EPV278/#248 A randomized controlled phase ii clinical trial of apatinib plus chemotherapy in the first-line(1L) treatment of ivb stage, recurrent or persistent cervical cancer

Objectives

This study evaluates the efficacy and safety of apatinib combined with chemotherapy in cervical cancer.

Methods

In this open-label phase II study, eligible patients were randomized(1:1) to receive treatment: Arm A) oral apatinib 375 mg once daily + intravenous paclitaxel (P) and cisplatin (DDP) or carboplatin (carb); Arm B) intravenous P and DDP or carb. Chemotherapy was administered for 4–6 cycles followed by apatinib. The primary endpoint was PFS assessed by RECIST1.1, and secondary endpoints included OS, ORR, DCR, DOR, and safety/tolerability.

Results

61 patients were randomized to Arm A (n = 31) and Arm B (n = 30). Until March 30, 2021, the median follow-up was 10.7 months (range 1.73–32.23). Compared with patients in Arm B, patients in Arm A showed a higher PFS (13.6 vs. 5.2 months, HR, 0.455; 95% CI 0.239–0.865; P = 0.014), ORR (58.10% vs. 23.3%), and DCR (80.60% vs. 53.3%). Treatment-related AEs (TRAEs) occurred in 87% (A) and 40% (B); Grade ≥3 TRAEs occurred in 77% (A) and 30% (B), respectively. The most commonly reported grade ≥3 AEs were hematologic in nature (eg, neutropenia) and consistent with known chemotherapy AEs. Serious TRAEs were reported in 8 patients (22.6% [A]; 3.3% [B]); TRAE leading to death was reported in 1 patient in Arm A.

Conclusions

As 1L treatment of IVB stage, recurrent or persistent cervical cancer, the addition of apatinib to chemotherapy significantly improved PFS and showed a higher ORR and DCR than chemotherapy alone. No new safety issues were identified with the addition of apatinib to chemotherapy.