PMID- 29158123
OWN - NLM
STAT- MEDLINE
DCOM- 20190408
LR  - 20221207
IS  - 1938-0690 (Electronic)
IS  - 1525-7304 (Linking)
VI  - 19
IP  - 2
DP  - 2018 Mar
TI  - Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE 
      Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer.
PG  - 130-138.e2
LID - S1525-7304(17)30278-4 [pii]
LID - 10.1016/j.cllc.2017.10.004 [doi]
AB  - INTRODUCTION: In a retrospective analysis of the SQUamous NSCLC treatment with 
      the Inhibitor of EGF REceptor (SQUIRE) study, we investigated the efficacy and 
      safety of single-agent necitumumab continuation therapy in patients with stage IV 
      squamous non-small-cell lung cancer and in a subpopulation of patients with 
      epidermal growth factor receptor (EGFR)-expressing tumors. PATIENTS AND METHODS: 
      Patients were randomized 1:1 for </= 6 cycles of gemcitabine and cisplatin either 
      with or without necitumumab. Patients who received necitumumab continued 
      receiving single-agent necitumumab until progressive disease (necitumumab 
      continuation). Tissue collection was mandatory in SQUIRE. EGFR protein expression 
      was assessed using immunohistochemistry in a central lab. In this subgroup 
      analysis we compared patients treated with necitumumab monotherapy after 
      completion of >/= 4 cycles of chemotherapy with those in the chemotherapy arm who 
      were progression-free and did not discontinue because of adverse events (AEs) 
      after completion of >/= 4 cycles of chemotherapy (gemcitabine-cisplatin 
      nonprogressors). The same analysis was done for the subgroup of EGFR-expressing 
      patients (EGFR > 0). RESULTS: Baseline characteristics and chemotherapy exposure 
      were well balanced between the necitumumab continuation (n = 261) and 
      gemcitabine-cisplatin nonprogressor (n = 215) arms and in the EGFR-expressing 
      population. Median overall survival (OS) from randomization in the necitumumab 
      with gemcitabine-cisplatin versus gemcitabine-cisplatin nonprogressor arm was 
      15.9 versus 15.0 months (hazard ratio [HR], 0.85; 95% confidence interval [CI], 
      0.69-1.05) and median progression-free survival (PFS) from randomization was 7.4 
      versus 6.9 months (HR, 0.86; 95% CI, 0.70-1.06). OS and PFS benefits were similar 
      when assessed from the postinduction period and in EGFR-expressing patients. No 
      new safety findings emerged. CONCLUSION: There was a consistent treatment effect 
      in favor of necitumumab continuation versus that in gemcitabine-cisplatin 
      nonprogressors, with no unexpected increases in AEs in intention-to-treat as well 
      as EGFR-expressing populations.
CI  - Copyright (c) 2017 Elsevier Inc. All rights reserved.
FAU - Ciuleanu, Tudor
AU  - Ciuleanu T
AD  - Medical Oncology, Institute of Oncology Ion Chiricuta and UMF Iuliu Hatieganu, 
      Cluj Napoca, Romania. Electronic address: tudor@iocn.ro.
FAU - Socinski, Mark A
AU  - Socinski MA
AD  - Florida Hospital Cancer Institute Executive Offices, Orlando, FL.
FAU - Obasaju, Coleman
AU  - Obasaju C
AD  - Medical Oncology, Eli Lilly and Company, Indianapolis, IN.
FAU - Luft, Alexander V
AU  - Luft AV
AD  - Leningrad Regional Clinical Hospital, St Petersburg, Russian Federation.
FAU - Szczesna, Aleksandra
AU  - Szczesna A
AD  - Department of Lung Diseases, Regional Lung Disease Hospital, Otwock, Poland.
FAU - Szafranski, Wojciech
AU  - Szafranski W
AD  - Department of Lung Diseases, Voivodeship Specialist Hospital, Radom, Poland.
FAU - Ramlau, Rodryg
AU  - Ramlau R
AD  - Department of Oncology, Poznan University of Medical Sciences, Poznan, Poland.
FAU - Balint, Beatrix
AU  - Balint B
AD  - Csongrad County Hospital of Chest Diseases, Deszk, Hungary.
FAU - Molinier, Olivier
AU  - Molinier O
AD  - Pneumology, Hospital Center, Le Mans, France.
FAU - Depenbrock, Henrik
AU  - Depenbrock H
AD  - Medical Oncology, Lilly Deutschland GmbH, Bad Homburg, Germany.
FAU - Nanda, Shivani
AU  - Nanda S
AD  - Statistics Oncology, Eli Lilly and Company, Bridgewater, NJ.
FAU - Paz-Ares, Luis
AU  - Paz-Ares L
AD  - Medical Oncology, University Hospital Doce de Octubre, CNIO and Complutense 
      University, Madrid, Spain.
FAU - Thatcher, Nick
AU  - Thatcher N
AD  - Medical Oncology, The Christie Hospital, Manchester, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT00981058
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20171013
PL  - United States
TA  - Clin Lung Cancer
JT  - Clinical lung cancer
JID - 100893225
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 2BT4C47RUI (necitumumab)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - Q20Q21Q62J (Cisplatin)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - Carcinoma, Squamous Cell/*drug therapy/mortality
MH  - Cisplatin/therapeutic use
MH  - Deoxycytidine/analogs & derivatives/therapeutic use
MH  - ErbB Receptors/immunology
MH  - Female
MH  - Humans
MH  - Immunotherapy/*methods
MH  - Lung Neoplasms/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Survival Analysis
MH  - Gemcitabine
OTO - NOTNLM
OT  - Clinical trial
OT  - Epidermal growth factor receptor inhibitor
OT  - Maintenance therapy
OT  - Monoclonal antibody
OT  - Squamous NSCLC
EDAT- 2017/11/22 06:00
MHDA- 2019/04/09 06:00
CRDT- 2017/11/22 06:00
PHST- 2017/04/21 00:00 [received]
PHST- 2017/10/04 00:00 [accepted]
PHST- 2017/11/22 06:00 [pubmed]
PHST- 2019/04/09 06:00 [medline]
PHST- 2017/11/22 06:00 [entrez]
AID - S1525-7304(17)30278-4 [pii]
AID - 10.1016/j.cllc.2017.10.004 [doi]
PST - ppublish
SO  - Clin Lung Cancer. 2018 Mar;19(2):130-138.e2. doi: 10.1016/j.cllc.2017.10.004. 
      Epub 2017 Oct 13.