2994 - Apatinib combined with docetaxel in second-line treatment of advanced gastric cancer: a prospective clinical study (Data updated)

Background

Antiangiogenic therapy in combination with chemotherapy has shown improved clinical benefit in advanced cancer. In third-line therapy, apatinib(a TKI against VEGFR-2) has shown good safety and efficacy for advanced gastric cancer. However, the safety and efficacy of apatinib combined with docetaxel in second-line treatment of advanced gastric cancer remains unclear.

Methods

From Mar 2017 to Dec 2018, 40 patients with advanced gastric cancer after failure of first-line chemotherapy were enrolled in this open-lable, prospective study. All patients were treated by apatinib (500mg, qd) with docetaxel (60mg/m2,d1, q21d). According to the docetaxel course of treatment, study treatment was continued as a 21-day cycle. After 6 cycles, apatinib alone maintenance. Efficacy was evaluated every 2 cycle based on RECIST version 1.1. The primary endpoint was progression-free survival (PFS). The secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), safety and quality of life.

Results

Forty enrolled patients baseline characteristics are shown in the table below. The partial response (PR) 5 cases, stable disease rat (SD) 27 cases, and progression disease (PD) 8 cases. The median PFS 4.6 months. The ORR and DCR were 12.5% and 80.0%, respectively. During the treatment period, a patient with multiple hepatic metastases of gastric antral adenocarcinoma received 6 cycles of apatinib combined with docetaxel and sustained by apatinib alone. The disease-free survival time was 10.4 months.The main adverse reactions in this study were hypertension (67.5%, n = 27), proteinuria (30.0%, n = 14), bone marrow depression (22.5%, n = 9), fecal occult blood (7.5%, n = 3). The adverse reactions in the course of treatment were controlled after symptomatic treatment, and most of them did not affect normal activities.

Conclusions

In the second-line treatment for patients with advanced gastric cancer, apatinib combined with docetaxel exhibits superior activity. Moreover, the toxicities were tolerable and could be clinically managed.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

China Anti-Cancer Association, Chinese Society of Clinical Oncology.

Disclosure

All authors have declared no conflicts of interest.