PMID- 28111429 OWN - NLM STAT- MEDLINE DCOM- 20180601 LR - 20221207 IS - 2005-9256 (Electronic) IS - 1598-2998 (Print) IS - 1598-2998 (Linking) VI - 49 IP - 4 DP - 2017 Oct TI - 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. PG - 937-946 LID - 10.4143/crt.2016.423 [doi] AB - PURPOSE: 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. MATERIALS AND METHODS: All patients received up to six 3-week cycles of gemcitabine (days 1 and 8, 1,250 mg/m(2)) and cisplatin (day 1, 75 mg/m(2)). 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. CONCLUSION: 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. FAU - Park, Keunchil AU - Park K AD - Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. FAU - Cho, Eun Kyung AU - Cho EK AD - Department of Medicine, Gachon University Gil Medical Center, Incheon, Korea. FAU - Bello, Maximino AU - Bello M AD - Saint Luke's Medical Center, Quezon City, Philippines. FAU - Ahn, Myung-Ju AU - Ahn MJ AD - Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. FAU - Thongprasert, Sumitra AU - Thongprasert S AD - Chief Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Maharaj Nakorn Chiang Mai, Chiang Mai University, Chiang Mai, Thailand. FAU - Song, Eun-Kee AU - Song EK AD - Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, Korea. FAU - Soldatenkova, Victoria AU - Soldatenkova V AD - Lilly Deutschland GmbH, Bad Homburg, Germany. FAU - Depenbrock, Henrik AU - Depenbrock H AD - Lilly Deutschland GmbH, Bad Homburg, Germany. FAU - Puri, Tarun AU - Puri T AD - Eli Lilly and Company, Gurgaon, India. FAU - Orlando, Mauro AU - Orlando M AD - Eli Lilly Interamerica Inc., Buenos Aires, Argentina. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170106 PL - Korea (South) TA - Cancer Res Treat JT - Cancer research and treatment JID - 101155137 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0W860991D6 (Deoxycytidine) RN - 2BT4C47RUI (necitumumab) RN - Q20Q21Q62J (Cisplatin) RN - 0 (Gemcitabine) SB - IM MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal/administration & dosage MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - *Asian People MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/*pathology MH - Cisplatin/administration & dosage MH - Deoxycytidine/administration & dosage/analogs & derivatives MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Lung Neoplasms/*drug therapy/mortality/*pathology MH - Male MH - Middle Aged MH - Neoplasm Metastasis MH - Neoplasm Staging MH - Treatment Outcome MH - Gemcitabine PMC - PMC5654161 OTO - NOTNLM OT - Cisplatin OT - East Asian OT - Epidermal growth factor receptor OT - Gemcitabine OT - Necitumumab OT - Non-small-cell lung carcinoma COIS- This study was sponsored by Eli Lilly, the manufacturer/ licensee of necitumumab. Medical writing assistance was provided by Justine Southby, PhD, CMPP, and Luke Carey, PhD, of ProScribe-Envision Pharma Group, and was funded by Eli Lilly. ProScribe's services complied with international guidelines for Good Publication Practice (GPP3). Eli Lilly was involved in the study design, data collection, data analysis, and preparation of the manuscript. V.S., H.D., T.P., and M.O. are employees of and own stock in Eli Lilly. T.P. is on the Board of Directors of Eli Lilly and Company (India) Pvt. Ltd. K.P. has an advisory role with Eli Lilly. E.K.C., M.B., M.-J.A., S.T., and E.-K.S. have no conflicts of interest to declare. EDAT- 2017/01/24 06:00 MHDA- 2018/06/02 06:00 PMCR- 2017/10/01 CRDT- 2017/01/24 06:00 PHST- 2016/09/02 00:00 [received] PHST- 2016/12/14 00:00 [accepted] PHST- 2017/01/24 06:00 [pubmed] PHST- 2018/06/02 06:00 [medline] PHST- 2017/01/24 06:00 [entrez] PHST- 2017/10/01 00:00 [pmc-release] AID - crt.2016.423 [pii] AID - crt-2016-423 [pii] AID - 10.4143/crt.2016.423 [doi] PST - ppublish SO - Cancer Res Treat. 2017 Oct;49(4):937-946. doi: 10.4143/crt.2016.423. Epub 2017 Jan 6.