PMID- 26693077 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20151222 LR - 20201001 IS - 2156-6976 (Print) IS - 2156-6976 (Electronic) IS - 2156-6976 (Linking) VI - 5 IP - 10 DP - 2015 TI - A multi-center phase II study of nintedanib as second-line therapy for patients with advanced non-small-cell lung cancer in China. PG - 3270-5 AB - PURPOSE: This study examined the efficacy and safety of using nintedanib as single-regimen in 2(nd)-line chemotherapy for Chinese patients with advanced (beyond stage IIIB) non-small-cell lung cancer (NSCLC). METHODS: Chinese patients were those with stage IIIB or IV NSCLC and had unsuccessful 1(st)-line platinum based chemotherapy. Patients received two oral intakes of 200 mg nintedanib everyday from day 1 to day 21, on every 4-week cycle. Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS) and disease control rate. RESULTS: There were 62 eligible patients enrolled in the study. Half of the patients were male (n = 31, 50.0%). The median age was 64.2 years with youngest age of 33 years and oldest age of 83 years. Median PFS was 3.9 months (95% CI, 2.7-6.4 months). Median OS was 6.7 months (95% CI, 4.8-10.1 months). No patients (0.0%) had complete response. Thirty-one patients (50.0%) had stable disease and 23 patients (37.1%) had partial response. The most common severe adverse events (AEs), graded as 3 or 4, were heart failure (n = 12, 19.4%), hypertension (n = 7, 11.8%) and diarrhea (n = 6, 9.8%). CONCLUSION: NSCLC Patients in 2(nd)-line chemotherapy reached similar PFS, as compared with other FDA-approved second-line regimens. Also, the toxicity of nintedanib was well tolerated. Thus, nintedanib may be used as a standard regimen for 2(nd)-line chemotherapy for patients with advanced NSCLC. FAU - Dai, Wenxin AU - Dai W AD - Fourth Ward of Medical Care Center, Hainan Provincial People's Hospital Haikou 570311, Hainan Province, China ; The First Xiangya Hospital of Central South University, Central South University Changshai 410083, Hunan Province, China. FAU - Luo, Bailing AU - Luo B AD - The First Xiangya Hospital of Central South University, Central South University Changshai 410083, Hunan Province, China. FAU - Wu, Zhiyong AU - Wu Z AD - Fourth Ward of Medical Care Center, Hainan Provincial People's Hospital Haikou 570311, Hainan Province, China. FAU - Chen, Juan AU - Chen J AD - Fourth Ward of Medical Care Center, Hainan Provincial People's Hospital Haikou 570311, Hainan Province, China. FAU - Feng, Guangqiu AU - Feng G AD - Fourth Ward of Medical Care Center, Hainan Provincial People's Hospital Haikou 570311, Hainan Province, China. FAU - Guan, Ping AU - Guan P AD - Fourth Ward of Medical Care Center, Hainan Provincial People's Hospital Haikou 570311, Hainan Province, China. LA - eng PT - Journal Article DEP - 20150915 PL - United States TA - Am J Cancer Res JT - American journal of cancer research JID - 101549944 CIN - Am J Cancer Res. 2016;6(7):1547-8. PMID: 27508096 PMC - PMC4656748 OTO - NOTNLM OT - Non-small-cell lung cancer OT - OS OT - PFS OT - nintedanib OT - second-line chemotherapy EDAT- 2015/12/23 06:00 MHDA- 2015/12/23 06:01 PMCR- 2015/09/15 CRDT- 2015/12/23 06:00 PHST- 2015/05/19 00:00 [received] PHST- 2015/06/13 00:00 [accepted] PHST- 2015/12/23 06:00 [entrez] PHST- 2015/12/23 06:00 [pubmed] PHST- 2015/12/23 06:01 [medline] PHST- 2015/09/15 00:00 [pmc-release] PST - epublish SO - Am J Cancer Res. 2015 Sep 15;5(10):3270-5. eCollection 2015.