Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Department of Respiratory Medicine, Municipal Tsuruga Hospital, Fukui, Japan.
Oncology. 2024;102(7):593-603. doi: 10.1159/000535994. Epub 2024 Jan 30.
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.
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).
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.
Nab-PTX monotherapy may be an effective subsequent treatment option after ICI treatment.
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。
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。
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。
nab-PTX 单药治疗可能是 ICI 治疗后的一种有效后续治疗选择。
