Apatinib and Oral Etoposide in Platinum-Resistant/Refractory Ovarian Cancer
In a Chinese single-center phase II study reported in The Lancet Oncology, Lan et al found a high response rate with oral apatinib plus oral etoposide in patients with platinum-resistant or refractory ovarian cancer.
Study Details
The study included 35 patients with progression within 6 months after last platinum treatment or progression during initial platinum-based treatment enrolled at Sun Yat-sen University Cancer Center between August 2016 and November 2017. Patients had a median age of 55 years. Most patients had stage IIIC (57%) or IVB (24%) disease, 77% had high-grade serous carcinoma, and 63% had received three to six previous lines of chemotherapy. Treatment consisted of apatinib at 500 mg once daily on a continuous basis and oral etoposide 50 mg once daily on days 1 to 14 of 21-day cycles, with etoposide given for a maximum of six cycles. Treatment was continued until disease progression or unacceptable toxicity.
Responses
At data cutoff in December 2017, 20 (57%) patients had discontinued the study and 15 (43%) remained on treatment. Objective response (all partial response) was observed in 19 (54%) of 35 patients in the intention-to-treat population and in 19 (61%) of 31 in the per-protocol population (those compliant with treatment protocol); an additional 31% and 36% of patients had stable disease. Median duration of response was 7.4 months. Median progression-free survival was 8.1 months.
Adverse Events
The most common grade 3 or 4 adverse events were neutropenia (50%), fatigue (32%), anemia (29%), mucositis (24%), thrombocytopenia (18%), hand-foot syndrome (15%), and vomiting (15%). Serious adverse events were reported in two patients, with one hospitalized for anemia and anorexia and one hospitalized for increased ascites due to disease progression. No treatment-related deaths were reported.
The investigators concluded, “The combination of apatinib with oral etoposide shows promising efficacy and manageable toxicities in patients with platinum-resistant or platinum-refractory ovarian cancer, and further study in phase III trials is warranted.”
The authors reported that there was no funding for the study.
Xin Huang, MD, of the Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, is the corresponding author for The Lancet Oncology article.
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