Jones J R, Cairns D A, Gregory W M, Collett C, Pawlyn C, Sigsworth R, Striha A, Henderson R, Kaiser M F, Jenner M, Cook G, Russell N H, Williams C, Pratt G, Kishore B, Lindsay J, Drayson M T, Davies F E, Boyd K D, Owen R G, Jackson G H, Morgan G J
The Institute of Cancer Research, London, UK.
The Royal Marsden Hospital NHS Foundation Trust, London, UK.
Blood Cancer J. 2016 Dec 9;6(12):e506. doi: 10.1038/bcj.2016.114.
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.
我们开展了迄今为止针对新诊断骨髓瘤患者的最大规模随机试验，其中来那度胺被用作诱导和维持治疗方案，在此报告其对第二原发性恶性肿瘤（SPM）发病率和病理的影响。经审查，在2732例试验患者中的96例中确诊了104例SPM。SPM的累积发病率在1年、2年和3年时分别为0.7%（95%置信区间（CI）0.4 - 1.0%）、2.3%（95%CI 1.6 - 2.7%）和3.8%（95%CI 2.9 - 4.6%）。接受来那度胺维持治疗的患者总体SPM发病率显著更高（P = 0.011）。年龄是一个风险因素，在接受来那度胺维持治疗的74岁以上不符合移植条件的患者中观察到最高的SPM发病率。该组的3年累积发病率为17.3%（95%CI 8.2 - 26.4%），而仅接受观察的患者为6.5%（95%CI 0.2 - 12.9%）（P = 0.049）。血液学SPM的总体发病率较低（0.5%）。接受来那度胺维持治疗的患者中较高的SPM发病率，尤其是在老年患者中，尽管对生存的益处可能超过风险，但仍需要持续监测。
