An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202)

Abstract

Background: Apatinib has been proved to be effective and well tolerated among patients in phase II and III studies. Here, we evaluated the safety and effectiveness of apatinib in advanced gastric cancer patients in a real-world setting. Methods: This study enrolled advanced gastric cancer patients who had progressed or relapsed despite systemic chemotherapy. The primary outcome was safety and the secondary outcomes included overall survival (OS) and progression-free survival (PFS). Results: A total of 337 patients were included. In total, 62 (18.4%), 102 (30.3%), and 173 (51.3%) patients received first, second, and third or higher line apatinib therapy, respectively. Grade 3/4 treatment-emergent adverse events (AEs) were infrequent (<5%), with hypertension (6.8%) being the only grade 3/4 AE occurring in more than 5% of the patients and across the low-dose (250 mg, 7.3%), mid-dose (425–500 mg, 6.1%), and high-dose group (675–850 mg, 2/15, 13.3%). The median OS and PFS were 7.13 months (95% CI, 6.17–7.93) and 4.20 months (95% CI, 4.60–4.77), respectively, and were comparable among the low-, mid-, and high-dose groups. Conclusion: Lower daily doses of apatinib achieved comparable OS and PFS versus higher daily doses of apatinib while maintaining a more benign safety profile in advanced gastric cancer patients. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT02668380.

Efficacy and Response Biomarkers of Apatinib in the Treatment of Malignancies in China: A Review

“…However, these doubts have not affected the large-scale clinical use of apatinib in patients with advanced GC in China. Subsequent clinical trial results revealed that apatinib showed acceptable efficacy and safety in real-world Chinese patients with metastatic GC (7,8); low doses of apatinib (250 mg or 500 mg/day) were tolerated by and beneficial to patients with advanced GC who had been heavily treated previously (9), and a lower dose of apatinib achieved comparable OS and PFS with a higher daily dose of apatinib while maintaining better safety (20). Apatinib has been further tested in other therapeutic scenarios.…”

Apatinib inhibits tumour progression and promotes antitumour efficacy of cytotoxic drugs in oesophageal squamous cell carcinoma

“… 4 Lower daily doses of apatinib have greater benefits than higher daily doses in advanced gastric cancer patients. 8 Apatinib also has reliable efficacy in advanced non‐small‐cell lung cancer (NSCLC) patients and chemotherapy‐refractory metastatic colorectal cancer. 6 , 9 Furthermore, apatinib enhances antitumour effect of chemotherapeutic drugs on several cancers.…”

“…Apatinib prolongs median overall survival (mOS) and progression‐free survival (mPFS) of patients with advanced gastric cancer 4 . Lower daily doses of apatinib have greater benefits than higher daily doses in advanced gastric cancer patients 8 . Apatinib also has reliable efficacy in advanced non‐small‐cell lung cancer (NSCLC) patients and chemotherapy‐refractory metastatic colorectal cancer 6,9 .…”

Efficacy and Safety of Apatinib for Elderly Patients with Advanced or Metastatic Gastric Cancer After Failure of at Least First-Line Chemotherapy: A Multi-Center, Single-Arm, Phase II Study

“…Recently, a real-world study of apatinib in advanced GC patients in China (AHEAD-G202) with 337 patients included showed that majority (95.6%) of patients received the dose of 250–500 mg and only 15 (4.4%) patients took 675–850 mg as the starting dose. 27 Moreover, the sub-analysis of the AHEAD-G202 study revealed no significant difference in PFS and OS among the low- (250 mg), mid- (425–500 mg), and high-dose (625–850 mg) groups. 28 In our study, the initial dosage of apatinib was 250 mg or 500 mg once daily at the discretion of the investigators.…”