Clinical efficacy and safety of apatinib in treatment of alpha fetoprotein-positive advanced gastric cancer.

Abstract

e15513 Background: Alpha fetoprotein (AFP)-producing gastric cancer (APGC) is a minor subtype of gastric cancer (GC) with high malignancy, rapid progress, high metastatic rate and poor prognosis. Treatment of AFP-positive GC is not different from that of AFP-negative GC, but the efficacy can not match for the latter. Apatinib, a novel inhibitor of VEGFR-2, has achieved survival improvement in advanced GC patients. We aimed to evaluate the efficacy and safety of apatinib in AFP-positive advanced gastric cancer patients. Methods: This was a single-arm, open-label, exploratory study design. Eligibility criteria included histologically proven GC; patient age 18-75 years; AFP-positive; clinical stage III or IV; and ECOG performance status of 1 or 2. A history of receiving previous treatment was not required. All the patients were orally given apatinib at an initial dose of 500 mg (qd) until disease progression or death. Dose reduction to 250 mg was allowed. Results: A total of 16 pts including 15 males and 1 female were eligible. The median age was 62.5 years (range 26-74 years). Poorly differentiated adenocarcinoma was the main histological type, and the main metastatic sites were liver (12/16) and abdominal (2/16). Ten pts received gastric surgery and 13 had previous chemotherapy prior to apatinib, and 10 patients received chemotherapy along with apatinib. Among the 16 pts, 14 were available for the efficacy evaluation. Two pts achieved partial response (PR), 10 had stable disease (SD), and 2 had progressive disease (PD). The objective response rate (ORR) and the disease control rate (DCR) were 14.3% (2/14) and 85.7% (12/14), respectively. All pts were included for safety analysis. The incidence of adverse events (AEs) was 87.5%. Main AEs were bone marrow suppression (43.75%), hypertension (50%), and abdominal pain (31.25%). Conclusions: Administration of apatinib make clinical benefit to AFP positive advanced gastric cancer with a comparable disease control and tolerable adverse reactions. Clinical trial information: ChiCTR-OPC-16008295. Clinical trial information: ChiCTR-OPC-16008295.