KEY TAKEAWAYS
- The FRESCO-2 phase 3 trial aimed to investigate the impact of fruquintinib plus BSC on maintaining QoL in patients with refractory mCRC.
- Researchers noticed that fruquintinib plus BSC delays ECOG PS deterioration, supporting its use as a new treatment option for patients with refractory mCRC.
Maintaining quality of life (QoL) is an important treatment goal, as metastatic colorectal cancer (mCRC) and its treatment can adversely impact QoL. In the global, randomized, double-blind, phase 3 FRESCO-2 study, treatment with fruquintinib (a highly selective oral inhibitor of all 3 VEGF receptors) + best supportive care (BSC) vs placebo+BSC significantly improved overall survival (OS) and progression-free survival (PFS) in patients with refractory mCRC, with a manageable toxicity profile and without deterioration in QoL.
Jeneth Aquino and the team aimed to assess the impact of fruquintinib plus BSC on OS, PFS, and maintenance of QoL in patients with refractory mCRC.
They performed an inclusive analysis in which patients were randomized 2:1 to receive either fruquintinib (5 mg) or matching placebo orally, once daily for 21 out of every 28 days + BSC. This post-hoc analysis evaluated the time from randomization to the first occurrence of Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 or death (overall or within 37 days of the last dose).
The study utilized stratified log-rank tests and stratified Cox models to assess the treatment effect of fruquintinib plus BSC. Patient assessments were conducted on Day 1 of each cycle, Day 21 of Cycles 1 to 3, at the end of treatment, and safety follow-up (within 37 days after the last dose).
About 691 patients were randomized from August 14, 2020, to December 2, 2021 (fruquintinib+BSC: 461; placebo+BSC: 230) with baseline ECOG PS of 0 (n=298) or 1 (n=393). Patients treated with fruquintinib+BSC experienced a significantly delayed time to first occurrence of ECOG PS ≥2 or death within 37 days after the last dose compared to placebo+BSC (median 6.6 vs 2.9 months; HR: 0.551; 95% CI, 0.436−0.697).
When deaths within 37 days after the last dose were censored, fruquintinib+BSC recipients still demonstrated a significantly delayed time to ECOG PS ≥2 or death compared to placebo+BSC (stratified HR: 0.667; 95% CI, 0.508−0.877; P=0.004). In the analysis including all deaths observed during the study, fruquintinib+BSC showed a significantly delayed time to ECOG PS ≥2 or death compared to placebo+BSC (median 5.3 vs 2.9 months; HR: 0.637; 95% CI, 0.528−0.767).
The study concluded that fruquintinib plus BSC delayed ECOG PS worsening compared to placebo plus BSC, with significant improvements in OS and PFS and a favorable toxicity profile, supporting its use as a new treatment option for refractory mCRC.
The trial was sponsored by the Hutchison Medipharma Limited.
Source: https://ons.confex.com/ons/2024/meetingapp.cgi/Paper/15068
Clinical Trial: https://clinicaltrials.gov/study/NCT04322539
Aquino J, Dasari A, Eng C, et al. (2024). “Effect of fruquintinib plus best supportive care on Eastern Cooperative Oncology Group performance status deterioration in patients with refractory metastatic colorectal cancer: Post-hoc analysis of the phase 3 placebo-controlled FRESCO-2 study.” Presented at ONS 2024 (Abstract I1).
