Experience in daily practice with ipilimumab for the treatment of patients with metastatic melanoma: an early increase in lymphocyte and eosinophil counts is associated with improved survival
Experience in daily practice with ipilimumab for the treatment of patients with metastatic melanoma: an early increase in lymphocyte and eosinophil counts is associated with improved survival
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DOI：
10.1093/annonc/mdt027
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发表时间：
2013-06-01
影响因子：
50.5
通讯作者：
Robert, C.
中科院分区：
文献类型：
--
作者：
Delyon, J.;Mateus, C.;Robert, C.
背景：易普利姆玛（Ipilimumab）是最近批准的一种免疫疗法，已证明可以改善转移性黑色素瘤患者的总生存期（OS）。我们报告了在同情使用计划中治疗患者的单一机构经验。 患者和方法：在这项前瞻性研究中，患者在 2010 年 6 月至 2011 年 9 月期间接受治疗。纳入标准是诊断为不可切除的 III 期或 IV 期黑色素瘤，至少接受过一次化疗，并在第一次灌注后存活 12 周。每 3 周以 3 mg/kg 的剂量给予 4 个疗程的 ipilimumab。 结果：纳入 73 名患者。从伊匹单抗开始使用起，中位 OS 为 9.1 个月 (95% CI 6.4-11.3)。 45 例患者 (62%) 观察到免疫相关不良事件，其中 19 例 3-4 级事件 (26%)。没有发生与药物相关的死亡。第二个疗程开始时淋巴细胞计数 >1000/mm(3) 以及第一次和第二次输注之间嗜酸性粒细胞计数增加 >100/mm(3) 与 OS 改善相关。结论：伊匹单抗毒性作用在现实生活中是可控的。第二次伊匹单抗输注时的淋巴细胞和嗜酸性粒细胞计数等生物学数据似乎是与更好的 OS 相关的早期标志物。
Background: Ipilimumab is a recently approved immunotherapy that has demonstrated an improvement in the overall survival (OS) of patients with metastatic melanoma. We report a single-institution experience in patients treated in a compassionate-use program.Patients and methods: In this prospective study, patients were treated between June 2010 and September 2011. Inclusion criteria were a diagnosis of unresectable stage III or IV melanoma, at least one previous line of chemotherapy, and survival 12 weeks after the first perfusion. Four courses of ipilimumab were administered at a dose of 3 mg/kg every 3 weeks.Results: Seventy-three patients were included. Median OS was 9.1 months (95% CI 6.4-11.3) from the start of ipilimumab. Immune-related adverse events were observed in 45 patients (62%), including 19 grade 3-4 events (26%). No drug-related death occurred. A lymphocyte count >1000/mm(3) at the start of the second course and an increase in the eosinophil count >100/mm(3) between the first and second infusions were correlated with an improved OS.Conclusion: Ipilimumab toxic effect is manageable in real life. Biological data such as lymphocyte and eosinophil counts at the time of the second ipilimumab infusion appear to be early markers associated with better OS.