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)

Abstract

Background: Apatinib was shown to improve the survival of Chinese patients with refractory metastatic gastric cancer (mGC). As an orally administered drug, it has been widely used in elderly patients because the dosing schedule can be adjusted flexibly. However, data on the efficacy and safety of apatinib in elderly patients is scarce. The aim of this study was to evaluate the toxicity and effectiveness of apatinib for elderly patients with mGC in a real-world setting.Methods: Data from the sub-population of patients who were ≥65 years enrolled in the AHEAD-G202 trial were analyzed. Patients with mGC were prospectively registered and initially received ≤850 mg oral apatinib daily combined or not combined with chemotherapy, at the investigator's discretion. The primary endpoint was safety. The secondary endpoints were overall survival (OS) and progression-free survival (PFS).Results: A total of 117 patients were included. There were 51 (43.59%) patients in the low-dose (250 mg) group, 60 (51.28%) patients in the mid-dose (425 to 500 mg) group, and 6 (5.13%) patients in the high-dose (850 mg) group according to the initial daily doses. Hypertension (6.84%) was the only grade 3-4 adverse event (AE) with a prevalence of more than 5% and across the low-dose (11.76%), mid-dose (3.33%) and high-dose group (0%). The median OS and PFS were 7.13 months (95% CI: 5.04 to 9.22 months) and 4.27 months (95% CI: 3.24 to 5.29 months), respectively. The OS and PFS were similar among the 65-74 and ≥75 years groups (χ 2 =1.406, P=0.306; χ 2 =0.378, P=0.066, respectively). The OS and PFS were also comparable among the 3 dose groups.Conclusions: Elderly patients with mGC can tolerate and benefit from apatinib therapy. A lower initial daily dosing strategy may be a suitable choice for elderly patients in clinical practice.

Phase I trial of apatinib and paclitaxel+oxaliplatin+5‐FU/levoleucovorin for treatment‐naïve advanced gastric cancer

“…efficacy. [23][24][25] In our study, improvements in PFS, OS, and ORR were observed in the high-dose apatinib cohort compared with the low-dose cohort, consistent with outcomes from a phase I study. 26 Furthermore, a retrospective cohort study revealed that the presence of grade 3-4 apatinib-specific TEAEs was accompanied by higher efficacy.…”

“…These may result in a greater likelihood of discontinuing treatment early to compromise outcomes in such studies. 14,23,24 Ramucirumab, a monoclonal antibody, acts similarly to apatinib; however, ramucirumab targets the extracellular domain of VEGFR2, whereas apatinib targets the intracellular domain. 14,28 In both the phase III RAINFALL study, which combined ramucirumab with cisplatin and fluoropyrimidine, 28 and the phase II RAINSTORM trial, which paired it with S-1 and oxaliplatin, the combinations of ramucirumab and chemotherapy failed as first-line treatments for AGC.…”

The efficacy of oxaliplatin, surufatinib, and camrelizumab on neuroendocrine carcinoma: a case report and literature review

“…Therefore, several vascular endothelial growth factor tyrosine kinase inhibitors (VEGF-TKIs) have been approved in several solid tumors ( 24 ). Apatinib is one such VEGF-TKI that has shown promising results in the treatment of gastric cancer ( 25 ). In line with these results, treatment with apatinib as second-line therapy in Chinese patients with advanced hepatocellular carcinoma resulted in an ORR of 10.7% ( 26 ).…”

Real-World Study: A Powerful Tool for Malignant Tumor Research in General Surgery

“…An RWS has also confirmed that lower doses of apatinib therapy can bring survival benefits to patients with advanced GC, and the patients tolerated it well. Therefore, a lower dose of apatinib therapy can optimize the therapeutic effect of apatinib and minimize its side effects in clinical practice [ 83 ]. A multicenter, prospective study from China simultaneously confirmed the effectiveness and safety of apatinib in first-line treatment; it is especially pointed out that the regimen of apatinib combined with paclitaxel will bring greater survival benefits to GC patients [ 84 ].…”