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

被引:0
作者
Signorelli, Carlo [1 ]
Chilelli, Mario Giovanni [1 ]
Giannarelli, Diana [2 ]
Basso, Michele [3 ]
Calegari, Maria Alessandra [3 ]
Anghelone, Annunziato [3 ]
Lucchetti, Jessica [4 ]
Minelli, Alessandro [4 ]
Angotti, Lorenzo [4 ]
Zurlo, Ina Valeria [5 ]
Schirripa, Marta [1 ]
Morelli, Cristina [6 ]
Dell'Aquila, Emanuela [7 ]
Cosimati, Antonella [7 ]
Gemma, Donatello [8 ]
Ribelli, Marta [9 ]
Emiliani, Alessandra [9 ]
Corsi, Domenico Cristiano [9 ]
Arrivi, Giulia [10 ]
Mazzuca, Federica [10 ]
Zoratto, Federica [11 ]
Morandi, Maria Grazia [12 ]
Santamaria, Fiorenza [13 ,14 ]
Saltarelli, Rosa [15 ]
Ruggeri, Enzo Maria [1 ]
机构
[1] ASL Viterbo, Belcolle Hosp, Med Oncol Unit, I-01100 Viterbo, Italy
[2] Fdn Policlin Univ Agostino Gemelli, IRCCS, Biostat Unit, Sci Directorate, I-00168 Rome, Italy
[3] Fdn Policlin Univ Agostino Gemelli, IRCCS, Comprehens Canc Ctr, Unit Med Oncol, I-00168 Rome, Italy
[4] Policlin Univ Campus Biomed, Div Med Oncol, I-00128 Rome, Italy
[5] Vito Fazzi Hosp, Med Oncol, I-73100 Lecce, Italy
[6] Tor Vergata Univ Hosp, Dept Syst Med, Med Oncol Unit, I-00133 Rome, Italy
[7] IRCCS Regina Elena Natl Canc Inst, Med Oncol 1, I-00144 Rome, Italy
[8] ASL Frosinone, Med Oncol Unit, I-03039 Sora, FR, Italy
[9] Isola Tiberina Hosp Gemelli Isola, Med Oncol Unit, I-00186 Rome, Italy
[10] Sapienza Univ Rome, St Andrea Univ Hosp, Dept Clin & Mol Med, Oncol Unit, I-00189 Rome, Italy
[11] ASL Latina, Med Oncol Unit, I-04100 Latina, Italy
[12] ASL Rieti, San Camillo de Lellis Hosp, Med Oncol Unit, I-02100 Rieti, Italy
[13] Policlin Umberto 1, UOC Oncol A, I-00185 Rome, Italy
[14] Sapienza Univ Rome, Dept Expt Med, Expt Med Network Oncol & Precis Med, I-00189 Rome, Italy
[15] ASL RM5, San Giovanni Evangelista Hosp, UOC Oncol, I-00019 Tivoli, RM, Italy
关键词
metastatic colorectal cancer; regorafenib; trifluridine/tipiracil; first drug treatment duration; sequential treatment; third-line therapy; real-world study; CLINICAL-PRACTICE; ASIAN PATIENTS; DOUBLE-BLIND; TAS-102; MULTICENTER; MONOTHERAPY; SAFETY; TRIAL;
D O I
10.3390/cancers15245758
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: 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. Patients and Methods: 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. Results: 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, p = 0.0069) and a longer median PFS (10.8 vs. 8.5 months, p = 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. Conclusions: 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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页数:13
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