Oral fruquintinib has shown improvement in overall survival in refractory metastatic colorectal cancer (mCRC). The phase 3 FRESCO-2 trial, studied patients with heavily pretreated mCRC patients, and demonstrated remarkable improvements in overall survival and progression-free survival when compared to a placebo.
Study Overview
Metastatic colorectal cancer remains a formidable challenge, especially for patients who have exhausted standard therapies. While Vascular Endothelial Growth Factor (VEGF)-targeted treatments like bevacizumab, ramucirumab, and regorafenib have shown efficacy in earlier lines of therapy, the need for effective later-line treatments persists.
The trial is an international, randomized, double-blind, placebo-controlled phase 3 trial called FRESCO-2. Notably, these patients had experienced disease progression on various standard treatments, including chemotherapy, bevacizumab, EGFR-targeted therapy (for RAS wild-type cancers), BRAFV600E-targeted therapy (for BRAFV600E-mutant cancers), and immune checkpoint inhibitors.. Importantly, a significant portion of participants (73%) had received more than 3 lines of prior therapy, and about 40% had been treated with both trifluridine-tipiracil (Lonsurf) chemotherapy and regorafenib (Stivarga).
After a median follow-up of 11.3 months, the results were reported as improvement in various endpoints:
- Overall Survival: Patients treated with fruquintinib exhibited significantly improved overall survival compared to those who received a placebo (7.4 vs. 4.8 months). The hazard ratio was 0.66, demonstrating a substantial survival benefit (P<0.0001).
- Progression-Free Survival: Fruquintinib demonstrated an impressive extension of progression-free survival, with 3.7 months compared to 1.8 months in the placebo group. The hazard ratio was 0.32, indicating a significant reduction in disease progression (P<0.0001).
- Objective Response Rate: Although the objective response rate was low for both fruquintinib and placebo (2% and 0%, respectively), the disease control rate was higher with fruquintinib (56% vs. 16%; P<0.0001).
- Adverse Events: Grade 3 or higher adverse events were reported in 63% of patients receiving fruquintinib and 50% of those receiving a placebo. Notably, dose reductions of fruquintinib were needed due to hand-foot syndrome (5% of patients), hypertension (4%), and asthenia (4%).
Table: Key Results
| Endpoint | Fruquintinib Group | Placebo Group |
|---|---|---|
| Median Overall Survival (months) | 7.4 | 4.8 |
| Hazard Ratio (OS) | 0.66 | – |
| Median Progression-Free Survival (months) | 3.7 | 1.8 |
| Hazard Ratio (PFS) | 0.32 | – |
| Objective Response Rate (%) | 2% | 0% |
| Disease Control Rate (%) | 56% | 16% |
| Grade 3 or Higher Adverse Events (%) | 63% | 50% |
As research continues, the impact of fruquintinib on quality of life and its long-term benefits will be further explored, paving the way for more effective therapies and improved outcomes in the fight against advanced colorectal cancer.
(c) 2023 Other:Other Co.
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