医学
耐受性
队列
内科学
中性粒细胞减少症
恶心
转移性乳腺癌
肿瘤科
乳腺癌
胃肠病学
置信区间
癌症
不利影响
毒性
作者
Joline S.J. Lim,Samuel G.W. Ow,Andrew Barnabas Wong,Matilda X. W. Lee,Gloria Chan,Jia Li Low,Raghav Sundar,Joan R.E. Choo,Wan Qin Chong,Yvonne Ang,Bee Choo Tai,Soo Chin Lee
标识
DOI:10.1016/j.ejca.2023.113311
摘要
Fluoropyrimidines are commonly used in the treatment of metastatic breast cancer (MBC), and trifluridine/tipiracil (FTD/TPI) has shown activity in patients with colorectal and gastric cancers despite prior exposure to fluoropyrimidines. We investigate the role of FTD/TPI in patients with MBC with or without prior fluoropyridines in a single-arm phase II study.Patients with MBC were enroled first into a run-in dose confirmation phase, followed by two parallel cohorts including patients with (Cohort A) and without (Cohort B) prior exposure to fluoropyrimidines, where they were treated with FTD/TPI. Primary objectives for each cohort included determination of progression-free survival (PFS), and secondary objectives included determination of objective response rates (ORR), safety, and tolerability.Seventy-four patients (42 Cohort A, 32 Cohort B) were enroled, all of whom were evaluable for toxicity and survival, with 72 evaluable for response. Median PFS was 5.7 months (95% confidence interval 3.8-8.3) and 9.4 months (95% CI 5.5-14.0) respectively in Cohorts A and B. Responses were observed regardless of prior exposure to fluoropyrimidines, with ORR of 19.5% (95% CI 8.8-34.9) and 16.1% (95% CI 5.5-33.7) in Cohorts A and B, and 6-month clinical benefit rates of 56.1% (95% CI 39.7-71.5) and 61.3% (95% CI 42.2-78.2) respectively. The safety profile was consistent with known toxicities of FTD/TPI, including neutropenia, fatigue, nausea, and anorexia, mitigated with dose modifications.FTD/TPI showed promising antitumour activity with manageable toxicity and is a clinically valid option in patients with MBC.
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