Hematology, Department of Cellular Biotechnologies and Hematology, Sapienza University of Rome, Rome, Italy.
Biostatistical Unit, Regina Elena National Cancer Institute, Rome, Italy.
Cancer Med. 2017 Jun;6(6):1233-1239. doi: 10.1002/cam4.1081. Epub 2017 May 23.
Aim of this study is to explore the role of different treatments on the development of secondary malignancies (SMs) in a large cohort of essential thrombocythemia (ET) patients. We report the experience of a regional cooperative group in a real-life cohort of 1026 patients with ET. We divided our population into five different groups: group 0, no treatment; group 1, hydroxyurea (HU); group 2, alkylating agents (ALK); group 3, ALK + HU sequentially or in combination; and group 4, anagrelide (ANA) and/or α-interferon (IFN) only. Patients from groups 1, 2, and 3 could also have been treated either with ANA and/or IFN in their medical history, considering these drugs not to have an additional cytotoxic potential. In all, 63 of the 1026 patients (6%) developed 64 SM during the follow-up, after a median time of 50 months (range: 2-158) from diagnosis. In univariate analysis, a statistically significant difference was found only for gender (P = 0.035) and age (P = 0.0001). In multivariate analysis, a statistically significant difference was maintained for both gender and age (gender HR1.7 [CI 95% 1.037-2.818] P = 0.035; age HR 4.190 [CI 95% 2.308-7.607] P = 0.0001). The impact of different treatments on SMs development was not statistically significant. In our series of 1026 ET patients, diagnosed and followed during a 30-year period, the different therapies administered, comprising HU and ALK, do not appear to have impacted on the development of SM. A similar rate of SMs was observed also in untreated patients. The only two variables which showed a statistical significance were male gender and age >60 years.
本研究旨在探讨不同治疗方法对大量原发性血小板增多症 (ET) 患者继发恶性肿瘤 (SMs) 发展的影响。我们报告了一个地区合作组在 1026 例 ET 患者真实队列中的经验。我们将人群分为五组:0 组,未治疗;1 组,羟基脲 (HU);2 组,烷化剂 (ALK);3 组,ALK+HU 序贯或联合治疗;4 组,仅用安纳格雷德 (ANA) 和/或 α-干扰素 (IFN)。1、2、3 组患者在其病史中也可能接受了 ANA 和/或 IFN 治疗,因为这些药物不具有额外的细胞毒性潜力。在随访期间,1026 例患者中有 63 例 (6%) 发展为 64 例 SM,从诊断到中位时间为 50 个月 (范围:2-158)。单因素分析发现,仅性别 (P=0.035) 和年龄 (P=0.0001) 有统计学差异。多因素分析发现,性别和年龄均有统计学差异 (性别 HR1.7 [95%CI 1.037-2.818] P=0.035;年龄 HR 4.190 [95%CI 1.037-2.818] P=0.0001)。不同治疗方法对 SMs 发展的影响无统计学意义。在我们的 1026 例 ET 患者系列中,在 30 年的时间里进行了诊断和随访,不同的治疗方法,包括 HU 和 ALK,似乎并没有影响 SM 的发展。未治疗患者的 SMs 发生率也相似。唯一具有统计学意义的两个变量是男性性别和年龄 >60 岁。