Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
Oncologist. 2013 Jun;18(6):726-32. doi: 10.1634/theoncologist.2012-0464. Epub 2013 May 28.
The outcome of patients with mucosal melanoma treated with ipilimumab is not defined. To assess the efficacy and safety of ipilimumab in this melanoma subset, we performed a multicenter, retrospective analysis of 33 patients with unresectable or metastatic mucosal melanoma treated with ipilimumab. The clinical characteristics, treatments, toxicities, radiographic assessment of disease burden by central radiology review at each site, and mutational profiles of the patients' tumors were recorded. Available peripheral blood samples were used to assess humoral immunity against a panel of cancer-testis antigens and other antigens. By the immune-related response criteria of the 30 patients who underwent radiographic assessment after ipilimumab at approximately week 12, there were 1 immune-related complete response, 1 immune-related partial response, 6 immune-related stable disease, and 22 immune-related progressive disease. By the modified World Health Organization criteria, there were 1 immune-related complete response, 1 immune-related partial response, 5 immune-related stable disease, and 23 immune-related progressive disease. Immune-related adverse events (as graded by Common Terminology Criteria for Adverse Events version 4.0) consisted of six patients with rash (four grade 1, two grade 2), three patients with diarrhea (one grade 1, two grade 3), one patient with grade 1 thyroiditis, one patient with grade 3 hepatitis, and 1 patient with grade 2 hypophysitis. The median overall survival from the time of the first dose of ipilimumab was 6.4 months (range: 1.8-26.7 months). Several patients demonstrated serologic responses to cancer-testis antigens and other antigens. Durable responses to ipilimumab were observed, but the overall response rate was low. Additional investigation is necessary to clarify the role of ipilimumab in patients with mucosal melanoma.
接受伊匹单抗治疗的黏膜黑色素瘤患者的预后尚未明确。为评估伊匹单抗在这一黑色素瘤亚组中的疗效和安全性，我们对 33 例接受伊匹单抗治疗的不可切除或转移性黏膜黑色素瘤患者进行了多中心回顾性分析。记录了患者的临床特征、治疗、毒性、各中心的中央影像学评估的疾病负担、以及肿瘤的突变特征。对可用的外周血样本进行了分析，以评估针对一组癌症睾丸抗原和其他抗原的体液免疫。根据 30 例接受伊匹单抗治疗后约 12 周进行影像学评估的患者的免疫相关反应标准，有 1 例免疫相关完全缓解，1 例免疫相关部分缓解，6 例免疫相关稳定疾病，22 例免疫相关进展疾病。根据改良的世界卫生组织标准，有 1 例免疫相关完全缓解，1 例免疫相关部分缓解，5 例免疫相关稳定疾病，23 例免疫相关进展疾病。免疫相关不良事件（按通用不良事件术语标准 4.0 分级）包括 6 例皮疹（4 级 1 例，2 级 2 例），3 例腹泻（1 级 1 例，3 级 2 例），1 例甲状腺炎，1 例肝炎，1 例垂体炎。从伊匹单抗首次给药到死亡的中位总生存期为 6.4 个月（范围：1.8-26.7 个月）。一些患者对癌症睾丸抗原和其他抗原表现出了血清学反应。观察到伊匹单抗的持久反应，但总体反应率较低。需要进一步研究来阐明伊匹单抗在黏膜黑色素瘤患者中的作用。
