Abstract 450P
Background
Regorafenib (REGO) and trifluridine/tipiracil (FTD/TPI) as late-line treatment has been available since 2012, however, their impact on the total OS of pts that is measured from the initiation of first-line CT in clinical practice. We previously demonstrated late-line treatment with REGO or FTD/TPI could improve OS, however, the number of events and the follow-up time was insufficient. Thus, we conducted an updated analysis of our study.
Methods
Data cutoff for this updated analysis was Dec 2019 (previously, Sep 2018). We retrospectively collected the data of consecutive mCRC pts who received first-line CT at 3 institutions between Jan 2005 and Sep 2016. We divided the pts into 3 groups according to the availability of drugs at the initiation of first-line CT; pts who initiated between Jan 2005 and Dec 2006 (cohort A), Jan 2007 and Dec 2011 (cohort B), and Jan 2012 and Sep 2016 (cohort C). The primary outcome is to compare OS between cohort A, B and C.
Results
A total of 1,426 pts were analyzed. Pts’ characteristics of cohort A (165 pts), B (626 pts) and C (635 pts) were as follows; median age, 62 /63/65 years; ECOG PS ≥2, 8.5%/8.8%/8.2%; number of metastatic sites ≥2, 63.6%/61.3%/58.1%, respectively. Median OS in cohort A, B, and C, was 18.8, 25.3, and 25.8 M, respectively. Hazard ratio (HR) (95% confidence interval [CI]) for cohort B vs. A was 0.82 (0.68-0.98), for C vs. A was 0.75 (0.62-0.90), and for C vs. B was 0.92 (0.81-1.04), respectively. Multivariate analysis revealed PS ≥2, right sided tumors, number of metastatic sites ≥2, WBC≥10,000/μL, ALP≥300IU/L, and LDH≥ 400U/L were poor prognostic factors. The adjusted HR (95% CI) for cohort B vs. A was 0.79 (0.66-0.95), cohort C vs. A was 0.76 (0.63-0.91), and cohort C vs. B 0.96 (0.84-1.08) after adjusting for poor prognostic factors above.
Conclusions
This updated analysis showed late-line treatment with REGO or FTD/TPI would contribute to prolong total OS of mCRC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
T. Kawakami: Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Chugai Pharmaceutical; Advisory/Consultancy: Bayer Pharmaceutical; Honoraria (self): Takeda Pharmaceutical. K. Yamazaki: Honoraria (self): Chugai Pharma, Diichi Sankyo, Yakult Honsha, Takeda, Bayer, Merck Serono, Taiho Pharmaceutical, Lilly, Sanofi, Ono Pharmaceutical, MSD, Bristol-Meyers Squibb. T. Masuishi: Honoraria (self): Takeda, Chugai, Merck Bio Pharma, Taiho, Bayer, Lilly Japan, Yakult Honsha, Sanofi; Research grant/Funding (institution): MSD, Daiichi Sankyo, Ono. Y. Kawamoto: Honoraria (self): Taiho Pharmaceutical. S. Yuki: Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Bayer. K. Yamamoto: Honoraria (self): Taiho Pharmaceutical. T. Yamanaka: Honoraria (self): Bayer. Y. Komatsu: Speaker Bureau/Expert testimony: ASAHNippon Kayaku Co.,Ltd. I Kasei Pharma Corporation, Bristol-Myers Squibb Co, Eli Lilly Japan K.K. Mitsubishi Tanabe Pharma Corporation, Nipro Corporation, Ono Pharmaceutical Co., Ltd. Pfizer Japan Inc. Sanofi K.K. Taiho Pharmaceutical Co., Ltd. Takeda ; Honoraria (self): Asahi Kasei Pharma Corporation. Bayer Yakuhin, Ltd Chugai Pharmaceutical Co., Ltd. Daiichi Sankyo Company, Limited. Eli Lilly Japan K.K. Kyowa Kirin Co., Ltd. Merck Biopharma Co., Ltd. Sanofi K.K. Shire Japan K.K. Taiho Pharmaceutical Co., Ltd. Yakult Hons; Research grant/Funding (institution): A2 Healthcare Corp. Astellas Pharma Inc. Bayer Yakuhin, Ltd Daiichi Sankyo Company, Limited Dainippon Sumitomo Pharma Co., Ltd. Eisai Co., Ltd. MSD K.K. NanoCarrier Co., Ltd. Ono Pharmaceutical Co., LTD. Parexel International Corporation. Sanofi-aventis S. K. Muro: Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Sanofi; Honoraria (self), Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Parexel International; Research grant/Funding (institution): Shionogi Pharmaceutical; Research grant/Funding (institution): Sumitomo Dainippon Pharma; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Mediscience Planning; Research grant/Funding (institution): Solasia Pharma; Research grant/Funding (institution): Merck Serono; Honoraria (self): Eli Lilly; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Takeda Pharmaceutical; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Bristol-Meyers Squibb; Honoraria (self): Bayer. All other authors have declared no conflicts of interest.