Apatinib plus pegylated liposomal doxorubicin (PLD) may be an alternative treatment option for patients with platinum-resistant, recurrent ovarian cancer, according to research published in JAMA Oncology.
Researchers found that apatinib plus PLD reduced the risk of progression or death by 56%, when compared with PLD alone.
The researchers compared the treatments in the phase 2 APPROVE trial (ClinicalTrials.gov Identifier: NCT04348032). The trial enrolled 152 patients with platinum-resistant, recurrent ovarian cancer, and they were randomly assigned to receive PLD alone (n = 74) or in combination with apatinib (n = 78).
At baseline, the median age was 54 (range, 22-76) years in the apatinib arm and 56 (range, 33-72) years in the PLD-alone arm. All patients in the apatinib arm and 94.6% in the PLD-alone arm had serous / adenocarcinoma histology.
All patients had prior exposure to paclitaxel. Most had no prior exposure to PARP inhibitor therapy or antiangiogenic therapy. About half had received 2 or more prior lines of therapy.
All patients received PLD at 40 mg / m2 intravenously, every 4 weeks for up to 6 cycles. Patients in the apatinib arm took 250 mg of the oral drug daily.
The combination of apatinib and PLD significantly prolonged progression-free survival (PFS). The median PFS was 5.8 months in the apatinib arm and 3.3 months in the PLD-alone arm (hazard ratio [HR], 0.44; 95% CI, 0.28-0.71; P <.001).
There was no significant difference in overall survival (OS) between the treatment arms. The median OS was 23.0 months in the apatinib arm and 14.4 months in the PLD-alone arm (HR, 0.66; 95% CI, 0.40-1.09; P = .10).
The objective response rate (ORR) was 43.1% in the apatinib arm and 10.9% in the PLD-alone arm. The disease control rate was 81.5% and 53.1%, respectively.
The rate of treatment-emergent adverse events (TEAEs) was 93.2% in the apatinib arm and 84.7% in the PLD-alone arm. The rate of grade 3 or higher TEAEs was 43.2% and 19.4%, respectively.
The most common grade 3 or higher TEAEs (in the apatinib and PLD-alone arms, respectively) were decreased neutrophil counts (14.9% vs 8.3%), hypertension (8.1% vs 0), and decreased white blood cell counts (6.8% vs 4.2%).
“[C]ompared with treatment with PLD alone, apatinib combined with PLD led to significant improvements in PFS and ORR, with manageable toxic effects, ”the researchers wrote.
They noted that outcomes with apatinib plus PLD are comparable to outcomes seen with bevacizumab plus PLD. However, oral apatinib “allows for timely dose adjustments and is much more convenient for patients” than intravenous bevacizumab.
The researchers therefore concluded that apatinib plus PLD “could be considered an alternative treatment option” for platinum-resistant, recurrent ovarian cancer.
Disclosures: The drugs used in this study were provided by Jiangsu HengRui Medicine Co., Ltd. (apatinib) and CSPC Pharmaceutical Group Co Ltd (PLD). Some study authors declared affiliations with both companies. Please see the original reference for a full list of disclosures.
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. Published online June 30, 2022. doi: 10.1001 / jamaoncol.2022.2253