Global Study Shows Fruquintinib Improves HRQoL in FRESCO-2 Trial

The global phase 3 FRESCO-2 research (NCT04322539) showed that in patients with refractory metastatic colorectal cancer, fruquintinib (F) significantly increased overall survival (HR=0.66 [95% CI: 0.55-0.80]; p0.001) and progression-free survival (HR=0.32 [95% CI: 0.27-0.39]; p<0.001) (mCRC). F had a safety profile that was in line with what was expected from monotherapy. Tolerability and health-related quality-of-life assessments are presented here.
Patients were assigned to receive either F + BSC or P + BSC in a two-to-one ratio. At baseline and on Day 1 of each Cycle (C) until treatment cessation, the EORTC QLQ-C30 and EQ-5D-5L were evaluated, and the ECOG PS was evaluated on Days 1 and 21 of Cycles 1 through 3. The mixed model repeated measures approach was used to determine the least-squares-mean (LSM) change in QLQ-C30 scale scores (e.g., global health status [GHS]/QoL) and EQ-5D-5L scale scores (e.g., visual analogue scale [VAS]) from baseline to post-baseline visits. Minimal clinically relevant differences (MIDs) were established for each scale in order to evaluate changes in clinical status.

Using the Kaplan-Meier method, the adjusted log-rank test, and the stratified Cox PH model, we calculated the time to deterioration (TTD), where TTD was defined as a worsening from baseline in scale-specific MID or death. The ITT population was analysed using the QLQ-C30 and EQ-5D-5L, whereas the safety population was analysed using the ECOG PS. About 691 patients were assigned to receive study drug (F: 461 vs. P: 230). (F: 456 vs P: 230). F received three cycles (range: 1–20) of therapy while P received two (range: 1–13). Patients in both groups scored higher on the QLQ-C30, EQ-5D-5L, and ECOG PS at least once before and after treatment began. At baseline, there was no significant difference between F and P in terms of GHS/QoL; instead, the LSM differences between F and P were 1.7 (95% CI: -1.7, 5.0) for C2 and 1.6 (95% CI: -3.2, 6.4) for C3. Thirty or fewer P patients were available at C4. F had a higher percentage of patients who were either stable (MID -6.38 to -8.43) or improved (8.43) than P did

(C2: 61.5% vs. 57.1%; C3: 56.4% vs. 50.6%).

The median time to diagnose was 2.1 months in females and 1.8 months in males

(HR=0.9; 95% CI: 0.7-1.0; P=0.098). At baseline, F and P had comparable scores on the EQ-5D VAS; LSM differences between F and P ranged from 0.6 (95% CI, -2.3 to 3.5) on C2 and 1.4 (95% CI, -2.8 to 5.6) on C3. F and P had comparable rates of patients who were stable (MID -7 to -7) or better (MID 7)

(C2: 64.6% vs. 58.3%; C3: 64.2% vs. 64.8%). The median time to diagnosis (TTD) for females was 2.6 months, while it was 1.9 months for males (HR=0.8, 95% CI: 0.6-0.9; P=0.001). Increases in ECOG PS of 1 point from baseline were seen in 52.1% of patients in F and 54.0% in P, respectively.

As a result of receiving treatment with F, there was no detrimental effect on HRQoL. Patients who are given F have a higher TTD on the EQ-5D health utility scale. These data add to the growing body of evidence suggesting that F may be an effective novel treatment for patients with refractory mCRC, thanks to its increased OS and PFS and benign toxicity profile.

Source:https://meetings.asco.org/abstracts-presentations/215922

Clinical trial: https://clinicaltrials.gov/ct2/show/NCT04322539/

Sobrero, A.F., Dasari, A., Lonardi, S., Garcia-Carbonero, R., Elez, E., Yoshino, T., Yao, J.C., Garcia-Alfonso, P., Kocsis, J., Cubillo, A., Sartore-Bianchi, A., Satoh, T., Randrian, V., Tomasek, J., Chong, G., Yang, Z., Schelman, W.R., Kania, M.K., Tabernero, J. and Eng, C. (2023). Health-related quality of life (HRQoL) associated with fruquintinib in the global phase 3, placebo-controlled, double-blind FRESCO-2 study. Journal of Clinical Oncology, 41(4_suppl), pp.67–67. doi:https://doi.org/10.1200/jco.2023.41.4_suppl.67.