Shun Lu1, Lu Li, Yi Luo, Li Zhang, Gang Wu, Zhiwei Chen, Cheng Huang, Shuliang Guo, Yiping Zhang, Xiangqun Song, Yongfeng Yu, Caicun Zhou, Wei Li, Meilin Liao, Baolan Li, Liyan Xu, Ping Chen, Chunhong Hu, Chengping Hu. 1. *Department of Oncology, Shanghai Lung Cancer Center, Chest Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China; †Department of Thoracic Cancer, Cancer Center, West China Hospital, Sichuan University, Chengdu, China; ‡Department of Medical Oncology, Hunan Provincial Tumor Hospital, Changsha, Hunan, China; §Department of Medical Oncology, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, China; ‖The Cancer Center of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; ¶Department of Medical Oncology, Fujian Provincial Tumor Hospital, Fujian Medical University Educational Hospital, Fuzhou, China; #Department of Respiratory Medicine, The First Affiliated Hospital, Chongqing University of Medical Sciences, Chongqing, China; **Chemotherapy Center of Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China; ††Department of Chemotherapy, Affiliated Tumor Hospital, Guangxi Medical University, Guangxi, China; ‡‡Department of Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China; §§Cancer Center of the First University Hospital, Jilin University, Changchun, China; ‖‖Department of General, Beijing Chest Hospital, Beijing, China; ¶¶Department of Oncology, Second Xiangya Hospital of Central-South University, Changsha, China; and ##Department of Respiratory Disease, Xiang-ya Hospital, Central Southern University, Hunan, Changsha, China.
Abstract
BACKGROUND: Based on promising efficacy in a single-arm study, a randomized phase II trial was designed to compare the efficacy and safety of adding rh-endostatin (Endostar) to first-line standard etoposide and carboplatin (EC) chemotherapy for treatment of extensive-stage small-cell lung cancer. METHODS:One hundred forty Chinese patients with pathologically confirmed, extensive-stage small-cell lung cancer were randomly assigned to EC alone or rh-endostatin + EC for 4-6 cycles, followed by single-agent rh-endostatin until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival, Objective response rate (ORR), and quality of life. RESULTS:Median PFS was 6.4 months with rh-endostatin + EC (n = 69) and 5.9 months with EC (n = 69) (hazard ratio 0.8 [95% confidence interval 0.6-1.1]). PFS was significantly higher with rh-endostatin + EC than with EC (hazard ratio 0.4 [0.2-0.9; p = 0.020]) in female. Median overall survival was similar in both groups (12.1 versus 12.4 months, respectively [p = 0.82]). ORR was higher in the rh-endostatin + EC group (75.4%) than in the EC group (66.7%) (p = 0.348). The efficacy of rh-endostatin + EC relative to that of EC was reflected by greater improvements in patient-assessed quality of life scores after 4 and 6 weeks of treatment. There was no difference between each regimen in the incidence of nonhematological or Grade III-IV hematological toxicities. CONCLUSIONS: Addition of rh-endostatin to EC for the treatment of extensive-stage small-cell lung cancer had an acceptable toxicity profile, but did not improve overall survival, PFS, and ORR.
RCT Entities:
BACKGROUND: Based on promising efficacy in a single-arm study, a randomized phase II trial was designed to compare the efficacy and safety of adding rh-endostatin (Endostar) to first-line standard etoposide and carboplatin (EC) chemotherapy for treatment of extensive-stage small-cell lung cancer. METHODS: One hundred forty Chinese patients with pathologically confirmed, extensive-stage small-cell lung cancer were randomly assigned to EC alone or rh-endostatin + EC for 4-6 cycles, followed by single-agent rh-endostatin until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival, Objective response rate (ORR), and quality of life. RESULTS: Median PFS was 6.4 months with rh-endostatin + EC (n = 69) and 5.9 months with EC (n = 69) (hazard ratio 0.8 [95% confidence interval 0.6-1.1]). PFS was significantly higher with rh-endostatin + EC than with EC (hazard ratio 0.4 [0.2-0.9; p = 0.020]) in female. Median overall survival was similar in both groups (12.1 versus 12.4 months, respectively [p = 0.82]). ORR was higher in the rh-endostatin + EC group (75.4%) than in the EC group (66.7%) (p = 0.348). The efficacy of rh-endostatin + EC relative to that of EC was reflected by greater improvements in patient-assessed quality of life scores after 4 and 6 weeks of treatment. There was no difference between each regimen in the incidence of nonhematological or Grade III-IV hematological toxicities. CONCLUSIONS: Addition of rh-endostatin to EC for the treatment of extensive-stage small-cell lung cancer had an acceptable toxicity profile, but did not improve overall survival, PFS, and ORR.
Authors: Tiandong Kong; Lu Chen; Xiaoli Zhao; Fangfang Duan; Hanli Zhou; Lei Wang; Danna Liu Journal: Invest New Drugs Date: 2022-07-05 Impact factor: 3.651