Randomized phase II trial of carboplatin-paclitaxel (CP) compared to carboplatin-paclitaxel-bevacizumab (CP-B) in advanced (stage III-IV) or recurrent endometrial cancer: The MITO END-2 trial.

5502 Background: The prognosis of advanced or recurrent endometrial cancer (AEC) is dismal. The antiangiogenic drug Bevacizumab (B) has reported activity in AEC with response rates ranging from 13 to 22% and 6-month disease control up to 40%. The This randomized phase II trial was designed to compare CP vs CP-B in the treatment of AEC in terms of progression free survival (PFS).(EUDRACT Number 003301-16) Methods: Eligible pts had advanced (stage III-IV) or recurrent (progression > 6 months after completion of previous platinum chemotherapy) endometrial cancer, and ≤ 1 prior CT lines. All patients had measurable or evaluable disease and both type 1 and 2 endometrial cancers were eligible. Pts were randomized 1:1 to receive CP standard dose for 6-8 cycles with or without Bevacizumab 15 mg/kg in combination and maintenance until progression or unacceptable toxicity. Results: From January 2012 to October 2014, 108 pts were randomized (CP: 54 pts; CPB 54 pts). Overall, 2 out of 3 of pts presented with recurren...