Background: No long-term randomized controlled clinical trial has compared the efficacy of cryosurgery alone vs cryosurgery following fluorouracil applications for the treatment of actinic keratosis.Objective: To determine the 6-month outcome of a 1-week course of 0.5% fluorouracil followed by cryosurgery.Design: Prospective, multicenter, randomized, doubleblind, vehicle-controlled clinical trial performed in community and academic outpatient clinics.Patients: A total of 144 patients with 5 or more visible or palpable actinic keratoses on the face.Interventions: Topical 0.5% fluorouracil or vehicle once daily for 7 days. At the 4-week follow-up visit, residual lesions were treated with cryosurgery.Main Outcome Measure: Reduction in facial actinic keratoses from baseline to 4 weeks and 6 months.Results: At 4 weeks, mean actinic keratosis lesion count was reduced by 62.4% in the 0.5% fluorouracil group vs 28.8% in the vehicle group (PϽ.001), and complete clearance was achieved in 16.7% of patients in the 0.5% fluorouracil group vs 0% of those in the vehicle group (PϽ.001). At 6 months, mean lesion count was reduced by 67.0% in the 0.5% fluorouracil plus cryosurgery group vs 45.6% in the vehicle plus cryosurgery group (P=.01), and significantly more patients in the 0.5% fluorouracil plus cryosurgery group than in the vehicle plus cryosurgery group had complete clearance (30% vs 7.7%; PϽ.001).Conclusions: A 1-week course of topical 0.5% fluorouracil before cryosurgery is significantly more effective in reducing patients' numbers of actinic keratosis lesions 6 months after treatment than cryosurgery alone. The high occurrence rate of actinic keratosis lesions at 6 months suggests a need for follow-up.
Brentuximab vedotin is a monoclonal anti-CD30 antibody-drug conjugate that has been used to treat a variety of CD30+ neoplasms. The phenomenon of antigen loss has been observed in patients treated with the anti-CD20 antibody rituximab. This study seeks to assess for antigen loss in the setting of recurrent CD30+ neoplasms treated with brentuximab vedotin. We report 9 cases of persistent/recurrent cutaneous CD30+ lymphoid neoplasms that demonstrated variable CD30 expression after treatment with brentuximab vedotin. Cases include mycosis fungoides (n¼6), cutaneous T cell lymphoma, not otherwise specified (n¼1), and anaplastic large cell lymphoma, both primary (n¼1) and systemic (n¼1). Immunohistochemical staining revealed decreased CD30 expression following brentuximab vedotin therapy in 7 of 9 cases. In these 7 cases, the pre-treatment percent of tumor cells staining for CD30 ranged from 10-100% (mean 50.0%, SD 27.8%), compared to 5-50% (mean 14.5%, SD 14.8%, p¼0.003) at recurrence. This case series highlights the finding that CD30 positivity can be variable in recurrences after treatment with anti-CD30 antibodies. This serves to raise awareness of the phenomenon of antigen loss after treatment with brentuximab vedotin and underscores the utility of performing multiple biopsies and/or employing molecular diagnostic techniques in patients with recurrent/persistent disease.
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