Rapoport Bernardo L, Vorobiof Daniel A, Dreosti Lydia M, Nosworthy Adam, McAdam Georgina, Jordaan Johan P, Miller-Jansön Helen, de Necker Margreet, de Beer Janetta C, Duvenhage Hennie
, Medical Oncology Centre of Rosebank; , Sandton Oncology Center; , Wits Oncology Donald Gordon Medical Center; , Bristol-Myers Squibb South Africa, Johannesburg; , University of Pretoria, Pretoria; , Rondebosch Oncology Medical Center, Cape Town; , Westridge Oncology Center, Durban; and , , and , HEXOR, Midrand, South Africa.
J Glob Oncol. 2016 Nov 2;3(5):515-523. doi: 10.1200/JGO.2016.006544. eCollection 2017 Oct.
The primary objective of this study was to evaluate 1- and 2-year survival rates and durable remissions in pretreated patients with advanced (unresectable or metastatic) malignant melanoma treated with ipilimumab in a South African expanded-access program (SA-EAP).
This multicenter, retrospective study obtained data from pretreated patients with advanced malignant melanoma who were eligible for the ipilimumab SA-EAP. Ipilimumab was administered at a dose of 3 mg/kg intravenously every 3 weeks for four cycles to adults with advanced melanoma for whom at least one line of treatment for metastatic disease had failed. Data from the medical records of 108 patients treated within the SA-EAP were collected and statistically analyzed to determine overall (OS) and progression-free survival (PFS) at 1 and 2 years.
In the population of 108 patients, a median OS of 8.98 months (95% CI, 7.47 to 10.79 months) was observed. One-year OS was 36% (95% CI, 26% to 45%), and 2-year survival was observed as 20% (95% CI, 12% to 27%). The median survival without progression (ie, PFS) was 3.44 months (95% CI, 2.98 to 4.16 months), and 1- and 2-year PFS were 22% (95% CI, 14% to 29%) and 14% (95% CI, 8% to 21%), respectively. The longest recorded survival was 3.4 years. No independent prognostic variables were identified to predict for OS by multivariate Cox proportional hazards model.
In this multicenter South African setting, ipilimumab at a dose of 3 mg/kg was an effective treatment with long-term OS in a subset of patients with pretreated advanced malignant melanoma.
本研究的主要目的是评估在南非扩大使用项目（SA-EAP）中接受伊匹木单抗治疗的晚期（不可切除或转移性）恶性黑色素瘤预处理患者的1年和2年生存率以及持久缓解情况。
这项多中心回顾性研究收集了符合伊匹木单抗SA-EAP条件的晚期恶性黑色素瘤预处理患者的数据。对于至少一线转移性疾病治疗失败的晚期黑色素瘤成人患者，伊匹木单抗以3 mg/kg的剂量静脉注射，每3周一次，共四个周期。收集了SA-EAP中治疗的108例患者的病历数据，并进行统计分析以确定1年和2年的总生存期（OS）和无进展生存期（PFS）。
在108例患者中，观察到中位OS为8.98个月（95%CI，7.47至10.79个月）。1年OS为36%（95%CI，26%至45%），2年生存率为20%（95%CI，12%至27%）。无进展（即PFS）的中位生存期为3.44个月（95%CI，2.98至4.16个月），1年和2年PFS分别为22%（95%CI，14%至29%）和14%（95%CI，8%至21%）。记录到的最长生存期为3.4年。多变量Cox比例风险模型未识别出可预测OS的独立预后变量。
在南非的这种多中心环境中，3 mg/kg剂量的伊匹木单抗对一部分预处理晚期恶性黑色素瘤患者来说是一种有效的长期OS治疗方法。
