PMID- 22710607
OWN - NLM
STAT- MEDLINE
DCOM- 20121108
LR  - 20240322
IS  - 1791-2431 (Electronic)
IS  - 1021-335X (Print)
IS  - 1021-335X (Linking)
VI  - 28
IP  - 3
DP  - 2012 Sep
TI  - A multi-centre randomized, open-label phase II trial of continuous erlotinib plus 
      gemcitabine or gemcitabine as first-line therapy in ECOG PS2 patients with 
      advanced non-small cell lung cancer.
PG  - 763-7
LID - 10.3892/or.2012.1871 [doi]
AB  - Erlotinib and gemcitabine are active in NSCLC and have synergy in other cancers. 
      This study investigated the activity and tolerability of this combination as 
      first-line therapy in ECOG PS 2 patients. Chemotherapy-naive patients with NSCLC, 
      either stage IIIB (with plural effusion) or stage IV, with measurable disease and 
      ECOG PS 2, and adequate organ function were randomized to receive either 
      erlotinib (150 mg/day p.o.) plus gemcitabine (1000 mg/m2, days 1, 8, 15, every 4 
      weeks) in Arm A or gemcitabine monotherapy (Arm B). The primary end-point was 
      progression-free survival. Seventeen patients of a planned 120 patients were 
      randomized (12 males; 16 Caucasians, 4 large cell, 9 adenocarcinoma; 13 former 
      and 1 never smokers); 16 patients received treatment (8 in each arm). The 
      incidence of treatment-related adverse events (AEs) was 8/8 in Arm A and 6/8 in 
      Arm B; most AEs were grade 1 or 2. The most common treatment-related 
      non-hematological AEs were grade 1 or 2 rash (7/8) and diarrhea (7/8) in Arm A. 
      Two patients in Arm A had partial responses, with durations of 16 and 47 weeks, 
      respectively. Overall disease control rate (N=15) was 86% in Arm A versus 50% for 
      the control arm. Erlotinib plus gemcitabine for the treatment of ECOG 2 NSCLC 
      patients warrants further investigation including intermittent erlotinib 
      regimens.
FAU - Michael, M
AU  - Michael M
AD  - Division of Hematology and Medical Oncology, Peter MacCallum Cancer Centre, East 
      Melbourne, Australia. michael.michael@petermac.org
FAU - Pavlakis, N
AU  - Pavlakis N
FAU - Clingan, P
AU  - Clingan P
FAU - De Boer, R
AU  - De Boer R
FAU - Johnston, M
AU  - Johnston M
FAU - Clarke, S
AU  - Clarke S
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120615
PL  - Greece
TA  - Oncol Rep
JT  - Oncology reports
JID - 9422756
RN  - 0 (Quinazolines)
RN  - 0W860991D6 (Deoxycytidine)
RN  - DA87705X9K (Erlotinib Hydrochloride)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality
MH  - Deoxycytidine/administration & dosage/analogs & derivatives
MH  - Disease-Free Survival
MH  - Early Termination of Clinical Trials
MH  - Erlotinib Hydrochloride
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Quinazolines/administration & dosage
MH  - Severity of Illness Index
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - Gemcitabine
PMC - PMC3583431
EDAT- 2012/06/20 06:00
MHDA- 2012/11/09 06:00
PMCR- 2012/06/15
CRDT- 2012/06/20 06:00
PHST- 2012/01/24 00:00 [received]
PHST- 2012/03/13 00:00 [accepted]
PHST- 2012/06/20 06:00 [entrez]
PHST- 2012/06/20 06:00 [pubmed]
PHST- 2012/11/09 06:00 [medline]
PHST- 2012/06/15 00:00 [pmc-release]
AID - or-28-03-0763 [pii]
AID - 10.3892/or.2012.1871 [doi]
PST - ppublish
SO  - Oncol Rep. 2012 Sep;28(3):763-7. doi: 10.3892/or.2012.1871. Epub 2012 Jun 15.