Li Jing-Jing, Wang Jiu-Hong, Dingv Ya, Li Dan-Dan, Wen Xi-Zhi, Zhao Jing-Jing, Jiang Hang, Liu Xing, Huang Fu-Xue, Zhang Xiao-Shi
Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China.
J Cancer Res Clin Oncol. 2022 May;148(5):1159-1169. doi: 10.1007/s00432-021-03700-9. Epub 2021 Jun 28.
This retrospective study aimed to evaluate the combined effect of anti-PD-1 inhibitor and nanoparticle albumin-bound (nab)-paclitaxel for refractory melanoma among Chinese patients.
Data from January 2018 to March 2021 were retrospectively collected and analyzed. Sixty-four patients were eligible for analysis from a single Chinese cancer center.
The median follow-up was 16.0 months at data cutoff. The objective response rate (ORR) was 29.7%, and the disease control rate (DCR) was 67.2% in all patients. Treatment-naïve patients had significantly higher ORR than pretreated patients (42.9% vs 13.8%, p = 0.011). Cutaneous melanoma patients with NRAS gene mutation benefited more than non-mutated patients (DCR of 100% vs. 54.5%) (p = 0.030). The median progression-free survival (mPFS) of all patients was 5.2 months and the duration of response was 10.8 months. Median duration of disease control was 7.7 months. Prior treatment-naïve patients had significantly longer PFS than those who accepted prior treatments (7.2 vs. 5.1 months, p = 0.024). Patients with abnormally high LDH level had shorter mPFS (3.6 months vs. 6.6 months, p = 0.020). Median overall survival was not reached in this study. Most patients experienced adverse events (AEs), but only 17.2% of patients experienced grade 3 severe AEs. The most common AEs were alopecia (89.1%), neutropenia (18.8%), pruritus (15.6%), and arthralgia (14.1%). Some patients had immune related AEs (irAEs). No grade 4 or 5 AEs were observed. Patients with ≥ 3 AEs or with irAEs had longer mPFS (p < 0.05).
Nab-paclitaxel combined with PD-1 antibody is a well-tolerated and effective regimen for Chinese patients with refractory melanoma.
本回顾性研究旨在评估抗程序性死亡蛋白1（PD-1）抑制剂与纳米白蛋白结合型（nab）紫杉醇联合应用于中国难治性黑色素瘤患者的疗效。
回顾性收集并分析2018年1月至2021年3月的数据。从中国一家癌症中心选取64例符合分析条件的患者。
在数据截止时，中位随访时间为16.0个月。所有患者的客观缓解率（ORR）为29.7%，疾病控制率（DCR）为67.2%。初治患者的ORR显著高于经治患者（42.9%对13.8%，p = 0.011）。NRAS基因突变的皮肤黑色素瘤患者比未突变患者获益更多（DCR为100%对54.5%）（p = 0.030）。所有患者的中位无进展生存期（mPFS）为5.2个月，缓解持续时间为10.8个月。疾病控制的中位持续时间为7.7个月。初治患者的PFS显著长于接受过前期治疗的患者（7.2对5.1个月，p = 0.024）。乳酸脱氢酶（LDH）水平异常升高的患者mPFS较短（3.6个月对6.6个月，p = 0.020）。本研究中总生存期未达到中位值。大多数患者经历了不良事件（AE），但只有17.2%的患者经历了3级严重AE。最常见的AE是脱发（89.1%）、中性粒细胞减少（18.8%）、瘙痒（15.6%）和关节痛（14.1%）。一些患者出现了免疫相关不良事件（irAE）。未观察到4级或5级AE。发生≥3次AE或有irAE的患者mPFS更长（p < 0.05）。
nab紫杉醇联合PD-1抗体对于中国难治性黑色素瘤患者是一种耐受性良好且有效的治疗方案。
