Single-drug Chemotherapy Plus Immunotherapy as First-line Treatment for Stage Ⅳ Non-small Cell Lung Cancer Elderly Patients: A Phase II Clinical Trial UNICORN Study

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical lung cancer Pub Date : 2024-07-27 DOI:10.1016/j.cllc.2024.07.005

Jia Ma , Min Peng , Jianping Bi , Qian Chen , Guoliang Pi , Ying Li , Yi Peng , Fanyu Zeng , Chuangying Xiao , Guang Han

{"title":"Single-drug Chemotherapy Plus Immunotherapy as First-line Treatment for Stage Ⅳ Non-small Cell Lung Cancer Elderly Patients: A Phase II Clinical Trial UNICORN Study","authors":"Jia Ma , Min Peng , Jianping Bi , Qian Chen , Guoliang Pi , Ying Li , Yi Peng , Fanyu Zeng , Chuangying Xiao , Guang Han","doi":"10.1016/j.cllc.2024.07.005","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>Lung cancer remains the most common malignancy and the leading cancer-related death among the elderly in China, which deserves more research attention. Immunotherapy combined with platinum-based doublet chemotherapy has been approved as the standard treatment for advanced non-small cell lung cancer (NSCLC) patients who are devoid of specific gene mutations or fusions. Given that patients with NSCLC over the age of 65 typically exhibit declining organ function and physical condition, they often showed reduced tolerance for this rigorous treatment regimen. However, the KEYNOTE-042 study illuminated a promising pathway: in patients testing positive for programmed death-ligand 1 (PD-L1), immunotherapy alone has demonstrated a superior overall survival (OS) compared to platinum-based doublet chemotherapy. This suggests that moderating the intensity of chemotherapy and prioritizing immunotherapy may be a gentler alternative in elderly demographic.</div></div><div><h3>Patients and Methods</h3><div>This multicenter phase II clinical trial named UNICORN aimed to enroll 49 patients aged 65 and older, utilizing paclitaxel or nab-paclitaxel for those with squamous NSCLC, and pemetrexed for those diagnosed with lung adenocarcinoma. The treatment protocol entails 4 cycles of serplulimab plus chemotherapy followed by an extended regimen of serplulimab maintenance, spanning a total of 35 cycles. Primary endpoints of this study are progression-free survival (PFS), disease control rate (DCR) and the secondary endpoints are OS, objective control rate (ORR) and safety metrics.</div></div><div><h3>Conclusion</h3><div>This is the first study to evaluate the efficacy and safety of serplulimab combined with either paclitaxel or pemetrexed in elderly treatment-naïve patients with stage IV NSCLC whose PD-L1 are positive.</div></div>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":"25 8","pages":"Pages e389-e392"},"PeriodicalIF":3.3000,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical lung cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S152573042400144X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction

Lung cancer remains the most common malignancy and the leading cancer-related death among the elderly in China, which deserves more research attention. Immunotherapy combined with platinum-based doublet chemotherapy has been approved as the standard treatment for advanced non-small cell lung cancer (NSCLC) patients who are devoid of specific gene mutations or fusions. Given that patients with NSCLC over the age of 65 typically exhibit declining organ function and physical condition, they often showed reduced tolerance for this rigorous treatment regimen. However, the KEYNOTE-042 study illuminated a promising pathway: in patients testing positive for programmed death-ligand 1 (PD-L1), immunotherapy alone has demonstrated a superior overall survival (OS) compared to platinum-based doublet chemotherapy. This suggests that moderating the intensity of chemotherapy and prioritizing immunotherapy may be a gentler alternative in elderly demographic.

Patients and Methods

This multicenter phase II clinical trial named UNICORN aimed to enroll 49 patients aged 65 and older, utilizing paclitaxel or nab-paclitaxel for those with squamous NSCLC, and pemetrexed for those diagnosed with lung adenocarcinoma. The treatment protocol entails 4 cycles of serplulimab plus chemotherapy followed by an extended regimen of serplulimab maintenance, spanning a total of 35 cycles. Primary endpoints of this study are progression-free survival (PFS), disease control rate (DCR) and the secondary endpoints are OS, objective control rate (ORR) and safety metrics.

Conclusion

This is the first study to evaluate the efficacy and safety of serplulimab combined with either paclitaxel or pemetrexed in elderly treatment-naïve patients with stage IV NSCLC whose PD-L1 are positive.

查看原文本刊更多论文

单药化疗加免疫疗法作为Ⅳ期非小细胞肺癌老年患者的一线治疗：II期临床试验UNICORN研究

导言肺癌仍是中国最常见的恶性肿瘤，也是老年人因癌症死亡的主要原因，值得更多研究关注。免疫治疗联合铂类双药化疗已被批准为治疗无特定基因突变或融合的晚期非小细胞肺癌（NSCLC）患者的标准疗法。鉴于 65 岁以上的 NSCLC 患者通常器官功能和身体状况都在下降，他们对这种严格治疗方案的耐受性往往较差。然而，KEYNOTE-042 研究揭示了一条有希望的途径：在程序性死亡配体 1（PD-L1）检测呈阳性的患者中，单用免疫疗法的总生存期（OS）优于铂类双重化疗。患者和方法这项名为UNICORN的多中心II期临床试验旨在招募49名65岁及以上的患者，对鳞状NSCLC患者使用紫杉醇或纳布紫杉醇，对确诊为肺腺癌的患者使用培美曲塞。治疗方案包括4个周期的舍普利单抗加化疗，然后是舍普利单抗维持治疗的延长方案，共35个周期。本研究的主要终点是无进展生存期（PFS）和疾病控制率（DCR），次要终点是OS、客观控制率（ORR）和安全性指标。结论这是第一项评估PD-L1阳性的IV期NSCLC老年治疗无效患者中，舍普利单抗联合紫杉醇或培美曲塞的疗效和安全性的研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Clinical lung cancer 医学-肿瘤学

CiteScore

7.00

自引率

2.80%

发文量

159

审稿时长

24 days

期刊介绍： Clinical Lung Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of lung cancer. Clinical Lung Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of lung cancer. The main emphasis is on recent scientific developments in all areas related to lung cancer. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.