Apatinib Plus Pegylated Liposomal Doxorubicin Demonstrates Efficacy, Safety in Platinum-Resistant Ovarian Cancer

Apatinib plus pegylated liposomal doxorubicin (PLD) yielded promising results in efficacy and safety as treatment for patients with platinum-resistant ovarian cancer, according to results from the APPROVE trial published in JAMA Oncology.

“There are substantial unmet therapeutic needs in patients with platinum-resistant recurrent ovarian cancer, and novel therapeutic strategies should be explored.,” wrote lead author Tiantian Wang, MD,  National Cancer Center, Chinese Academy of Medical Sciences, Beijing, China, and coauthors.

The open-label, randomized clinical trial assessed 152 patients with platinum resistant ovarian cancer at 11 hospitals in China between March 22, 2018, and November 16, 2020. Patients either received up to 6 cycles of 40 mg/m² intravenous PLD alone every 4 weeks (n = 78; 51.3%), or 250 mg of daily oral apatinib plus PLD at the same dosage and schedule (n = 74; 48.7%). The primary end point of the study was progression-free survival (PFS) with a secondary end point of overall survival (OS).

With the median follow-up duration of 8.7 months, treatment with apatinib plus PLD yielded a median PFS of 5.8 months (95% confidence interval [CI], 3.8 to 8.8) vs 3.3 months (95% CI, 2.1 to 3.8) in patients treated with PLD only (hazard ratio [HR] 0.44; 95% CI, 0.28 to 0.71; P < .001). The median OS was 23 months (95% CI, 18.9 to not reached) vs 14.4 months (95% CI, 12.1 to 23.4) in the apatinib plus PLD and PLD only arms, respectively.

The most common grade ≥3 treatment-emergent adverse events in with both treatment regimens were decreased neutrophil counts (14.9% of the apatinib plus PLD group vs 8.3% treated with PLD only), hypertension (8.1% vs 0%), and decreased white blood cell count (6.8% vs 4.2%). In the apatinib plus PLD group, 2 patients reported grade 2 fistulas.

“The trial results found that apatinib plus PLD may be a novel alternative treatment option for patients with platinum-resistant recurrent ovarian cancer,” concluded Dr Wang and colleagues.

Source:

Wang T, Tang J, Yang H, et al. Effect of apatinib plus pegylated liposomal doxorubicin vs pegylated liposomal doxorubicin alone on platinum-resistant recurrent ovarian cancer: The APPROVE randomized clinical trial. JAMA Oncol. 2022;8(8):1169-1176. doi:10.1001/jamaoncol.2022.2253