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

被引：9

作者：

Signorelli, Carlo ^{[1
]}

Calegari, Maria Alessandra ^{[2
]}

Basso, Michele ^{[2
]}

Anghelone, Annunziato ^{[2
]}

Lucchetti, Jessica ^{[3
]}

Minelli, Alessandro ^{[3
]}

Angotti, Lorenzo ^{[3
]}

Zurlo, Ina Valeria ^{[4
]}

Schirripa, Marta ^{[1
]}

Chilelli, Mario Giovanni ^{[1
]}

Morelli, Cristina ^{[5
]}

Dell'Aquila, Emanuela ^{[6
]}

Cosimati, Antonella ^{[6
]}

Gemma, Donatello ^{[7
]}

Ribelli, Marta ^{[8
]}

Emiliani, Alessandra ^{[8
]}

Corsi, Domenico Cristiano ^{[8
]}

Arrivi, Giulia ^{[9
]}

Mazzuca, Federica ^{[9
]}

Zoratto, Federica ^{[10
]}

Morandi, Maria Grazia ^{[11
]}

Santamaria, Fiorenza ^{[12
,13
]}

Saltarelli, Rosa ^{[14
]}

Ruggeri, Enzo Maria ^{[1
]}

机构：

[1] Belcolle Hosp, ASL Viterbo, Med Oncol Unit, I-01100 Viterbo, Italy

[2] Fdn Policlin Univ Agostino Gemelli, IRCCS, Comprehens Canc Ctr, Unit Med Oncol, I-00168 Rome, Italy

[3] Policlin Univ Campus Biomed, Div Med Oncol, I-00128 Rome, Italy

[4] Vito Fazzi Hosp, Med Oncol, I-73100 Lecce, Italy

[5] Tor Vergata Univ Hosp, Dept Syst Med, Med Oncol Unit, I-00133 Rome, Italy

[6] IRCCS Regina Elena Natl Canc Inst, Med Oncol 1, I-00144 Rome, Italy

[7] ASL Frosinone, Med Oncol Unit, I-03039 Sora, FR, Italy

[8] Osped San Giovanni Calib Fatebenefratelli, Med Oncol Unit, I-00186 Rome, Italy

[9] Sapienza Univ Rome, St Andrea Hosp, Dept Clin & Mol Med, Oncol Unit, I-00189 Rome, Italy

[10] ASL Latina, Med Oncol Unit, I-04100 Latina, Italy

[11] San Camillo De Lellis Hosp, Med Oncol Unit, ASL Rieti, I-02100 Rieti, Italy

[12] Sapienza Univ Rome, Dept Expt Med, I-00185 Rome, Italy

[13] Sapienza Univ Rome, Dept Radiol Oncol & Pathol Sci, Med Oncol A, Policlin Umberto I, I-00185 Rome, Italy

[14] San Giovanni Evangelista Hosp, UOC Oncol, ASL RM5, I-00019 Tivoli, RM, Italy

来源：

CURRENT ONCOLOGY | 2023年 / 30卷 / 06期

关键词：

metastatic colorectal cancer; regorafenib; trifluridine; tipiracil; third-line therapy; real-world study; CLINICAL-PRACTICE; ASIAN PATIENTS; DOUBLE-BLIND; TAS-102; SAFETY; CHEMOTHERAPY; MONOTHERAPY; EFFICACY; TRIAL; PLUS;

D O I：

10.3390/curroncol30060413

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：5456 / 5469

页数：14

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