Effect of trifluridine/tipiracil in patients treated in RECOURSE by prognostic factors at baseline: an exploratory analysis.

Autor:	Tabernero J; Vall d'Hebron Institute of Oncology, UVic-UCC, Medical Oncology, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain jtabernero@vhio.net., Argiles G; Vall d'Hebron Institute of Oncology, UVic-UCC, IOB-QuironMedical Oncology, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain., Sobrero AF; Medical Oncology, Ospedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l'Oncologia, Genova, Liguria, Italy., 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., Vidot L; Centre of EXcellence Methodology and Valorization of Data (CentEX MVD), Institut de Recherches Internationales Servier, Suresnes, France., Moreno Vera SR; Global Medical Affairs, Les Laboratoires Servier SAS, Suresnes, Île-de-France, France., Van Cutsem E; Digestive Oncology, KU Leuven University Hospitals Leuven, Leuven, Flanders, Belgium.
Jazyk:	angličtina
Zdroj:	ESMO open [ESMO Open] 2020 Aug; Vol. 5 (4).
DOI:	10.1136/esmoopen-2020-000752
Abstrakt:	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. Competing Interests: Competing interests: JT has received personal fees from Array Biopharma, AstraZeneca, Bayer AG, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Eli Lilly and Company, Merck, Menarini, Merck Serono, Merrimack Pharmaceuticals, Merus, Molecular Partners, Novartis, Peptomyc, Pfizer, Pharmacyclics, ProteoDesign SL, Rafael Pharmaceuticals, F. Hoffmann-La Roche, Sanofi, Seattle Genetics, Servier, Symphogen, Taiho Pharmaceutical, VCN Biosciences, Biocartis, Foundation Medicine, HalioDX, SAS Pharmaceuticals and Roche Diagnostics. GA has had an advisory role, or received honoraria or travel grants from Hoffmann-La Roche, Merck Serono, Amgen, Sanofi, Bayer, Servier and Bristol-Myers Squibb. AFS has had an advisory role for Amgen, Bayer, Celgene, Roche, Merck Serono, Sanofi, and Servier, and has attended a speakers’ bureau for Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Lilly, Merck Serono, Roche, Sanofi and Takeda. EVC has received research funding from Amgen, Bayer, Boehringer Ingelheim, Celgene, Ipsen, Lilly, Merck, Merck KgA, Novartis, Roche, Sanofi and Servier, and has attended advisory boards for Astellas, Astrazeneca, Bayer, Bristol-Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche, and Servier. CB has attended advisory boards for Roche, Servier and Sanofi, and has received a research grant from Roche. AO has received honoraria from Ono, BMS, Chugai, Taiho, Eisai and Amgen, and has received research funding from Bristol-Myers Squibb. An immediate family member of AO has been employed by Celgene. RJM declares no conflicts of interest. LV and SRMV are employees of Servier. (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)
Databáze:	MEDLINE
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