616P - Sequential treatment with regorafenib (REG) and trifluridine/tipiracil (TAS) +/- bevacizumab (Bev) in refractory metastatic colorectal cancer (mCRC) in community clinical practice in the USA

Background

REG and TAS are approved for the treatment of refractory mCRC. However, data on their sequential use in any setting is limited. The aim of this study was to describe the characteristics and clinical outcomes of patients (pts) with mCRC treated sequentially in community clinical practice in the USA.

Methods

This was a retrospective cohort study using the nationwide de-identified Flatiron Health electronic health record-derived database. Pts aged ≥18 years at mCRC diagnosis treated sequentially with REG and TAS±Bev from Jan 2015 to Sep 2022 were divided into two cohorts: R-T (REG followed by TAS±Bev) and T-R (TAS±Bev followed by REG). Index date was the initiation of the first therapy in a sequence. Minimum follow up was 3 months (mos). Clinical outcomes included overall survival (OS), time to treatment discontinuation (TTD), neutropenia, and use of granulocyte-colony stimulating factor (G-CSF).

Results

A total of 818 pts were included (n=393 R-T; n=425 T-R). Most pts received index therapy in 3L (41.9%) or 4L (23.7%). Baseline characteristics were similar between cohorts (Table). Median OS improved with R-T vs T-R in both 3L and 4L (13.1 vs 11.5 mos in 3L; 11.6 vs 10.3 mos in 4L), though the differences were not statistically significant (HR [95% CI]: 0.94 [0.74, 1.19] 3L; 0.86 [0.63, 1.18] 4L). TTD was slightly longer with R-T vs T-R in 3L (8.7 vs 8.1 mos, HR 0.91 [0.73, 1.14]) and 4L (8.5 vs 7.9 mos, HR 0.86 [0.63, 1.16]). Frequency of neutropenia and use of G-CSF were lower with R-T vs T-R (38.9% vs 48.0% neutropenia; 14.0% vs 17.9% G-CSF).

Table: 616P

Conclusions

This real-world study showed that pts treated with sequential R-T vs T-R appeared to have longer OS and TTD, and less neutropenia and G-CSF use. Sequential therapy starting with REG may provide a chemotherapy break to improve tolerability and reduce myelosuppression in pts with refractory mCRC.

Clinical trial identification

Editorial acknowledgement

Editorial assistance in the preparation of this abstract was provided by Open Health Scientific Communications, London UK, with financial support from Bayer.

Legal entity responsible for the study

The authors.

Funding

Bayer.

Disclosure

T. Bekaii-Saab: Financial Interests, Institutional, Advisory Board: Bayer, Pfizer, Incyte, Ipsen, Seattle Genetics, Genentech, Merck KGA, Merus, Eisai, Servier; Financial Interests, Institutional, Other, DSMB: Merck; Financial Interests, Personal, Advisory Board: AbbVie, Boehringer Ingelheim, Janssen, AstraZeneca, Daiichi Sankyo, Natera, Celularity, Exact Science, Sobi, BeiGene, Xilis, Foundation Medicine, Stemline, Blueprint, Celularity, Caladrius, GSK, Deciphera, Zai Labs, Illumina, Sanofi; Financial Interests, Personal, Other, DSMB: AstraZeneca, Exelixis, The Valley Hospital, Fibrogen; Financial Interests, Personal, Other, DSMC: PanCAN; Financial Interests, Personal, Royalties, WO/2018/183488: HUMAN PD1 PEPTIDE Vaccines and Uses Thereof – Licensed to Imugene: Imugene; Financial Interests, Personal, Royalties, WO/2019/055687: Methods and Compositions for the Treatment of Cancer Cachexia – Licensed to Recursion: Recursion; Financial Interests, Institutional, Research Grant: Agios, Arys, Bayer, Amgen, Ipsen, Clovis, Pfizer, Celgene, Novartis, Arcus, Atreca, Bristol Myers Squibb, Mirati, Merus, Abgenomics; Financial Interests, Institutional, Coordinating PI: Boston Biomedical, Incyte; Financial Interests, Institutional, Steering Committee Member: Seattle Genetics; Non-Financial Interests, Advisory Role: Imugene, Sun Biopharma. D. Ahn: Financial Interests, Personal, Speaker, Consultant, Advisor: Genentech, Exelixis, Incyte, Daiichi Sankyo; Financial Interests, Institutional, Research Funding: Bayer, AstraZeneca. C. Yuan, X. Jiao, M. Kurtinecz, X. Pan, Z. Vassilev, H. Ostojic: Financial Interests, Personal, Full or part-time Employment: Bayer.