# Sunitinib in advanced gastrointestinal stromal tumour after failure of imatinib

Source: https://onco.cc/key-papers/paper-demetri-sunitinib-gist-lancet-2006/  
OnCo record `paper-demetri-sunitinib-gist-lancet-2006` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Sunitinib more than quadrupled the time to progression compared with placebo in gastrointestinal stromal tumours that had become resistant to or intolerant of imatinib, establishing the standard second-line treatment.

## Summary

Phase 3 placebo-controlled trial of 312 patients with advanced gastrointestinal stromal tumour after imatinib failure randomised 2:1 to sunitinib 50 mg daily (four weeks on, two off) or placebo, unblinded early after an interim analysis.

Median time to progression was 27.3 versus 6.4 weeks (hazard ratio 0.33) with a survival benefit at interim analysis (hazard ratio 0.49); fatigue, diarrhoea, skin discolouration and hand-foot syndrome were common.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: The Lancet
- Year: 2006
- DOI: 10.1016/S0140-6736(06)69446-4
- Authors: Demetri GD, van Oosterom AT, Garrett CR, et al.
- Findings: Median time to progression 27.3 vs 6.4 weeks; hazard ratio 0.33.; Interim overall survival hazard ratio 0.49.
- What it means: Sunitinib is the standard second-line kinase inhibitor for GIST, with particular activity against KIT exon 9 and exon 13/14 secondary mutations.
- Caveats: Trial unblinded early; final survival analysis confounded by crossover.; Less active against exon 17/18 secondary mutations.

## Sources

- Lancet 2006: https://doi.org/10.1016/S0140-6736(06)69446-4
- PubMed: https://pubmed.ncbi.nlm.nih.gov/17046465/

## Connected records

- cancers: [Imatinib-resistant GIST](https://onco.cc/cancers/gist-imatinib-resistant/)
- drugs: [Imatinib](https://onco.cc/drugs/imatinib/), [Sunitinib](https://onco.cc/drugs/sunitinib/)
- journals: [The Lancet](https://onco.cc/journals/lancet/)

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