Abstract 398P
Background
Regorafenib (R) and Trifluridine/tipiracil (T) are of proven efficacy in patients (pts) with refractory metastatic colorectal cancer (mCRC). Our aim was to evaluate the efficacy and safety of these agents in a real-world setting.
Methods
This study was retrospectively conducted in 12 centers in Lazio Region from July 2012 to March 2022. All pts with refractory mCRC and receiving T and/or R were eligible. Overall survival (OS), progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), and adverse events (AEs) were compared.
Results
765 pts were included. Of these, 315 (41.1%) received T, 314 (41%) R, 69 (9%) T followed by R, and 67 (8.7%) the reverse sequence. M/F=440/325; median age 68 (42-86); median duration of follow-up 30.3 months (mos). The prevalent ECOG PS was 2 (54.6%). Median OS and PFS of T-group were modestly longer than R-group: 3.2 vs 3 mos (HR=1,03; 95%CI=0,86-1,24; p=0.71) and 5.9 vs 5 (HR= 0,91; 95%CI=0,75-1,11; p=0.37), respectively; in pts receiving T/R or R/T sequence, median OS and PFS from first therapy were 10.6 vs 12.9 mos (HR=0,65; 95%CI=0,42-1,00; p=0.05) and 8.5 vs 11 mos (HR=0,66; 95%CI=0,44-0,99; p=0.04), respectively. The ORR was similar (R 2.3% vs T 3%; T/R 5.7% vs R/T 4%); 1 complete response was achieved with R. DCR was modestly in favor of the T-group (R 22.8%, T 26.9%; p=0.28) while it was shown to be in benefit of R/T (T/R 30.7% vs R/T 46.9%; p=0.10). Safety profiles were similar to published data. Dose reduction was more frequent with R and T/R (45% and 60%, respectively). The most common grade 3/4 AE with T was neutropenia (48.6%); on the other hand, hand-foot syndrome (HF sdr) (19.7%) (p=<0.001). Toxicities such as neutropenia (42.6%) occurred more in T/R sequence, while events such as HF sdr (22.2%) were reported in R/T. Only 2 pts discontinued T.
Conclusions
Our analysis is in line with phase III trials. The efficacy of T and R was similar with no relevant differences. In the matched groups, PFS was significantly longer in the R/T sequence. R and T used sequentially could extend survival while only R/T stabilizes cancer growth. Prospective clinical trials directly comparing R and T or R/T and T/R are needed.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
C. Signorelli.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.