Abstract 46P
Background
The best approach for pts with mCRC ineligible for intravenous chemotherapy remains unclear. Fruquintinib, a highly specific inhibitor of VEGFR1/2/3, is a standard therapy in pts with previous-treated mCRC. Here, we aimed to evaluate the efficacy and safety of fruquintinib plus capecitabine as first-line treatment in mCRC pts who were not candidates for intravenous chemotherapy.
Methods
This was a phase II, single arm study (NCT04866108), eligible pts had at least one measurable disease, ECOG PS 0-2, adequate organ function and were unfit for intravenous chemotherapy. Pts received fruquintinib (4 mg QD, D1-14) plus capecitabine (825mg/m2 BID, D1-14) every 3 weeks until disease progression or unacceptable toxicity. Simon’s 2-stage design was applied. If ≥11 of 14 pts in stage 1 reached disease control (DC), further 29 pts would be enrolled; otherwise, the enrollment would be discontinued. Primary endpoint was DCR (RECIST v1.1), secondary endpoints were ORR, PFS, OS and safety (NCI-CTCAE v5.0).
Results
As of Jan 30, 2024, 3 (21.4 %) pts had partial response (PR) and 10 (71.4 %) pts had stable disease (SD). The study proceeded to the second stage. As of Apr 4, 2024, 20 pts were enrolled. Median age was 76 years (41-86), male in 66.7%, KRAS mutation in 55.6%, ECOG PS 1 in 50% and 2 in 5.5%, left colon tumors in 50.0% and rectal tumors in 44.4%. 44.4% pts had liver metastasis and 22.2% had ≥2 metastatic sites. ORR was 20.0% (3/15) and DCR was 93.3% (14/15) in efficacy evaluable pts. One patient reached a PFS of 498 days. 3 pts had PFS exceeded 365 days and were still in treatment. Median PFS and OS were not reached with 12 pts still in treatment. All pts experienced treatment-related adverse events (TRAEs) but most were grade 1-2. Grade 3 TRAEs were reported in 5 pts and no treatment related deaths were reported.
Conclusions
Fruquintinib plus capecitabine as first-line treatment in elderly mCRC pts ineligible for intravenous chemotherapy demonstrated encouraging clinical activity with acceptable toxicities. The trial is ongoing and further results will be presented in the future.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.