Efficacy and safety of second-line therapy with apatinib combined with chemotherapy as second-line therapy in advanced gastric cancer: a single-arm, open-label, prospective, multicenter study.

Background: For advanced gastric cancer (GC) patients who fail first-line treatment, chemotherapy alone is of limited benefit. Ramucirumab combined with paclitaxel and apatinib combined with docetaxel provided clinical benefit in previous studies, but the feasibility of apatinib combined with other chemotherapy agents remains unknown. The aim of the present study was to evaluate the efficacy and safety of apatinib combined with chemotherapy as a second-line treatment for advanced GC. Methods: Patients aged 18-75 years with histologically or cytologically confirmed advanced or metastatic GC or gastroesophageal junction adenocarcinoma that had progressed with first-line treatment were recruited and received apatinib 250 or 500 mg oral apatinib and chemotherapy regimens, including docetaxel, paclitaxel, tegafur, oxaliplatin, and capecitabine. Each treatment cycle was 28 days (4 weeks). During post-discontinuation follow-up, all patients were followed for survival [every 8 weeks (+0 to 7 days)] until disease progression, death, or study completion. Overall survival (OS) was the primary endpoint. Secondary endpoints were overall response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Adverse events (AEs) were also noted. Tumor response and progression were assessed according to RECIST 1.1. AEs were graded following the National Cancer Institute common terminology criteria for AEs (NCI-CTCAE 4.0). Results: Between August 31, 2016 and February 17, 2020, a total of 32 patients were enrolled in the present study, and 29 were evaluable. At the time of data cut-off, median follow-up was 7.00 months (IQR, 4.60-12.23 months). The ORR and DCR were 18.52% and 92.59%, respectively. The median PFS was 3.06 months, and the median OS was 6.93 months. In the population receipt of apatinib plus docetaxel, the median OS was 6.51 months. AEs were observed in 22 patients. Leukopenia was the most common AE (24.1%), followed by hypertension (24.1%) and neutropenia (17.2%). Patients did not develop any AEs that were grade 4 or higher. Conclusions: The combination of apatinib and chemotherapy demonstrated clinical activity and acceptable toxicity as a second-line treatment for advanced GC, and may provide new second-line treatment options for advanced GC patients.