Apatinib, a small molecule VEGFR TKI, has been approved in the treatment of advanced or metastatic gastric cancer (GC) in China. We performed a real world study to observe the current status, efficacy and safety of apatinib treatment in clinical practice, and preliminarily define patients (pts) who could benefit from apatinib.
From September 2017, pts (age ≥18 yrs) with pathologically or histologically diagnosed GC who were given apatinib treatment met the inclusion criteria. The target sample size is 1000.
As of April 2018, 651 pts from 37 centers were eligible. There are 491 (75.4%) males and 160 (24.6%) females. The median age was 62.5 yrs. The majority pts were at stage IV (399, 61.3%), had prior surgery (370, 56.8%) and chemotherapy (341, 52.4%). Pts with ECOG PS 0–2 were 520 (79.9%), and ECOG PS 1 was most common (403, 61.9%). Metastases were detected in 370 (56.8%) pts, which mainly were hepatic and pulmonary metastases. Pts received apatinib monotherapy or in combination with chemotherapy. The dose of apatinib in most pts (70.0%) was 500 mg qd. Apatinib was used in perioperative treatment for 269 (41.3%) pts. 382 (58.7%) pts with unresectable locally advanced, recurrent, or metastatic disease received apatinib as different lines of systemic therapy; among whom, 284 pts were evaluable for response, and 113 pts obtained complete clinical efficacy and safety assessment. 12 achieved partial response, 79 had stable disease and 22 got progressive disease. Thus, the objective response rate (ORR) and disease control rate (DCR) were 10.6% and 80.5%. 78.8% pts reported adverse events (AEs). The incidence of grade 3-4 AEs was 22.1%. Main apatinib-related AEs were hypertension (20.3%), and hand-foot syndrome (26.5%). There were tendencies showed that prognostic factors related with higher ORR were lines of apatinib (≤2, 11.3%; >2, 9.5%) and duration of medication (< 90 days, 7.1%; 90-120 days, 6.7%; >120 days, 11.9%).
In the real world, GC pts receiving apatinib therapy are mainly elderly men, stage IV, and ECOG PS 1. Apatinib is confirmed to be effective and safe for GC pts. Further analysis is needed to identify pts who obtain benefits from apatinib treatment.
Clinical trial identification
Legal entity responsible for the study
The First Affiliated Hospital of Anhui Medical University.
Has not received any funding.
There is no editorial assistance.
All authors have declared no conflicts of interest.