PMID- 24352251
OWN - NLM
STAT- MEDLINE
DCOM- 20140710
LR  - 20151119
IS  - 1432-0843 (Electronic)
IS  - 0344-5704 (Linking)
VI  - 73
IP  - 3
DP  - 2014 Mar
TI  - A phase II trial of erlotinib as maintenance treatment after concurrent 
      chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician 
      Lung Cancer Group (GGCP) study.
PG  - 451-7
LID - 10.1007/s00280-013-2370-z [doi]
AB  - PURPOSE: This single arm, phase II study aims to evaluate the role of epidermal 
      growth factor receptor-tyrosine-kinase inhibitor erlotinib as maintenance therapy 
      following concurrent chemoradiotherapy (cCRT) in unresectable locally advanced 
      non-small-cell lung cancer (NSCLC). METHODS: Patients with unresectable stage 
      IIIA o dry IIIB NSCLC with no evidence of tumor progression after receiving a 
      standard cCRT regimen with curative intent were included. Oral erlotinib 150 
      mg/day was administered within 4-6 weeks after the end of the cCRT for a maximum 
      of 6 months if no disease progression or intolerable toxicity occurred. Primary 
      end point was the progression-free rate (PFR) at 6 months. Secondary end points 
      included time to progression (TTP) and overall survival (OS). RESULTS: Sixty-six 
      patients were enrolled and received maintenance treatment with erlotinib 
      [average: 4.5 months (95 % CI 4.0-5.0)]. PFR at 6 months was 63.5 % (41/66). With 
      a median follow-up of 22.7 months (95 % CI 13.5-37.1), the median TTP was 9.9 
      months (95 % CI 6.2-12.1), and the median OS was 24.0 months (95 % CI 17.3-48.6). 
      Most common adverse events (AEs) related to erlotinib were rash (78.8 %; 16.7 % 
      grade 3), diarrhea (28.8 %; 1.5 % grade 3), fatigue (15.2 %; 1.5 % grade 3), 
      anorexia (7.6 %; 1.5 % grade 3) and vomiting (4.6 %; none grade 3). Five patients 
      (7.6 %) were withdrawn due to AEs. CONCLUSIONS: Erlotinib as maintenance therapy 
      is an active treatment after cCRT in unselected patients with stage III NSCLC, 
      reaching a 6-month PFR of 63.5 % and a median OS of 24 months. The safety profile 
      of maintenance erlotinib was as expected and manageable.
FAU - Casal Rubio, J
AU  - Casal Rubio J
AD  - Medical Oncology Department, Complexo Hospitalario Universitario de Vigo (CHUVI), 
      Vigo, Spain, joaquin.casal.rubio@sergas.es.
FAU - Firvida-Perez, J L
AU  - Firvida-Perez JL
FAU - Lazaro-Quintela, M
AU  - Lazaro-Quintela M
FAU - Baron-Duarte, F J
AU  - Baron-Duarte FJ
FAU - Alonso-Jaudenes, G
AU  - Alonso-Jaudenes G
FAU - Santome, L
AU  - Santome L
FAU - Afonso-Afonso, F J
AU  - Afonso-Afonso FJ
FAU - Amenedo, M
AU  - Amenedo M
FAU - Huidobro, G
AU  - Huidobro G
FAU - Campos-Balea, B
AU  - Campos-Balea B
FAU - Lopez-Vazquez, M D
AU  - Lopez-Vazquez MD
FAU - Vazquez, S
AU  - Vazquez S
LA  - eng
SI  - ClinicalTrials.gov/NCT00466284
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20131219
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Quinazolines)
RN  - DA87705X9K (Erlotinib Hydrochloride)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology
MH  - Chemoradiotherapy
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Erlotinib Hydrochloride
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Prognosis
MH  - Protein Kinase Inhibitors/*administration & dosage/adverse effects
MH  - Quinazolines/*administration & dosage/adverse effects
MH  - Survival Rate
EDAT- 2013/12/20 06:00
MHDA- 2014/07/11 06:00
CRDT- 2013/12/20 06:00
PHST- 2013/10/03 00:00 [received]
PHST- 2013/12/11 00:00 [accepted]
PHST- 2013/12/20 06:00 [entrez]
PHST- 2013/12/20 06:00 [pubmed]
PHST- 2014/07/11 06:00 [medline]
AID - 10.1007/s00280-013-2370-z [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2014 Mar;73(3):451-7. doi: 10.1007/s00280-013-2370-z. 
      Epub 2013 Dec 19.