Prospective multicenter study of pegylated liposomal doxorubicin treatment in patients with advanced or refractory mycosis fungoides or Sézary syndrome.
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).


METHODS
Prospective, open, multicenter study.


METHODS
Thirteen dermatology departments in France.


METHODS
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.


METHODS
Administration of Caelyx intravenously once every 4 weeks at a dose of 40 mg/m(2).


METHODS
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/m(2) does not seem to improve the effectiveness but increases toxic effects (especially hematologic toxic effects) compared with the dose previously tested of 20 mg/m(2).
Quereux
Gaëlle
G
Departments of Dermatology, Centre Hospitalier Universitaire, Nantes, France.
Marques
Sonia
S
Nguyen
Jean-Michel
JM
Bedane
Christophe
C
D'incan
Michel
M
Dereure
Olivier
O
Puzenat
Elisabeth
E
Claudy
Alain
A
Martin
Ludovic
L
Joly
Pascal
P
Delaunay
Michele
M
Beylot-Barry
Marie
M
Vabres
Pierre
P
Celerier
Philippe
P
Sasolas
Bruno
B
Grange
Florent
F
Khammari
Amir
A
Dreno
Brigitte
B
D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000175:diagnosis / Q000188:drug therapy*; D009367:Neoplasm Staging; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D013577:Syndrome; D016896:Treatment Outcome
C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin