Phase II study of ramucirumab and docetaxel for previously platinum-treated patients with non-small cell lung cancer and malignant pleural effusion (PLEURAM study).

IF 4 2区 医学 Q2 ONCOLOGY Translational lung cancer research Pub Date : 2024-10-31 Epub Date: 2024-10-24 DOI:10.21037/tlcr-24-508
Shinnosuke Takemoto, Minoru Fukuda, Ryosuke Ogata, Hiroaki Senju, Nanae Sugasaki, Katsumi Nakatomi, Hiromi Tomono, Takayuki Suyama, Eisuke Sasaki, Midori Matsuo, Kazumasa Akagi, Fumiko Hayashi, Yosuke Dotsu, Sawana Ono, Noritaka Honda, Hirokazu Taniguchi, Hiroshi Gyotoku, Takaya Ikeda, Seiji Nagashima, Hiroshi Soda, Akitoshi Kinoshita, Hiroshi Mukae
{"title":"Phase II study of ramucirumab and docetaxel for previously platinum-treated patients with non-small cell lung cancer and malignant pleural effusion (PLEURAM study).","authors":"Shinnosuke Takemoto, Minoru Fukuda, Ryosuke Ogata, Hiroaki Senju, Nanae Sugasaki, Katsumi Nakatomi, Hiromi Tomono, Takayuki Suyama, Eisuke Sasaki, Midori Matsuo, Kazumasa Akagi, Fumiko Hayashi, Yosuke Dotsu, Sawana Ono, Noritaka Honda, Hirokazu Taniguchi, Hiroshi Gyotoku, Takaya Ikeda, Seiji Nagashima, Hiroshi Soda, Akitoshi Kinoshita, Hiroshi Mukae","doi":"10.21037/tlcr-24-508","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The prognosis of patients with lung cancer and malignant pleural effusion (MPE) caused by carcinomatous pleurisy is poor. Chemical pleurodesis is commonly performed clinically, however, often has a high failure rate. Furthermore, prolonged sustained drainage and delayed introduction of systemic chemotherapy could increase the risk of worsening the Eastern Cooperative Oncology Group Performance Status (ECOG PS) in the treatment of patients with non-small cell lung cancer (NSCLC). Therefore, both systemic and local treatments are crucial to control MPE. Ramucirumab, an antibody targeting vascular endothelial growth factor receptor 2, is expected to be effective for treatment of MPE. However, there are no data supporting this hypothesis. Herein, we performed a prospective phase II study to evaluate the efficacy and safety of ramucirumab plus docetaxel in NSCLC patients with MPE.</p><p><strong>Methods: </strong>A single-arm phase II study was conducted to elucidate the efficacy and safety of ramucirumab plus docetaxel as a combined treatment for patients NSCLC and MPE previously treated with platinum-based chemotherapy. The primary endpoint was the MPE control proportion at eight weeks after protocol treatment initiation. The secondary endpoints of the study were objective response rate (ORR), progression-free survival (PFS), one-year survival rate, overall survival (OS), and toxicity profile.</p><p><strong>Results: </strong>Between September 2019 and March 2022, 15 patients were enrolled. The pleural effusion control proportion at eight weeks was 100% [90% confidence interval (CI): 84.0-100%, and 95% CI: 78.4-100%], and the primary endpoint of this study was met. The ORR was 6.7% (95% CI: 0.2-32.0%), the median PFS was 6.3 months (95% CI: 1.9-6.9), and the median OS was 10.4 months (95% CI: 3.2-16.5). No Grade 5 or unexpected adverse events were observed.</p><p><strong>Conclusions: </strong>Ramucirumab plus docetaxel is a promising and safe treatment option for previously treated patients with NSCLC and MPE, showing a high pleural effusion control rate.</p>","PeriodicalId":23271,"journal":{"name":"Translational lung cancer research","volume":null,"pages":null},"PeriodicalIF":4.0000,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535820/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Translational lung cancer research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21037/tlcr-24-508","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/24 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Background: The prognosis of patients with lung cancer and malignant pleural effusion (MPE) caused by carcinomatous pleurisy is poor. Chemical pleurodesis is commonly performed clinically, however, often has a high failure rate. Furthermore, prolonged sustained drainage and delayed introduction of systemic chemotherapy could increase the risk of worsening the Eastern Cooperative Oncology Group Performance Status (ECOG PS) in the treatment of patients with non-small cell lung cancer (NSCLC). Therefore, both systemic and local treatments are crucial to control MPE. Ramucirumab, an antibody targeting vascular endothelial growth factor receptor 2, is expected to be effective for treatment of MPE. However, there are no data supporting this hypothesis. Herein, we performed a prospective phase II study to evaluate the efficacy and safety of ramucirumab plus docetaxel in NSCLC patients with MPE.

