长春瑞滨
医学
培美曲塞
内科学
转移性乳腺癌
临床终点
乳腺癌
肿瘤科
卡培他滨
临床研究阶段
癌症
随机对照试验
外科
化疗
结直肠癌
顺铂
作者
Dae-Won Lee,Kyung Hae Jung,Kyung-Hun Lee,Yeon Hee Park,Keun Seok Lee,Joohyuk Sohn,Hee Kyung Ahn,Jae Ho Jeong,Su‐Jin Koh,Jee Hyun Kim,Hee Jin Kim,Kyoung Eun Lee,Hee-Jun Kim,Yaewon Yang,Kyong Hwa Park,Jieun Lee,Hye Sung Won,Tae-Yong Kim,Seock Ah Im
标识
DOI:10.1016/j.ejca.2023.113456
摘要
Metastatic breast cancer refractory to anthracycline and taxanes often shows rapid progression. The development of effective and tolerable combination regimens for these patients is needed. This phase II trial investigated the efficacy of pemetrexed plus vinorelbine in patients with metastatic breast cancer.This randomized, open-label, phase II trial was conducted in 17 centers in Korea. Patients with advanced breast cancer who had previously been treated with anthracyclines and taxanes were randomly assigned in a 1:1 ratio to receive either vinorelbine or pemetrexed plus vinorelbine. Randomization was stratified by prior capecitabine treatment and hormone receptor status. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included the objective response rate, overall survival, safety, and quality of life.Between March 2017 and August 2019, a total of 125 patients were enrolled. After a median follow-up duration of 14.1 months, 118 progression events and 88 death events had occurred. Sixty-two patients were assigned to the pemetrexed plus vinorelbine arm, and 63 were assigned to the vinorelbine arm. Pemetrexed plus vinorelbine significantly prolonged PFS compared to vinorelbine (5.7 vs. 1.5 months, p < 0.001). The combination arm had higher disease control rate (76.8% vs. 45.9%, p = 0.001) and a tendency toward longer overall survival (16.8 vs. 10.5 months, p = 0.102). Anemia was more frequent in the pemetrexed plus vinorelbine arm per cycle compared with vinorelbine (7.9% vs. 1.9%, p < 0.001), but there was no difference in the incidence of grade 3-4 neutropenia per cycle between the pemetrexed plus vinorelbine arm and the vinorelbine single arm (14.7% vs. 19.5%, p = 0.066).This phase II study showed that pemetrexed plus vinorelbine led to a longer PFS than vinorelbine. Adverse events of pemetrexed plus vinorelbine were generally manageable.
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