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A 10-year retrospective cohort study of ruxolitinib and association with non-melanoma skin cancer in polycythemia vera and myelofibrosis patients
Journal of the American Academy of Dermatology ( IF 13.8 ) Pub Date : 2021-10-11 , DOI: 10.1016/j.jaad.2021.10.004
John Q Lin 1 , Shirley Q Li 2 , Shufeng Li 1 , Eileen F Kiamanesh 3 , Sumaira Z Aasi 1 , Bernice Y Kwong 1 , Anne Lynn Su Chang 1
Affiliation  

Background

Clinical trials report occurrence of non-melanoma skin cancers (NMSC) with ruxolitinib in polycythemia (PV) or myelofibrosis (MF) patients, however the level of risk and effect of covariates are not known in the real-world setting.

Objective

To systematically assess the risk of developing non-melanoma skin cancer (NMSC) after ruxolitinib exposure in PV or MF patients.

Methods

A 10-year retrospective cohort of PV or MF patients at Stanford Medical Center was identified and matched on age, gender, race, Charlson comorbidity index, disease diagnosis, and follow-up time. The main outcome measure was Hazard Ratio (HR) for NMSC (comprised of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)) after ruxolitinib exposure, adjusted for covariates.

Results

The study cohort consisted of 564 patients (188 exposed to ruxolitinib for at least 4 weeks, 376 unexposed). Ruxolitinib-exposed PV or MF patients had an adjusted NMSC HR of 2.69 (95% Confidence Interval (CI), 1.03-7.02). In particular, ruxolitinib exposure was associated with SCC, HR=3.24 (95% CI, 1.45-7.22), with non-JAK2 mutated patients showing even higher SCC risk, HR=7.40 (2.54-21.63).

Limitations

Retrospective design.

Conclusions and Relevance

Our real-world results indicate that SCC risk is increased in PV or MF patients taking ruxolitinib and supports consideration of skin cancer monitoring.



中文翻译:

ruxolitinib 及其与真性红细胞增多症和骨髓纤维化患者非黑色素瘤皮肤癌相关性的 10 年回顾性队列研究

背景

临床试验报告了在红细胞增多症 (PV) 或骨髓纤维化 (MF) 患者中使用鲁索替尼后非黑色素瘤皮肤癌 (NMSC) 的发生率,但是在现实环境中协变量的风险水平和影响尚不清楚。

客观的

系统评估 PV 或 MF 患者在接触鲁索替尼后发生非黑色素瘤皮肤癌 (NMSC) 的风险。

方法

确定了斯坦福医学中心 PV 或 MF 患者的 10 年回顾性队列,并在年龄、性别、种族、查尔森合并症指数、疾病诊断和随访时间方面进行了匹配。主要结果指标是暴露于鲁索替尼后 NMSC(由基底细胞癌(BCC)和鳞状细胞癌(SCC)组成)的风险比(HR),并针对协变量进行了调整。

结果

研究队列包括 564 名患者(188 名暴露于鲁索替尼至少 4 周,376 名未暴露)。Ruxolitinib 暴露的 PV 或 MF 患者的调整后 NMSC HR 为 2.69(95% 置信区间 (CI),1.03-7.02)。特别是,ruxolitinib 暴露与 SCC 相关,HR = 3.24(95% CI,1.45-7.22),非 JAK2 突变患者显示出更高的 SCC 风险,HR = 7.40(2.54-21.63)。

限制

回顾性设计。

结论和相关性

我们的真实世界结果表明,服用 ruxolitinib 的 PV 或 MF 患者的 SCC 风险增加,支持考虑进行皮肤癌监测。

更新日期:2021-10-11
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