Phase II study of trifluridine/tipiracil in metastatic breast cancers with or without prior exposure to fluoropyrimidines

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...

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Published in:European journal of cancer (1990) 2023-11, Vol.193, p.113311-113311, Article 113311
Main Authors: Lim, Joline S.J., Ow, Samuel G.W., Wong, Andrea L.A., Lee, Matilda X.W., Chan, Gloria H.J., Low, Jia Li, Sundar, Raghav, Choo, Joan R.E., Chong, Wan Qin, Ang, Yvonne L.E., Tai, Bee Choo, Lee, Soo Chin
Format: Article
Language:English
Subjects:
Chemotherapy
FTD/TPI
Metastatic breast cancer
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Summary: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. •Chemotherapy remains mainstay treatment for patients with metastatic breast cancer.•FTD/TPI is effective in GI cancers even after prior fluoropyrimidine exposure.•Our study showed that FTD/TPI had good safety and promising anti-tumour activity.•FTD/TPI is an attractive oral option for patients with metastatic breast cancer.
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2023.113311