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
Therapy
  • 54 Downloads

Abstract

Introduction

Bexarotene is a synthetic retinoid effective in early and advanced stages of mycosis fungoides (MF)/Sezary Syndrome (SS) both in monotherapy and combination schemes.

Objectives

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.

Key words

mycosis fungoides bexarotene PUVA 

Abbreviations

AEs

Adverse Events

IFN-α

Interferon alpha

CPK

Creatine Phosphokinase

CR

Complete Remission

CTCL

Cutaneous T-cell Lymphomas

ECP

Extracorporeal photopheresis

EFS

Event Free Survival

EORTC

European Organisation for Research and Treatment of Cancer

Ft3

Free Triiodothyronine

Ft4

Free thyroxine

ISCL

International Society for Cutaneous Lymphomas

J/cm2

Joul/centimeter(s)

KG

Kilogram(s)

LDH

Lactate Dehydrogenase

m2

Meter(s) square

MF

Mycosis Fungoides

MG

Milligram(s)

µg

Microgram(s)

MU

Million Units

OR

Overall Response

ORR

Overall Response Rate

P.O.

Per os/by mouth/orally

PAD

PS-341 Anthracycline Dexamethasone

PD

Progressive Disease

PLD

Pegylated liposomal doxorubicin

PR

Partial Remission

PUVA

Psoralen and Ultraviolet A

RXR

Retinoid X Receptor

SD

Stable Disease

SS

Sezary Syndorme

SWAT

Severity Weighted Assessment Tool

TBSA

Total Body Surface Area

TNMB

Tumor Node Metastatic Blood

TSH

Thyroid-stimulating Hormone

UVB-NB

Narrowband UVB

WHO

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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