102P - A real-world study comparing apatinib combined with irinotecan versus irinotecan as second-line or above therapy in patients with advanced or metastatic gastric cancer

Background

Irinotecan monotherapy was the standard second-line treatment regimen for metastatic gastric cancer. Previous researches revealed that apatinib combined with chemotherapy is more effective compared with apatinib or chemotherapy alone.The present study was conducted to evaluate the efficacy and safety of apatinib combined with irinotecan versus irinotecan as second-line or above therapy for patients with advanced or metastatic gastric cancer.

Methods

Patients with advanced or metastatic gastric cancer who have failed prior treatment and treated with apatinib combined with irinotecan or irinotecan from November 2017 to April 2020 were analyzed. The primary end point was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.

Results

26 patients received apatinib combined with irinotecan and 29 patients received irinotecan. The ORR in the combination therapy and monotherapy population were 26.9% and 17.2%, respectively. The DCR in the combination group was higher than in monotherapy population (80.8% vs. 55.2%, P=0.043). Median PFS was 4.2 months in the combination group and 3.3 months in the monotherapy group (P=0.020). Median OS was 8.0 months in the combination group and 5.9months in the monotherapy group (P=0.048).Except for ECOG PS 2, PFS and OS were generally consistent across subgroups by sex, age, number of metastatic sites and primary tumor site. The incidence of Grade 3-4 adverse events in combination and monotherapy group was 23.1% and 20.7%, respectively. In combination group, adverse events that were attributed to apatinib were secondary hypertension (in 7 patients, 26.9%), hand-foot syndrome (5, 19.2%) and proteinuria (5, 19.2%). Univariate analysis demonstrated that secondary hypertension was considered to be a potential predictive factor (P = 0.040) for longer OS in combination group.

Conclusions

Apatinib combined with irinotecan significantly improved PFS, OS and DCR compared with irinotecan as second-line or above therapy for patients with advanced or metastatic gastric cancer, with a tolerable safety profile.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Medical Science and Technique Foundation of Henan Province.

Disclosure

All authors have declared no conflicts of interest.