PMID- 23591160
OWN - NLM
STAT- MEDLINE
DCOM- 20140123
LR  - 20221207
IS  - 1556-1380 (Electronic)
IS  - 1556-0864 (Linking)
VI  - 8
IP  - 7
DP  - 2013 Jul
TI  - Efficacy of pemetrexed as second-line therapy in advanced NSCLC after either 
      treatment-free interval or maintenance therapy with gemcitabine or erlotinib in 
      IFCT-GFPC 05-02 phase III study.
PG  - 906-14
LID - 10.1097/JTO.0b013e31828cb505 [doi]
AB  - INTRODUCTION: Maintenance therapy in advanced non-small-cell lung cancer (NSCLC) 
      might lead to resistance to subsequent treatments. IFCT-GFPC 0502 study showed a 
      progression-free survival (PFS) benefit with gemcitabine or erlotinib maintenance 
      compared with observation after cisplatin-gemcitabine chemotherapy. The trial 
      included a pre-defined pemetrexed second-line therapy, allowing post-hoc 
      assessment of its efficacy according to previous maintenance treatment or 
      treatment-free interval. METHODS: Stage IIIB/IV NSCLC patients were randomized 
      after four cycles of cisplatin-gemcitabine chemotherapy to either observation or 
      to receive maintenance therapy with gemcitabine or erlotinib. Pemetrexed was 
      given as second-line treatment on disease progression in all arms. PFS and 
      overall survival (OS) were assessed from the beginning of pemetrexed therapy 
      according to randomization arm. RESULTS: Of the 464 randomized patients, 360 (78 
      %) received second-line pemetrexed (130 [84%], 114 [74%], and 116 [75%] in 
      observation, gemcitabine, and erlotinib arm, respectively). Median number of 
      pemetrexed cycles was 3 (1-40) in all arms. Median PFS did not differ between 
      gemcitabine and observation arms (4.2 versus 3.9 months, hazard ratio [HR] [95% 
      confidence interval [CI] 0.81 [0.62-1.06]) or between erlotinib and observation 
      arms (4.2 versus 3.9 months, HR 0.83 [0.64-1.09]). OS data showed a 
      non-significant improvement with gemcitabine arm versus observation arm (8.3 
      versus 7.5 months, HR 0.81 [0.61-1.07]) or erlotinib arm versus observation arm 
      (9.1 versus 7.5 months, HR 0.80 [0.61-1.05]). Results were similar for 
      non-squamous patients. Grade 3 to 4 treatment-related adverse events (AEs) were 
      comparable in all arms. CONCLUSIONS: Maintenance therapy with gemcitabine 
      continuation or erlotinib does not seem to impair efficacy of second-line 
      pemetrexed comparatively to administration after a treatment-free interval.
FAU - Bylicki, Olivier
AU  - Bylicki O
AD  - Hospices Civils de Lyon, Lyon, France.
FAU - Ferlay, Celine
AU  - Ferlay C
FAU - Chouaid, Christos
AU  - Chouaid C
FAU - Lavole, Armelle
AU  - Lavole A
FAU - Barlesi, Fabrice
AU  - Barlesi F
FAU - Dubos, Catherine
AU  - Dubos C
FAU - Westeel, Virginie
AU  - Westeel V
FAU - Crequit, Jacky
AU  - Crequit J
FAU - Corre, Roman
AU  - Corre R
FAU - Vergnenegre, Alain
AU  - Vergnenegre A
FAU - Monnet, Isabelle
AU  - Monnet I
FAU - Le Caer, Herve
AU  - Le Caer H
FAU - Fournel, Pierre
AU  - Fournel P
FAU - Vaylet, Fabien
AU  - Vaylet F
FAU - Falchero, Lionel
AU  - Falchero L
FAU - Poudenx, Michel
AU  - Poudenx M
FAU - Linard, Pauline
AU  - Linard P
FAU - Perol, David
AU  - Perol D
FAU - Zalcman, Gerald
AU  - Zalcman G
FAU - Perol, Maurice
AU  - Perol M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Thorac Oncol
JT  - Journal of thoracic oncology : official publication of the International 
      Association for the Study of Lung Cancer
JID - 101274235
RN  - 0 (Glutamates)
RN  - 0 (Quinazolines)
RN  - 04Q9AIZ7NO (Pemetrexed)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 5Z93L87A1R (Guanine)
RN  - DA87705X9K (Erlotinib Hydrochloride)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/mortality/pathology
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
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
MH  - Female
MH  - Follow-Up Studies
MH  - Glutamates/administration & dosage
MH  - Guanine/administration & dosage/analogs & derivatives
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/mortality/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Pemetrexed
MH  - Prognosis
MH  - Quinazolines/administration & dosage
MH  - *Salvage Therapy
MH  - Survival Rate
MH  - Gemcitabine
EDAT- 2013/04/18 06:00
MHDA- 2014/01/24 06:00
CRDT- 2013/04/18 06:00
PHST- 2013/04/18 06:00 [entrez]
PHST- 2013/04/18 06:00 [pubmed]
PHST- 2014/01/24 06:00 [medline]
AID - S1556-0864(15)32874-4 [pii]
AID - 10.1097/JTO.0b013e31828cb505 [doi]
PST - ppublish
SO  - J Thorac Oncol. 2013 Jul;8(7):906-14. doi: 10.1097/JTO.0b013e31828cb505.