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晚期 HER2 阴性食管胃腺癌的首选铂类和氟嘧啶类方案是什么?来自 AGAMENON-SEOM 登记研究的 1293 例患者的结果。

Is there a preferred platinum and fluoropyrimidine regimen for advanced HER2-negative esophagogastric adenocarcinoma? Insights from 1293 patients in AGAMENON-SEOM registry.

机构信息

Doctoral Program in Pharmacy, Universidad de Granada, Barrio Verxeles n°13 2°, CP 27850, Granada, Viveiro, Spain.

Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.

出版信息

Clin Transl Oncol. 2024 Jul;26(7):1674-1686. doi: 10.1007/s12094-024-03388-6. Epub 2024 Feb 15.

Abstract

BACKGROUND

The optimal chemotherapy backbone for HER2-negative advanced esophagogastric cancer, either in combination with targeted therapies or as a comparator in clinical trials, is uncertain. The subtle yet crucial differences in platinum-based regimens' safety and synergy with combination treatments need consideration.

METHODS

We analyzed cases from the AGAMENON-SEOM Spanish registry of HER2-negative advanced esophagogastric adenocarcinoma treated with platinum and fluoropyrimidine from 2008 to 2021. This study focused exclusively on patients receiving one of the four regimens: FOLFOX (5-FU and oxaliplatin), CAPOX (capecitabine and oxaliplatin), CP (capecitabine and cisplatin) and FP (5-FU and cisplatin). The aim was to determine the most effective and tolerable platinum and fluoropyrimidine-based chemotherapy regimen and to identify any prognostic factors.

RESULTS

Among 1293 patients, 36% received either FOLFOX (n = 468) or CAPOX (n = 466), 20% CP (n = 252), and 8% FP (n = 107). FOLFOX significantly increased PFS (progression free survival) compared to CP, with a hazard ratio of 0.73 (95% CI 0.58-0.92, p = 0.009). The duration of treatment was similar across all groups. Survival outcomes among regimens were similar, but analysis revealed worse ECOG-PS (Eastern Cooperative Oncology Group-Performance Status), > 2 metastatic sites, bone metastases, hypoalbuminemia, higher NLR (neutrophil-to-lymphocyte ratio), and CP regimen as predictors of poor PFS. Fatigue was common in all treatments, with the highest incidence in FOLFOX (77%), followed by FP (72%), CAPOX (68%), and CP (60%). Other notable toxicities included neuropathy (FOLFOX 69%, CAPOX 62%), neutropenia (FOLFOX 52%, FP 55%), hand-foot syndrome in CP (46%), and thromboembolic events (FP 12%, CP 11%).

CONCLUSIONS

FOLFOX shown better PFS than CP. Adverse effects varied: neuropathy was more common with oxaliplatin, while thromboembolism was more frequent with cisplatin.

摘要

背景

对于 HER2 阴性晚期胃食管腺癌,哪种化疗方案作为联合治疗的基础或作为临床试验的对照药物最佳仍不明确。含铂方案的安全性和与联合治疗的协同作用存在细微但关键的差异,需要考虑。

方法

我们分析了西班牙 AGAMENON-SEOM 注册中心 2008 年至 2021 年期间接受铂类和氟嘧啶治疗的 HER2 阴性晚期胃食管腺癌患者的病例。本研究仅关注接受以下四种方案之一的患者:FOLFOX(5-FU 和奥沙利铂)、CAPOX(卡培他滨和奥沙利铂)、CP(卡培他滨和顺铂)和 FP(5-FU 和顺铂)。目的是确定最有效和耐受的基于铂类和氟嘧啶的化疗方案,并确定任何预后因素。

结果

在 1293 名患者中,36%(n=468)接受 FOLFOX 或 CAPOX(n=466),20%(n=252)接受 CP,8%(n=107)接受 FP。与 CP 相比,FOLFOX 显著增加了 PFS(无进展生存期),风险比为 0.73(95%CI 0.58-0.92,p=0.009)。所有组的治疗持续时间相似。但方案之间的生存结果相似,但分析显示较差的 ECOG-PS(东部合作肿瘤组-表现状态)、>2 个转移部位、骨转移、低白蛋白血症、较高的 NLR(中性粒细胞与淋巴细胞比值)和 CP 方案是 PFS 不良的预测因素。所有治疗中均常见疲劳,FOLFOX(77%)最高,其次是 FP(72%)、CAPOX(68%)和 CP(60%)。其他值得注意的毒性包括神经病变(FOLFOX 69%,CAPOX 62%)、中性粒细胞减少(FOLFOX 52%,FP 55%)、CP 手足综合征(46%)和血栓栓塞事件(FP 12%,CP 11%)。

结论

与 CP 相比,FOLFOX 显示出更好的 PFS。不良反应各不相同:奥沙利铂更常见神经病变,顺铂更常见血栓栓塞事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0631/11178610/e76a30c200e1/12094_2024_3388_Fig1_HTML.jpg

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