KEY TAKEAWAYS
- LONBRECA, a phase II trial, investigated the role of FTD/TPI in MBC patients, comparing those with prior exposure to fluoropyrimidines or without it.
- Patients were treated with FTD/TPI and followed for PFS and ORR.
- The study concluded that FTD/TPI showed promising anti-tumor activity and safety in patients with MBC, warranting further investigation.
FTD/TPI, an oral drug combination, has shown activity in colorectal and gastric cancers despite prior exposure to fluoropyrimidines. Researchers aimed to explore the role of FTD/TPI in metastatic breast cancer (MBC) patients, comparing those with prior exposure to fluoropyrimidines (Cohort A) and those without such exposure (Cohort B).
Patients were treated with FTD/TPI. The study’s primary objectives were to determine progression-free survival (PFS) in each cohort, while secondary objectives included assessing objective response rates (ORR), safety, and tolerability.
The study enrolled 74 patients (42 for Cohort A, 32 for Cohort B), with 4 participating in the lead-in phase. Dosing of FTD/TPI was confirmed as 35 mg/m2 on specific days of 4-week cycles, and no dose-limiting toxicities were observed. Median progression-free survival (PFS) was 5.7 months (95% CI 3.8 to 8.3) for Cohort A and 9.4 months (95% CI 5.5 to 14.0) for Cohort B. Similar response rates were seen regardless of prior fluoropyrimidine exposure, with overall response rates (ORR) of 19.5% (95% CI 8.8 to 34.9) for Cohort A and 16.1% (95% CI 5.5 to 33.7) for Cohort B. Six-month clinical benefit rates were 56.1% (95% CI 39.7 to 71.5) for Cohort A and 61.3% (95% CI 42.2 to 78.2) for Cohort B. FTD/TPI has manageable side effects, including neutropenia, fatigue, nausea, and anorexia. Most side effects were managed with dose reduction or cycle prolongation. Only one patient had to discontinue therapy due to toxicity.
The study concluded that FTD/TPI offers meaningful benefits in MBC, including prior fluoropyrimidine-exposed patients, with manageable toxicity, and merits further investigation in randomized studies.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.1099
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04280536
Joline Si Jing Lim, Samuel Guan Wei Ow, Andrea Wong, Matilda Lee, Gloria HJ Chan, Jia Li Low, Raghav Sundar, Joan RE Choo, Bee Choo Tai, and Soo-Chin Lee. | Journal of Clinical Oncology 2023 41:16_suppl, 1099-1099
