Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena, Tuscan Cancer Institute, Siena.
Ann Oncol. 2013 Nov;24(11):2911-5. doi: 10.1093/annonc/mdt376. Epub 2013 Sep 25.
Patients with advanced uveal melanoma have a poor prognosis and limited treatment options. Ipilimumab is approved for pre-treated adult patients with advanced melanoma. However, because previous clinical trials with ipilimumab have excluded patients with uveal melanoma, data in this patient population are limited.
Pre-treated patients with advanced uveal melanoma received ipilimumab 3 mg/kg through an expanded access programme, every 3 weeks for four doses. Tumour assessments were conducted at baseline and after completion of treatment and patients were monitored throughout for adverse events.
Among 82 assessable patients, 4 (5%) had an immune-related objective response and 24 (29%) had immune-related stable disease lasting ≥3 months for an immune-related disease control rate of 34%. With a median follow-up of 5.6 months, median overall survival (OS) was 6.0 months and median progression-free survival (PFS) was 3.6 months. The 1-year rates of OS and PFS were 31% and 11%, respectively. The safety profile of ipilimumab was similar to that in patients with cutaneous melanoma.
These data suggest ipilimumab 3 mg/kg is a feasible option in pre-treated patients with metastatic uveal melanoma. Evidence of disease control and a 1-year survival rate of 31% indicate the need for further investigation in randomised, controlled trials to determine the optimal timing and use of ipilimumab in this patient population.
晚期葡萄膜黑色素瘤患者预后较差，治疗选择有限。伊匹单抗获批用于治疗预处理的成人晚期黑色素瘤患者。然而，由于之前的伊匹单抗临床试验排除了葡萄膜黑色素瘤患者，因此该患者人群的数据有限。
接受过预处理的晚期葡萄膜黑色素瘤患者通过扩大准入计划接受伊匹单抗 3mg/kg，每 3 周一次，共 4 个剂量。在基线和治疗完成后进行肿瘤评估，并且在整个过程中监测患者的不良反应。
在 82 例可评估患者中，有 4 例（5%）发生了免疫相关的客观缓解，24 例（29%）发生了免疫相关的稳定疾病，持续时间≥3 个月，免疫相关疾病控制率为 34%。中位随访 5.6 个月时，中位总生存期（OS）为 6.0 个月，中位无进展生存期（PFS）为 3.6 个月。1 年 OS 率和 PFS 率分别为 31%和 11%。伊匹单抗的安全性与皮肤黑色素瘤患者相似。
这些数据表明，伊匹单抗 3mg/kg 是转移性葡萄膜黑色素瘤预处理患者的可行选择。疾病控制的证据和 1 年生存率为 31%，表明需要进一步在随机对照试验中研究，以确定在该患者人群中使用伊匹单抗的最佳时机和用法。
