# Randomized trial of TAS-102 for refractory metastatic colorectal cancer (RECOURSE)

Source: https://onco.cc/key-papers/paper-mayer-recourse-tas-102-nejm-2015/  
OnCo record `paper-mayer-recourse-tas-102-nejm-2015` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An oral chemotherapy that works where fluorouracil no longer does, adding 1.8 months after everything else has failed, and delaying the slide in performance status by nearly two months.

## Summary

Mayer, Van Cutsem, Falcone and colleagues randomly assigned 800 patients with refractory colorectal cancer 2:1 to TAS-102, an oral agent combining trifluridine and tipiracil hydrochloride, or placebo in a double-blind trial, with overall survival as the primary end point. Early trials conducted primarily in Japan had suggested activity in this setting.

One death related to TAS-102 was reported. The time to worsening of ECOG performance status from 0 or 1 to 2 or more was a pre-specified secondary endpoint and favoured treatment.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Tags: colorectal-evidence
- Journal: New England Journal of Medicine
- Year: 2015
- DOI: 10.1056/NEJMoa1414325
- Authors: Mayer RJ, Van Cutsem E, Falcone A, et al.
- Findings: Median overall survival 7.1 months with TAS-102 against 5.3 months with placebo: hazard ratio 0.68 (95 percent CI 0.58 to 0.81, p<0.001).; Neutropenia in 38 percent and leukopenia in 21 percent of those treated; febrile neutropenia in 4 percent.; Median time to worsening performance status 5.7 against 4.0 months (hazard ratio 0.66, 0.56 to 0.78, p<0.001).
- What it means: Trifluridine-tipiracil became the other refractory-line standard alongside regorafenib, and the backbone that SUNLIGHT later improved on by adding bevacizumab.
- Caveats: Myelosuppression rather than the hand-foot toxicity of regorafenib; the two drugs differ in how they are tolerated rather than in how much they add.; No predictive biomarker.; Funded by the manufacturer.

## Sources

- N Engl J Med 2015: https://doi.org/10.1056/NEJMoa1414325
- PubMed: https://pubmed.ncbi.nlm.nih.gov/25970050/

## Connected records

- key papers: [Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT)](https://onco.cc/key-papers/paper-grothey-correct-regorafenib-lancet-2013/), [Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer (SUNLIGHT)](https://onco.cc/key-papers/paper-prager-sunlight-trifluridine-tipiracil-bevacizumab-nejm-2023/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Trifluridine/tipiracil](https://onco.cc/drugs/trifluridine-tipiracil/)
- companies: [Taiho Pharmaceutical (Otsuka)](https://onco.cc/companies/taiho/)
- terms: [Performance status (ECOG, Karnofsky)](https://onco.cc/terms/performance-status/)
- people: [Eric Van Cutsem](https://onco.cc/people/eric-van-cutsem/), [Heinz-Josef Lenz](https://onco.cc/people/heinz-josef-lenz/), [Josep Tabernero](https://onco.cc/people/josep-tabernero/), [Takayuki Yoshino](https://onco.cc/people/yoshino-takayuki/)
- bottlenecks: [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)
- roadmaps: [Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation](https://onco.cc/roadmaps/colorectal-roadmap/)

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