Methods: A single-arm phase II study was conducted to elucidate the efficacy and safety of ramucirumab plus docetaxel as a combined treatment for patients NSCLC and MPE previously treated with platinum-based chemotherapy. The primary endpoint was the MPE control proportion at eight weeks after protocol treatment initiation. The secondary endpoints of the study were objective response rate (ORR), progression-free survival (PFS), one-year survival rate, overall survival (OS), and toxicity profile.

Results: Between September 2019 and March 2022, 15 patients were enrolled. The pleural effusion control proportion at eight weeks was 100% [90% confidence interval (CI): 84.0-100%, and 95% CI: 78.4-100%], and the primary endpoint of this study was met. The ORR was 6.7% (95% CI: 0.2-32.0%), the median PFS was 6.3 months (95% CI: 1.9-6.9), and the median OS was 10.4 months (95% CI: 3.2-16.5). No Grade 5 or unexpected adverse events were observed.

Conclusions: Ramucirumab plus docetaxel is a promising and safe treatment option for previously treated patients with NSCLC and MPE, showing a high pleural effusion control rate.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
针对既往接受过铂类治疗的非小细胞肺癌和恶性胸腔积液患者进行的ramucirumab和多西他赛II期研究(PLEURAM研究)。
背景:肺癌和癌性胸膜炎引起的恶性胸腔积液(MPE)患者的预后很差。临床上通常采用化学胸膜腔穿刺术,但往往失败率较高。此外,在治疗非小细胞肺癌(NSCLC)患者时,长期持续引流和延迟引入全身化疗可能会增加东部合作肿瘤学组(ECOG)绩效状态(ECOG PS)恶化的风险。因此,全身和局部治疗对于控制 MPE 至关重要。Ramucirumab 是一种靶向血管内皮生长因子受体 2 的抗体,有望有效治疗 MPE。然而,目前还没有数据支持这一假设。在此,我们进行了一项前瞻性II期研究,评估ramucirumab联合多西他赛治疗NSCLC MPE患者的有效性和安全性:我们开展了一项单臂 II 期研究,以阐明拉穆单抗联合多西他赛治疗既往接受过铂类化疗的 NSCLC 和 MPE 患者的有效性和安全性。主要终点是方案治疗开始后八周的 MPE 控制率。研究的次要终点是客观反应率(ORR)、无进展生存期(PFS)、一年生存率、总生存期(OS)和毒性概况:2019年9月至2022年3月,15名患者入组。8周时胸腔积液控制率为100%[90%置信区间(CI):84.0-100%,95%CI:78.4-100%],达到了本研究的主要终点。ORR为6.7%(95% CI:0.2-32.0%),中位PFS为6.3个月(95% CI:1.9-6.9),中位OS为10.4个月(95% CI:3.2-16.5)。未观察到5级或意外不良事件:结论:对于既往接受过治疗的NSCLC和MPE患者来说,Ramucirumab联合多西他赛是一种前景广阔且安全的治疗方案,胸腔积液控制率高。
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 去求助
来源期刊
CiteScore
7.20
自引率
2.50%
发文量
137
期刊介绍: Translational Lung Cancer Research(TLCR, Transl Lung Cancer Res, Print ISSN 2218-6751; Online ISSN 2226-4477) is an international, peer-reviewed, open-access journal, which was founded in March 2012. TLCR is indexed by PubMed/PubMed Central and the Chemical Abstracts Service (CAS) Databases. It is published quarterly the first year, and published bimonthly since February 2013. It provides practical up-to-date information on prevention, early detection, diagnosis, and treatment of lung cancer. Specific areas of its interest include, but not limited to, multimodality therapy, markers, imaging, tumor biology, pathology, chemoprevention, and technical advances related to lung cancer.
期刊最新文献
Systems mapping: a novel approach to national lung cancer screening implementation in Australia. The time-to-surgery interval and its effect on pathological response after neoadjuvant chemoimmunotherapy in non-small cell lung cancer: a retrospective cohort study. TQB2450 with or without anlotinib as maintenance treatment in subjects with locally advanced/unresectable non-small cell lung cancer that have not progressed after prior concurrent/sequential chemoradiotherapy (R-ALPS): study protocol for a randomized, double-blind, placebo-controlled, multicenter phase III trial. Triple-targeted therapy of dabrafenib, trametinib, and osimertinib for the treatment of the acquired BRAF V600E mutation after progression on EGFR-tyrosine kinase inhibitors in advanced EGFR-mutated non-small cell lung cancer patients. What do we know about the role of neoadjuvant targeted therapy in early-stage EGFR-mutant and ALK-fused non-small cell lung cancer?-a narrative review of the current literature.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1