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纳武利尤单抗治疗经大量预处理的转移性胃癌患者:来自西方人群的真实世界数据。

Nivolumab in Heavily Pretreated Metastatic Gastric Cancer Patients: Real-Life Data from a Western Population.

作者信息

Petrillo Angelica, Tirino Giuseppe, Zito Marino Federica, Pompella Luca, Sabetta Rosalaura, Panarese Iacopo, Pappalardo Annalisa, Caterino Marianna, Ventriglia Anna, Laterza Maria Maddalena, Morgillo Floriana, Orditura Michele, Ciardiello Fortunato, Franco Renato, De Vita Ferdinando

机构信息

Division of Medical Oncology, Department of Precision Medicine, School of Medicine, University of Study of Campania "Luigi Vanvitelli", Naples 80131, Italy.

Pathology Unit, University of Study of Campania "Luigi Vanvitelli", Naples 80138, Italy.

出版信息

Onco Targets Ther. 2020 Jan 29;13:867-876. doi: 10.2147/OTT.S229813. eCollection 2020.

DOI:10.2147/OTT.S229813
PMID:32099391
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6996223/
Abstract

PURPOSE

ATTRACTION-2 trial assessed the role of Nivolumab as a new standard treatment for Asian patients with pretreated metastatic gastric cancer (mGC). The aim of this analysis was to evaluate the safety and efficacy of Nivolumab in a real-life Western population, considering the lack of evidence to date.

PATIENTS AND METHODS

Patients progressed after ≥2 chemotherapy regimens and able to receive Nivolumab (3 mg/kg q14) were eligible for the analysis.

RESULTS

16 patients received Nivolumab as third (81.3%) or fourth line (18.7%) from September 2017 to July 2019. The safety was in line with the literature and only one patient discontinued treatment due to persistent hematological toxicity. Overall response rate and disease control rate were 18.7% and 31.2%, respectively. Median duration of response was 5 months. With a median follow-up of 21 months, median OS was 6 months (7, 21 and 22 months in the responders) and median PFS 3 months. PD-L1 and microsatellite status were retrospectively collected in 12 patients. All the major responders were MSI, although no statistically significant difference in OS or PFS was observed according to molecular analysis.

CONCLUSION

Nivolumab is feasible and effective in Western patients with mGC. Further investigation is urgently needed also in non-Asians.

摘要

目的

ATTRACTION - 2试验评估了纳武利尤单抗作为亚洲经治转移性胃癌(mGC)患者新标准治疗的作用。鉴于目前缺乏相关证据,本分析旨在评估纳武利尤单抗在西方真实人群中的安全性和疗效。

患者与方法

在≥2种化疗方案后病情进展且能够接受纳武利尤单抗(3mg/kg,每14天一次)治疗的患者符合分析条件。

结果

2017年9月至2019年7月,16例患者接受纳武利尤单抗作为三线(81.3%)或四线(18.7%)治疗。安全性与文献一致,仅有1例患者因持续性血液学毒性而停药。总缓解率和疾病控制率分别为18.7%和31.2%。中位缓解持续时间为5个月。中位随访21个月,中位总生存期为6个月(缓解者分别为7、21和22个月),中位无进展生存期为3个月。对12例患者回顾性收集了PD - L1和微卫星状态。所有主要缓解者均为微卫星高度不稳定(MSI),尽管根据分子分析在总生存期或无进展生存期方面未观察到统计学显著差异。

结论

纳武利尤单抗在西方mGC患者中可行且有效。非亚洲人群也迫切需要进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef60/6996223/ce7ea1a16e46/OTT-13-867-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef60/6996223/f9589ec3bf64/OTT-13-867-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef60/6996223/fc4a04666363/OTT-13-867-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef60/6996223/ce7ea1a16e46/OTT-13-867-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef60/6996223/f9589ec3bf64/OTT-13-867-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef60/6996223/fc4a04666363/OTT-13-867-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef60/6996223/ce7ea1a16e46/OTT-13-867-g0003.jpg

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Predictive biomarkers for the efficacy of nivolumab as ≥ 3-line therapy in patients with advanced gastric cancer: a subset analysis of ATTRACTION-2 phase III trial.晚期胃癌患者接受纳武利尤单抗作为≥3 线治疗的疗效预测生物标志物:ATTRACTION-2 期 III 期试验的亚组分析。
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