3D illustration of the colon – Stock.adobe.com
The combination of fruquintinib (Fruzakura) and optimal supportive care led to
Results from an in-phase post-hoc analysis show that quality-adjusted time to absence of symptoms of disease or toxicity increased when compared with placebo and optimal supportive care in previously treated patients with metastatic colorectal cancer (CRC). The 3 FRESCO-2 study (NCT04322539) revealed a significant improvement in Q-TWiST. 2024 Gastrointestinal Cancer Symposium.1
Mean Q-TWiST was 6.25 months (95% CI, 5.89-6.61) in the fruquintinib group versus 4.21 months (95% CI, 3.81-4.60) in patients receiving placebo and best supportive care. (difference, 2.04, difference: 2.04). 95% CI, 1.51-2.57; P <.05). Furthermore, the mean time from randomization to toxic disease progression (TWiST) in each group was 4.06 months (95% CI, 3.75-4.36) vs. 1.92 months (95% CI, 1.75-2.10, difference 2.14; 95% CI). , 1.78-2.49. P <.05), mean time spent in grade 3/4 treatment-emergent adverse effects (TEAEs) from randomization to disease progression (TOX) was 0.45 months (95% CI, 0.37-0.53) versus 0.21 months (95% CI). , 0.15-0.28; difference, 0.24; 95% CI, 0.13-0.34; P <.05).
For patients in the fruquintinib group, the mean time from disease progression to death or censoring (REL) was 3.93 months (95% CI, 3.55 to 4.32) compared with 4.36 months (95% CI, 3.75 to 4.96). (difference, -0.43; 95% CI, -1.15 to 0.29; P ≧.05).
The researchers reported consistent improvement in Q-TWiST with fruquintinib combination in all patient subgroups except those with unknown primary tumor site and patients with right-sided and left-sided tumors. These outcomes are likely attributable to a very small number of patients within these subgroups. Based on sensitivity analysis, the mean duration of Q-TWIST was 6.41 months in the fruquintinib group and 4.26 months in the placebo group, with a difference in Q-TWIST of 2.14 months (95% CI, 1.61-2.68; P <.05), representing a relative 33.0% improvement with fruquintinib.
“Post-hoc Q-TWiST showed that fruquintinib slows disease progression and prolongs patient survival without significantly increasing toxicity. This is especially noteworthy considering the fact that it has been so successful,” said Sebastian Stinzing, MD, professor and dean of medicine. Professor of Hematology, Oncology and Tumor Immunology at the Charité University of Berlin said during his presentation: “Fruquintinib has the potential to improve quality of life and extend survival.” [QOL] For patients who have received previous treatment [metastatic] I am a patient with colorectal cancer who has limited treatment options. ”
In the FRESCO-2 trial, 691 patients with metastatic colorectal cancer from North America, Europe, Japan, and Australia received oral fruquintinib 5 mg (n = 461) or equivalent placebo (n = 230) and 2 patients in the best-of-breed treatment group. :1 randomly assigned. Supportive care is done as part of his 28-day cycle of 3 weeks on and 1 week off.
The primary endpoint of this trial was overall survival. Secondary endpoints included progression-free survival, objective response rate, disease control rate, duration of response, safety, and health-related quality of life.
As part of the post-hoc Q-TWiST analysis, the researchers divided patients’ survival times into three health states: TOX, TWiST, and REL. The researchers calculated Q-TWiST as the utility-weighted sum of the average duration of each of the aforementioned health states. Additionally, we used Kaplan-Meier estimates to determine the average time spent in these health conditions in each treatment group.
The study also included a sensitivity analysis to account for serious AEs that may have affected patients’ quality of life and their ability to tolerate active treatment. For this analysis, Q-TWiST was recalculated using severe TEAEs rather than grade 3/4 TEAEs for TOX health status.
Results from the FRESCO-2 trial supported FDA approval of fruquintinib for metastatic colorectal cancer in November 2023.2 Specifically, this approval also extended to patients who had previously been treated with fluoropyrimidine, oxaliplatin, or irinotecan-based chemotherapy and anti-VEGF agents. moreover, R.A.S. Wild-type disease previously treated with anticancer drugsEGFR Treatment was considered eligible for treatment with fruquintinib.