title: A phase I study to assess the safety and activity of topical lovastatin (FP252S) for the prevention of chemotherapy-induced alopecia.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  Lovastatin was well-tolerated at the maximum concentration achievable but showed little efficacy.
authors.affiliation: Medical Oncology, Royal Adelaide Hospital Cancer Centre, Royal Adelaide Hospital, Adelaide, SA 5000, Australia.
authors.forename: Rohit
authors.initials: R
authors.lastname: Joshi
authors.forename: Ian
authors.initials: I
authors.lastname: Olver
authors.forename: Dorothy
authors.initials: D
authors.lastname: Keefe
authors.forename: Toni
authors.initials: T
authors.lastname: Marafioti
authors.forename: Keith
authors.initials: K
authors.lastname: Smith
mesh_terms: D000287:Administration, Topical; D000505:Alopecia / Q000139:chemically induced* / Q000517:prevention & control*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004317:Doxorubicin / Q000009:adverse effects; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D008148:Lovastatin / Q000008:administration & dosage*; D043823:Taxoids / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D003879:Dermatologic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D043823:Taxoids; D004317:Doxorubicin; D008148:Lovastatin