PMID- 24481719
OWN - NLM
STAT- MEDLINE
DCOM- 20140620
LR  - 20190221
IS  - 1097-0142 (Electronic)
IS  - 0008-543X (Linking)
VI  - 120
IP  - 9
DP  - 2014 May 1
TI  - A randomized phase 2 trial of erlotinib versus pemetrexed as second-line therapy 
      in the treatment of patients with advanced EGFR wild-type and EGFR FISH-positive 
      lung adenocarcinoma.
PG  - 1379-86
LID - 10.1002/cncr.28591 [doi]
AB  - BACKGROUND: The current study was undertaken to investigate the efficacy and 
      safety of erlotinib versus pemetrexed as second-line therapy for patients with 
      advanced epidermal growth factor receptor (EGFR) wild-type and EGFR fluorescence 
      in situ hybridization (FISH)-positive lung adenocarcinoma. METHODS: In this 
      open-label, randomized, phase 2 study, patients with EGFR wild-type and EGFR 
      FISH-positive adenocarcinoma who had developed disease progression after 1 prior 
      platinum-based chemotherapy were randomly assigned (1:1) to receive erlotinib or 
      pemetrexed until the time of disease progression or death, unacceptable toxicity, 
      or a request for discontinuation by the patient. The primary endpoint was 
      progression-free survival (PFS). RESULTS: A total of 123 patients were enrolled 
      (61 in the erlotinib arm and 62 in the pemetrexed arm). The median PFS was 4.1 
      months (95% confidence interval [95% CI], 1.6 months-6.6 months) in the erlotinib 
      group versus 3.9 months (95% CI, 2.7 months-5.1 months) in the pemetrexed group. 
      The difference in PFS between the 2 treatment groups was not significant (hazard 
      ratio, 0.92; 95% CI, 0.62-1.37 [P= .683]). The objective response rate appeared 
      to be higher among patients receiving erlotinib compared with those receiving 
      pemetrexed (19.7% vs 8.1%; P= .062). The 3 most commonly recorded adverse events 
      were rash (54.1%), fatigue (19.7%), and diarrhea (16.4%) in the erlotinib group 
      and fatigue (25.8%), nausea (24.2%), and anorexia (14.5%) in the pemetrexed 
      group. CONCLUSIONS: There were no significant differences noted with regard to 
      efficacy between erlotinib and pemetrexed in the second-line setting for patients 
      with advanced EGFR wild-type and EGFR FISH-positive lung adenocarcinoma. Both 
      regimens appear to be effective treatment options for these patients.
CI  - (c) 2014 American Cancer Society.
FAU - Li, Ning
AU  - Li N
AD  - Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key 
      Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer 
      Medicine, Guangzhou, China.
FAU - Ou, Wei
AU  - Ou W
FAU - Yang, Hua
AU  - Yang H
FAU - Liu, Qian-Wen
AU  - Liu QW
FAU - Zhang, Song-Liang
AU  - Zhang SL
FAU - Wang, Bao-Xiao
AU  - Wang BX
FAU - Wang, Si-Yu
AU  - Wang SY
LA  - eng
SI  - ClinicalTrials.gov/NCT01565538
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20140130
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0 (Glutamates)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Quinazolines)
RN  - 04Q9AIZ7NO (Pemetrexed)
RN  - 5Z93L87A1R (Guanine)
RN  - DA87705X9K (Erlotinib Hydrochloride)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/*enzymology/genetics/pathology
MH  - Adenocarcinoma of Lung
MH  - Adult
MH  - Aged
MH  - Antimetabolites, Antineoplastic/adverse effects/*therapeutic use
MH  - ErbB Receptors/*biosynthesis/genetics
MH  - Erlotinib Hydrochloride
MH  - Female
MH  - Gene Dosage
MH  - Glutamates/adverse effects/*therapeutic use
MH  - Guanine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Humans
MH  - In Situ Hybridization, Fluorescence
MH  - Lung Neoplasms/*drug therapy/*enzymology/genetics/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Pemetrexed
MH  - Protein Kinase Inhibitors/adverse effects/*therapeutic use
MH  - Quinazolines/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - epidermal growth factor receptor (EGFR) copy number
OT  - erlotinib
OT  - non-small cell lung cancer
OT  - pemetrexed
OT  - second-line therapy
EDAT- 2014/02/01 06:00
MHDA- 2014/06/21 06:00
CRDT- 2014/02/01 06:00
PHST- 2013/11/19 00:00 [received]
PHST- 2013/12/25 00:00 [revised]
PHST- 2013/12/30 00:00 [accepted]
PHST- 2014/02/01 06:00 [entrez]
PHST- 2014/02/01 06:00 [pubmed]
PHST- 2014/06/21 06:00 [medline]
AID - 10.1002/cncr.28591 [doi]
PST - ppublish
SO  - Cancer. 2014 May 1;120(9):1379-86. doi: 10.1002/cncr.28591. Epub 2014 Jan 30.