A phase III, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancer
Background: Carboxyamidotriazole (CAI), a calcium channel blocker, inhibits tumor cell proliferation, metastasis, and angiogenesis. This trial aimed to determine whether CAI combined with conventional chemotherapy could prolong progression-free survival (PFS) in non-small cell lung cancer (NSCLC) pa...
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doaj-139061d82c9d427297f29127b1efa5a02020-12-01T08:05:11ZengSAGE PublishingTherapeutic Advances in Medical Oncology1758-83592020-11-011210.1177/1758835920965849A phase III, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancerXiaoyan SiJinwan WangYing ChengJianhua ShiLiying CuiHelong ZhangYunchao HuangWei LiuLei ChenJiang ZhuShucai ZhangWei LiYan SunHanping WangXiaotong ZhangMengzhao WangLin YangLi ZhangBackground: Carboxyamidotriazole (CAI), a calcium channel blocker, inhibits tumor cell proliferation, metastasis, and angiogenesis. This trial aimed to determine whether CAI combined with conventional chemotherapy could prolong progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients. Methods: Patients were assigned into groups (3:1 ratio) to receive either chemotherapy + CAI or chemotherapy alone. Cisplatin (25 mg/m 2 ) was administered by intravenous infusion on days 1, 2, and 3, and vinorelbine (25 mg/m 2 ) on days 1 and 8 of each 3-week cycle for four cycles. CAI was administered at 100 mg daily with concomitant chemotherapy; this treatment was continued after chemotherapy was ceased until serious toxicity or disease progression had occurred. PFS was the primary endpoint, and the secondary endpoints were objective response rate (ORR), disease control rate, overall survival (OS), and quality of life. Results: In total, 495 patients were enrolled in the trial: 378 in the chemotherapy + CAI group and 117 in the chemotherapy + placebo group. PFS was significantly greater in the chemotherapy + CAI [median, 134 days; 95% confidence interval (CI) 127–139] than in the chemotherapy + placebo (median, 98 days; 95% CI: 88–125) group, with a hazard ratio of 0.690 (95% CI: 0.539–0.883; p = 0.003). There was no difference in the OS rates of both groups. The ORR was greater in the chemotherapy + CAI group than in the chemotherapy + placebo group (34.6% versus 25.0%, p = 0.042). Adverse events of ⩾grade 3 occurred more frequently in the CAI group [256 (68.1%) versus 64 (55.2%); p = 0.014]. Conclusion: CAI + platinum-based chemotherapy prolonged PFS and could be a useful therapeutic option to treat NSCLC. Clinical Trial Registration: chinadrugtrials.org.cn identifier: CTR20160395https://doi.org/10.1177/1758835920965849 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Xiaoyan Si Jinwan Wang Ying Cheng Jianhua Shi Liying Cui Helong Zhang Yunchao Huang Wei Liu Lei Chen Jiang Zhu Shucai Zhang Wei Li Yan Sun Hanping Wang Xiaotong Zhang Mengzhao Wang Lin Yang Li Zhang |
spellingShingle |
Xiaoyan Si Jinwan Wang Ying Cheng Jianhua Shi Liying Cui Helong Zhang Yunchao Huang Wei Liu Lei Chen Jiang Zhu Shucai Zhang Wei Li Yan Sun Hanping Wang Xiaotong Zhang Mengzhao Wang Lin Yang Li Zhang A phase III, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancer Therapeutic Advances in Medical Oncology |
author_facet |
Xiaoyan Si Jinwan Wang Ying Cheng Jianhua Shi Liying Cui Helong Zhang Yunchao Huang Wei Liu Lei Chen Jiang Zhu Shucai Zhang Wei Li Yan Sun Hanping Wang Xiaotong Zhang Mengzhao Wang Lin Yang Li Zhang |
author_sort |
Xiaoyan Si |
title |
A phase III, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancer |
title_short |
A phase III, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancer |
title_full |
A phase III, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancer |
title_fullStr |
A phase III, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancer |
title_full_unstemmed |
A phase III, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancer |
title_sort |
phase iii, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancer |
publisher |
SAGE Publishing |
series |
Therapeutic Advances in Medical Oncology |
issn |
1758-8359 |
publishDate |
2020-11-01 |
description |
Background: Carboxyamidotriazole (CAI), a calcium channel blocker, inhibits tumor cell proliferation, metastasis, and angiogenesis. This trial aimed to determine whether CAI combined with conventional chemotherapy could prolong progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients. Methods: Patients were assigned into groups (3:1 ratio) to receive either chemotherapy + CAI or chemotherapy alone. Cisplatin (25 mg/m 2 ) was administered by intravenous infusion on days 1, 2, and 3, and vinorelbine (25 mg/m 2 ) on days 1 and 8 of each 3-week cycle for four cycles. CAI was administered at 100 mg daily with concomitant chemotherapy; this treatment was continued after chemotherapy was ceased until serious toxicity or disease progression had occurred. PFS was the primary endpoint, and the secondary endpoints were objective response rate (ORR), disease control rate, overall survival (OS), and quality of life. Results: In total, 495 patients were enrolled in the trial: 378 in the chemotherapy + CAI group and 117 in the chemotherapy + placebo group. PFS was significantly greater in the chemotherapy + CAI [median, 134 days; 95% confidence interval (CI) 127–139] than in the chemotherapy + placebo (median, 98 days; 95% CI: 88–125) group, with a hazard ratio of 0.690 (95% CI: 0.539–0.883; p = 0.003). There was no difference in the OS rates of both groups. The ORR was greater in the chemotherapy + CAI group than in the chemotherapy + placebo group (34.6% versus 25.0%, p = 0.042). Adverse events of ⩾grade 3 occurred more frequently in the CAI group [256 (68.1%) versus 64 (55.2%); p = 0.014]. Conclusion: CAI + platinum-based chemotherapy prolonged PFS and could be a useful therapeutic option to treat NSCLC. Clinical Trial Registration: chinadrugtrials.org.cn identifier: CTR20160395 |
url |
https://doi.org/10.1177/1758835920965849 |
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