Abstract 82P
Background
Maintenance treatment and treatment discontinuation are options to mCRC patients who response to first-line treatment. We conducted this study to evaluate the efficacy and safety of fruquintinib as maintenance therapy following first-line treatment for mCRC.
Methods
FRONT study is an ongoing, multicenter, open-label, randomized clinical trial. Patients (pts) with unresectable right-sided mCRC or RAS-mutant left-sided mCRC, who hadn’t had progressed disease after first-line standard treatment (chemotherapy with or without bevacizumab) for four to six months, were eligible. According to the protocol, 110 patients would be randomly allocated to fruquintinib (FR) group (4mg orally per day in 21-day-on/7-day-off cycles) or observation (OB) group at a 2:1 ratio via interactive web response system. The primary endpoint was progression-free survival (PFS).
Results
Up to June 20, 2024, 36 and 19 patients had been enrolled in FR group and OB group, of whom the median age was 59.5 (44 to 73) vs. 66 (36 to 81), including 25 (69%) vs. 13 (68%) males, respectively. With a median follow-up of 19.12 months, 35 and 19 pts in two groups received at least one response evaluation after baseline. The median PFS were 3.91 (95% CI: 3.09-8.15) months and 2.94 (95% CI: 1.97-4.63) months (HR=0.48, 95% CI: 0.24 to 0.95; univariate Cox proportional hazard p=0.0341). The 3-month PFS rate was 70.94 (95% CI: 53.75-88.14) % vs. 44.44 (95% CI: 21.49-67.40) %, and the 6-month PFS rate was 43.35 (95% CI: 22.96-63.74) % vs. 20.00 (0.61-39.38) %.The DCR was 85.71% (30/35) vs. 52.63% (10/19) (OR=5.40, 95% CI: 1.46-19.95; Fisher exact test p=0.0203). The common AEs in FR group were hypertension, hand-foot syndrome, fatigue, rash, oral mucositis, and proteinuria, while AEs of grades≥3 were hand-foot syndrome, hypertension, oral mucositis, and proteinuria.
Conclusions
Compared to treatment discontinuation, fruquintinib demonstrated better outcomes as a maintenance therapy after first-line treatment with acceptable toxicity in mCRC.
Clinical trial identification
NCT04296019.
Editorial acknowledgement
The authors thank all the patients involved in this study. We also thank Chao Zhao and Zheng Wang from HUTCHMED for the assistance in data analysis and writing.
Legal entity responsible for the study
The authors.
Funding
Chinese Society of Clinical Oncology Eli Lilly and Company Pharmaceutical/Biotech Company.
Disclosure
All authors have declared no conflicts of interest.