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免疫检查点抑制剂在中国转移性黑色素瘤患者中的应用经验:一项回顾性病例系列研究。

The experience of immune checkpoint inhibitors in Chinese patients with metastatic melanoma: a retrospective case series.

作者信息

Wen Xizhi, Ding Ya, Li Jingjing, Zhao Jingjing, Peng Ruiqing, Li Dandan, Zhu Baoyan, Wang Yao, Zhang Xing, Zhang Xiaoshi

机构信息

Biotherapy Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, 510060, Guangdong, People's Republic of China.

出版信息

Cancer Immunol Immunother. 2017 Sep;66(9):1153-1162. doi: 10.1007/s00262-017-1989-8. Epub 2017 Apr 25.

Abstract

Melanomas in Chinese patients show relatively higher rates of acral and mucosal types than in other populations. However, the efficacy of checkpoint inhibitor therapies against these melanoma subtypes is not well defined. We analyzed 52 patients treated with ipilimumab, pembrolizumab, or a combination of both to evaluate the efficacy and safety of checkpoint inhibitors in Chinese patients with advanced melanoma, particularly those with acral and mucosal types. The objective response rates (ORRs) were 0, 25, and 20% for ipilimumab, pembrolizumab, and pembrolizumab plus ipilimumab, respectively. Pembrolizumab contained therapy was as effective in acral and mucosal melanoma patients (ORR 26.7 and 20%, respectively) as in non-acral cutaneous melanoma patients (ORR 26.7%). Baseline lactate dehydrogenase levels and relative lymphocyte counts were independent prognostic factors for PFS and OS. The incidences of grade 3-4 adverse events were 14% in the two monotherapy groups and 30% in the combined therapy group. The most frequent adverse events were elevation of aminotransferase, skin toxicity, thyroid dysfunction, pyrexia, and fatigue. Treatment-related rash or vitiligo was associated with a better prognosis. In summary, pembrolizumab-based therapy resulted in meaningful efficacy and good tolerability in Chinese patients with melanoma, including those with acral and mucosal types.

摘要

中国患者的黑色素瘤中,肢端型和黏膜型的比例相对高于其他人群。然而,检查点抑制剂疗法对这些黑色素瘤亚型的疗效尚不明确。我们分析了52例接受伊匹木单抗、帕博利珠单抗或两者联合治疗的患者,以评估检查点抑制剂对中国晚期黑色素瘤患者,尤其是肢端型和黏膜型患者的疗效和安全性。伊匹木单抗、帕博利珠单抗以及帕博利珠单抗联合伊匹木单抗的客观缓解率(ORR)分别为0%、25%和20%。含帕博利珠单抗的治疗方案对肢端和黏膜黑色素瘤患者(ORR分别为26.7%和20%)与非肢端皮肤黑色素瘤患者(ORR为26.7%)的疗效相同。基线乳酸脱氢酶水平和相对淋巴细胞计数是无进展生存期(PFS)和总生存期(OS)的独立预后因素。两个单药治疗组3-4级不良事件的发生率为14%,联合治疗组为30%。最常见的不良事件是转氨酶升高、皮肤毒性、甲状腺功能障碍、发热和疲劳。治疗相关的皮疹或白癜风与较好的预后相关。总之,基于帕博利珠单抗的治疗方案对中国黑色素瘤患者,包括肢端型和黏膜型患者,产生了有意义的疗效且耐受性良好。

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