Retrospective Correlation between First Drug Treatment Duration and Survival Outcomes in Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer: A Real-World Subgroup Analysis

<i>Background</i>: Patients with refractory metastatic colorectal cancer (mCRC) rarely receive third-line or further treatment. In this context, regorafenib (R) and trifluridine/tipiracil (T) are two important novel therapeutic choices with statistically significant increases in overall...

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Main Authors: Carlo Signorelli, Mario Giovanni Chilelli, Diana Giannarelli, Michele Basso, Maria Alessandra Calegari, Annunziato Anghelone, Jessica Lucchetti, Alessandro Minelli, Lorenzo Angotti, Ina Valeria Zurlo, Marta Schirripa, Cristina Morelli, Emanuela Dell’Aquila, Antonella Cosimati, Donatello Gemma, Marta Ribelli, Alessandra Emiliani, Domenico Cristiano Corsi, Giulia Arrivi, Federica Mazzuca, Federica Zoratto, Maria Grazia Morandi, Fiorenza Santamaria, Rosa Saltarelli, Enzo Maria Ruggeri
Format: Article
Language:English
Published: MDPI AG 2023-12-01
Series:Cancers
Subjects:
Online Access:https://www.mdpi.com/2072-6694/15/24/5758
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author Carlo Signorelli
Mario Giovanni Chilelli
Diana Giannarelli
Michele Basso
Maria Alessandra Calegari
Annunziato Anghelone
Jessica Lucchetti
Alessandro Minelli
Lorenzo Angotti
Ina Valeria Zurlo
Marta Schirripa
Cristina Morelli
Emanuela Dell’Aquila
Antonella Cosimati
Donatello Gemma
Marta Ribelli
Alessandra Emiliani
Domenico Cristiano Corsi
Giulia Arrivi
Federica Mazzuca
Federica Zoratto
Maria Grazia Morandi
Fiorenza Santamaria
Rosa Saltarelli
Enzo Maria Ruggeri
author_facet Carlo Signorelli
Mario Giovanni Chilelli
Diana Giannarelli
Michele Basso
Maria Alessandra Calegari
Annunziato Anghelone
Jessica Lucchetti
Alessandro Minelli
Lorenzo Angotti
Ina Valeria Zurlo
Marta Schirripa
Cristina Morelli
Emanuela Dell’Aquila
Antonella Cosimati
Donatello Gemma
Marta Ribelli
Alessandra Emiliani
Domenico Cristiano Corsi
Giulia Arrivi
Federica Mazzuca
Federica Zoratto
Maria Grazia Morandi
Fiorenza Santamaria
Rosa Saltarelli
Enzo Maria Ruggeri
author_sort Carlo Signorelli
collection DOAJ
description <i>Background</i>: Patients with refractory metastatic colorectal cancer (mCRC) rarely receive third-line or further treatment. In this context, regorafenib (R) and trifluridine/tipiracil (T) are two important novel therapeutic choices with statistically significant increases in overall survival (OS), progression-free survival (PFS), and disease control, with different toxicity profiles. This study is a subgroup analysis of our larger retrospective study, already published, whose objective was to assess the outcomes of patients when R and T were given sequentially. <i>Patients and Methods</i>: The study involved thirteen Italian cancer centers on a 10-year retrospective observation (2012–2022). In this subgroup analysis, we focused our attention on the correlation between the first drug treatment duration (<3 months, 3 to <6 months and ≥6 months) and survival outcomes in patients who had received the sequence regorafenib-to-trifluridine/tipiracil, or vice versa. <i>Results</i>: The initial study included 866 patients with mCRC who received sequential T/R, or R/T, or T or R alone. This analysis is focused on evaluating the impact of the duration of the first treatment in the sequence on clinical outcomes (OS, PFS) and includes 146 and 116 patients of the T/R and R/T sequences, respectively. Based on the duration of the first drug treatment, subgroups for the T/R sequence included 27 patients (18.4%) who received T for <3 months, 86 (58.9%) treated for 3 to <6 months, and 33 (22.6%) treated for ≥6 months; in the reverse sequence (R as the first drug), subgroups included 18 patients (15.5%) who received their first treatment for <3 months, 62 (53.4%) treated for 3 to <6 months, and 35 (31.0%) treated for ≥6 months. In patients who received their first drug treatment for a period of 3 to <6 months, the R/T sequence had a significantly longer median OS (13.7 vs. 10.8 months, <i>p</i> = 0.0069) and a longer median PFS (10.8 vs. 8.5 months, <i>p</i> = 0.0003) than the T/R group. There were no statistically significant differences between groups with first drug treatment durations of <3 months and ≥6 months. <i>Conclusions</i>: Our analysis seems to suggest that the administration of R for a period of 3 to <6 months before that of T can prolong both OS and PFS, as compared to the opposite sequence.
