Combination of pembrolizumab plus temozolomide therapy in unresectable and advanced melanoma: a multicenter retrospective analysis in China.
Combination of pembrolizumab plus temozolomide therapy in unresectable and advanced melanoma: a multicenter retrospective analysis in China.
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DOI：
10.21037/atm-21-5738
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发表时间：
2021-11
影响因子：
--
通讯作者：
Chen Y
中科院分区：
文献类型：
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作者：
Hu T;Sun W;Xu Y;Qu X;Jin Y;Luo Z;Chen Y
本研究旨在评估抗PD-1联合替莫唑胺一线治疗不可切除的晚期黑色素瘤患者的效果。回顾了 2018 年 5 月至 2020 年 2 月在三个癌症中心首次接受派姆单抗联合替莫唑胺、单独派姆单抗或基于替莫唑胺化疗的不可切除晚期黑色素瘤患者的记录。对患者进行随访直至死亡或 2020 年 10 月 30 日。对数据进行回顾性审查和统计分析，以了解最佳客观缓解率 (ORR) 和无进展生存期 (PFS) 以及毒性。 69 例患者被确诊，其中 28 例（40.6%）患有肢端黑色素瘤，18 例（26.1%）患有皮肤黑色素瘤，21 例（30.4%）患有粘膜黑色素瘤，2 例（2.9%）患有未知原发性黑色素瘤。派姆单抗联合替莫唑胺（8/20，40.0%）治疗晚期黑色素瘤的 ORR 高于单独使用派姆单抗（3/24，12.5%）和化疗（1/25，4.0%）作为一线治疗。派姆单抗联合替莫唑胺作为晚期黑色素瘤一线治疗的中位 PFS 为 9.8 个月 [95% 置信区间 (CI)：1.7–17.9 个月]，比化疗 4.2 个月的 PFS 显着改善（95% CI：2.6–5.8 个月）[风险比 (HR) 0.415，95% CI： 0.185–0.931，P=0.033]。派姆单抗的中位 PFS 为 6.2 个月（95% CI：2.5-9.9），与化疗相比无显着差异（HR 0.647，95% CI：0.334-1.252，P=0.196）。抗PD-1与替莫唑胺联合治疗晚期黑色素瘤的疗效优于基于替莫唑胺的化疗或单独抗PD-1，且不会增加毒性。因此，抗PD-1联合替莫唑胺可优先作为不可切除晚期黑色素瘤的一线治疗方案。
This study aimed to evaluate the effect of anti-PD-1 combined with temozolomide as front-line therapy in patients with unresectable advanced melanoma. The records of patients with unresectable advanced melanoma first treated with pembrolizumab plus temozolomide, pembrolizumab alone, or temozolomide-based chemotherapy at three cancer centers from May 2018 to February 2020 were reviewed. Patients were followed up until death or October 30, 2020. Data were retrospectively reviewed and statistically analyzed for the best objective response rate (ORR) and progression-free survival (PFS), as well as toxicities. Sixty-nine individuals were identified, including 28 (40.6%) with acral melanoma, 18 (26.1%) with cutaneous melanoma, 21 (30.4%) with mucosal melanoma, and two (2.9%) with unknown primary melanoma. The ORR of pembrolizumab plus temozolomide (8/20, 40.0%) in advanced melanoma was higher than pembrolizumab (3/24, 12.5%) and chemotherapy (1/25, 4.0%) alone as front-line therapies. The median PFS of pembrolizumab plus temozolomide as front-line therapy for advanced melanoma was 9.8 months [95% confidence interval (CI): 1.7–17.9 months], which was a significant improvement on the chemotherapy PFS of 4.2 months (95% CI: 2.6–5.8 months) [hazard ratio (HR) 0.415, 95% CI: 0.185–0.931, P=0.033]. The median PFS of pembrolizumab was 6.2 months (95% CI: 2.5–9.9), with no significant difference compared with chemotherapy (HR 0.647, 95% CI: 0.334–1.252, P=0.196). Combining anti-PD-1 with temozolomide has better efficacy than temozolomide-based chemotherapy or anti-PD-1 alone for advanced melanoma treatment without increasing toxicity. Therefore, anti-PD-1 combined with temozolomide may be preferentially used as a front-line regimen for unresectable advanced melanoma.