Sistema de Salut de Catalunya
Institut Català de la Salut
[Tabernero J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, Barcelona, Catalunya, Spain. Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Argiles G] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, IOB-Quiron, Barcelona, Catalunya, Spain. Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Sobrero AF] Medical Oncology Ospedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l'Oncologia. [Borg C] Department of Medical Oncology, University Hospital Centre Besançon, Besancon, Bourgogne Franche-Comté, France. [Ohtsu A] Kashiwa, National Cancer Center-Hospital East, Kashiwa, Chiba, Japan. [Mayer RJ] Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts, USA
Vall d'Hebron Barcelona Hospital Campus
2021-09-20T13:10:54Z
2021-09-20T13:10:54Z
2020-08-19
Quimioteràpia; Metàstasis; Pronòstic
Quimioterapia; Metástasis; Pronóstico
Chemotherapy; Metastases; Prognosis
Background The choice of treatment in patients with metastatic colorectal cancer (mCRC) is generally influenced by tumour and patient characteristics, treatment efficacy and tolerability, and quality of life. Better patient selection might lead to improved outcomes. Methods This post hoc exploratory analysis examined the effect of prognostic factors on outcomes in the Randomized, Double-blind, Phase 3 Study of trifluridine tipiracil (FTD/TPI) plus Best Supportive Care (BSC) versus Placebo plus BSC in Patients with mCRC Refractory to Standard Chemotherapies (RECOURSE) trial. Patients were redivided by prognosis into two subgroups: those with <3 metastatic sites at randomisation (low tumour burden) and ≥18 months from diagnosis of metastatic disease to randomisation (indolent disease) were included in the good prognostic characteristics (GPC) subgroup; the remaining patients were considered to have poor prognostic characteristics (PPC). Results GPC patients (n=386) had improved outcome versus PPC patients (n=414) in both the trifluridine/tipiracil and placebo arms. GPC patients receiving trifluridine/tipiracil (n=261) had an improved median overall survival (9.3 vs 5.3 months; HR (95% CI) 0.46 (0.37 to 0.57), p<0.0001) and progression-free survival (3.3 vs 1.9 months; HR (95% CI) 0.56 (0.46 to 0.67), p<0.0001) than PPC patients receiving trifluridine/tipiracil (n=273). Improvements in survival were irrespective of age, Eastern Cooperative Oncology Group Performance Status (ECOG PS), KRAS mutational status, and site of metastases at randomisation. In the trifluridine/tipiracil arm, time to deterioration of ECOG PS to ≥2 and proportion of patients with PS=0–1 discontinuing treatment were longer for GPC than for PPC patients (7.8 vs 4.2 months and 89.1% vs 78.4%, respectively). Conclusion Low tumour burden and indolent disease were factors of good prognosis in late-line mCRC, with patients experiencing longer progression-free survival and greater overall survival.
The RECOURSE study was funded by Taiho Oncology and Taiho Pharmaceutical Co.; this analysis was funded by Servier in partnership with Taiho.
Article
Published version
English
Còlon - Càncer; Recte - Càncer; Quimioteràpia combinada; DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Clinical Protocols::Antineoplastic Protocols::Antineoplastic Combined Chemotherapy Protocols; Other subheadings::Other subheadings::/therapeutic use; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::protocolos clínicos::protocolos antineoplásicos::protocolos de quimioterapia antineoplásica combinada; Otros calificadores::Otros calificadores::/uso terapéutico
BMJ
ESMO Open;5
https://doi.org/10.1136/esmoopen-2020-000752
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
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