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阿帕替尼联合化疗联合或不联合免疫治疗与单纯化疗作为晚期胃癌一线治疗的安全性和有效性。

Safety and efficacy of apatinib in combination with chemotherapy with or without immunotherapy versus chemotherapy alone as first-line treatment for advanced gastric cancer.

机构信息

Department of Gastrointestinal Medical Oncology, Harbin Medical University Cancer Hospital, 150 Haping Road, Harbin, Heilongjiang Province 150001, China.

Department of Radiation Oncology, Quzhou People's Hospital, Quzhou, China.

出版信息

Invest New Drugs. 2024 Apr;42(2):161-170. doi: 10.1007/s10637-024-01423-5. Epub 2024 Feb 17.

DOI:10.1007/s10637-024-01423-5
PMID:38367168
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10944401/
Abstract

The specific first-line regimen for advanced gastric cancer (GC) is still controversial. The benefit of apatinib for first-line treatment of advanced GC remains unknown and needs to be further explored. Eighty-two patients with advanced GC treated in our institution from October 2017 to March 2023 were retrospectively reviewed. All individuals had her-2 negative GC and had received at least two cycles of first-line treatment, including 44 patients in the combination treatment group (apatinib in combination with chemotherapy with or without immunotherapy) and 38 patients in the simple chemotherapy group. We evaluated the efficacy and safety of apatinib in combination with chemotherapy with or without immunotherapy in the first-line treatment of advanced GC by comparing the efficacy, progression-free survival (PFS), and adverse events in two groups of patients. The median PFS of the simple chemotherapy group was 9.25 months (95% confidence interval (CI), 6.1-11.2 months), and that of the combination treatment group was 10.9 months (95% CI, 7.9-15.8 months), which was 1.65 months longer than the simple chemotherapy group. Statistically significant differences are shown (P = 0.022). The objective response rate (ORR) of the combination treatment group was 65.9%, and 36.8% in the simple chemotherapy group. Statistically significant differences are shown (P = 0.014). No serious (Grade IV) adverse events occurred in either group. Our study indicates that apatinib in combination with chemotherapy with or without immunotherapy as first-line treatment for advanced GC exhibits good anti-tumor activity and is well tolerated by patients.

摘要

对于晚期胃癌(GC),具体的一线治疗方案仍存在争议。阿帕替尼作为晚期 GC 一线治疗的获益尚不明确,需要进一步探索。

回顾性分析 2017 年 10 月至 2023 年 3 月在我院治疗的 82 例晚期 GC 患者,所有患者均为 HER-2 阴性 GC,均接受至少 2 个周期的一线治疗,联合治疗组(阿帕替尼联合化疗+/-免疫治疗)44 例,单纯化疗组 38 例。比较两组患者的疗效、无进展生存期(PFS)及不良反应,评价阿帕替尼联合化疗+/-免疫治疗在晚期 GC 一线治疗中的疗效及安全性。

单纯化疗组的中位 PFS 为 9.25 个月(95%置信区间:6.1-11.2 个月),联合治疗组为 10.9 个月(95%置信区间:7.9-15.8 个月),联合治疗组比单纯化疗组长 1.65 个月。差异有统计学意义(P=0.022)。联合治疗组的客观缓解率(ORR)为 65.9%,单纯化疗组为 36.8%。差异有统计学意义(P=0.014)。两组均未发生严重(Ⅳ级)不良反应。

本研究表明,阿帕替尼联合化疗+/-免疫治疗作为晚期 GC 的一线治疗方案具有较好的抗肿瘤活性,且患者耐受良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d65/10944401/ea91ed794542/10637_2024_1423_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d65/10944401/33f2de05596a/10637_2024_1423_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d65/10944401/ea91ed794542/10637_2024_1423_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d65/10944401/33f2de05596a/10637_2024_1423_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d65/10944401/ea91ed794542/10637_2024_1423_Fig2_HTML.jpg

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