Association of proteinuria, hypertension, and hand-foot-skin reaction with efficacy of apatinib in gastric cancer: Results from the post-marketing study (Ahead-G201).

Abstract

73 Background: Ahead-G201 is an ongoing open-label, multicenter, post-marketing Phase IV trial assessing safety and efficacy of apatinib in 2000+ patients (pts) with chemotherapy-refractory advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction. Proteinuria (PTN), hypertension (HTN) and hand-foot-skin reaction (HFSR) are common adverse events (AEs) related to anti-angiogenesis drugs. Methods: As of 2017/7/10, 1037 and 820 pts were evaluable for safety and survival. Clinical outcomes were compared between pts with and without PTN / PTN / HFSR using Kaplan–Meier methods and multivariate Cox regression model. Results: 200 (19.3%), 194 (18.8%) and 115 (11.1%) pts had PTN, HTN and HFSR, respectively. Similar mean daily dosage was found between pts with and without PTN, HTN or HFSR (from 520.6 to 551.0 mg/day). Pts developed PTN / HTN / HFSR had longer median medication durations (57 vs. 33 / 55 vs. 35 / 65 vs. 36 days; p<0.001). However, there was no significant difference in tumor response and progression free survival (PFS) between pts with and without PTN/HTN/HFSR (Table). Only pts had HFSR showed significantly longer overall survival (OS) (8.38 vs. 5.95 months; p=0.0003). After adjusted for baseline and treatment characteristics, presence of HFSR was found to be independently associated with prolonged OS (HR: 1.82 [95%CI, 1.25–2.66]). Conclusions: Occurrence of HFSR is an independent predictor of better OS. Prior analysis based on Phase II and III indicated the relationship between HTN and prolonged OS, which needs to be further analyzed. Clinical trial information: NCT02426034. [Table: see text]