Abstract 58P
Background
Combination therapy of FTD/TPI plus BEV showed a survival benefit in the late-line treatment for patients with mCRC. In addition, several phase II studies suggested that the bi-weekly schedule of FTD/TPI (days 1-5 in a 2-week cycle) plus BEV reduced hematological toxicities without reducing efficacy. To assess the clinical outcomes of FTD/TPI plus BEV, this pooled analysis was conducted.
Methods
IPD for patients who received FTD/TPI plus BEV was corrected from 5 clinical trials, C-TASK FORCE, TAS-CC3, TAS-CC4, TRUSTY, and KSCC1602. This report presents an analysis of IPD from 3 clinical trials in the late-line treatment, C-TASK FORCE, TAS-CC3, and TAS-CC4. The safety and efficacy of FTD/TPI plus BEV were evaluated, including different schedules of FTD/TPI, bi-weekly vs. standard schedule (days 1-5 and 8-12 in a 4-week cycle).
Results
In 3 clinical trials, 101 patients received FTD/TPI plus BEV. The baseline characteristics were as follows: median age, 63 years; male, 56%; ECOG PS 0, 76%; RAS wild-type, 50%. The incidence of major grade 3 or 4 adverse events was as follows: neutropenia, 40%; anemia, 9%; thrombocytopenia, 50%; fatigue, 4%; anorexia, 4%; nausea, 3%. Median progression-free survival (PFS) and disease control rate (DCR) were 4.2 (95% CI 3.5-4.9) months and 70 (95% CI 60-79)%. The bi-weekly and standard schedule of FTD/TPI plus BEV were administrated in 44 and 57 patients, respectively. The patient characteristics were well balanced except for the metastatic site. The incidence of grade 3 or 4 neutropenia (16/58%) and thrombocytopenia (0/12%) was significantly lower in bi-weekly schedule. Median PFS and DCR were 4.2 (95% CI 3.2-5.4) / 4.4 (95% CI 2.4-5.6) months (HR 1.05 [95% CI 0.70-1.58], p = 0.804) and 73 (95% CI 57-85) / 68 (95% CI 55-80)% (OR 1.06 [95% CI 0.83-1.37] p = 0.639).
Conclusions
The safety and efficacy of this pooled analysis were similar to those previously reported. The bi-weekly FTD/TPI plus BEV may be comparable efficacy and reduce the incidence of severe hematological adverse events compared standard schedule FTD/TPI plus BEV. An updated analysis of overall survival will be reported in the presentation.
Clinical trial identification
UMIN000041621.
Legal entity responsible for the study
The 22nd Century Cutting-Edge Medical IT Organization.
Funding
Taiho Pharmaceutical.
Disclosure
K. Yamazaki: Financial Interests, Personal, Invited Speaker: Chugai Pharma, Daiichi Sankyo, Yakult Honsha, Takeda, Bayer, Merck Serono, Taiho Pharmaceutical, Lilly, Sanofi, Ono Pharmaceutical, MSD, Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical. T. Yamada: Financial Interests, Personal, Research Grant: AFI Technology. Y. Kuboki: Financial Interests, Personal, Advisory Board: Takeda, Amgen, Abbie, Incyte, Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Taiho, Lilly; Financial Interests, Institutional, Invited Speaker: Taiho, Astellas, Lilly, Takeda, AstraZeneca, Boehringer Ingelheim, Chugai, Genmab, Incyte, Abbie, Amgen, Merck, Novartis, Hengrui; Non-Financial Interests, Member: JSMO, ASCO, JSCO, JCA. E. Oki: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eli Lilly, Bristol Myers Squibb, MSD, Takeda Pham; Financial Interests, Institutional, Research Grant: Guardant Health. T. Yoshino: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., Bayer Yakuhin, Ltd., Ono Pharmaceutical Co., Ltd., MSD K.K., Takeda Pharmaceutical Co., Ltd.; Financial Interests, Personal, Other, Consultancy: Sumitomo Corp.; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical Co., Ltd., Sanofi K.K., MSD K.K., Taiho Pharmaceutical Co., Ltd., Molecular Health GmbH, Amgen K.K., Pfizer Japan Inc., Genomedia Inc., Sysmex Corp., Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Eisai Co., Ltd., Roche Diagnostics K.K., Falco Biosystems Ltd. T. Hamano: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical co. ltd.; Financial Interests, Institutional, Officer: P4 Statistics Co. Ltd.; Financial Interests, Personal, Stocks/Shares: P4 Statistics Co. Ltd. T. Kawakami: Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Other, honoraria: Bristol Myers Squibb, Ono Pharmaceutical, Yakult Honsha, Daiichi Sankyo, Eli Lilly, Merck Biopharma, Taiho Pharmaceutical, AstraZeneca.