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Blood, Vol. 92 No. 10 (November 15), 1998:
pp. 3578-3581
Prospective Randomized Multicenter Clinical Trial on the Use of
Interferon  -2a Plus Acitretin Versus Interferon -2a Plus PUVA in
Patients With Cutaneous T-Cell Lymphoma Stages I and II
R. Stadler,
H.-G. Otte,
T. Luger,
B.M. Henz,
P. Kühl,
T. Zwingers, and
W. Sterry
From the Department of Dermatology, University of Ulm, Ulm, Germany;
the Department of Dermatology, Medical Center Minden, Minden, Germany;
the Department of Dermatology, University of Münster,
Münster, Germany; the Department of Dermatology, University of
Essen, Essen, Germany; the Department of Dermatology, University of
Berlin-Charité, Berlin, Germany; the Department of Dermatology,
University of Magdeburg, Magdeburg, Germany; the Department of
Dermatology, Clinic of Dortmund, Dortmund, Germany; the Department of
Dermatology, University of Heidelberg, Heidelberg, Germany; the
Department of Dermatology, University of Berlin-Benjamin Franklin,
Berlin, Germany; the Department of Dermatology, University of Zurich,
Zurich, Switzerland; the Department of Dermatology, University of
Vienna, Vienna, Austria; the Department of Dermatology,
Ferdinand-Sauerbruch-Clinic Wuppertal, Wuppertal, Germany; the
Department of Dermatology, University of Kiel, Kiel, Germany; the
Department of Dermatology, University of Göttingen,
Göttingen, Germany; the Department of Dermatology, University of
Würzburg, Würzburg, Germany; the Department of
Dermatology, St. Barbara Hospital Duisburg, Duisburg, Germany; the
Department of Dermatology, Clinic St. Georg Hamburg, Hamburg, Germany;
the Department of Dermatology, University of Greifswald, Greifswald,
Germany; the Department of Dermatology, University of Erlangen,
Erlangen, Germany; the Department of Dermatology, Clinic of Dresden,
Dresden, Germany; and the Department of Dermatology, Insel Spital Bern,
Bern, Switzerland.
Cutaneous T-cell lymphoma (CTCL) constitutes a malignant
proliferative disease involving mostly CD4+ T cells
arising in the skin. Because of the lack of curative treatment options,
interferons (IFN) have been introduced into the therapy of CTCL.
Although effective even in advanced disease, response rates were about
50% and the duration of response was short. To improve the results of
interferon monotherapy, combinations of IFN with oral photochemotherapy
(PUVA) or retinoids were investigated in nonrandomized trials showing
higher response rates. We have therefore conducted this prospective
randomized multicenter trial to compare these two combination
therapies, ie, IFN plus PUVA and IFN plus acitretin. IFN -2a
was administered at 9 MU three times weekly subcutaneously in both
groups, with lower increasing doses during the first week.
Photochemotherapy was applied after oral intake of 8-methoxypsoralen
(0.6 mg/kg body weight) 5× weekly during the first 4 weeks, 3×
weekly from weeks 5 through 23, and 2× weekly from weeks 24 through
48, with escalating doses beginning with 0.25 J/cm2.
Twenty-five milligrams of acitretin was administered daily during the
first week, and 50 mg was administered from weeks 2 through 48. Of 98 patients randomized in this study, 82 stage I and II patients were
evaluable: 40 in the IFN+PUVA group and 42 in the IFN+acitretin
group. With 70% complete remissions in the IFN+PUVA group, this
treatment was significantly superior to the IFN+acitretin group with
only 38.1% complete remissions. Time to response was significantly
shorter in the IFN+PUVA group, with 18.6 weeks compared with 21.8 weeks in the IFN+acitretin group. Side effects were mostly mild to
moderate and did not differ significantly in both treatment groups.
However, there were more adverse events leading to study
discontinuation in the IFN+acitretin group. Based on these findings,
we conclude that IFN plus oral photochemotherapy is superior to
IFN plus acitretin, inducing more complete remissions in patients
with CTCL stages I and II.
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