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

Dengfeng Ren,1– 3 Guoxiu Wang,4 Yu Zhang,5 Jie Kan,6 Qiuxia Dong,7 Junhui Zhao,3 Faxiang Ji,3 Hao Li,3 Yushuang Luo,3 Mingzhe Lin,3 Guoyuan Li,3 Zhibo Liu,3 Xinfu Ma,8 Qijing Guo,3 Fuxing Zhao,1,2 Guoshuang Shen,2,8 Jiuda Zhao1– 3 1Research Center for High Altitude Medicine, Qinghai University, Xining, People’s Republic of China; 2Breast Disease Diagnosis and Treatment Center, Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University, Xining, People’s Republic of China; 3Department of Medical Oncology, Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University, Xining, People’s Republic of China; 4Department of Medical Oncology, Yangquan No.1 People’s Hospital, Yangquan, People’s Republic of China; 5Department of Medical Oncology, Qinghai Red Cross Hospital, Xining, People’s Republic of China; 6Department of Medical Oncology, People’s Hospital of Qinghai Province, Xining, People’s Republic of China; 7Department of Medical Oncology, The Fifth People’s Hospital of Qinghai Province, Xining, People’s Republic of China; 8Department of Surgical Oncology, Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University, Xining, People’s Republic of ChinaCorrespondence: Jiuda ZhaoResearch Center for High Altitude Medicine, Qinghai University, Xining, 810000, People’s Republic of ChinaTel +86 13327661976Email jiudazhao@126.comGuoshuang ShenBreast Disease Diagnosis and Treatment Center, Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University, Xining, 810000, People’s Republic of ChinaTel +86 13109708777Email guoshuangshen@126.comBackground: 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.Keywords: apatinib, efficacy, safety, elderly patients, advanced gastric cancer