P1.12-14 Phase II Trial of Apatinib Plus Chemotherapy for Second-Line and Above Treatment of Advanced SCLC: Focus on Efficacy and Safety

Abstract

Small-cell lung cancer (SCLC), which accounts for ∼15% of all lung cancers, is characterised by its rapid proliferation. The clinical outcomes of second-line and above treatments are unsatisfactory, resulting in a median progression-free survival (PFS) of less than 3 months. There is currently none targeted drugs or new chemotherapeutic drugs that can achieve breakthroughs in advanced SCLC. This study aims to observe whether apatinib in combination with chemotherapy can be a new choice for second-line and above treatment of advanced SCLC. This is a prospective, single-center, single-arm clinical study designed to evaluate the efficacy and safety of apatinib plus chemotherapy for second-line and above treatment of advanced SCLC (ClinicalTrials.gov NCT03547804). Patients received 500mg apatinib qd orally, if the patient has a grade 3/4 adverse reaction during the treatment, it can be reduced to apatinib 250mg qd orally. Chemotherapeutic agents are limited to irinotecan or docetaxel alone. The primary endpoint was the progression-free survival (PFS). The secondary endpoints included overall survival (OS), disease control rate (DCR), objective response rate (ORR), and adverse events (AEs). Twenty patients were enrolled from March 2018 to March 2019. Fifteen patients were available for response evaluation. The ORR and DCR were 33.33% (5/15) and 93.33% (14/15), respectively. The predicted median PFS time was 5.8 months (95% confidence interval [CI] 5.1-6.5 months) (SPSS 20.0 software). The most common treatment-related AEs were neutropenia (45.0%), leucopenia(35.0%), abnormal liver function (20%), nausea and vomiting (20%) and thrombocytopenia (20.0%), without any treatment-related deaths. It is worth noting, 12 patients underwent apatinib reduction due to grade 3/4 adverse reactions. Apatinib plus single agent chemotherapy showed promising efficacy in a patients with advanced SCLC who had failed chemotherapy. And the recommended phase II dose of apatinib as combination therapy was 250 mg qd.