title: Efficacy and Safety of First-Line Necitumumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in East Asian Patients with Stage IV Squamous Non-small Cell Lung Cancer: A Subgroup Analysis of the Phase 3, Open-Label, Randomized SQUIRE Study.
abstract: OBJECTIVE
  The phase 3 randomized SQUIRE study revealed significantly longer overall survival (OS) and progression-free survival (PFS) for necitumumab plus gemcitabine and cisplatin (neci+GC) than for gemcitabine and cisplatin alone (GC) in 1,093 patients with previously untreated advanced squamous non-small cell lung cancer (NSCLC). This post hoc subgroup analysis assessed the efficacy and safety of neci+GC among East Asian (EA) patients enrolled in the study.
  
  
  METHODS
  All patients received up to six 3-week cycles of gemcitabine (days 1 and 8, 1,250 mg/m²) and cisplatin (day 1, 75 mg/m²). Patients in the neci+GC arm also received necitumumab (days 1 and 8, 800 mg) until disease progression or unacceptable toxicity. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated from stratified Cox proportional hazards models.
  
  
  RESULTS
  In EA patients, there were improvements for neci+GC (n=43) versus GC (n=41) in OS (HR, 0.805; 95% CI, 0.484 to 1.341) and PFS (HR, 0.720; 95% CI, 0.439 to 1.180), consistent with the results for non-EA patients observed in the present study. The overall safety data were consistent between EA and non-EA patients. A numerically higher proportion of patients experienced serious adverse events (AEs), grade ≥ 3 AEs, and AEs with an outcome of death for neci+GC versus GC in EA patients and EA patients versus non-EA patients for neci+GC.
  
  
  CONCLUSIONS
  Although limited by the small sample size and post hoc nature of the analysis, these findings are consistent with those of the overall study and suggest that neci+GC offers a survival advantage and favorable benefit/risk for EA patients with advanced squamous NSCLC.
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
authors.affiliation: Department of Medicine, Gachon University Gil Medical Center, Incheon, Korea.
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.affiliation: Saint Luke's Medical Center, Quezon City, Philippines.
authors.forename: Maximino
authors.initials: M
authors.lastname: Bello
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Myung-Ju
authors.initials: MJ
authors.lastname: Ahn
authors.affiliation: Chief Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Maharaj Nakorn Chiang Mai, Chiang Mai University, Chiang Mai, Thailand.
authors.forename: Sumitra
authors.initials: S
authors.lastname: Thongprasert
authors.affiliation: Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, Korea.
authors.forename: Eun-Kee
authors.initials: EK
authors.lastname: Song
authors.affiliation: Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Victoria
authors.initials: V
authors.lastname: Soldatenkova
authors.affiliation: Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Depenbrock
authors.affiliation: Eli Lilly and Company, Gurgaon, India.
authors.forename: Tarun
authors.initials: T
authors.lastname: Puri
authors.affiliation: Eli Lilly Interamerica Inc., Buenos Aires, Argentina.
authors.forename: Mauro
authors.initials: M
authors.lastname: Orlando
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; C527969:necitumumab; D002945:Cisplatin; D000093542:Gemcitabine
keywords: Cisplatin; East Asian; Epidermal growth factor receptor; Gemcitabine; Necitumumab; Non-small-cell lung carcinoma