A phase I study to assess the safety and activity of topical lovastatin (FP252S) for the prevention of chemotherapy-induced alopecia

Abstract

Introduction A phase I study was performed to establish the minimum effective dose safety of the topical 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitor lovastatin (FP252S) in preventing chemotherapy-induced alopecia in cohorts of three patients receiving their first doses of chemotherapy with doxorubicin (eight patients) or taxanes (four patients). Results One patient at the first dose level receiving doxorubicin and cyclophosphamide had only grade 1 hair loss at 3 weeks. At dose level 2, one patient on doxorubicin took more than 4 weeks to lose her hair and another on docetaxel retained some hair throughout her chemotherapy. At level 3, one patient had grade 2 hair loss at week 4 and another on docetaxel for 6 cycles showed evidence of hair growth between cycles. There were no grade 3 or 4 toxicities, but at the fourth dose level, no higher concentrations could be formulated. Discussion Lovastatin was well-tolerated at the maximum concentration achievable but showed little efficacy.