394P - Apatinib plus etoposide capsules as third-line or further-line treatment for extensive stage small cell lung cancer patients: A multicenter, single arm, phase II clinical trial

Background

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.

Methods

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.

Results

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.

Conclusions

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.

Clinical trial identification

NCT03389087.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.