Department of Respiratory Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan;
Department of Respiratory Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Anticancer Res. 2024 Nov;44(11):5105-5111. doi: 10.21873/anticanres.17335.
BACKGROUND/AIM: The efficacy of cytotoxic chemo-therapy has been reported to improve after immune checkpoint inhibitor (ICI) administration. We previously conducted a multicenter prospective clinical study to evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-PTX) after ICI treatment. In that study, some patients showed a long-term response to nab-PTX, which is not usually observed with single-agent chemotherapy. The present study aimed to evaluate the clinical characteristics of these patients.
We retrospectively analyzed updated data from 29 patients enrolled in our clinical study who received nab-PTX monotherapy after ICI treatment. We defined a "long-term responder" as a patient who achieved a 1-year progression-free survival (PFS).
Among the 29 patients, 10 (34.5%) were long-term responders, two of whom achieved a 5-year PFS. A key difference between long-term and non-long-term responders was that the long-term responders had a significantly higher number of patients with Eastern Cooperative Oncology Group-performance status of 0 (70.0% versus 10.5%; p=0.002). Furthermore, median cycles of previous ICIs and median treatment cycles were significantly higher in long-term responders than in non-long-term responders (8 cycles versus 3 cycles; p=0.03) (5.9 months versus 2.0 months; p=0.02). In the 10 long-term responders, six patients required at least a one-stage dose reduction owing to adverse events, and four patients required a two-stage dose reduction.
Nab-PTX administration after ICI treatment may elicit a long-term response. A long-term response can be achieved even with a dose reduction due to adverse events.
背景/目的:免疫检查点抑制剂(ICI)给药后,细胞毒性化疗的疗效已被报道有所改善。我们之前进行了一项多中心前瞻性临床研究,以评估 ICI 治疗后纳米白蛋白结合紫杉醇(nab-PTX)的疗效和安全性。在该研究中,一些患者对 nab-PTX 表现出长期反应,而这在单药化疗中通常观察不到。本研究旨在评估这些患者的临床特征。
我们回顾性分析了 29 名参加我们临床研究的患者的更新数据,这些患者在接受 ICI 治疗后接受了 nab-PTX 单药治疗。我们将“长期应答者”定义为达到 1 年无进展生存期(PFS)的患者。
在 29 名患者中,有 10 名(34.5%)是长期应答者,其中 2 名患者达到了 5 年 PFS。长期应答者和非长期应答者之间的一个关键区别是,长期应答者的体力状况为 0 的患者比例明显更高(70.0%对 10.5%;p=0.002)。此外,长期应答者的既往 ICIs 治疗周期中位数和治疗周期中位数均显著高于非长期应答者(8 个周期对 3 个周期;p=0.03)(5.9 个月对 2.0 个月;p=0.02)。在 10 名长期应答者中,有 6 名患者因不良反应需要至少一个阶段剂量减少,有 4 名患者需要两个阶段剂量减少。
ICI 治疗后给予 nab-PTX 可能会引发长期反应。即使因不良反应需要剂量减少,也可以达到长期反应。