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
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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.

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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。
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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.
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