Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study.

Yingying Du,Chaoping Zhou,Hua Xie,Changjun Yu,Jinguo Wang,Song Wang,Zonghui Jiang,Yanshun Zhang,Tengyun Xu,Jun Zhang,Donghui Lu,Hui Liang,Xinzhong Li,Guoping Sun,Yong Zhao,Jinhua Zhou,Zhiqiang Hu,Lei Li,Congqiao Jiang,Wenjun Hu,Guihe Wang,Daoqin Wang,Yang Xu ,Qinqin Cao ,Cheng Ji ,Cheng Huang ,Ning Zong

doi:10.1002/cam4.3105

Abstract

Apatinib has been demonstrated to be effective and safe among patients with gastric cancer failing after at least two lines chemotherapy. This study aimed to evaluate its effectiveness and safety of low‐dose apatinib for the treatment of gastric cancer in real‐world practice. We performed a prospective, multicenter observation study in a real‐world setting. Patients with advanced gastric cancer more than 18 years old were eligible and received low‐dose apatinib (500 mg or 250mg per day) therapy. The median progression‐free survival (PFS), median overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety were assessed. Between September 2017 and April 2019, a total of 747 patients were enrolled. The mPFS was 5.56 months (95% CI 4.47‐6.28), and mOS was 7.5 months (95% CI 6.74‐8.88). Four patients achieved complete response, 47 achieved partial response, and 374 patients achieved stable disease. The ORR was 6.83% and DCR was 56.89%. In addition, multivariate Cox regression analysis indicated that hand‐foot syndrome was one independent predictor for PFS and OS. The most common adverse events (AEs) at any grade were hypertension (36.55%), proteinuria (10.26%), hand‐foot syndrome (33.53%), fatigue (24.9%), anemia (57.35%), leukopenia (44.49%), thrombocytopenia (34.21%), and neutropenia (53.33%). Grade 3‐4 AEs with incidences of 5% or greater were anemia (13.97%), thrombocytopenia (7.14%), and neutropenia (6.67%). No treatment‐related death was observed during the treatment of apatinib. The prospective study suggested that low‐dose apatinib was an effective regimen for the treatment of advanced gastric cancer with tolerable or controlled toxicity in real world.Trial registration: NCT03333967.

Highlights

Gastric cancer is one of the most common digestive system malignancy, with high morbidity and mortality worldwide, which is only to lung cancer and liver cancer.[1]
Clinical responses were evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) until disease progression
The responses were classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Summary

Introduction

Gastric cancer is one of the most common digestive system malignancy, with high morbidity and mortality worldwide, which is only to lung cancer and liver cancer.[1]. For the early stage patients, surgery is the best treatment, approximately 80% of patients are initially diagnosed incurable due to locally advanced or metastatic gastric cancer.[2]. With the development of chemotherapeutic drugs, targeted drugs, and immunotherapy, the median survival of advanced gastric cancer has been extended to more than 12 months.[3]. The survival rate of 5 years remain poor with

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