title: Results of a prospective phase II trial with oral low-dose bexarotene plus photochemotherapy (PUVA) in refractory and/or relapsed patients with mycosis fungoides.
abstract: BACKGROUND
  Bexarotene is a synthetic retinoid effective in early and advanced stages of mycosis fungoides (MF)/Sezary Syndrome (SS) both in monotherapy and combination schemes. We aimed to assess disease response to low-dose bexarotene and PUVA in maintenance in refractory and/or resistant patients with early and advanced stage MF/SS.
  
  
  METHODS
  We followed prospectively 21 patients (stages IB-IV): 15 with early stage MF and 6 with advanced disease. "Mini" and standard protocols were respectively applied to patients who failed PUVA or several systemic regimens. The dose of bexarotene and the administration of PUVA were titrated individually and tailored during induction and maintenance according to previous therapy, disease stage and toxicity. We evaluated overall response (OR) at the end of maintenance, safety and event-free survival (EFS).
  
  
  RESULTS
  After induction phase, OR was 85.6%, higher in early MF (93.4%) than in advanced disease (66.6%). At the end of maintenance, OR was 76.2%, including 33.3% of CR. Median EFS for the whole group was 31 months. Bexarotene was well tolerated regarding the side effects, with prophylaxis and progressive drug increase in the induction phase of the protocol. Side effects were mainly of low and moderate grades.
  
  
  CONCLUSIONS
  We observed a favorable rate of therapeutic effects and few, generally mild, side effects with low doses of bexarotene combined with PUVA.
authors.affiliation: Clinic of Hematology.
authors.forename: Serena
authors.initials: S
authors.lastname: Rupoli
authors.affiliation: Clinic of Hematology.
authors.forename: Lucia
authors.initials: L
authors.lastname: Canafoglia
authors.affiliation: Institute of Pathology.
authors.forename: Gaia
authors.initials: G
authors.lastname: Goteri
authors.affiliation: Clinic of Hematology.
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
authors.affiliation: Clinic of Dermatology, AOU Ospedali Riuniti Umberto I, via Conca 71, 60126 Ancona, Italy.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Brandozzi
authors.affiliation: Clinic of Hematology.
authors.forename: Irene
authors.initials: I
authors.lastname: Federici
authors.affiliation: Clinic of Hematology.
authors.forename: Giorgia
authors.initials: G
authors.lastname: Micucci
authors.affiliation: Institute of Pathology.
authors.forename: Federica
authors.initials: F
authors.lastname: Giantomassi
authors.affiliation: Clinic of Dermatology, INRCA Ancona, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Mozzicafreddo
authors.affiliation: Division of Hematology, Dept. Clinical and Experimental Medicine.
authors.forename: Renato
authors.initials: R
authors.lastname: Alterini
authors.affiliation: Clinic of Dermatology, JESI.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Filosa
authors.affiliation: Clinic of Dermatology, INRCA Ancona, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ricotti
authors.affiliation: Clinic of Dermatology, Macerata, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Simonacci
authors.affiliation: Clinic of Hematology.
authors.forename: Anna Rita
authors.initials: AR
authors.lastname: Scortechini
authors.affiliation: Institute of Pathology.
authors.forename: Antonio
authors.initials: A
authors.lastname: Zizzi
authors.affiliation: Division of Dermatology, Dept. Surgery and Translational Medicine, University of Florence Medical School, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Pimpinelli
mesh_terms: D000328:Adult; D000368:Aged; D016588:Anticarcinogenic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000077610:Bexarotene; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000188:drug therapy*; D010778:Photochemotherapy; D011446:Prospective Studies; D013764:Tetrahydronaphthalenes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D016588:Anticarcinogenic Agents; D013764:Tetrahydronaphthalenes; D000077610:Bexarotene
keywords: PUVA; bexarotene; mycosis fungoides