PMID- 15758009
OWN - NLM
STAT- MEDLINE
DCOM- 20050315
LR  - 20240206
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 352
IP  - 10
DP  - 2005 Mar 10
TI  - Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma.
PG  - 987-96
AB  - BACKGROUND: Glioblastoma, the most common primary brain tumor in adults, is 
      usually rapidly fatal. The current standard of care for newly diagnosed 
      glioblastoma is surgical resection to the extent feasible, followed by adjuvant 
      radiotherapy. In this trial we compared radiotherapy alone with radiotherapy plus 
      temozolomide, given concomitantly with and after radiotherapy, in terms of 
      efficacy and safety. METHODS: Patients with newly diagnosed, histologically 
      confirmed glioblastoma were randomly assigned to receive radiotherapy alone 
      (fractionated focal irradiation in daily fractions of 2 Gy given 5 days per week 
      for 6 weeks, for a total of 60 Gy) or radiotherapy plus continuous daily 
      temozolomide (75 mg per square meter of body-surface area per day, 7 days per 
      week from the first to the last day of radiotherapy), followed by six cycles of 
      adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 
      28-day cycle). The primary end point was overall survival. RESULTS: A total of 
      573 patients from 85 centers underwent randomization. The median age was 56 
      years, and 84 percent of patients had undergone debulking surgery. At a median 
      follow-up of 28 months, the median survival was 14.6 months with radiotherapy 
      plus temozolomide and 12.1 months with radiotherapy alone. The unadjusted hazard 
      ratio for death in the radiotherapy-plus-temozolomide group was 0.63 (95 percent 
      confidence interval, 0.52 to 0.75; P<0.001 by the log-rank test). The two-year 
      survival rate was 26.5 percent with radiotherapy plus temozolomide and 10.4 
      percent with radiotherapy alone. Concomitant treatment with radiotherapy plus 
      temozolomide resulted in grade 3 or 4 hematologic toxic effects in 7 percent of 
      patients. CONCLUSIONS: The addition of temozolomide to radiotherapy for newly 
      diagnosed glioblastoma resulted in a clinically meaningful and statistically 
      significant survival benefit with minimal additional toxicity.
CI  - Copyright 2005 Massachusetts Medical Society.
FAU - Stupp, Roger
AU  - Stupp R
AD  - Multidisciplinary Oncology Center, Centre Hospitalier Universitaire Vaudois, 
      Lausanne, Switzerland. roger.stupp@chuv.hospvd.ch
FAU - Mason, Warren P
AU  - Mason WP
FAU - van den Bent, Martin J
AU  - van den Bent MJ
FAU - Weller, Michael
AU  - Weller M
FAU - Fisher, Barbara
AU  - Fisher B
FAU - Taphoorn, Martin J B
AU  - Taphoorn MJ
FAU - Belanger, Karl
AU  - Belanger K
FAU - Brandes, Alba A
AU  - Brandes AA
FAU - Marosi, Christine
AU  - Marosi C
FAU - Bogdahn, Ulrich
AU  - Bogdahn U
FAU - Curschmann, Jurgen
AU  - Curschmann J
FAU - Janzer, Robert C
AU  - Janzer RC
FAU - Ludwin, Samuel K
AU  - Ludwin SK
FAU - Gorlia, Thierry
AU  - Gorlia T
FAU - Allgeier, Anouk
AU  - Allgeier A
FAU - Lacombe, Denis
AU  - Lacombe D
FAU - Cairncross, J Gregory
AU  - Cairncross JG
FAU - Eisenhauer, Elizabeth
AU  - Eisenhauer E
FAU - Mirimanoff, Rene O
AU  - Mirimanoff RO
CN  - European Organisation for Research and Treatment of Cancer Brain Tumor and 
      Radiotherapy Groups
CN  - National Cancer Institute of Canada Clinical Trials Group
LA  - eng
GR  - 5U10CA11488-30/CA/NCI NIH HHS/United States
GR  - 5U10CA11488-31/CA/NCI NIH HHS/United States
GR  - 5U10CA11488-32/CA/NCI NIH HHS/United States
GR  - 5U10CA11488-33/CA/NCI NIH HHS/United States
GR  - 5U10CA11488-34/CA/NCI NIH HHS/United States
PT  - Clinical Trial
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Antineoplastic Agents, Alkylating)
RN  - 7GR28W0FJI (Dacarbazine)
RN  - YF1K15M17Y (Temozolomide)
SB  - IM
CIN - N Engl J Med. 2005 Mar 10;352(10):1036-8. PMID: 15758016
CIN - N Engl J Med. 2005 Jun 2;352(22):2350-3; author reply 2350-3. PMID: 15938011
CIN - N Engl J Med. 2005 Jun 2;352(22):2350-3; author reply 2350-3. PMID: 15938012
CIN - N Engl J Med. 2005 Jun 2;352(22):2350-3; author reply 2350-3. PMID: 15938013
MH  - Adrenal Cortex Hormones/therapeutic use
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents, Alkylating/adverse effects/*therapeutic use
MH  - Brain Neoplasms/*drug therapy/mortality/*radiotherapy
MH  - Chemotherapy, Adjuvant
MH  - Dacarbazine/adverse effects/*analogs & derivatives/*therapeutic use
MH  - Disease Progression
MH  - Female
MH  - Glioblastoma/*drug therapy/mortality/*radiotherapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Radiotherapy, Computer-Assisted/adverse effects
MH  - Survival Analysis
MH  - Temozolomide
EDAT- 2005/03/11 09:00
MHDA- 2005/03/16 09:00
CRDT- 2005/03/11 09:00
PHST- 2005/03/11 09:00 [pubmed]
PHST- 2005/03/16 09:00 [medline]
PHST- 2005/03/11 09:00 [entrez]
AID - 352/10/987 [pii]
AID - 10.1056/NEJMoa043330 [doi]
PST - ppublish
SO  - N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.