Lan CY, et al. - In patients with platinum-resistant or platinum-refractory ovarian cancer, researchers evaluated the safety and effectiveness of the combination of apatinib and oral etoposide, bearing in mind the advantage of home administration with no hospital admission. In patients with platinum-resistant or platinum-refractory ovarian cancer, apatinib in combination with oral etoposide demonstrated efficacy and manageable toxicities. Neutropenia, fatigue, anemia, and mucositis were the most common grade 3 or 4 adverse events.

Methods

• Participants in this phase 2, single-arm, prospective study were patients aged 18–70 years with platinum-resistant or platinum-refractory ovarian cancer at the Sun Yat-sen University Cancer Center (China).
• The treatment was apatinib at an initial dose of 500 mg once daily on a continuous basis, and oral etoposide at a dose of 50 mg once daily on days 1–14 of a 21-day cycle.
• For a maximum of six cycles, oral etoposide was administered.
• Researchers continued treatment until disease progression, patient withdrawal, or unacceptable toxic effects.
• Defined by Response Evaluation Criteria in Solid Tumors, version 1.1, the proportion of patients achieving an objective response was the primary endpoint.
• Simon's two-stage design was used, and examined effectiveness in the intention-to-treat and per-protocol populations.
• Safety analyses involved selected patients who received at least one dose of study medication, excluding those without any safety data.

Results

• Researchers screened 38 and selected 35 subjects between August 10, 2016 and November 9, 2017.
• Twenty (57%) patients had discontinued the study, and 15 (43%) patients stayed on treatment at the data cutoff point (December 31, 2017).
• It was noted that objective responses were achieved in 19 (54%; 95% CI 36.6–71.2) of 35 patients in the intention-to-treat population and in 19 (61%; 42.2–78.2) of 31 patients in the per-protocol population.
• Neutropenia (17 [50%]), fatigue (11 [32%]), anemia (ten [29%]), and mucositis (eight [24%]) were the most common grade 3 or 4 adverse events.
• They encountered serious adverse events in two subjects who were admitted to hospital; one had anemia and anorexia and the other had increased ascites due to disease progression.
• They did not record treatment-related deaths in this analysis.