Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma

James R. Perry; Normand Laperriere; Christopher J. O'Callaghan; Alba A. Brandes; Johan Menten; Claire Phillips; Michael Fay; Ryo Nishikawa; J. Gregory Cairncross; Wilson Roa; David Osoba; John P. Rossiter; Arjun Sahgal; Hal Hirte; Florence Laigle-Donadey; Enrico Franceschi; Olivier Chinot; Vassilis Golfinopoulos; Laura Fariselli; Antje Wick; Loic Feuvret; Michael Back; Michael Tills; Chad Winch; Brigitta G. Baumert; Wolfgang Wick; Keyue Ding; Warren P. Mason; Trial Investigators

doi:10.1056/NEJMoa1611977

Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma

James R. Perry^*, Normand Laperriere, Christopher J. O'Callaghan, Alba A. Brandes, Johan Menten, Claire Phillips, Michael Fay, Ryo Nishikawa, J. Gregory Cairncross, Wilson Roa, David Osoba, John P. Rossiter, Arjun Sahgal, Hal Hirte, Florence Laigle-Donadey, Enrico Franceschi, Olivier Chinot, Vassilis Golfinopoulos, Laura Fariselli, Antje WickLoic Feuvret, Michael Back, Michael Tills, Chad Winch, Brigitta G. Baumert, Wolfgang Wick, Keyue Ding, Warren P. Mason, Trial Investigators

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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 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.)

Original language	English
Pages (from-to)	1027-1037
Number of pages	11
Journal	New England Journal of Medicine
Volume	376
Issue number	11
DOIs	https://doi.org/10.1056/NEJMoa1611977
Publication status	Published - 16 Mar 2017

Keywords

MALIGNANT ASTROCYTOMA
PROMOTER METHYLATION
PHASE-3 TRIAL
RADIOTHERAPY
MULTIFORME
CHEMOTHERAPY
CONCOMITANT
PATTERNS
ADJUVANT
TUMORS

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10.1056/NEJMoa1611977

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Perry, J. R., Laperriere, N., O'Callaghan, C. J., Brandes, A. A., Menten, J., Phillips, C., Fay, M., Nishikawa, R., Cairncross, J. G., Roa, W., Osoba, D., Rossiter, J. P., Sahgal, A., Hirte, H., Laigle-Donadey, F., Franceschi, E., Chinot, O., Golfinopoulos, V., Fariselli, L., ... Trial Investigators (2017). Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma. New England Journal of Medicine, 376(11), 1027-1037. https://doi.org/10.1056/NEJMoa1611977

@article{325c9fc38e794d2c84e34d3a1d8a9edf,

title = "Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma",

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 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.)",

keywords = "MALIGNANT ASTROCYTOMA, PROMOTER METHYLATION, PHASE-3 TRIAL, RADIOTHERAPY, MULTIFORME, CHEMOTHERAPY, CONCOMITANT, PATTERNS, ADJUVANT, TUMORS",

author = "Perry, {James R.} and Normand Laperriere and O'Callaghan, {Christopher J.} and Brandes, {Alba A.} and Johan Menten and Claire Phillips and Michael Fay and Ryo Nishikawa and Cairncross, {J. Gregory} and Wilson Roa and David Osoba and Rossiter, {John P.} and Arjun Sahgal and Hal Hirte and Florence Laigle-Donadey and Enrico Franceschi and Olivier Chinot and Vassilis Golfinopoulos and Laura Fariselli and Antje Wick and Loic Feuvret and Michael Back and Michael Tills and Chad Winch and Baumert, {Brigitta G.} and Wolfgang Wick and Keyue Ding and Mason, {Warren P.} and {Trial Investigators}",

year = "2017",

month = mar,

day = "16",

doi = "10.1056/NEJMoa1611977",

language = "English",

volume = "376",

pages = "1027--1037",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOCIETY",

number = "11",

}

Perry, JR, Laperriere, N, O'Callaghan, CJ, Brandes, AA, Menten, J, Phillips, C, Fay, M, Nishikawa, R, Cairncross, JG, Roa, W, Osoba, D, Rossiter, JP, Sahgal, A, Hirte, H, Laigle-Donadey, F, Franceschi, E, Chinot, O, Golfinopoulos, V, Fariselli, L, Wick, A, Feuvret, L, Back, M, Tills, M, Winch, C, Baumert, BG, Wick, W, Ding, K, Mason, WP & Trial Investigators 2017, 'Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma', New England Journal of Medicine, vol. 376, no. 11, pp. 1027-1037. https://doi.org/10.1056/NEJMoa1611977

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 -

Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma

Abstract

Keywords

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