Real-World Data Support Fruquintinib Efficacy in Previously Treated mCRC

Findings from a retrospective, real-world analysis presented at the European Society for Medical Oncology Gastrointestinal (ESMO GI) meeting highlight the clinical utility of fruquintinib (Fruzaqla) for patients with metastatic colorectal cancer (mCRC) in the United States.

The study, which utilized data from the Flatiron Health Research Database, demonstrates that fruquintinib remains an effective and manageable option for patients who have already progressed through multiple lines of therapy.

Bridging the gap between trials and practice

For patients with mCRC, treatment options in the third-line setting or later (3L+) have historically been limited, typically including regorafenib (Stivarga), TAS-102 (Lonsurf) with or without bevacizumab (Avastin), and more recently, fruquintinib. While the phase 3 FRESCO and FRESCO-2 clinical trials established the efficacy of fruquintinib — a highly selective oral inhibitor of VEGFR-1, -2, and -3 — real-world evidence (RWE) is essential to understand how these outcomes translate to a broader, more heterogeneous patient population.

"Real-world evidence complements [clinical trial] data by extending the generalizability of trial findings and characterizing treatment effectiveness in the broader... populations encountered in clinical practice," the investigators noted in the presentation.

Study design and patient population

The analysis included 488 patients with mCRC who initiated fruquintinib treatment between November 2023 and February 2025. The patient population reflected the complexities of clinical practice: the median age was 62 years, 53.9% had liver metastases at the index date, and 13.5% had an ECOG Performance Status of 2 or higher

Prior treatment patterns were diverse, with 54.3% of patients having received TAS-102 plus bevacizumab, 22.5% having received regorafenib, and 12.9% having received TAS-102 monotherapy before starting fruquintinib.

Survival outcomes and efficacy

The study assessed real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) across various lines of therapy (3L, 4L, and 5L+). In the overall cohort (n=239 with at least 9 months of follow-up), the median rwOS was 7.0 months (95% CI: 5.8–8.4) and the median rwPFS was 3.6 months (95% CI: 3.2–4.5).

The data suggested that earlier use of fruquintinib yielded superior results. Patients who received fruquintinib in the third-line setting experienced the longest outcomes, with a median rwOS of 8.1 months (95% CI: 5.8–NR) and a median rwPFS of 4.8 months (95% CI: 2.6–5.9). Even in heavily pretreated patients (5L+), fruquintinib remained active, showing a median rwOS of 5.9 months.The researchers also evaluated outcomes based on prior exposure to other 3L therapies. Notably, patients who were naïve to TAS-102 plus bevacizumab showed improved rwOS and rwPFS compared to those previously exposed, regardless of the line in which they initiated fruquintinib.

Safety and dosing considerations for nurses

From an oncology nursing perspective, understanding the safety profile and dosing of fruquintinib is paramount for patient education and monitoring. The study found that 90.8% of patients initiated treatment at the recommended 5 mg starting dose. Dose reductions were required in 18.4% of patients.

Common toxicities observed in this real-world setting included:

• Fatigue: 13.3%
• Diarrhea: 7.6%
• Hypertension: 7.6%
• Palmar-plantar erythrodysesthesia (PPE): 5.1%

The investigators reported that a lower proportion of patients in this real-world study experienced diarrhea, hypertension, and PPE compared to those in the FRESCO and FRESCO-2 clinical trials. The researchers also noted that the time to treatment discontinuation (rwTTD) was consistent across all lines of therapy, with an overall median of 3.3 months.

Clinical implications

This study represents one of the largest real-world evaluations of fruquintinib in the United States to date. Despite the inherent limitations of retrospective electronic health record analyses — such as potential missing data or unknown reasons for discontinuation — the findings support the clinical utility and effectiveness of fruquintinib in a real-world setting.

For oncology nurses, these data reinforce the importance of managing patient expectations and monitoring for common side effects like fatigue and hypertension. The findings also suggest that utilizing fruquintinib in the 3L setting may maximize survival benefits for patients with mCRC.

Reference

Shergill A, Dasari A, Vaidya N, Clark S, Peng J, Kopetz S. Real-world treatment patterns, effectiveness, and safety of fruquintinib in patients with metastatic colorectal cancer. Poster presented at: ESMO Gastrointestinal Cancers Congress; June 2026.