一线来那度胺为基础的治疗方案治疗多发性骨髓瘤的老年患者中的第二原发恶性肿瘤：基于人群的分析。

Second primary malignancy among older adults with multiple myeloma receiving first-line lenalidomide-based therapy: A population-based analysis.

机构信息

Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham, AL, United States of America; Division of Hematology/Oncology, University of Alabama at Birmingham, Birmingham, AL, United States of America.

Alpert Medical School of Brown University, Providence, RI, United States of America; Division of Hematology-Oncology, Lifespan Cancer Institute, Providence, RI, United States of America.

出版信息

J Geriatr Oncol. 2021 Mar;12(2):256-261. doi: 10.1016/j.jgo.2020.07.007. Epub 2020 Jul 17.

DOI:10.1016/j.jgo.2020.07.007

PMID:32684352

Abstract

OBJECTIVES

Clinical trials have suggested that patients with myeloma treated with lenalidomide may have an increased risk of second primary malignancies (SPM). Whether such risks are of significant relevance in the real-world clinical practice, particularly among older patients receiving first-line lenalidomide based therapy, remains unclear.

METHODS

Using Surveillance Epidemiology and End Results-Medicare database, we identified adults ≥ 65 years with plasma cell myeloma diagnosed in 2007-2015 who received at least one oral anti-myeloma agent. We defined first-line lenalidomide-containing therapy as use within 90 days of diagnosis. SPM was defined as a malignancy reported to a cancer registry > 90 days after myeloma diagnosis. We computed cumulative incidence of SPM (with death being a competing event) and compared SPM rates between patients treated with or without first-line lenalidomide using a Fine-Gray's model, adjusting for age, sex, race, ethnicity, prior malignancy, and histologic subtype.

RESULTS

Of 9850 Medicare beneficiaries, 4009 (41%) received first-line lenalidomide. During median follow up of 5.0 years, 423 patients (4.3%) developed SPM, including 361 solid tumors (85%) and 61 hematologic malignancies (14%). The cumulative incidence of any SPM at 5 years was similar among those who received first-line lenalidomide and those who did not (5.3% vs 4.4%; sub-hazard ratio, SHR 1.06, P = .53). Consistent results were seen in the risk of solid tumor (4.7% vs 3.6%; SHR 1.13, P = .24) or hematologic malignancy (4.7 vs 3.6%, SHR 0.73; P = .72).

CONCLUSION

First-line lenalidomide therapy among older adults with myeloma was not associated with a significantly increased risk of any SPM.

摘要

目的

临床试验表明，接受来那度胺治疗的骨髓瘤患者发生第二原发恶性肿瘤（SPM）的风险可能增加。然而，在真实临床实践中，特别是在接受一线来那度胺为基础治疗的老年患者中，这些风险是否具有重要意义尚不清楚。

方法

我们利用监测、流行病学和最终结果-医疗保险数据库，确定了 2007 年至 2015 年期间诊断患有浆细胞瘤且年龄≥65 岁的成年人，这些患者至少接受过一种口服抗骨髓瘤药物治疗。我们将一线含来那度胺的治疗定义为在诊断后 90 天内使用。SPM 定义为在骨髓瘤诊断后 90 天以上向癌症登记处报告的恶性肿瘤。我们计算了 SPM 的累积发生率（以死亡为竞争事件），并用 Fine-Gray 模型比较了接受或不接受一线来那度胺治疗的患者之间的 SPM 发生率，调整了年龄、性别、种族、民族、既往恶性肿瘤和组织学亚型等因素。

结果

在 9850 名医疗保险受益人中，有 4009 人（41%）接受了一线来那度胺治疗。在中位随访 5.0 年后，423 名患者（4.3%）发生了 SPM，包括 361 例实体瘤（85%）和 61 例血液恶性肿瘤（14%）。在接受一线来那度胺治疗和未接受治疗的患者中，5 年时任何 SPM 的累积发生率相似（5.3% vs 4.4%；亚危险比，SHR 1.06，P=0.53）。在实体瘤（4.7% vs 3.6%；SHR 1.13，P=0.24）或血液恶性肿瘤（4.7% vs 3.6%，SHR 0.73；P=0.72）的风险方面也观察到了一致的结果。