Feasibility and Safety of PD-1 Blockades Among Elderly Patients with Metastatic Esophageal Squamous Cell Carcinoma: A Real-World Study

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL Drug Design, Development and Therapy Pub Date : 2024-09-16 DOI:10.2147/dddt.s476457

Ming Bai, Wei-Xue Wang, Ting Deng, Jing-Jing Duan, Yi Ba

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Abstract

Objective: This study aimed to identify the effectiveness and safety of PD-1 blockades among elderly patients with metastatic esophageal squamous cell carcinoma (ESCC) clinically.
Methods: A total of 78 elderly patients with previously treated metastatic ESCC aged ≥ 65 years who received PD-1 blockades monotherapy were included retrospectively. Demographic characteristics, therapeutic effectiveness and adverse reactions of the elderly patients who underwent PD-1 blockade therapy were recorded. Regular follow-up was conducted for all patients. The analysis aimed to identify potential risk factors for OS by examining the correlation between prognosis and subgroups based on baseline characteristics.
Results: The median age of the 78 elderly patients was 73 years, ranging from 65 to 87 years. Among the 78 patients, 18 cases showed partial response, 26 cases had stable disease, 29 cases experienced progressive disease and 5 cases were not assessable for response, yielding an ORR of 23.1%, a DCR of 56.4%. The prognostic outcomes indicated that among the 78 patients with metastatic ESCC who received PD-1 blockades, the median PFS was 3.1 months [95% confidence interval (CI): 1.64– 4.56], and the median OS was 10.9 months (95% CI: 6.02– 15.78), 24-month OS rate was 22.7% (95% CI: 12.8– 34.2%). In terms of the safety profile, among the 78 patients with metastatic ESCC during PD-1 blockades single-agent treatment, a total of 61 patients (78.2%) experienced any grade adverse reactions and the incidence of grade ≥ 3 adverse reactions were 20.5%. Briefly, the common adverse reactions manifested as fatigue (32.1%), gastrointestinal reaction (24.4%), diarrhea (19.2%), anemia (17.9%) and rash (16.7%). Overall tolerability of PD-1 blockade monotherapy in elderly patients with metastatic ESCC was acceptable and manageable.
Conclusion: PD-1 blockades single agent demonstrated encouraging effectiveness and acceptable safety profile for elderly patients with previously treated metastatic ESCC in clinical practice. Prospective study should be performed to elucidate the conclusion in this study subsequently.

Keywords: elderly patients, esophageal squamous cell carcinoma, PD-1 blockades, effectiveness, safety

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在转移性食管鳞状细胞癌老年患者中使用 PD-1 阻断剂的可行性和安全性：一项真实世界研究

研究目的本研究旨在确定PD-1受体阻滞剂在转移性食管鳞状细胞癌（ESCC）老年患者中的临床有效性和安全性：方法：回顾性纳入78例既往接受过转移性ESCC治疗且年龄≥65岁、接受过PD-1受体阻滞剂单药治疗的老年患者。记录接受PD-1阻滞剂治疗的老年患者的人口统计学特征、疗效和不良反应。对所有患者进行了定期随访。分析旨在通过研究预后与基于基线特征的亚组之间的相关性，确定OS的潜在风险因素：78名老年患者的中位年龄为73岁，从65岁到87岁不等。78例患者中，18例出现部分反应，26例病情稳定，29例病情进展，5例无法评估反应，ORR为23.1%，DCR为56.4%。预后结果显示，在78例接受PD-1阻断剂治疗的转移性ESCC患者中，中位PFS为3.1个月[95%置信区间（CI）：1.64- 4.56]，中位OS为10.9个月（95% CI：6.02- 15.78），24个月OS率为22.7%（95% CI：12.8- 34.2%）。在安全性方面，78例转移性ESCC患者在PD-1受体阻滞剂单药治疗期间，共有61例患者（78.2%）出现任何级别的不良反应，≥3级不良反应的发生率为20.5%。简而言之，常见的不良反应表现为疲劳（32.1%）、胃肠道反应（24.4%）、腹泻（19.2%）、贫血（17.9%）和皮疹（16.7%）。PD-1阻断剂单药治疗老年转移性ESCC患者的总体耐受性是可以接受和控制的：结论：在临床实践中，PD-1阻断剂单药对既往接受过治疗的转移性ESCC老年患者具有令人鼓舞的疗效和可接受的安全性。关键词：老年患者；食管鳞状细胞癌；PD-1 阻滞剂；有效性；安全性

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.