학술논문
Treatment Settings and Outcomes with Regorafenib and Trifluridine/Tipiracil at Third-Line Treatment and beyond in Metastatic Colorectal Cancer: A Real-World Multicenter Retrospective Study.
Document Type
Article
Author
Signorelli, Carlo; Calegari, Maria Alessandra; Basso, Michele; Anghelone, Annunziato; Lucchetti, Jessica; Minelli, Alessandro; Angotti, Lorenzo; Zurlo, Ina Valeria; Schirripa, Marta; Chilelli, Mario Giovanni; Morelli, Cristina; Dell'Aquila, Emanuela; Cosimati, Antonella; Gemma, Donatello; Ribelli, Marta; Emiliani, Alessandra; Corsi, Domenico Cristiano; Arrivi, Giulia; Mazzuca, Federica; Zoratto, Federica
Source
Subject
*COLORECTAL cancer
*METASTASIS
*REGORAFENIB
*PROGRESSION-free survival
*OVERALL survival
*HAND-foot syndrome
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Language
ISSN
1198-0052
Abstract
Background: Patients with refractory mCRC rarely undergo third-line or subsequent treatment. This strategy could negatively impact their survival. In this setting, regorafenib (R) and trifluridine/tipiracil (T) are two key new treatment options with statistically significant improvements in overall survival (OS), progression-free survival (PFS), and disease control with different tolerance profiles. This study aimed to retrospectively evaluate the efficacy and safety profiles of these agents in real-world practice. Materials and Methods: In 2012–2022, 866 patients diagnosed with mCRC who received sequential R and T (T/R, n = 146; R/T, n = 116]) or T (n = 325]) or R (n = 279) only were retrospectively recruited from 13 Italian cancer institutes. Results: The median OS is significantly longer in the R/T group (15.9 months) than in the T/R group (13.9 months) (p = 0.0194). The R/T sequence had a statistically significant advantage in the mPFS, which was 8.8 months with T/R vs. 11.2 months with R/T (p = 0.0005). We did not find significant differences in outcomes between groups receiving T or R only. A total of 582 grade 3/4 toxicities were recorded. The frequency of grade 3/4 hand-foot skin reactions was higher in the R/T sequence compared to the reverse sequence (37.3% vs. 7.4%) (p = 0.01), while grade 3/4 neutropenia was slightly lower in the R/T group than in the T/R group (66.2% vs. 78.2%) (p = 0.13). Toxicities in the non-sequential groups were similar and in line with previous studies. Conclusions: The R/T sequence resulted in a significantly longer OS and PFS and improved disease control compared with the reverse sequence. R and T given not sequentially have similar impacts on survival. More data are needed to define the best sequence and to explore the efficacy of sequential (T/R or R/T) treatment combined with molecular-targeted drugs. [ABSTRACT FROM AUTHOR]