of temozolomide to short-course radiotherapy resulted in longer survival than short-course radiotherapy alone. (Funded by the Canadian Cancer Society Research Institute and others; ClinicalTrials.gov number, NCT00482677 .). [ABSTRACT FROM AUTHOR] - Abstract: Copyright of New England Journal of Medicine is the property of New England Journal of Medicine and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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