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Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2

C. Eng, A. Dasari, S. Lonardi, R. Garcia-Carbonero, E. Elez, T. Yoshino, A. Sobrero, J. Yao, P. Garcia-Alfonso, J. Kocsis, AC. Gracian, A. Sartore-Bianchi, T. Satoh, V. Randrian, J. Tomasek, G. Chong, Z. Yang, F. Guevara, W. Schelman, R. Pallai,...

. 2025 ; 30 (3) : . [pub] 20250310

Language English Country England, Great Britain

Document type Journal Article, Randomized Controlled Trial, Clinical Trial, Phase III

Persistent link   https://www.medvik.cz/link/bmc25009525

Grant support
HUTCHMED

BACKGROUND: Fruquintinib 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 METHODS: Patients 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. RESULTS: Incidences 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. CONCLUSION: Fruquintinib + 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.

Department of Complex Oncology Care Masaryk Memorial Cancer Institute Brno 60200 Czech Republic

Department of Gastroenterological Surgery Graduate School of Medicine Osaka University Suita 565 0871 Japan

Department of Gastroenterology and Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Chiba 277 8577 Japan

Department of Gastrointestinal Medical Oncology The University of Texas MD Anderson Cancer Center Houston TX 77030 United States

Department of Medical Oncology Azienda Ospedaliera San Martino Genoa 16132 Italy

Department of Medicine Division of Hematology and Oncology Vanderbilt Ingram Cancer Center Nashville TN 37232 United States

Department of Oncology and Hemato Oncology Università degli Studi di Milano Milan 20122 Italy

Department of Oncoradiology Bács Kiskun Megyei Oktatókórház Kecskemét 6000 Hungary

Hepato Gastroenterology Department CHU de Poitiers F 86000 Poitiers France

HUTCHMED International Corporation Florham Park NJ 07932 United States

Medical Oncology HM Universitario Sanchinarro Centro Integral Oncológico Clara Campal Madrid 28050 Spain

Medical Oncology Hospital Universitario Gregorio Marañón Madrid 28007 Spain

Medical Oncology Unit 1 Veneto Institute of Oncology IOV IRCCS Padua Padua 35128 Italy

Olivia Newton John Cancer and Wellness Centre Austin Hospital Heidelberg VIC 3084 Australia

Oncology Department Hospital Universitario 12 de Octubre Facultad de Medicina Universidad Complutense de Madrid Madrid 28041 Spain

Vall d'Hebron Barcelona Hospital Campus Vall d'Hebron Institute of Oncology Barcelona 08035 Spain

References provided by Crossref.org

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