PMID- 20371685 OWN - NLM STAT- MEDLINE DCOM- 20100812 LR - 20220330 IS - 1557-3265 (Electronic) IS - 1078-0432 (Print) IS - 1078-0432 (Linking) VI - 16 IP - 8 DP - 2010 Apr 15 TI - Survival of patients with newly diagnosed glioblastoma treated with radiation and temozolomide in research studies in the United States. PG - 2443-9 LID - 10.1158/1078-0432.CCR-09-3106 [doi] AB - PURPOSE: Novel agents are currently combined with radiation and temozolomide (RT + TMZ) in newly diagnosed glioblastoma using overall survival as the primary end point. Results of these phase II studies are typically compared with the phase III European Organization for Research and Treatment of Cancer (EORTC) survival data that resulted in RT + TMZ becoming standard therapy. EXPERIMENTAL DESIGN: The New Approaches to Brain Tumor Therapy (NABTT) Consortium assigned 365 patients with glioblastoma to four single-cohort studies with similar eligibility criteria. Patients received RT + TMZ with talampanel (n = 72), poly-ICLC (n = 97), or cilengitide (n = 112) or RT + TMZ alone with monitoring of CD4 counts (n = 84). Overall survival of those ages 18 to 70 years with glioblastoma was compared with published EORTC data. RESULTS: NABTT and EORTC patients had comparable performance status and debulking surgery. Median, 12-month, and 24-month survival rates for the EORTC patients (n = 287) and the comparable NABTT patients receiving RT + TMZ and novel agents (n = 244) are 14.6 versus 19.6 months, 61% versus 81%, and 27% versus 37%, respectively. This represents a 37% reduction in odds of death (P < 0.0001) through 2 years of follow-up. NABTT and EORTC patients receiving only RT + TMZ had similar survival. CONCLUSIONS: Newly diagnosed glioblastoma treated recently with RT + TMZ and talampanel, poly-ICLC, or cilengitide had significantly longer survival than similar patients treated with only RT + TMZ accrued internationally from 2000 to 2002. These differences could result from the novel agents or changing patterns of care. Until the reasons for these different survival rates are clarified, comparisons of outcomes from phase II studies with published RT + TMZ survival data should be interpreted with caution. FAU - Grossman, Stuart A AU - Grossman SA AD - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland, USA. grossman@jhmi.edu. FAU - Ye, Xiaobu AU - Ye X FAU - Piantadosi, Steven AU - Piantadosi S FAU - Desideri, Serena AU - Desideri S FAU - Nabors, Louis B AU - Nabors LB FAU - Rosenfeld, Myrna AU - Rosenfeld M FAU - Fisher, Joy AU - Fisher J CN - NABTT CNS Consortium LA - eng GR - U01 CA062475-14/CA/NCI NIH HHS/United States GR - U01 CA062475/CA/NCI NIH HHS/United States GR - UM1 CA137443/CA/NCI NIH HHS/United States GR - U01 CA137443/CA/NCI NIH HHS/United States GR - CA62475/CA/NCI NIH HHS/United States GR - CA137443/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20100406 PL - United States TA - Clin Cancer Res JT - Clinical cancer research : an official journal of the American Association for Cancer Research JID - 9502500 RN - 0 (Antineoplastic Agents, Alkylating) RN - 0 (Interferon Inducers) RN - 0 (Receptors, AMPA) RN - 0 (Snake Venoms) RN - 12794-10-4 (Benzodiazepines) RN - 25104-18-1 (Polylysine) RN - 4EDF46E4GI (Cilengitide) RN - 7GR28W0FJI (Dacarbazine) RN - 7KYP9TKT70 (poly ICLC) RN - CVS43XG1L5 (talampanel) RN - K679OBS311 (Carboxymethylcellulose Sodium) RN - O84C90HH2L (Poly I-C) RN - YF1K15M17Y (Temozolomide) SB - IM MH - Adult MH - Aged MH - Antineoplastic Agents, Alkylating/*therapeutic use MH - Benzodiazepines/therapeutic use MH - Biomedical Research MH - Brain Neoplasms/drug therapy/*mortality/radiotherapy/*therapy MH - Carboxymethylcellulose Sodium/analogs & derivatives/therapeutic use MH - Clinical Trials, Phase II as Topic MH - Clinical Trials, Phase III as Topic MH - Combined Modality Therapy MH - Cranial Irradiation MH - Dacarbazine/*analogs & derivatives/therapeutic use MH - Drug Therapy, Combination MH - Female MH - Glioblastoma/drug therapy/*mortality/radiotherapy/*therapy MH - Humans MH - Interferon Inducers/therapeutic use MH - Male MH - Middle Aged MH - Poly I-C/therapeutic use MH - Polylysine/analogs & derivatives/therapeutic use MH - Receptors, AMPA/antagonists & inhibitors MH - Snake Venoms/therapeutic use MH - Survival Rate MH - Temozolomide MH - Treatment Outcome MH - United States MH - Young Adult PMC - PMC2861898 MID - NIHMS182857 EDAT- 2010/04/08 06:00 MHDA- 2010/08/13 06:00 PMCR- 2011/04/15 CRDT- 2010/04/08 06:00 PHST- 2010/04/08 06:00 [entrez] PHST- 2010/04/08 06:00 [pubmed] PHST- 2010/08/13 06:00 [medline] PHST- 2011/04/15 00:00 [pmc-release] AID - 1078-0432.CCR-09-3106 [pii] AID - 10.1158/1078-0432.CCR-09-3106 [doi] PST - ppublish SO - Clin Cancer Res. 2010 Apr 15;16(8):2443-9. doi: 10.1158/1078-0432.CCR-09-3106. Epub 2010 Apr 6.