Efficacy and safety of Brucea javanica oil soft capsules combined with oral chemotherapy for maintenance therapy in advanced gastric cancer

Abstract

The objective of this study is to compare the efficacy and safety of Brucea javanica (Yadanzi) oil soft capsules (YDZ capsules) with or without Capecitabine/S-1 in maintenance therapy for advanced gastric cancer (GC). From January 2019 to December 2021, 105 patients treated at Jiangsu Cancer Hospital were enrolled and categorized into 3 treatment groups: Group A received YDZ capsules, Group B received Capecitabine or S-1, and Group C received a combination of YDZ capsules with Capecitabine or S-1. The study compared the efficacy across these groups using the Objective Response Rate (ORR) and Disease Control Rate (DCR) metrics, focusing on the differences between Group A and Group B, and between Group B and Group C. Additionally, safety profiles were assessed and compared between these groups to evaluate the tolerability of each regimen. YDZ capsules alone had lower efficacy than chemotherapy (DCR: 51.4% vs. 68.6%, p = .14). While combination showed significantly higher efficacy with improved ORR (65.7% vs. 37.2%, p < .05) and DCR (88.6% vs. 68.6%, p < .05). YDZ capsules showed a significantly lower overall incidence of adverse reactions (ADRs) compared to capecitabine/S-1-treated group (p < .05). Combination therapy had significantly reduced the incidence of ADRs such as anemia, thrombocytopenia, nausea, vomiting, and fatigue (p < .05). Combination of YDZ capsules and Capecitabine/S-1 demonstrate an obvious synergism and attenuation in maintenance treatment for advanced GC, highlighting their therapeutic potential especially for patients treated with palliative chemotherapy.

Keywords

advanced gastric cancer / Brucea javanica oil (YDZ) soft capsules / efficacy / maintenance therapy / safety

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RIGHTS & PERMISSIONS

2025 The Author(s). Precision Medical Sciences published by John Wiley & Sons Australia, Ltd on behalf of Nanjing Medical University Affiliated Cancer Hospital & Jiangsu Cancer Hospital.