Second-line dovitinib in FGFR2-mutated and FGFR2-non-mutated advanced or metastatic endometrial cancer had single-agent activity, but it did not reach the prespecified study criteria, a recent study published online first in the journal The Lancet Oncology.
For the non-randomized, two-group, two-stage, phase II trial, researchers enrolled 53 patients with FGFR2-mutated or FGFR2-non-mutated advanced or metastatic endometrial cancer whose disease had progressed after first-line chemotherapy. All women received dovitinib 500mg orally daily for 5 days and 2 days off until disease progression, unacceptable toxicity, study discontinuation, or death.
Results showed that the 18-week progression-free survival rates were 31.8% (95% CI: 13.9-54.9) in the FGFR2-mutated and 29.0% (95% CI: 14.2-48.0) FGFR2-non-mutated group.
In regard to safety, the most common serious adverse events associated with dovitinib use were pulmonary embolism, vomiting, dehydration, and diarrhea. One participant died due to treatment-related causes.
The findings suggest that efficacy of dovitinib is independent of FGFR2 mutation status. Additional studies are warranted to study the efficacy of dovitinib.
We assessed the safety and activity of dovitinib as second-line therapy both in patients with FGFR2-mutated endometrial cancer and in those with FGFR2-non-mutated endometrial cancer.