Effect of performance status on the therapeutic effect of nivolumab in recurrent or metastatic squamous cell carcinoma of the head and neck.

IF 1.9 3区医学 Q2 OTORHINOLARYNGOLOGY

European Archives of Oto-Rhino-Laryngology Pub Date : 2024-11-14 DOI:10.1007/s00405-024-09065-2

Ari Nishimura, Chie Ishida, Akihisa Tanaka, Takahiro Kimura, Yumi Yoshii, Hirokazu Uemura, Masayuki Takeda, Tadashi Kitahara

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引用次数: 0

Abstract

Background: Systemic chemotherapy is the primary treatment strategy for recurrent or metastatic squamous cell carcinoma of the head and neck (RM-SCCHN). Therapeutic strategies are changing considerably with the introduction of molecular-targeted and immune checkpoint inhibitor (ICI) therapies in addition to conventional cytotoxic therapy. The CheckMate-141 and KEYNOTE-048 trials have enabled the use of ICIs as first-line treatment to improve the overall prognosis of RM-SCCHN. However, background factors affecting treatment responses, including performance status (PS), remain poorly defined. Therefore, we investigated the effect of PS in patients treated with nivolumab.

Methods: We retrospectively reviewed the treatment outcomes and backgrounds of 31 patients with RM-SCCHN who received nivolumab monotherapy between April 2017 and March 2023.

Results: The patient background was male/female = 29/2, median age was 68 years (range 39-85), PS0/1/2 = 14/15/2, and oral/oropharynx/hypopharynx/larynx = 2/12/12/5. Median overall survival was 8.0 months (95% confidence interval [CI]: 4.3-30.6 months), median progression-free survival was 3.0 months (95% CI 1.7-9.1 months), and objective response rate was 22.6% (95% CI 11.1-40.1%). Immune-related adverse events of grade 3 or higher were observed in three patients (9.7%). Eight (29.6%) of the 27 patients (excluding four patients who maintained complete response for over 2 years) were successfully transferred to post-treatment. In the multivariate analysis, Eastern Cooperative Oncology Group (ECOG) PS (Hazard Ratio: 9.87, 95% CI 1.79-54.56) was associated with poor survival.

Conclusion: The efficacy of nivolumab is reduced in patients with poor PS.

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头颈部复发性或转移性鳞状细胞癌患者的表现状态对尼伐单抗治疗效果的影响。

背景：全身化疗是头颈部复发性或转移性鳞状细胞癌（RM-SCCHN）的主要治疗策略。除了传统的细胞毒疗法外，分子靶向疗法和免疫检查点抑制剂（ICI）疗法的引入使治疗策略发生了巨大变化。CheckMate-141和KEYNOTE-048试验使ICIs成为一线治疗手段，从而改善了RM-SCCHN的总体预后。然而，包括表现状态（PS）在内的影响治疗反应的背景因素仍未明确。因此，我们研究了PS对接受nivolumab治疗的患者的影响：我们回顾性地回顾了2017年4月至2023年3月期间接受nivolumab单药治疗的31例RM-SCCHN患者的治疗结果和背景：患者背景为男性/女性=29/2，中位年龄为68岁（39-85岁），PS0/1/2=14/15/2，口腔/咽/下咽/喉=2/12/12/5。中位总生存期为 8.0 个月（95% 置信区间 [CI]：4.3-30.6 个月），中位无进展生存期为 3.0 个月（95% CI：1.7-9.1 个月），客观反应率为 22.6%（95% CI：11.1-40.1%）。3名患者（9.7%）出现了3级或以上的免疫相关不良反应。27名患者中，有8名患者（29.6%）（不包括4名保持完全应答超过2年的患者）成功转入后期治疗。在多变量分析中，东部合作肿瘤学组（ECOG）PS（危险比：9.87，95% CI 1.79-54.56）与生存率低有关：结论：PS较差的患者使用尼妥珠单抗的疗效会降低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Archives of Oto-Rhino-Laryngology 医学-耳鼻喉科学

CiteScore

5.30

自引率

7.70%

发文量

537

审稿时长

2-4 weeks

期刊介绍： Official Journal of European Union of Medical Specialists – ORL Section and Board Official Journal of Confederation of European Oto-Rhino-Laryngology Head and Neck Surgery "European Archives of Oto-Rhino-Laryngology" publishes original clinical reports and clinically relevant experimental studies, as well as short communications presenting new results of special interest. With peer review by a respected international editorial board and prompt English-language publication, the journal provides rapid dissemination of information by authors from around the world. This particular feature makes it the journal of choice for readers who want to be informed about the continuing state of the art concerning basic sciences and the diagnosis and management of diseases of the head and neck on an international level. European Archives of Oto-Rhino-Laryngology was founded in 1864 as "Archiv für Ohrenheilkunde" by A. von Tröltsch, A. Politzer and H. Schwartze.