Dave Levitan writing for Modern Medicine reports A phase II trial found that apatinib combined with etoposide offers promising efficacy in patients with platinum-resistant ovarian cancer. The regimen could offer advantages due to its home-based administration that does not require hospital admission.
“Some preclinical studies have shown that the combination of oral topotecan and the angiogenesis inhibitor pazopanib was effective, and toxicity was tolerable in patients with solid tumors, including ovarian cancer,” wrote study authors led by Chun-Yan Lan, MD, of Sun Yat-sen University Cancer Center in Guangzhou, China. Apatinib is a small-molecule tyrosine kinase inhibitor that selectively inhibits VEGFR2, and has shown promise in earlier small studies of ovarian cancer.
The new AEROC trial was a single-arm phase II study, including 35 patients with platinum-resistant or platinum-refractory ovarian cancer, conducted at a single center. Patients received apatinib 500 mg once daily along with oral etoposide at a dose of 50 mg on days 1–14 of a 21-day cycle. Patients had a median age of 55 years, and most (63%) had received 3 to 6 prior lines of chemotherapy. The results of the trial were published in Lancet Oncology.
A total of 19 of 35 patients in the intention-to-treat population achieved an objective response to the treatment (54%); in 31 patients included in a per-protocol analysis, the objective response rate was 61%. Disease control was achieved in 30 patients, for a rate of 86% in the intention-to-treat population; the disease control rate was 97% in the per-protocol analysis. The median duration of response was 7.4 months, and the median progression-free survival in the study was 8.1 months.
Every patient in the study had at least one adverse event of any grade, regardless of cause. Four patients (12% of those with safety data) discontinued the study because of adverse events; these included neutropenia, hypertension, thrombocytopenia, and hand-foot syndrome. The most common grade 3/4 adverse events included neutropenia (50%), fatigue (32%), anemia (29%), and mucositis (24%). There were no fatal adverse events reported in the study; two patients had serious events and were admitted to the hospital.
The authors noted the study’s limitations, including its single-arm design, which could introduce the possibility for selection bias. Still, they concluded that “the combination of therapy of apatinib with oral etoposide shows promising efficacy and manageable toxicities in patients with platinum-resistant or platinum-refractory recurrent ovarian cancer, and further study in phase III trials is warranted.”
Sun Yat-sen University Cancer Center in Guangzhou, China
Chun-Yan Lan, MD