FRESCO-2

In heavily pretreated refractory metastatic colorectal cancer, does fruquintinib plus best supportive care improve overall survival versus placebo plus best supportive care?

Evidence snapshot updated 23 October 2026. Source links are provided below; this is an evidence summary, not a substitute for current local guidelines or individual clinical judgement.

Population and treatment

691 patients with refractory metastatic colorectal cancer previously treated with standard therapies including fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF and, when indicated, anti-EGFR therapy.

Intervention and comparator: Fruquintinib 5 mg orally once daily on days 1–21 of each 28-day cycle plus best supportive care versus placebo plus best supportive care, until progression or unacceptable toxicity.

ClinicalTrials.gov: NCT04322539 ↗

Key results

Median OS 7.4 vs 4.8 months; HR 0.66 (95% CI 0.55–0.80; P<.001). Grade ≥3 AEs occurred in 63% vs 50%; grade ≥3 hypertension 14% and hand–foot syndrome 6% with fruquintinib.

Overall survival · Median OS; time-to-event

Absolute-effect interpretation: Median OS difference 2.6 months is not an NNT. Do not calculate NNT from medians or hazard ratio.

Toxicity and treatment burden

Hypertension, asthenia, hand–foot syndrome, proteinuria, diarrhoea and dysphonia are important. Monitor blood pressure, urine protein, hepatic function and wound-healing risks; treatment is oral but not toxicity-free.

Interpretation and limitations

FRESCO-2 addresses a heavily pretreated population with few remaining options; do not extrapolate to earlier lines or use as a direct comparison with active standard regimens. Regulatory availability varies by country.

Use endpoint definitions, follow-up, analysis population and comparator exactly as reported. Do not infer NNT from a hazard ratio or median survival. Subgroup findings should not be treated as predictive unless the trial design and interaction testing support that interpretation.

Primary source and further reading

Primary publication / authoritative source ↗

Trial registry (NCT04322539) ↗

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