Prediction of survival in patients with advanced, refractory colorectal cancer in treatment with trifluridine/tipiracil: real-world vs clinical trial data

被引：11

作者：

Fernandez Montes, Ana ^{[1
]}

Carmona-Bayonas, Alberto ^{[2
]}

Jimenez-Fonseca, Paula ^{[3
]}

Vazquez Rivera, Francisca ^{[4
]}

Martinez Lago, Nieves ^{[5
]}

Covela Rua, Marta ^{[6
]}

Cousillas Castineiras, Antia ^{[7
]}

Gonzalez Villarroel, Paula ^{[8
]}

De la Camara Gomez, Juan ^{[9
]}

Carlos Mendez Mendez, Jose ^{[10
]}

Carriles Fernandez, Carmen ^{[11
]}

Sanchez Canovas, Manuel ^{[12
]}

Garcia Garcia, Teresa ^{[13
]}

机构：

[1] Complexo Hosp Univ Ourense, Med Oncol Dept, Orense, Spain

[2] Hosp Univ Morales Meseguer, Dept Hematol & Med Oncol, UMU, IMIB, Murcia, Spain

[3] Hosp Univ Cent Asturias, Dept Med Oncol, IPSA, Oviedo, Spain

[4] Univ Santiago, Med Oncol Dept, Hosp Clin, Santiago, Spain

[5] Complexo Hosp Univ A Coruna, Med Oncol Dept, La Coruna, Spain

[6] Hosp Univ Lucus Augusti, Med Oncol Dept, Lugo, Spain

[7] Hosp Prov Pontevedra, Med Oncol Dept, Pontevedra, Spain

[8] Hosp Univ Alvaro Cunqueiro, Med Oncol Dept, Vigo, Spain

[9] Hosp Univ Arquitecto Marcide, Med Oncol Dept, Ferrol, Spain

[10] Ctr Oncol Galicia, Med Oncol Dept, La Coruna, Spain

[11] Hosp Univ Cent Asturias, Dept Pharm, IPSA, Oviedo, Spain

[12] Hosp Univ Morales Meseguer, Dept Hematol & Med Oncol, Murcia, Spain

[13] Hosp Univ Santa Lucia, Dept Med Oncol, Cartagena, Spain

来源：

SCIENTIFIC REPORTS | 2021年 / 11卷 / 01期

关键词：

TAS-102; CHEMOTHERAPY;

D O I：

10.1038/s41598-021-93732-5

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

Trifluridine/tipiracil increases overall survival (OS) in patients with refractory, metastatic colorectal cancer (mCRC). A post hoc exploratory analysis of the RECOURSE randomized clinical trial (RCT) established two categories, a good prognosis corresponding to subjects having a low tumor burden and indolent disease. Other models in refractory mCRC are the FAS-CORRECT and Colon Life nomogram. The main objective was to externally validate the prognostic factors of the RECOURSE and FAS-CORRECT trials, and the Colon Life nomogram in a multicenter, real-world series of mCRC treated in 3rd and successive lines with trifluridine/tipiracil. The secondary aim was to develop an OS predictive model, TAS-RECOSMO. Between 2016 and 2019, 244 patients were recruited. Median OS was 8.15 vs 8.12 months for the poor (85% of the subjects) and good (15%) prognosis groups from the RESOURCE trial, respectively, log-rank p=0.9. The most common grade 3-4 toxicities were neutropenia (17%), asthenia (6%), and anemia (5%). The AFT lognormal model TAS-RECOSMO included six variables: ECOG-PS, KRAS/NRAS/BRAF mutation status, time between diagnosis of metastasis and beginning of trifluridine/tipiracil, NLR, CEA, and alkaline phosphatase. The model's bootstrapped bias-corrected c-index was 0.682 (95% CI, 0.636-0.722). The factors from the Colon Life model, FAS-CORRECT, and RECOURSE displayed a c-index of 0.690, 0.630, and 0.507, respectively. TAS-RECOSMO, FAS-CORRECT, and the Colon Life nomogram appear to predict OS in patients with refractory mCCR who begin trifluridine/tipiracil treatment in the real world. The prognostic groups of the RECOURCE RCT were unable to capture the situation of real-world subjects treated with trifluridine/tipiracil in this series.

引用

页数：10

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