纳米白蛋白结合紫杉醇（nab-PTX）单药治疗非小细胞肺癌的疗效在免疫检查点抑制剂治疗后可提高：两项先前前瞻性临床研究的长期随访和更新分析。
Efficacy of Nanoparticle Albumin-Bound Paclitaxel (nab-PTX) Monotherapy Can Be Improved after Treatment with Immune Checkpoint Inhibitor in Patients with Non-Small Cell Lung Cancer: Long-Term Follow-Up and Updated Analysis of Two Previous Prospective Clinical Studies.
机构信息
Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Department of Respiratory Medicine, Municipal Tsuruga Hospital, Fukui, Japan.
出版信息
Oncology. 2024;102(7):593-603. doi: 10.1159/000535994. Epub 2024 Jan 30.
INTRODUCTION
Recent studies have suggested enhanced therapeutic effects of subsequent chemotherapy after immune checkpoint inhibitor (ICI) treatment, highlighting the importance of subsequent treatment selection. Nanoparticle albumin-bound paclitaxel (nab-PTX) is commonly used in subsequent chemotherapies; however, its efficacy as a subsequent treatment after ICI treatment has not been reported.
METHODS
We retrospectively evaluated the efficacy and safety of nab-PTX using two prospective studies that we previously reported. The first study evaluated the efficacy and safety of nab-PTX as a second-line treatment after the failure of the first-line cytotoxic chemotherapy, excluding ICI (study 1; n = 32), and the other as a subsequent treatment after failure of ICI treatment, regardless of treatment line (study 2; n = 29).
RESULTS
The objective response rate was significantly higher in study 2 {55.2% (95% confidence interval [CI]: 28.1-79.6)} than in study 1 (28.1% [95% CI: 13.7-46.7]) (p = 0.04). Although the disease control rate was slightly higher in study 2 (86.2% [95% CI: 65.9-97.0]) than in study 1 (71.9% [95% CI: 53.3-86.3]), there was no significant difference (p = 0.2). The median progression-free survival was significantly longer in study 2 than in study 1 (3.9 months [95% CI: 2.0-5.5] in study 1 vs. 5.6 months [95% CI: 3.0-12.8] in study 2; hazard ratio [HR]: 0.46 [95% CI: 0.27-0.81], p = 0.006). The median overall survival was slightly longer in study 2 despite the greater number of patients who received nab-PTX in late treatment line, but there was no significant difference between study 1 and study 2 (10.9 months [95% CI: 5.1-16.8] in study 1 vs. 11.9 months [95% CI: 7.6-24.8] in study 2; HR: 0.77 [95% CI: 0.46-1.31], p = 0.34). Safety profiles did not differ between the patients in studies 1 and 2.
CONCLUSION
Nab-PTX monotherapy may be an effective subsequent treatment option after ICI treatment.
简介
最近的研究表明，免疫检查点抑制剂（ICI）治疗后进行后续化疗可提高治疗效果，这凸显了后续治疗选择的重要性。纳米白蛋白结合紫杉醇（nab-PTX）常用于后续化疗，但尚未有报道其作为 ICI 治疗后的后续治疗的疗效。
方法
我们回顾性评估了两项我们之前报道的前瞻性研究中 nab-PTX 的疗效和安全性。第一项研究评估了 nab-PTX 作为一线细胞毒性化疗失败后的二线治疗（研究 1；n=32）的疗效和安全性，另一项研究评估了 nab-PTX 作为 ICI 治疗失败后的后续治疗（研究 2；n=29），无论治疗线如何。
结果
研究 2 的客观缓解率显著高于研究 1{55.2%（95%置信区间[CI]：28.1-79.6）}（p=0.04）。尽管研究 2 的疾病控制率略高于研究 1（86.2%[95%CI：65.9-97.0]）（p=0.2），但差异无统计学意义。研究 2 的中位无进展生存期显著长于研究 1（研究 1 中为 3.9 个月[95%CI：2.0-5.5]，研究 2 中为 5.6 个月[95%CI：3.0-12.8]；风险比[HR]：0.46[95%CI：0.27-0.81]，p=0.006）。尽管在研究 2 中接受 nab-PTX 治疗的患者数量较多，但研究 2 的中位总生存期略长，但研究 1 和研究 2 之间无显著差异（研究 1 中为 10.9 个月[95%CI：5.1-16.8]，研究 2 中为 11.9 个月[95%CI：7.6-24.8]；HR：0.77[95%CI：0.46-1.31]，p=0.34）。研究 1 和研究 2 中的患者安全性特征无差异。
结论
nab-PTX 单药治疗可能是 ICI 治疗后的一种有效后续治疗选择。
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