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spelling doaj.art-6de6073de544422dbcea339142307ac42023-12-22T13:58:47ZengMDPI AGCancers2072-66942023-12-011524575810.3390/cancers15245758Retrospective Correlation between First Drug Treatment Duration and Survival Outcomes in Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer: A Real-World Subgroup AnalysisCarlo Signorelli0Mario Giovanni Chilelli1Diana Giannarelli2Michele Basso3Maria Alessandra Calegari4Annunziato Anghelone5Jessica Lucchetti6Alessandro Minelli7Lorenzo Angotti8Ina Valeria Zurlo9Marta Schirripa10Cristina Morelli11Emanuela Dell’Aquila12Antonella Cosimati13Donatello Gemma14Marta Ribelli15Alessandra Emiliani16Domenico Cristiano Corsi17Giulia Arrivi18Federica Mazzuca19Federica Zoratto20Maria Grazia Morandi21Fiorenza Santamaria22Rosa Saltarelli23Enzo Maria Ruggeri24Medical Oncology Unit, Belcolle Hospital, ASL Viterbo, 01100 Viterbo, ItalyMedical Oncology Unit, Belcolle Hospital, ASL Viterbo, 01100 Viterbo, ItalyBiostatistics Unit, Scientific Directorate, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00168 Rome, ItalyUnit of Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00168 Rome, ItalyUnit of Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00168 Rome, ItalyUnit of Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00168 Rome, ItalyDivision of Medical Oncology, Policlinico Universitario Campus Bio-Medico, 00128 Rome, ItalyDivision of Medical Oncology, Policlinico Universitario Campus Bio-Medico, 00128 Rome, ItalyDivision of Medical Oncology, Policlinico Universitario Campus Bio-Medico, 00128 Rome, ItalyMedical Oncology, “Vito Fazzi” Hospital, 73100 Lecce, ItalyMedical Oncology Unit, Belcolle Hospital, ASL Viterbo, 01100 Viterbo, ItalyMedical Oncology Unit, Department of Systems Medicine, Tor Vergata University Hospital, 00133 Rome, ItalyMedical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, ItalyMedical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, ItalyMedical Oncology Unit, ASL Frosinone, 03039 Sora (FR), ItalyMedical Oncology Unit, Isola Tiberina Hospital-Gemelli Isola, 00186 Rome, ItalyMedical Oncology Unit, Isola Tiberina Hospital-Gemelli Isola, 00186 Rome, ItalyMedical Oncology Unit, Isola Tiberina Hospital-Gemelli Isola, 00186 Rome, ItalyDepartment of Clinical and Molecular Medicine, Oncology Unit, Sant’ Andrea University Hospital, Sapienza University of Rome, 00189 Rome, ItalyDepartment of Clinical and Molecular Medicine, Oncology Unit, Sant’ Andrea University Hospital, Sapienza University of Rome, 00189 Rome, ItalyMedical Oncology Unit, ASL Latina, 04100 Latina, ItalyMedical Oncology Unit, San Camillo de Lellis Hospital, ASL Rieti, 02100 Rieti, ItalyUOC Oncology A, Policlinico Umberto I, 00185 Rome, ItalyUOC Oncology, San Giovanni Evangelista Hospital, ASL RM5, 00019 Tivoli (RM), ItalyMedical Oncology Unit, Belcolle Hospital, ASL Viterbo, 01100 Viterbo, Italy<i>Background</i>: Patients with refractory metastatic colorectal cancer (mCRC) rarely receive third-line or further treatment. In this context, regorafenib (R) and trifluridine/tipiracil (T) are two important novel therapeutic choices with statistically significant increases in overall survival (OS), progression-free survival (PFS), and disease control, with different toxicity profiles. This study is a subgroup analysis of our larger retrospective study, already published, whose objective was to assess the outcomes of patients when R and T were given sequentially. <i>Patients and Methods</i>: The study involved thirteen Italian cancer centers on a 10-year retrospective observation (2012–2022). In this subgroup analysis, we focused our attention on the correlation between the first drug treatment duration (<3 months, 3 to <6 months and ≥6 months) and survival outcomes in patients who had