帕博利珠单抗治疗晚期黏膜黑色素瘤的抗肿瘤活性：KEYNOTE-001、002、006 的事后分析。
Antitumour activity of pembrolizumab in advanced mucosal melanoma: a post-hoc analysis of KEYNOTE-001, 002, 006.
机构信息
The Angeles Clinic and Research Institute, Los Angeles, CA, USA.
Gustave Roussy and Paris-Sud University, Villejuif, France.
出版信息
Br J Cancer. 2018 Sep;119(6):670-674. doi: 10.1038/s41416-018-0207-6. Epub 2018 Sep 11.
BACKGROUND
Mucosal melanoma is an aggressive melanoma with poor prognosis. We assessed efficacy of pembrolizumab in patients with advanced mucosal melanoma in KEYNOTE-001 (NCT01295827), -002 (NCT01704287), and -006 (NCT01866319).
METHODS
Patients received pembrolizumab 2 mg/kg every 3 weeks (Q3W) or 10 mg/kg Q2W or Q3W. Response was assessed by independent central review per RECIST v1.1.
RESULTS
1567 patients were treated and 84 (5%) had mucosal melanoma. Fifty-one of 84 were ipilimumab-naive. In patients with mucosal melanoma, the objective response rate (ORR) was 19% (95% CI 11-29%), with median duration of response (DOR) of 27.6 months (range 1.1 + to 27.6). Median progression-free survival (PFS) was 2.8 months (95% CI 2.7-2.8), with median overall survival (OS) of 11.3 months (7.7-16.6). ORR was 22% (95% CI 11-35%) and 15% (95% CI 5-32%) in ipilimumab-naive and ipilimumab-treated patients.
CONCLUSION
Pembrolizumab provides durable antitumour activity in patients with advanced mucosal melanoma regardless of prior ipilimumab.
背景
黏膜黑色素瘤是一种预后不良的侵袭性黑色素瘤。我们评估了 pembrolizumab 在 KEYNOTE-001（NCT01295827）、-002（NCT01704287）和 -006（NCT01866319）研究中晚期黏膜黑色素瘤患者中的疗效。
方法
患者接受 pembrolizumab 2 mg/kg，每 3 周（Q3W）或 10 mg/kg，每 2 周或每 3 周。根据 RECIST v1.1 独立中心评估来评估反应。
结果
共治疗了 1567 例患者，其中 84 例（5%）患有黏膜黑色素瘤。84 例中有 51 例是 ipilimumab 初治患者。在黏膜黑色素瘤患者中，客观缓解率（ORR）为 19%（95%CI 11-29%），缓解持续时间（DOR）中位数为 27.6 个月（范围 1.1+至 27.6）。无进展生存期（PFS）中位数为 2.8 个月（95%CI 2.7-2.8），总生存期（OS）中位数为 11.3 个月（7.7-16.6）。在 ipilimumab 初治和治疗的患者中，ORR 分别为 22%（95%CI 11-35%）和 15%（95%CI 5-32%）。
结论
pembrolizumab 为晚期黏膜黑色素瘤患者提供了持久的抗肿瘤活性，无论先前是否使用过 ipilimumab。
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