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Exploration of predictors of benefit from nivolumab monotherapy for patients with pretreated advanced gastric and gastroesophageal junction cancer: post hoc subanalysis from the ATTRACTION-2 study
Gastric Cancer ( IF 7.4 ) Pub Date : 2021-09-04 , DOI: 10.1007/s10120-021-01230-4
Yoon-Koo Kang , Satoshi Morita , Taroh Satoh , Min-Hee Ryu , Yee Chao , Ken Kato , Hyun Cheol Chung , Jen-Shi Chen , Kei Muro , Won Ki Kang , Kun-Huei Yeh , Takaki Yoshikawa , Sang Cheul Oh , Li-Yuan Bai , Takao Tamura , Keun-Wook Lee , Yasuo Hamamoto , Jong Gwang Kim , Keisho Chin , Do-Youn Oh , Keiko Minashi , Jae Yong Cho , Masahiro Tsuda , Hiroki Sameshima , Li-Tzong Chen , Narikazu Boku

Background

The phase 3 ATTRACTION-2 study demonstrated that nivolumab monotherapy was superior to placebo for patients with pretreated advanced gastric or gastroesophageal junction cancer, but early progression of tumors in some patients was of concern.

Methods

This post hoc analysis statistically explored the baseline characteristics of the ATTRACTION-2 patients and extracted a single-factor and double-factor combinations associated with early disease progression or early death. In the extracted patient subgroups, the 3-year restricted mean survival times of progression-free survival and overall survival were compared between the nivolumab and placebo arms.

Results

Two single factors (age and peritoneal metastasis) were extracted as independent predictors of early progression, but none of them, as a single factor, stratified patients into two subgroups with significant differences in restricted mean survival time. In contrast, two double-factor combinations (serum sodium level and white blood cell count; serum sodium level and neutrophil–lymphocyte ratio) stratifying patients into two subgroups with significant differences in the restricted mean survival time were extracted. Additional exploratory analysis of a triple-factor combination showed that patients aged < 60 years with peritoneal metastasis and low serum sodium levels (approximately 7% of all patients) might receive less benefit from nivolumab, and patients aged ≥ 60 years with no peritoneal metastasis and normal serum sodium levels might receive higher benefit.

Conclusions

A combination of age, peritoneal metastasis, and serum sodium level might predict benefit from nivolumab as salvage therapy in advanced gastric or gastroesophageal junction cancer patients, especially less benefit for patients having all three risk factors.



中文翻译:

预先治疗晚期胃癌和胃食管交界处癌患者的纳武单抗单药治疗获益预测因子的探索:来自 ATTRACTION-2 研究的事后亚组分析

背景

3 期 ATTRACTION-2 研究表明,对于预先治疗过的晚期胃癌或胃食管交界处癌患者,纳武单抗单药治疗优于安慰剂,但一些患者的肿瘤早期进展令人担忧。

方法

这项事后分析统计地探讨了 ATTRACTION-2 患者的基线特征,并提取了与早期疾病进展或早期死亡相关的单因素和双因素组合。在提取的患者亚组中,比较了 nivolumab 和安慰剂组的无进展生存期和总生存期的 3 年限制平均生存时间。

结果

提取了两个单一因素(年龄和腹膜转移)作为早期进展的独立预测因素,但没有一个因素作为单一因素将患者分为两个亚组,在限制平均生存时间方面存在显着差异。相比之下,提取了两种双因素组合(血清钠水平和白细胞计数;血清钠水平和中性粒细胞 - 淋巴细胞比率),将患者分为两个亚组,这些亚组在受限平均生存时间方面存在显着差异。对三因素组合的额外探索性分析表明,年龄 < 60 岁且有腹膜转移和低血清钠水平的患者(约占所有患者的 7%)可能从纳武单抗中获益较少,

结论

年龄、腹膜转移和血清钠水平的组合可能预测纳武单抗作为晚期胃癌或胃食管交界处癌患者的抢救治疗的益处,尤其是对具有所有三个危险因素的患者的益处较小。

更新日期:2021-09-06
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