received the sequence regorafenib-to-trifluridine/tipiracil, or vice versa. <i>Results</i>: The initial study included 866 patients with mCRC who received sequential T/R, or R/T, or T or R alone. This analysis is focused on evaluating the impact of the duration of the first treatment in the sequence on clinical outcomes (OS, PFS) and includes 146 and 116 patients of the T/R and R/T sequences, respectively. Based on the duration of the first drug treatment, subgroups for the T/R sequence included 27 patients (18.4%) who received T for <3 months, 86 (58.9%) treated for 3 to <6 months, and 33 (22.6%) treated for ≥6 months; in the reverse sequence (R as the first drug), subgroups included 18 patients (15.5%) who received their first treatment for <3 months, 62 (53.4%) treated for 3 to <6 months, and 35 (31.0%) treated for ≥6 months. In patients who received their first drug treatment for a period of 3 to <6 months, the R/T sequence had a significantly longer median OS (13.7 vs. 10.8 months, <i>p</i> = 0.0069) and a longer median PFS (10.8 vs. 8.5 months, <i>p</i> = 0.0003) than the T/R group. There were no statistically significant differences between groups with first drug treatment durations of <3 months and ≥6 months. <i>Conclusions</i>: Our analysis seems to suggest that the administration of R for a period of 3 to <6 months before that of T can prolong both OS and PFS, as compared to the opposite sequence.https://www.mdpi.com/2072-6694/15/24/5758metastatic colorectal cancerregorafenibtrifluridine/tipiracilfirst drug treatment durationsequential treatmentthird-line therapy
spellingShingle Carlo Signorelli
Mario Giovanni Chilelli
Diana Giannarelli
Michele Basso
Maria Alessandra Calegari
Annunziato Anghelone
Jessica Lucchetti
Alessandro Minelli
Lorenzo Angotti
Ina Valeria Zurlo
Marta Schirripa
Cristina Morelli
Emanuela Dell’Aquila
Antonella Cosimati
Donatello Gemma
Marta Ribelli
Alessandra Emiliani
Domenico Cristiano Corsi
Giulia Arrivi
Federica Mazzuca
Federica Zoratto
Maria Grazia Morandi
Fiorenza Santamaria
Rosa Saltarelli
Enzo Maria Ruggeri
Retrospective Correlation between First Drug Treatment Duration and Survival Outcomes in Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer: A Real-World Subgroup Analysis
Cancers
metastatic colorectal cancer
regorafenib
trifluridine/tipiracil
first drug treatment duration
sequential treatment
third-line therapy
title Retrospective Correlation between First Drug Treatment Duration and Survival Outcomes in Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer: A Real-World Subgroup Analysis
title_full Retrospective Correlation between First Drug Treatment Duration and Survival Outcomes in Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer: A Real-World Subgroup Analysis
title_fullStr Retrospective Correlation between First Drug Treatment Duration and Survival Outcomes in Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer: A Real-World Subgroup Analysis
title_full_unstemmed Retrospective Correlation between First Drug Treatment Duration and Survival Outcomes in Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer: A Real-World Subgroup Analysis
title_short Retrospective Correlation between First Drug Treatment Duration and Survival Outcomes in Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer: A Real-World Subgroup Analysis
title_sort retrospective correlation between first drug treatment duration and survival outcomes in sequential treatment with regorafenib and trifluridine tipiracil in refractory metastatic colorectal cancer a real world subgroup analysis
topic metastatic colorectal cancer
regorafenib
trifluridine/tipiracil
first drug treatment duration
sequential treatment
third-line therapy
url https://www.mdpi.com/2072-6694/15/24/5758
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