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Prospective Multicenter Study of Pegylated Liposomal Doxorubicin Treatment in Patients With Advanced or Refractory Mycosis Fungoides or Sézary Syndrome
Gaëlle Quereux, MD;
Sonia Marques, MD;
Jean-Michel Nguyen, MD, PhD;
Christophe Bedane, MD, PhD;
Michel D’incan, MD, PhD;
Olivier Dereure, MD, PhD;
Elisabeth Puzenat, MD;
Alain Claudy, MD, PhD;
Ludovic Martin, MD, PhD;
Pascal Joly, MD, PhD;
Michele Delaunay, MD;
Marie Beylot-Barry, MD, PhD;
Pierre Vabres, MD, PhD;
Philippe Celerier, MD;
Bruno Sasolas, MD;
Florent Grange, MD, PhD;
Amir Khammari, PhD;
Brigitte Dreno, MD, PhD
Arch Dermatol. 2008;144(6):727-733.
Objective To assess the rate of objective response to pegylated liposomal doxorubicin hydrochloride (Caelyx) in patients with advanced or refractory cutaneous T-cell lymphoma (CTCL).
Design Prospective, open, multicenter study.
Setting Thirteen dermatology departments in France.
Patients Twenty-five patients with either (1) stage II to stage IV CTCL previously unsuccessfully treated with at least 2 lines of treatments or (2) histologically transformed epidermotropic CTCL requiring chemotherapy.
Intervention Administration of Caelyx intravenously once every 4 weeks at a dose of 40 mg/m2.
Main Outcome Measures The response to treatment was evaluated by clinical evaluation.
Results At the end of treatment, we observed an objective response (primary end point) in 56% of the patients (14 of 25): 5 complete responses and 9 partial responses. The median overall survival time was 43.7 months. For the 14 patients who experienced an objective response, the median progression-free survival time after the end of treatment was 5 months.
Conclusions This prospective study demonstrates the effectiveness of Caelyx in treating CTCL, with an overall response rate of 56% in spite of the high proportion of patients with advanced-stage disease. Responses were observed in 2 subpopulations of patients in which the prognosis is known to be poorer: Sézary syndrome (overall response rate, 60%) and transformed CTCL (overall response rate, 50%). Moreover, this study shows that dose escalation to 40 mg/m2 does not seem to improve the effectiveness but increases toxic effects (especially hematologic toxic effects) compared with the dose previously tested of 20 mg/m2.
Author Affiliations: Pôle d’Information Médicale, d’Evaluation de Santé Publique du Centre Hospitalier Universitaire, Nantes, France (Dr Nguyen); Departments of Dermatology, Centre Hospitalier Universitaire, Nantes (Drs Quereux, Marques, Khammari, and Dreno), Centre Hospitalier Régional Universitaire, Limoges (Dr Bedane), Hôpital Hôtel Dieu, Clermont Ferrand (Dr D’incan), Hôpital Saint Eloi, Montpellier (Dr Dereure), Centre Hospitalier Régional Universitaire, Besançon (Dr Puzenat), Hôpital E. Herriot, Lyon (Dr Claudy), Centre Hospitalier Régional–Hôpital Porte Madeleine, Orleans (Dr Martin), Hôpital Charles Nicolle, Rouen (Dr Joly), Hôpital Saint André, Bordeaux (Dr Delaunay), Hôpital Haut Leveque, Pessac (Dr Beylot-Barry), Hôpital Bocage Sud, Dijon, (Dr Vabres), Centre Hospitalier Le Mans, Le Mans (Dr Celerier), Hôpital Morvan, Brest (Dr Sasolas), and Hospices Civils de Colmar, Colmar (Dr Grange), France.
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