文章：

来那度胺治疗背景下的第二恶性肿瘤：对纳入Myeloma XI试验的2732例骨髓瘤患者的分析

Second malignancies in the context of lenalidomide treatment: an analysis of 2732 myeloma patients enrolled to the Myeloma XI trial

原文发布日期：2016-12-09

DOI: 10.1038/bcj.2016.114

类型: Original Article

开放获取: 是

英文摘要：

We have carried out the largest randomised trial to date of newly diagnosed myeloma patients, in which lenalidomide has been used as an induction and maintenance treatment option and here report its impact on second primary malignancy (SPM) incidence and pathology. After review, 104 SPMs were confirmed in 96 of 2732 trial patients. The cumulative incidence of SPM was 0.7% (95% confidence interval (CI) 0.4–1.0%), 2.3% (95% CI 1.6–2.7%) and 3.8% (95% CI 2.9–4.6%) at 1, 2 and 3 years, respectively. Patients receiving maintenance lenalidomide had a significantly higher SPM incidence overall (P=0.011). Age is a risk factor with the highest SPM incidence observed in transplant non-eligible patients aged >74 years receiving lenalidomide maintenance. The 3-year cumulative incidence in this group was 17.3% (95% CI 8.2–26.4%), compared with 6.5% (95% CI 0.2–12.9%) in observation only patients (P=0.049). There was a low overall incidence of haematological SPM (0.5%). The higher SPM incidence in patients receiving lenalidomide maintenance therapy, especially in advanced age, warrants ongoing monitoring although the benefit on survival is likely to outweigh risk.

摘要翻译： 

我们开展了迄今规模最大的新确诊骨髓瘤患者随机试验，其中来那度胺被用作诱导和维持治疗方案，本文报告其对第二原发恶性肿瘤发病率和病理学的影响。经审核，2732例试验患者中96例确诊104例第二原发恶性肿瘤。累积发病率在1年、2年和3年分别为0.7%、2.3%和3.8%。接受来那度胺维持治疗的患者总体第二原发恶性肿瘤发病率显著更高。年龄是危险因素，在接受来那度胺维持治疗的74岁以上不适合移植患者中观察到最高发病率。该组3年累积发病率为17.3%，而仅观察组为6.5%。血液学第二原发恶性肿瘤总体发病率较低。接受来那度胺维持治疗的患者第二原发恶性肿瘤发病率更高，尤其在高龄患者中，需要持续监测，尽管其生存获益可能超过风险。

原文链接：

Second malignancies in the context of lenalidomide treatment: an analysis of 2732 myeloma patients enrolled to the Myeloma XI trial