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.

Autor: Signorelli C; Medical Oncology Unit, Belcolle Hospital, ASL Viterbo, 01100 Viterbo, Italy., Calegari MA; Unit of Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00168 Rome, Italy., Basso M; Unit of Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00168 Rome, Italy., Anghelone A; Unit of Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00168 Rome, Italy., Lucchetti J; Division of Medical Oncology, Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy., Minelli A; Division of Medical Oncology, Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy., Angotti L; Division of Medical Oncology, Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy., Zurlo IV; Medical Oncology, 'Vito Fazzi' Hospital, 73100 Lecce, Italy., Schirripa M; Medical Oncology Unit, Belcolle Hospital, ASL Viterbo, 01100 Viterbo, Italy., Chilelli MG; Medical Oncology Unit, Belcolle Hospital, ASL Viterbo, 01100 Viterbo, Italy., Morelli C; Medical Oncology Unit, Department of Systems Medicine, Tor Vergata University Hospital, 00133 Rome, Italy., Dell'Aquila E; Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Cosimati A; Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Gemma D; Medical Oncology Unit, ASL Frosinone, 03039 Sora (FR), Italy., Ribelli M; Medical Oncology Unit, Ospedale San Giovanni Calibita Fatebenefratelli, Isola Tiberina, Gemelli Isola, 00186 Rome, Italy., Emiliani A; Medical Oncology Unit, Ospedale San Giovanni Calibita Fatebenefratelli, Isola Tiberina, Gemelli Isola, 00186 Rome, Italy., Corsi DC; Medical Oncology Unit, Ospedale San Giovanni Calibita Fatebenefratelli, Isola Tiberina, Gemelli Isola, 00186 Rome, Italy., Arrivi G; Department of Clinical and Molecular Medicine, Sapienza University of Rome, Oncology Unit, Sant' Andrea Hospital, 00189 Rome, Italy., Mazzuca F; Department of Clinical and Molecular Medicine, Sapienza University of Rome, Oncology Unit, Sant' Andrea Hospital, 00189 Rome, Italy., Zoratto F; Medical Oncology Unit, ASL Latina, 04100 Latina, Italy., Morandi MG; Medical Oncology Unit, San Camillo de Lellis Hospital, ASL Rieti, 02100 Rieti, Italy., Santamaria F; Department of Experimental Medicine, Sapienza University of Rome, 00185 Rome, Italy.; Medical Oncology A, Department of Radiological, Oncological and Pathological Sciences, Policlinico Umberto I, Sapienza University of Rome, 00185 Rome, Italy., Saltarelli R; UOC Oncology, San Giovanni Evangelista Hospital, ASL RM5, 00019 Tivoli (RM), Italy., Ruggeri EM; Medical Oncology Unit, Belcolle Hospital, ASL Viterbo, 01100 Viterbo, Italy.
Jazyk: angličtina
Zdroj: Current oncology (Toronto, Ont.) [Curr Oncol] 2023 Jun 04; Vol. 30 (6), pp. 5456-5469. Date of Electronic Publication: 2023 Jun 04.
DOI: 10.3390/curroncol30060413
Abstrakt: 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.
Databáze: MEDLINE
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