P64.03 A Phase II Single-Arm Trial of Apatinib as Maintenance Treatment Following First-Line Chemotherapy in Extensive Stage Small Cell Lung Cancer

Abstract

For half a century, there is no breakthrough in maintenance therapy after first-line chemotherapy of extensive stage small cell lung cancer(ED-SCLC). Even though first-line chemotherapy combined with immunotherapy can prolong the overall survival(OS) of ED-SCLC patients, the benefit is not satisfactory. The disease often progresses rapidly, and the therapy after the first-line treatment is very limited. The development of therapy to delay cancer progression and prolong survival after initial chemotherapy for SCLC is an unmet clinical need. Recently, small, orally administered multi-target TKIs , such as apatinib, have exerted promising effects on SCLC. This study enrolled 12 ED-SCLC patients to study the efficacy and toxicity of apatinib in maintenance therapy after standard first-line chemotherapy. The primary endpoints were OS and progression-free survival (PFS). The secondary endpoints included toxicity and safety. Apatinib was given 250 mg/day during the chemotherapy interval, and as maintenance therapy after 4–6 cycles until the patient progressed, died, or was intolerant to drug toxicity. The patients who received apatinib as maintenance treatment exhibited a median PFS of 3.7 months (range=1.3–6.2). The median OS was 16.3 months (range=9.7-22.8). Two patients required dose reduction due to adverse effects. The most common AEs included hypertension (n = 4,33.33%) and hand-foot-skin reaction (n = 2, 16.67%). One patient developed diarrhea and one patient developed hemoptysis. The most serious side effect was intestinalobstruction As a maintenance treatment after first-line chemotherapy , apatinib not only showed anti-tumor activity for further tumor shrinkage, but also had the potential to prolong OS in ED-SCLC and would be a potent therapeutic option in future clinical practice.