Efficacy and safety of intermittent versus continuous dose apatinib plus docetaxel as second-line therapy in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma: a randomized controlled study

Ying Yan; Huimin Li; Shusheng Wu; Gang Wang; Huiqin Luo; Jiayu Niu; Lulu Cao; Xiaoxiu Hu; Huijun Xu; Wei Jia; Yubei Sun; Yiwei Yao; Wenju Chen; Lihong Ke; Bing Hu; Chushu Ji; Yancai Sun; Jian Chen; Mengge Li; Yifu He

doi:10.21037/atm-22-546

Efficacy and safety of intermittent versus continuous dose apatinib plus docetaxel as second-line therapy in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma: a randomized controlled study

Ann Transl Med. 2022 Feb;10(4):205. doi: 10.21037/atm-22-546.

Authors

Ying Yan¹, Huimin Li¹, Shusheng Wu¹, Gang Wang¹, Huiqin Luo¹, Jiayu Niu¹, Lulu Cao¹, Xiaoxiu Hu¹, Huijun Xu¹, Wei Jia¹, Yubei Sun¹, Yiwei Yao¹, Wenju Chen¹, Lihong Ke¹, Bing Hu¹, Chushu Ji¹, Yancai Sun², Jian Chen¹, Mengge Li¹, Yifu He¹

Affiliations

¹ Department of Medical Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
² Department of Pharmacy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.

Abstract

Background: Previous studies of the second-line treatment for advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJAC) had reported that apatinib combined with chemotherapy improved the treatment outcomes. However, the benefits were sometimes limited due to the tolerance of continuous dose regimen. This randomized controlled study aimed to investigate the efficacy and safety of intermittent or continuous dose apatinib plus docetaxel as a second-line therapy in patients with advanced GC/GEJAC.

Methods: Advanced GC/GEJAC patients who failed first-line chemotherapy were recruited (enrollment time: from September 15, 2017 to July 21, 2019), and randomly assigned to either the intermittent dose group (IG group) or the continuous dose group (CG group) (1:1 ratio) using the block randomization method. In the IG group, patients received apatinib 500 mg/d for 5 consecutive days then held for 2 days plus docetaxel 60 mg/m² q3w, in a 3-week cycle. In the CG group, patients received apatinib 500 mg daily plus docetaxel 60 mg/m² q3w, in a 3-week cycle. The progression free survival (PFS) was evaluated every two cycles and follow-ups were performed monthly. The primary endpoint was PFS, and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.

Results: In total, 76 eligible patients were enrolled and randomly assigned (1:1 ratio). The IG group exhibited similar PFS compared to the CG group [median PFS: 3.88 (95% CI: 1.72-6.03) months vs. 3.98 (95% CI: 1.06-6.90) months, P=0.546] and OS [median OS: 9.00 (95% CI: 5.31-12.70) months vs. 9.40 (95% CI: 5.20-13.59) months, P=0.310]. ORR (21.1% vs. 18.4%, P=0.773) and DCR (60.5% vs. 60.5%, P=1.000) were of not statistically different between the IG and CG groups. As for safety, the IG group exhibited less frequent hypoproteinemia (31.6% vs. 55.3%, P=0.037) and lactate dehydrogenase increased (18.4% vs. 44.7%, P=0.014), while no differences in other adverse events were observed between the two groups.

Conclusions: Intermittent dose apatinib plus docetaxel was equally effective and more tolerable than continuous dose apatinib plus docetaxel as a second-line therapy in patients with advanced GC/GEJAC.

Trial registration: ClinicalTrials.gov NCT03334591.

Keywords: Apatinib; continuous dose; docetaxel; gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJAC); intermittent dose.

Associated data

ClinicalTrials.gov/NCT03334591