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

Abstract

Background Apatinib improves progression-free survival and overall survival with an acceptable safety profile in Chinese patients with chemotherapy-refractory advanced or metastatic gastric cancer. However, the efficacy and safety of apatinib are unclear for elderly patients. This study was undertaken to prospectively investigate the efficacy and safety of apatinib for elderly patients with unresectable advanced or metastatic gastric cancer, who experienced progression to at least one lines of chemotherapy. Methods This open-label, single-arm, phase II study enrolled patients aged ≥60 years with advanced gastric cancer, who experienced progression to one or more lines of chemotherapy at five centers in China. Patients received apatinib in an oral dose of 500mg or 250mg daily according to the research physicians’ decision. The primary end point was progression-free survival, and the secondary end points were objective response rate, disease control rate, overall survival, and safety. Results Forty-eight patients were enrolled between June 2017 and September 2019. The median age was 65.5 years (range 60–80 years). Twenty-seven patients (56.3%) started treatment with an initial dose of 500 mg and 21 patients (43.7%) with 250 mg. The median progression-free survival and overall survival were 3.00 months (95% confidence interval, 2.17–3.84) and 8.10 months (95% confidence interval, 4.35–11.85), respectively. The objective response rate and disease control rate assessed by the investigators were 16.7% and 72.9%, respectively. The common side effects were fatigue (58.3%), hypertension (47.9%), abdominal pain (33.3%), proteinuria (29.2%), leukopenia (22.9%), and neutropenia (20.8%). Hypertension (22.9%) was the major grade 3/4 toxicity. Conclusion These data suggest that apatinib is effective and relatively tolerable for elderly patients with unresectable advanced or metastatic gastric cancer who have received at least first-line chemotherapy.

Safety and effectiveness of apatinib in elderly patients with metastatic gastric cancer: a sub-analysis from the large-scale, prospective observational study of apatinib for gastric cancer treatment in a real-world clinical setting (AHEAD-G202)

“…The incidence and severity of AEs in our study were generally consistent with the known safety profile of apatinib. The most common AEs were hypertension, fatigue, hand-foot syndrome, and nausea, which were also among the most frequently reported apatinib-related AEs in previous studies in GC, lung cancer, breast cancer, and ovarian cancer (8,(16)(17)(18)(19)(20)(21)(22)(23)(24). No new safety signals were observed.…”

Acute inflammatory reaction during anti-angiogenesis therapy combined with immunotherapy as a possible indicator of the therapeutic effect: Three case reports and literature review

“…In 2014, the drug was approved and listed in China to treat patients with advanced gastric adenocarcinoma or gastric esophageal junction adenocarcinoma who had progressed or relapsed after receiving at least two kinds of systematic chemotherapy. Currently, phase II/III clinical trials are being conducted in China, and good clinical results have been achieved in the treatment of GI tumors (20)(21)(22)(23).…”

Tumor vessel normalization and immunotherapy in gastric cancer

“… 126 In 2014, apatinib was approved in China for two or more advanced, or metastatic, GCs that cannot be treated with prior chemotherapy and is considered the standard third-line treatment in China. 127 Apatinib showed positive results in the Chinese GC population, leading to official approval for clinical use. However, the phase III clinical trial ANGEL, which is currently studying apatinib in a Western cohort, showed disappointing first results presented at the 2019 ESMO Annual Meeting.…”

“…126 In 2014, apatinib was approved in China for two or more advanced, or metastatic, GCs that cannot be treated with prior chemotherapy and is considered the standard third-line treatment in China. 127 Apatinib showed positive results in the Chinese GC population, leading to official approval for clinical use.…”