Randomized phase 3 trials, RECOURSE and TERRA, established trifluridine/tipiracil (FTD/TPI) as a salvage-line therapy for patients with metastatic colorectal cancer (mCRC). This retrospective, large cohort study, JFMC50, aims to assess the treatment pattern and outcomes of FTD/TPI for mCRC in routine clinical practice.
We collected data of patients with mCRC who received FTD/TPI during July 2014-September 2016 in Japanese institutions. However, we examined patients who fulfilled the eligibility criteria, through their backgrounds, treatment course, clinical outcomes, including the OS, time to treatment failure (TTF), disease control rate (DCR), and safety. The main eligibility criteria were the ECOG performance status (PS) 0-2 and the starting dose of FTD/TPI close to the standard dose.
From 127 Japanese institutions, we collected data of 2030 patients and assessed 1770 patients. Patients’ backgrounds were the median age [67 (23-92) years], males (60.1%), ECOG PS 0/1/2 (33.7%/56.7%/9.5%), right-sided tumor (25.4%), and prior regorafenib treatment (23.3%). The median OS and TTF were 8.1 and 2.7 months, respectively; the DCR was 21.0%. Major grade 3 or 4 adverse events were leukopenia, neutropenia, and anemia (25.9%, 39.3%, and 17.7%, respectively). At the data cutoff date, 1756 patients discontinued FTD/TPI therapy. The median OS because of treatment termination due to disease progression was 11.6 months in the progression after progressive disease (PD) by RECIST (n = 122), 9.2 months in PD by RECIST (n = 930), 7.8 months in the elevation of tumor marker (n = 109), and 4.9 months in clinical PD (n = 206).
Both efficacy and safety of FTD/TPI in the clinical practice were compatible with clinical trials. The continuous use of FTD/TPI after PD by RECIST could contribute to longer survival; however, further investigation is warranted.
Clinical trial identification
Legal entity responsible for the study
Japanese Foundation for Multidisciplinary Treatment of Cancer.
Taiho Pharmaceutical Co., Ltd.
The authors would like to thank Enago for the English language review.
T. Kawakami: Honoraria: Takeda, Chugai Pharma, Merck Serono, Lilly Japan, Taiho Pharmaceutical. K. Yamazaki: Speaker's bureau: Chugai, Takeda, Taiho, Yakult, Merck Serono, Lili, Sanofi, Bayer. E. Oki: Speakers' bureau: Taiho Pharmaceutical, Chugai. M. Shimokawa: Statistical consulting fee: Sysmex. T. Esaki: Speakers' bureau from Taiho, Bristol, Eli Lilly, Eisai, Daiichi-Sankyo, Merck Serono, Chugai, Ono, Takeda; Research funding: Daiichi-Sankyo, Merck Serono, Taiho, MSD, Novartis, Dainippon Sumitomo, Ono; Honoraria: Eli Lilly, Kyowa Kirin. Y. Tsuji: Honoraria: Merck Serono, Eli Lilly Japan, Chugai, Taiho, Ono, Daiichi Sankyo, Yakult Honsha, Eisai and Medicon outside the submitted work. Y. Shimada, Y. Komatsu: Research funding, Honoraria: Taiho Pharmaceutical. M. Ohue: Speakers' bureau: Taiho Pharmaceutical; Research funding: Taiho Pharmaceutical, Chugai. Y. Maehara: Speakers' bureau, Research funding: Taiho Pharmaceutical. All other authors have declared no conflicts of interest.