Advanced small cell lung cancer patients have very poor outcome, with a median overall survival (OS) of less than 1 year. We conducted this phase II clinical trial to evaluate the efficacy and safety of apatinib plus etoposide capsules in the third-line or further-line treatment of patients with extensive stage small cell lung cancer.
Patients with extensive stage small cell lung cancer who failed ≥ 2 lines of therapy were recruited from 11 hospital across China. All participants should have an Eastern Cooperative Oncology Group performance status of 0 to 2, at least one evaluable lesion according to response evaluation criteria in solid tumor (RESCIST 1.1). Participants received apatinib (250mg orally every day) and etoposide capsules (50mg orally from day 1 to 21, every 4 weeks) until disease progression, death or intolerable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoint was overall survival (OS) and safety.
Totally 52 patients with a median age of 60.5 (range, 30-77) years, including 40 men (77.0%) were enrolled in our study from December 2017 to August 2019. By the end of December 2019, 45 patients progressed and 36 died. Among 52 evaluable patients, 34 patients showed a stable disease, 11 patients achieved a partial response, showing an objective response rate (ORR) of 21.2% and disease control rate (DCR) of 86.5%. The median follow-up duration was 6.6 months. The median PFS was 3.3 months (95% CI, 2.56-4.05), and median OS was 4.5 months (95% CI, 3.50-4.90). 1-year survival rate was 11.54%. Major adverse events (AEs) included leukopenia (30.77%), anemia (25%), and fatigue (19.23%). No grade 3 or more AEs were reported.
Apatinib plus etoposide capsules showed reasonable efficacy and toxicity among extensive stage small cell lung cancer patients in third-line or above setting. Further exploration of apatinib in phase Ⅲ trials is warranted.
NCT03389087.
The authors.
Jiangsu Hengrui Pharmaceutical Co., Ltd.
All authors have declared no conflicts of interest.