Abstract 1455P
Background
After the failure of first-line treatment in patients with advanced gastric cancer, the benefit of existing single chemotherapy drugs is limited, and these patients are faced with difficult second-line drug selection. Currently, apatinib has been approved in China for third-line and above treatment of advanced gastric cancer. Furthermore, basic research has confirmed that apatinib combined with chemotherapy could enhance the anti-tumor efficacy. This study evaluated the efficacy and safety of apatinib combined with chemotherapy in second-line therapy for patients with advanced gastric cancer (ChiCTR-OON-16009713).
Methods
From August 31, 2016 to February 17, 2020, 32 patients were screened and 29 patients were enrolled. The enrolled patients received apatinib combined with chemotherapy, and the combined chemotherapy drugs were not limited. The enrolled patients were treated until disease progression, death, or severe intolerable toxicity, etc. The primary endpoint was overall survival (OS), and secondary endpoints were progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR). The adverse events were also recorded.
Results
The median follow-up time was 11.77 months(IQR: 7.00-15.50). Among the 29 patients enrolled, 22 received apatinib combined with docetaxel. 21 patients received apatinib with an initial dose of 250 mg and 8 patients started with 500 mg. 20 patients has more or equal to 2 metastatic lesions. The median PFS was 3.33 months (95% CI: 2.70-3.97), and the median OS was not reached. The median PFS was 3.07 months of patients who treated with apatinib plus docetaxel. 28 patients were available for efficacy evaluation. The ORR and DCR were 17.86% and 89.29%, respectively. During the treatment, 22 patients reported adverse events (AEs). The main adverse events were leukopenia (24.14%), hypertension (24.14%) and neutropenia (17.24%). No patients reported grade 4 or above AEs. Grade 3 AEs were hand-foot syndrome (n = 1,3.45%) and diarrhea (n = 1,3.45%).
Conclusions
Apatinib combined with chemotherapy showed certain efficacy and tolerable toxicity as second-line treatment for patients with advanced gastric cancer.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Jiangsu Cancer Hospital.
Funding
Cancer Research Foundation of The Chinese Society of Clinical Oncology (Y-HR2016-025).
Disclosure
All authors have declared no conflicts of interest.