PMID- 20615922
OWN - NLM
STAT- MEDLINE
DCOM- 20110103
LR  - 20220318
IS  - 1523-5866 (Electronic)
IS  - 1522-8517 (Print)
IS  - 1522-8517 (Linking)
VI  - 12
IP  - 10
DP  - 2010 Oct
TI  - Safety and efficacy of erlotinib in first-relapse glioblastoma: a phase II 
      open-label study.
PG  - 1061-70
LID - 10.1093/neuonc/noq072 [doi]
AB  - Erlotinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, 
      is active in glioblastoma. We evaluated erlotinib efficacy in patients with 
      first-relapse glioblastoma and assessed whether response was related to EGFR 
      amplification and/or concomitant use of enzyme-inducing antiepileptic drugs 
      (EIAEDs) in a phase II open-label study of glioblastoma patients in first 
      relapse. Patients took erlotinib daily until progression. Starting dose was 150 
      mg for patients not taking EIAEDs and 300 mg for patients taking EIAEDs. Tumors 
      were radiographically assessed every 8 weeks. Response was evaluated by 
      investigators and confirmed by an independent radiology facility (IRF). The 
      primary efficacy outcome was the objective response (OR) rate, according to the 
      modified WHO criteria. Enrollment (n = 48) was terminated after a planned interim 
      analysis due to an insufficient number of responses. The IRF confirmed 1 complete 
      and 2 partial responses (PRs), for an OR rate of 6.3% (95% confidence interval 
      [CI]: 1.7-17.0). Investigators determined 1 complete response and 3 PRs, median 
      response duration of 7.0 months, 6-month progression-free survival (PFS) of 20% 
      (95% CI: 10.0-32.4), and median survival of 9.7 months (95% CI: 5.9-11.6). 
      Outcomes were not related to EGFR amplification or EIAED status. Diarrhea and 
      rash were the most common adverse events (AEs); 23% of patients experienced grade 
      3-4 drug-related AEs. Despite the limited number of responses, 6-month PFS and 
      median survival reached or exceeded the previously reported values for patients 
      undergoing chemotherapy for recurrent glioblastoma. EGFR amplification was not 
      associated with erlotinib activity. Given the large CIs and nonrandomized nature 
      of the study, results should be interpreted cautiously.
FAU - Yung, W K Alfred
AU  - Yung WK
AD  - Department of Neuro-Oncology, MD Anderson Cancer Center, 1515 Holcombe Boulevard, 
      Houston, TX 77030, USA. wyung@mdanderson.org
FAU - Vredenburgh, James J
AU  - Vredenburgh JJ
FAU - Cloughesy, Timothy F
AU  - Cloughesy TF
FAU - Nghiemphu, Phioanh
AU  - Nghiemphu P
FAU - Klencke, Barbara
AU  - Klencke B
FAU - Gilbert, Mark R
AU  - Gilbert MR
FAU - Reardon, David A
AU  - Reardon DA
FAU - Prados, Michael D
AU  - Prados MD
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100708
PL  - England
TA  - Neuro Oncol
JT  - Neuro-oncology
JID - 100887420
RN  - 0 (Anticonvulsants)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Quinazolines)
RN  - DA87705X9K (Erlotinib Hydrochloride)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anticonvulsants/therapeutic use
MH  - Antineoplastic Agents/*therapeutic use
MH  - Brain Neoplasms/*drug therapy/genetics/mortality
MH  - Disease-Free Survival
MH  - Erlotinib Hydrochloride
MH  - Female
MH  - Genes, erbB-1
MH  - Glioblastoma/*drug therapy/genetics/mortality
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/drug therapy
MH  - Quinazolines/*therapeutic use
PMC - PMC3018931
EDAT- 2010/07/10 06:00
MHDA- 2011/01/05 06:00
PMCR- 2011/10/01
CRDT- 2010/07/10 06:00
PHST- 2010/07/10 06:00 [entrez]
PHST- 2010/07/10 06:00 [pubmed]
PHST- 2011/01/05 06:00 [medline]
PHST- 2011/10/01 00:00 [pmc-release]
AID - noq072 [pii]
AID - 10.1093/neuonc/noq072 [doi]
PST - ppublish
SO  - Neuro Oncol. 2010 Oct;12(10):1061-70. doi: 10.1093/neuonc/noq072. Epub 2010 Jul 
      8.