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-Reference-Cited by-同舟云学术

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

Published:2023-06-04 Issue:6 Volume:30 Page:5456-5469
ISSN:1718-7729
Container-title:Current Oncology
language:en
Short-container-title:Current Oncology

Author:

Signorelli Carlo¹^ORCID,Calegari Maria Alessandra²,Basso Michele²^ORCID,Anghelone Annunziato²,Lucchetti Jessica³^ORCID,Minelli Alessandro³,Angotti Lorenzo³,Zurlo Ina Valeria⁴,Schirripa Marta¹,Chilelli Mario Giovanni¹,Morelli Cristina⁵,Dell’Aquila Emanuela⁶,Cosimati Antonella⁶,Gemma Donatello⁷,Ribelli Marta⁸,Emiliani Alessandra⁸,Corsi Domenico Cristiano⁸^ORCID,Arrivi Giulia⁹,Mazzuca Federica⁹,Zoratto Federica¹⁰,Morandi Maria Grazia¹¹,Santamaria Fiorenza¹²¹³^ORCID,Saltarelli Rosa¹⁴,Ruggeri Enzo Maria¹

Affiliation:

1. Medical Oncology Unit, Belcolle Hospital, ASL Viterbo, 01100 Viterbo, Italy

2. Unit of Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00168 Rome, Italy

3. Division of Medical Oncology, Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy

4. Medical Oncology, “Vito Fazzi” Hospital, 73100 Lecce, Italy

5. Medical Oncology Unit, Department of Systems Medicine, Tor Vergata University Hospital, 00133 Rome, Italy

6. Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy

7. Medical Oncology Unit, ASL Frosinone, 03039 Sora (FR), Italy

8. Medical Oncology Unit, Ospedale San Giovanni Calibita Fatebenefratelli, Isola Tiberina, Gemelli Isola, 00186 Rome, Italy

9. Department of Clinical and Molecular Medicine, Sapienza University of Rome, Oncology Unit, Sant’ Andrea Hospital, 00189 Rome, Italy

10. Medical Oncology Unit, ASL Latina, 04100 Latina, Italy

11. Medical Oncology Unit, San Camillo de Lellis Hospital, ASL Rieti, 02100 Rieti, Italy

12. Department of Experimental Medicine, Sapienza University of Rome, 00185 Rome, Italy

13. Medical Oncology A, Department of Radiological, Oncological and Pathological Sciences, Policlinico Umberto I, Sapienza University of Rome, 00185 Rome, Italy

14. UOC Oncology, San Giovanni Evangelista Hospital, ASL RM5, 00019 Tivoli (RM), Italy

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.

Publisher

MDPI AG

Link

https://www.mdpi.com/1718-7729/30/6/413/pdf

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