A 10-year retrospective cohort study of ruxolitinib and association with non-melanoma skin cancer in polycythemia vera and myelofibrosis patients.

Abstract

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.

View details for DOI 10.1016/j.jaad.2021.10.004

View details for PubMedID 34648874