European Journal of Dermatology

, Volume 26, Issue 1, pp 13–20 | Cite as

Results of a prospective phase II trial with oral low-dose bexarotene plus photochemotherapy (PUVA) in refractory and/or relapsed patients with mycosis fungoides

  • Serena Rupoli
  • Lucia Canafoglia
  • Gaia Goteri
  • Pietro Leoni
  • Giuliano Brandozzi
  • Irene Federici
  • Giorgia Micucci
  • Federica Giantomassi
  • Giorgio Mozzicafreddo
  • Renato Alterini
  • Giorgio Filosa
  • Giuseppe Ricotti
  • Marco Simonacci
  • Anna Rita Scortechini
  • Antonio Zizzi
  • Nicola Pimpinelli



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.


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).


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.


We observed a favorable rate of therapeutic effects and few, generally mild, side effects with low doses of bexarotene combined with PUVA.

Key words

mycosis fungoides bexarotene PUVA 



Adverse Events


Interferon alpha


Creatine Phosphokinase


Complete Remission


Cutaneous T-cell Lymphomas


Extracorporeal photopheresis


Event Free Survival


European Organisation for Research and Treatment of Cancer


Free Triiodothyronine


Free thyroxine


International Society for Cutaneous Lymphomas






Lactate Dehydrogenase


Meter(s) square


Mycosis Fungoides






Million Units


Overall Response


Overall Response Rate


Per os/by mouth/orally


PS-341 Anthracycline Dexamethasone


Progressive Disease


Pegylated liposomal doxorubicin


Partial Remission


Psoralen and Ultraviolet A


Retinoid X Receptor


Stable Disease


Sezary Syndorme


Severity Weighted Assessment Tool


Total Body Surface Area


Tumor Node Metastatic Blood


Thyroid-stimulating Hormone


Narrowband UVB


World Health Organization


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Copyright information

© John Libbey Eurotext 2016

Authors and Affiliations

  • Serena Rupoli
    • 1
  • Lucia Canafoglia
    • 1
  • Gaia Goteri
    • 2
  • Pietro Leoni
    • 1
  • Giuliano Brandozzi
    • 3
  • Irene Federici
    • 1
  • Giorgia Micucci
    • 1
  • Federica Giantomassi
    • 2
  • Giorgio Mozzicafreddo
    • 4
  • Renato Alterini
    • 5
  • Giorgio Filosa
    • 6
  • Giuseppe Ricotti
    • 4
  • Marco Simonacci
    • 7
  • Anna Rita Scortechini
    • 1
  • Antonio Zizzi
    • 2
  • Nicola Pimpinelli
    • 8
  1. 1.Clinic of HematologyAOU Ospedali Riuniti Umberto IAnconaItaly
  2. 2.Institute of PathologyAOU Ospedali Riuniti Umberto IAnconaItaly
  3. 3.Clinic of DermatologyAOU Ospedali Riuniti Umberto IAnconaItaly
  4. 4.Clinic of DermatologyINRCAAnconaItaly
  5. 5.Division of Hematology, Dept. Clinical and Experimental MedicineJESIMacerataItaly
  6. 6.Clinic of DermatologyJESIMacerataItaly
  7. 7.Clinic of DermatologyMacerataItaly
  8. 8.Division of Dermatology, Dept. Surgery and Translational MedicineUniversity of Florence Medical SchoolFlorenceItaly

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