TY - JOUR
T1 - Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma
AU - Perry, James R.
AU - Laperriere, Normand
AU - O'Callaghan, Christopher J.
AU - Brandes, Alba A.
AU - Menten, Johan
AU - Phillips, Claire
AU - Fay, Michael
AU - Nishikawa, Ryo
AU - Cairncross, J. Gregory
AU - Roa, Wilson
AU - Osoba, David
AU - Rossiter, John P.
AU - Sahgal, Arjun
AU - Hirte, Hal
AU - Laigle-Donadey, Florence
AU - Franceschi, Enrico
AU - Chinot, Olivier
AU - Golfinopoulos, Vassilis
AU - Fariselli, Laura
AU - Wick, Antje
AU - Feuvret, Loic
AU - Back, Michael
AU - Tills, Michael
AU - Winch, Chad
AU - Baumert, Brigitta G.
AU - Wick, Wolfgang
AU - Ding, Keyue
AU - Mason, Warren P.
AU - Trial Investigators
PY - 2017/3/16
Y1 - 2017/3/16
N2 - 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 O-6-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.)
AB - 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 O-6-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.)
KW - MALIGNANT ASTROCYTOMA
KW - PROMOTER METHYLATION
KW - PHASE-3 TRIAL
KW - RADIOTHERAPY
KW - MULTIFORME
KW - CHEMOTHERAPY
KW - CONCOMITANT
KW - PATTERNS
KW - ADJUVANT
KW - TUMORS
U2 - 10.1056/NEJMoa1611977
DO - 10.1056/NEJMoa1611977
M3 - Article
C2 - 28296618
SN - 0028-4793
VL - 376
SP - 1027
EP - 1037
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 11
ER -