Wenxin Dai1, Bailing Luo2, Zhiyong Wu3, Juan Chen3, Guangqiu Feng3, Ping Guan3. 1. 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. 2. The First Xiangya Hospital of Central South University, Central South University Changshai 410083, Hunan Province, China. 3. Fourth Ward of Medical Care Center, Hainan Provincial People's Hospital Haikou 570311, Hainan Province, China.
Abstract
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.
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:NSCLCPatients 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.
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