Trial reportThe oncologist2025
Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2.
Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04322539 (A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Toxicities of Fruquintinib in Gastrointestinal Malignancies: A Systematic Review and Meta-Analysis.Oncology research · 2026Pooled it
- Efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer: a FRESCO-2 subgroup analysis of patients enrolled in Japan.International journal of clinical oncology · 2025Trial
- Later-line Treatment Selection in Metastatic Colorectal Cancer: Trifluridine/Tipiracil Plus Bevacizumab, Regorafenib, and Fruquintinib.Journal of gastrointestinal cancer · 2026Review
- Proteinuria as the cause of early dose modification in Japanese patients with metastatic colorectal cancer treated with fruquintinib: a multicenter real-world study.International journal of clinical oncology · 2026Article
- Expert opinion on treatment patterns in metastatic colorectal cancer management in Eastern Europe.BMC proceedings · 2026Article
- Early circulating tumor DNA dynamics predict fruquintinib efficacy in refractory metastatic colorectal cancer before imaging.Frontiers in medicine · 2026Article
- Explore the efficacy of microwave ablation combined with fruquintinib and tislelizumab in the treatment of metastatic colorectal cancer.Frontiers in oncology · 2026Article
- Myocarditis induced by a novel bifunctional PD-1/CTLA-4 combination antibody: a case report and literature review.BMC cardiovascular disorders · 2025Review
- A Real-World Pharmacovigilance Study of Fruquintinib Based on the FDA Adverse Event Reporting System (FAERS) Database.Cancer medicine · 2025Article
- Article
- Analysis of fruquintinib in patients with metastatic colorectal cancer who were enrolled in Spain: results from the global FRESCO-2 study.ESMO gastrointestinal oncology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
Abstract
backgroundFruquintinib is a highly selective, oral inhibitor of all 3 VEGF receptors. The global, randomized, double-blind phase 3 FRESCO-2 trial (NCT04322539) met its primary endpoint demonstrating significantly improved overall survival in patients with refractory metastatic colorectal cancer (mCRC) who received fruquintinib plus best supportive care (BSC) versus placebo plus BSC. Here we report detailed safety data from FRESCO-2 including an analysis of treatment-related adverse events of special interest (AESIs). PATIENTS AND
methodsPatients with mCRC eligible for FRESCO-2 had received all standard chemotherapies and prior anti-VEGF and anti-EGFR therapies if indicated, and displayed progression on, or intolerance to, TAS-102 and/or regorafenib. Prespecified AESIs based on VEGFR tyrosine kinase inhibitor drug classes were evaluated.
resultsIncidences of treatment-related AESIs were 64.9% with fruquintinib + BSC versus 23.0% with placebo + BSC. The most frequent all-grade treatment-related AESIs for fruquintinib were hypertension (28.9%; grade ≥3 10.7%), palmar-plantar erythrodysesthesia syndrome/hand-foot skin reaction (PPE 18.6%; grade ≥3 6.1%), and hypothyroidism (15.6%; grade ≥3 0.4%). Dose reductions due to treatment-related AESIs were reported in 10.3% of patients who received fruquintinib + BSC versus 0.4% with placebo + BSC. The most common treatment-related AESIs resulting in dose reduction for fruquintinib were PPE syndrome (5.0%), hypertension (2.9%), and proteinuria (1.3%). Overall, 5.9% versus 0.9% had treatment-related AESIs resulting in study drug discontinuation.
conclusionFruquintinib + BSC demonstrated a predictable and manageable safety profile in pretreated patients with mCRC and is a novel oral treatment option that prolongs survival and enriches the continuum of care in this population.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.