Single arm clinical observation of low-dose apatinib combined with temozolomide in the treatment of relapsed small cell lung cancer

Objective To investigate the objective response, clinical efficacy and adverse reactions of low dose apatinib combined with temozolomide in the treatment of relapsed small cell lung cancer (SCLC). Methods This study was a prospective, unblinded, one-arm study. Fifteen patients with pathological diagnosis of recurrent SCLC were enrolled from June 2016 to January 2019. All patients were diagnosed with SCLC by biopsy guided by fiberoptic bronchoscope, CT or exfoliating cell biopsy by pleural effusion. The fifteen patients were treated by apatinib (125-250 mg/d) and temozolomide[200 mg/(m²·d), continuously for 5 d, one cycle every 28 d]. The dosage of apatinib can be adjusted to 125 mg according to the patient's adverse reaction. These patients were treated until the disease progressed or an intolerable adverse reaction occurred. CT was reexamined every 2 cycles to evaluate the treatment effect, and progression free survival (PFS), overall survival (OS) time and adverse events (AEs) were recorded. Results The median PFS was 7.0 months, the median OS was 10.5 months, the objective remission rate was 46.7%, and the disease control rate was 66.7% within 6 months. AEs were mainly manifested as myelosuppression, digestive tract reaction, oral mucositis, and hand-foot syndrome. Serious AEs were less. Conclusion Low dose apatinib combined with temozolomide is effective and well tolerated in the treatment of relapsed small cell lung cancer.