title: Topical Application of a Galenical Formulation for the Management of Everolimus-Induced Mucositis in Patients with Metastatic Cancer: a Retrospective Study.
abstract: BACKGROUND
  Stomatitis is a common and potentially dose-limiting adverse event of the mammalian target of rapamycin (mTOR) inhibitor therapy. To minimize dose reductions or treatment delays that may affect therapeutic outcomes, management includes patient education, pain management strategies, and drug treatment. The aim of this study was to evaluate the effectiveness of a topically-applied galenical preparation to minimize the impact of everolimus-associated oral mucositis in patients with advanced cancer.
  
  
  METHODS
  Patients receiving everolimus plus exemestane for advanced breast cancer or everolimus alone for advanced renal cancer were eligible for inclusion. All patients were advised on procedures to maintain good oral hygiene and directed to use a dexamethasone-containing galenical preparation at the first signs of mucositis. Questionnaires were administered at baseline, and after cycles one, two, and three to evaluate the presence, duration, and intensity of oral mucositis.
  
  
  RESULTS
  Of the 19 patients included in the study (mean age 66 years; 16% male), mucositis developed in 10.5%, 47.4%, and 52.6% of patients after the first, second, and third cycles of everolimus, respectively. The median time to development of mucositis was 18.0 days, and the median time to mucositis resolution was 30.0 days. After the first, second, and third cycles of therapy, 5.3%, 10.5%, and 10.5% of patients required interruption of everolimus therapy; however, no dosage reductions for mucositis were necessary.
  
  
  CONCLUSIONS
  Patient education and the provision of an effective galenical preparation can minimize the effect of mTOR inhibitor-related mucositis.
authors.affiliation: Medical Oncology Unit, Annunziata Hospital, Cosenza, Italy.
authors.forename: Serafino
authors.initials: S
authors.lastname: Conforti
authors.affiliation: Medical Oncology Unit, Annunziata Hospital, Cosenza, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Minardi
authors.affiliation: University La Sapienza, Rome, Italy.
authors.forename: Ludovica
authors.initials: L
authors.lastname: Conforti
authors.affiliation: Medical Oncology Unit, Annunziata Hospital, Cosenza, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Turano
authors.affiliation: Pharmacy Annunziata Hospital, Cosenza, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Bilotta
authors.affiliation: Bufalini Hospital, Cesena, Italy.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Vilardo
authors.affiliation: Medical Oncology Unit, Annunziata Hospital, Cosenza, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Palazzo
keywords: Advanced cancer; Breast cancer; Everolimus; Oral mucositis; Renal cancer; mTOR inhibitor-associated stomatitis