Real-World Study Highlights Fruquintinib Efficacy in Metastatic CRC

A recent real-world study conducted in Portugal has revealed promising insights into the use of fruquintinib, a novel treatment for refractory metastatic colorectal cancer (mCRC). This research, presented at the 2025 ESMO Gastrointestinal Cancers Congress, indicates that fruquintinib exhibits a manageable safety profile and a trend towards efficacy in a cohort of patients who have exhausted other treatment options.

The study involved a prospective, non-interventional cohort of 23 patients treated with fruquintinib from January 2024 to March 2025 across five Portuguese healthcare centers. The findings showed a median overall survival (OS) of 4.0 months and a median progression-free survival (PFS) of 3.0 months. In comparison, the phase 3 FRESCO-2 trial had previously reported a median OS of 7.4 months and PFS of 3.7 months for patients treated with fruquintinib. According to Dr. Filipa R. Verdasca of the Unidade Local de Saúde de São José in Lisbon, the variation in outcomes is likely attributable to the broader comorbidities present in real-world populations and differences in clinical practices.

The patient cohort primarily consisted of older adults, with a median age of 61 years, and a predominance of male patients (70%). Most had undergone multiple prior therapies, with 61% having received three lines of treatment before initiating fruquintinib. Notably, treatment-related adverse effects were reported in 73.9% of patients, with 17.4% experiencing severe reactions classified as grade 3 or 4. Common side effects included fatigue, hypertension, and anemia.

Dr. Verdasca emphasized the significance of this study, stating, "This is one of the first non-Asian datasets analyzing the outcomes of fruquintinib in a European context, which can provide invaluable insights into the treatment of heavily pretreated mCRC patients." The FDA approved fruquintinib in November 2023 for patients who have previously undergone treatment with standard chemotherapy and anti-VEGF therapy. Similarly, the European Commission followed suit in June 2024, endorsing its use for patients who have progressed on or are intolerant to treatments such as TAS-102 or regorafenib.

As the research community continues to explore the efficacy of fruquintinib, future studies are anticipated to expand on these findings with larger sample sizes and longer follow-up periods. The implications of this study are significant, as they suggest that fruquintinib may play a vital role in the therapeutic arsenal for managing refractory mCRC, particularly in patients who have limited treatment options available.

The ongoing investigation into fruquintinib's clinical application highlights the need for continuous evaluation of cancer therapies in real-world settings to better inform treatment protocols and improve patient outcomes. This study serves as a critical step towards understanding the potential benefits and limitations of fruquintinib, reinforcing its role in addressing one of the most challenging aspects of oncology today.