PMID- 24575793
OWN - NLM
STAT- MEDLINE
DCOM- 20160322
LR  - 20221207
IS  - 1743-7563 (Electronic)
IS  - 1743-7555 (Linking)
VI  - 11
IP  - 1
DP  - 2015 Mar
TI  - Multicenter randomized, open-label phase II trial of sequential erlotinib and 
      gemcitabine compared with gemcitabine monotherapy as first-line therapy in 
      elderly or ECOG PS two patients with advanced NSCLC.
PG  - 4-14
LID - 10.1111/ajco.12178 [doi]
AB  - AIM: The potential beneficial interaction between erlotinib and chemotherapy may 
      require sequencing or pharmacodynamic separation. The aim of this study was to 
      evaluate the efficacy and tolerance of sequential erlotinib and gemcitabine 
      versus gemcitabine monotherapy as first-line therapy in elderly or ECOG PS-2 
      patients with advanced non-small cell lung carcinoma. METHODS: The primary 
      objective of this multicenter randomized Phase II study was progression-free 
      survival (PFS). Secondary objectives were overall response rate (ORR), disease 
      control rate, response duration, overall survival and safety. Patients were 
      randomized to either gemcitabine (1250 mg/m2 Day 1, 8 q28 days) followed by 
      erlotinib (150 mg/day on day 15 through day 28), (EG-arm), or gemcitabine 
      monotherapy (1000 mg/m2 Days 1, 8, 15 q28 days), (G-arm) for up to six cycles. 
      RESULTS: Fifty-four patients were recruited, 28 G-arm and 26 EG-arm. Overall, 
      efficacy results were not significantly different between study arms. Median PFS 
      and ORR for the G- versus EG-arms were 8.0 versus 10.3 weeks (hazard ratio 1.3; 
      95% confidence interval [0.63;2.68]; P=0.48) and 7.1 versus 3.8 percent 
      respectively (difference -3.30; 95% confidence interval [-17.5;10.9]). The 
      majority of adverse events (AEs) in both arms were Grade 1-2. The commonest AEs 
      recorded in the EG- and G-arms were rash-like events (65 percent) and nausea (42 
      percent) respectively. Four patients (17 percent) in EG-arm and five (16 percent) 
      in G-arm experienced at least one treatment-related serious AE. CONCLUSIONS: In 
      this study, patients with non-small cell lung carcinoma at ECOG PS-2 or aged >/=70 
      years derived no efficacy advantage from sequential erlotinib in combination with 
      gemcitabine relative to gemcitabine alone. No unexpected safety findings were 
      noted.
CI  - (c) 2014 Wiley Publishing Asia Pty Ltd.
FAU - Michael, Michael
AU  - Michael M
AD  - Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, 
      Australia.
FAU - White, Shane C
AU  - White SC
FAU - Abdi, Ehtesham
AU  - Abdi E
FAU - Nott, Louise
AU  - Nott L
FAU - Clingan, Phillip
AU  - Clingan P
FAU - Zimet, Allan
AU  - Zimet A
FAU - Button, Peter
AU  - Button P
FAU - Gregory, Daniel
AU  - Gregory D
FAU - Solomon, Benjamin
AU  - Solomon B
FAU - Dobrovic, Alexander
AU  - Dobrovic A
FAU - Do, Hongdo
AU  - Do H
FAU - Clarke, Stephen
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 - 20140227
PL  - Australia
TA  - Asia Pac J Clin Oncol
JT  - Asia-Pacific journal of clinical oncology
JID - 101241430
RN  - 0W860991D6 (Deoxycytidine)
RN  - DA87705X9K (Erlotinib Hydrochloride)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/mortality/pathology
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Carcinoma, Large Cell/*drug therapy/mortality/pathology
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/pathology
MH  - Carcinoma, Squamous Cell/*drug therapy/mortality/pathology
MH  - Deoxycytidine/administration & dosage/analogs & derivatives
MH  - Erlotinib Hydrochloride/administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/mortality/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Prognosis
MH  - Survival Rate
MH  - Gemcitabine
OTO - NOTNLM
OT  - EGFR
OT  - advanced NSCLC
OT  - elderly
OT  - erlotinib
EDAT- 2014/03/01 06:00
MHDA- 2016/03/24 06:00
CRDT- 2014/03/01 06:00
PHST- 2014/01/05 00:00 [accepted]
PHST- 2014/03/01 06:00 [entrez]
PHST- 2014/03/01 06:00 [pubmed]
PHST- 2016/03/24 06:00 [medline]
AID - 10.1111/ajco.12178 [doi]
PST - ppublish
SO  - Asia Pac J Clin Oncol. 2015 Mar;11(1):4-14. doi: 10.1111/ajco.12178. Epub 2014 
      Feb 27.