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

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),

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.

Informations de copyright

© 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.

Déclaration de conflit d'intérêts

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.