Pimecrolimus 1% cream for oral erosive lichen planus: a 6-week randomized, double-blind, vehicle-controlled study with a 6-week open-label extension to assess efficacy and safety.

OBJECTIVE: To assess the efficacy and safety of topical pimecrolimus 1% cream in the treatment of oral erosive lichen planus. DESIGN: A 6-week randomized, double-blind, vehicle-controlled phase followed by a 6-week open-label phase. SETTING: Outpatients of the Department of Dermatology, University of Utah. PATIENTS: Twenty-one patients with oral erosive lichen planus were randomized and treated with either pimecrolimus 1% cream or vehicle cream. INTERVENTION: Pimecrolimus 1% cream, or its vehicle, were applied twice daily for 6 weeks to each side of the mouth with a 2×2 inch gauze pad folded in half and placed directly on the erosive lesion. MAIN OUTCOME MEASURES: Efficacy was based on clinical evaluation of Investigator's Global Assessment (IGA) of the overall severity of the disease, erythema, measurement of the size of any target erosion in millimetres, and assessment of spontaneous pain. Blood levels of pimecrolimus were monitored in all subjects on day 0 and repeated on day 7. RESULTS: Pimecrolimus 1% cream was superior to vehicle cream in reducing mean IGA, pain, and erosion size. For the vehicle group that entered the open-label phase, pimecrolimus 1% cream improved the mean IGA, pain, erosion size, and erythema. Pimecrolimus levels were detected in nine out of 10 of the pimecrolimus-treated subjects. These levels were consistently low. The pimecrolimus cream was well-tolerated. No clinically relevant, drug-related adverse events were reported. CONCLUSION: Pimecrolimus 1% cream was superior to vehicle in reducing pain, erythema, decreasing erosion size, and improving overall severity of disease when compared with vehicle treatment.

Epirubicin chemotherapy and advanced breast cancer after adjuvant CMF chemotherapy.

There have been conflicting reports on the effect of prior adjuvant chemotherapy on the response of advanced breast cancer to primary chemotherapy. We report a retrospective review of the outcome of chemotherapy with epirubicin 100 mg/m2 for advanced breast cancer in 39 patients who had previously received adjuvant cyclophosphamide, methotrexate and 5-fluorouracil (CMF). The response rate (complete responses plus partial responses) was 38.5%, with a median duration of response of 33 weeks. There was no significant difference in the response rate or duration of survival when these patients were compared with matched controls who had not received adjuvant chemotherapy. However, the limitations of this study were such that an adverse effect of adjuvant CMF on the response to epirubicin cannot be excluded.