雷莫西尤单抗与多西他赛用于既往接受铂类治疗的非小细胞肺癌合并恶性胸腔积液患者的II期研究（PLEURAM研究）
Phase II study of ramucirumab and docetaxel for previously platinum-treated patients with non-small cell lung cancer and malignant pleural effusion (PLEURAM study).
作者信息
Takemoto Shinnosuke, Fukuda Minoru, Ogata Ryosuke, Senju Hiroaki, Sugasaki Nanae, Nakatomi Katsumi, Tomono Hiromi, Suyama Takayuki, Sasaki Eisuke, Matsuo Midori, Akagi Kazumasa, Hayashi Fumiko, Dotsu Yosuke, Ono Sawana, Honda Noritaka, Taniguchi Hirokazu, Gyotoku Hiroshi, Ikeda Takaya, Nagashima Seiji, Soda Hiroshi, Kinoshita Akitoshi, Mukae Hiroshi
机构信息
Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Department of Respiratory Medicine, Nagasaki Genbaku Isahaya Hospital, Isahaya, Japan.
出版信息
Transl Lung Cancer Res. 2024 Oct 31;13(10):2673-2682. doi: 10.21037/tlcr-24-508. Epub 2024 Oct 24.
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.
背景
肺癌合并癌性胸膜炎所致恶性胸腔积液（MPE）患者的预后较差。化学性胸膜固定术在临床上较为常用，但失败率往往较高。此外，在非小细胞肺癌（NSCLC）患者的治疗中，长时间持续引流和延迟引入全身化疗可能会增加东部肿瘤协作组体能状态（ECOG PS）恶化的风险。因此，全身治疗和局部治疗对于控制MPE都至关重要。雷莫西尤单抗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，尚无数据支持这一假设。在此，我们进行了一项前瞻性II期研究，以评估雷莫西尤单抗联合多西他赛治疗NSCLC合并MPE患者的疗效和安全性。
方法
开展一项单臂II期研究，以阐明雷莫西尤单抗联合多西他赛作为联合治疗方案对先前接受铂类化疗的NSCLC合并MPE患者的疗效和安全性。主要终点是方案治疗开始后8周时的MPE控制比例。该研究的次要终点是客观缓解率（ORR）、无进展生存期（PFS）、一年生存率、总生存期（OS）和毒性特征。
结果
2019年9月至2022年3月期间，共纳入15例患者。8周时的胸腔积液控制比例为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
雷莫西尤单抗联合多西他赛对于先前接受治疗的NSCLC合并MPE患者是一种有前景且安全的治疗选择，显示出较高的胸腔积液控制率。
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