# Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT)

Source: https://onco.cc/key-papers/paper-grothey-correct-regorafenib-lancet-2013/  
OnCo record `paper-grothey-correct-regorafenib-lancet-2013` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first pill to extend life after every standard treatment had failed, by 1.4 months, at the price of hand-foot skin reaction in one patient in six.

## Summary

Grothey, Van Cutsem, Sobrero and colleagues ran CORRECT at 114 centres in 16 countries in patients with metastatic colorectal cancer progressing during or within three months after the last standard therapy, randomising them 2:1 to best supportive care plus oral regorafenib 160 mg or placebo once daily for the first three weeks of each four-week cycle. The primary endpoint was overall survival, and efficacy analyses were by intention to treat.

Between April 2010 and March 2011, 760 patients were randomised (505 regorafenib, 255 placebo) and 753 started treatment. The primary endpoint was met at a preplanned interim analysis.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Tags: colorectal-evidence
- Journal: The Lancet
- Year: 2013
- DOI: 10.1016/S0140-6736(12)61900-X
- Authors: Grothey A, Van Cutsem E, Sobrero A, et al.
- Findings: Median overall survival 6.4 months with regorafenib against 5.0 months with placebo: hazard ratio 0.77 (95 percent CI 0.64 to 0.94, one-sided p=0.0052).; Treatment-related adverse events in 465 of 500 (93 percent) on regorafenib against 154 of 253 (61 percent) on placebo.; Commonest grade 3 or higher regorafenib-related events: hand-foot skin reaction 83 patients (17 percent), fatigue 48 (10 percent), diarrhoea 36 (7 percent), hypertension 36 (7 percent), rash or desquamation 29 (6 percent).
- What it means: The start of the refractory-line era in colorectal cancer: a survival benefit measured in weeks, with real toxicity, which is why dose-escalation strategies and patient selection have occupied the field since.
- Caveats: 1.4 months of median survival at a high rate of grade 3 toxicity; quality of life is the contested part of the result.; No biomarker selects responders, and none has been found since.; Funded by the manufacturer.

## Sources

- Lancet 2013: https://doi.org/10.1016/S0140-6736(12)61900-X
- PubMed: https://pubmed.ncbi.nlm.nih.gov/23177514/

## Connected records

- key papers: [Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2)](https://onco.cc/key-papers/paper-dasari-fresco-2-fruquintinib-lancet-2023/), [Randomized trial of TAS-102 for refractory metastatic colorectal cancer (RECOURSE)](https://onco.cc/key-papers/paper-mayer-recourse-tas-102-nejm-2015/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- fronts: [Targeted Therapy](https://onco.cc/fronts/targeted-therapy/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [VEGF / VEGFR](https://onco.cc/targets/vegf/)
- drugs: [Regorafenib](https://onco.cc/drugs/regorafenib/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- people: [Eric Van Cutsem](https://onco.cc/people/eric-van-cutsem/), [Heinz-Josef Lenz](https://onco.cc/people/heinz-josef-lenz/), [Takayuki Yoshino](https://onco.cc/people/yoshino-takayuki/)
- bottlenecks: [Acquired resistance to every therapy](https://onco.cc/bottlenecks/b-resistance/), [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)
- journals: [The Lancet](https://onco.cc/journals/lancet/)
- 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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