Practice for Oncology Ravensburg, Ravensburg, Germany.
University Hospital Giessen and Marburg GmbH, Marburg, Germany.
Cancer Med. 2021 Nov;10(22):8127-8137. doi: 10.1002/cam4.4310. Epub 2021 Oct 20.
Platinum-based chemotherapy remains a first-line standard of care for approximately 30% of patients with non-small cell lung cancer (NSCLC) not harboring a druggable alteration. Favorable efficacy and safety of the nab-paclitaxel/carboplatin (nab-P/C) combination was shown in the pivotal phase 3 trial. However, information on effectiveness of nab-P/C in a real-world setting in Germany is missing. The NEPTUN study prospectively investigated the effectiveness and safety of nab-P/C in patients with advanced NSCLC in a real-world setting.
Patients with advanced or metastatic NSCLC received first-line nab-P/C according to clinical routine. The primary endpoint was 6-month progression-free survival rate (PFS6). Other endpoints included further effectiveness parameters, safety and quality of life. Data were analyzed descriptively.
408 patients were enrolled. PFS6 was 40.8% (95% confidence interval [CI], 35.3-46.2); median PFS was 5.2 months (95% CI, 4.5-5.7). overall response rate was 41.5% (95% CI, 36.3-46.8). Median overall survival (OS) was 10.5 months (95% CI, 9.2-11.6). Subgroup analyses revealed median OS for squamous versus non-squamous histology (11.8 months [95% CI, 9.2-13.8] vs. 9.6 months [95% CI, 7.7-11.2]) and age ≥70 versus <70 years (11.7 months [95% CI, 9.4-14.3] vs. 9.6 months [95% CI, 7.5-11.2]). Most common treatment-emergent adverse events (TEAEs) were anemia (26.5%), leukopenia (25.7%), and thrombocytopenia (16.6%). Mostly reported grade 3/4 TEAEs were leukopenia (10.2%), anemia (8.6%), and pneumonia (5.1%). nab-paclitaxel-related deaths as reported by the investigator occurred in 0.8% of patients.
These real-world data support the effectiveness and safety of nab-P/C as first-line treatment for patients with advanced NSCLC independent of tumor histology. The results are comparable with the pivotal phase 3 trial. No new safety signals emerged.
铂类化疗仍然是大约 30%无靶向治疗改变的非小细胞肺癌（NSCLC）患者的一线标准治疗。在关键的 3 期试验中，纳布紫杉醇/卡铂（nab-P/C）联合显示出良好的疗效和安全性。然而，在德国，真实环境中纳布-P/C 的有效性信息尚不清楚。NEPTUN 研究前瞻性地调查了纳布-P/C 在真实环境中晚期 NSCLC 患者中的有效性和安全性。
根据临床常规，晚期或转移性 NSCLC 患者接受一线 nab-P/C 治疗。主要终点是 6 个月无进展生存率（PFS6）。其他终点包括进一步的有效性参数、安全性和生活质量。数据采用描述性分析。
共纳入 408 例患者。PFS6 为 40.8%（95%CI，35.3-46.2）；中位 PFS 为 5.2 个月（95%CI，4.5-5.7）。总缓解率为 41.5%（95%CI，36.3-46.8）。中位总生存期（OS）为 10.5 个月（95%CI，9.2-11.6）。亚组分析显示，鳞状与非鳞状组织学的中位 OS（11.8 个月[95%CI，9.2-13.8] vs. 9.6 个月[95%CI，7.7-11.2]）和年龄≥70 岁与<70 岁（11.7 个月[95%CI，9.4-14.3] vs. 9.6 个月[95%CI，7.5-11.2]）。最常见的治疗相关不良事件（TEAEs）为贫血（26.5%）、白细胞减少症（25.7%）和血小板减少症（16.6%）。报告的大多数 3/4 级 TEAEs 为白细胞减少症（10.2%）、贫血（8.6%）和肺炎（5.1%）。研究者报告的与纳布紫杉醇相关的死亡发生率为 0.8%。
这些真实世界的数据支持纳布-P/C 作为晚期 NSCLC 患者一线治疗的有效性和安全性，独立于肿瘤组织学。结果与关键的 3 期试验相当。没有出现新的安全性信号。
