[Primary treatment of hairy cell leukemia with low-dose human recombinant interferon-alpha-2c (Hr-IFn alpha 2c) in comparison with therapy following splenectomy. Interferon (IFn-alpha 2c) in HCL before or after splenectomy].
Within less than 14 months of recruitment 32 centers enrolled 97 patients in a multicenter trial for low-dose treatment of hairy cell leukemia (1.2 X 10(6) IU/m2 X 28 days s.c. with dose reduction according to clinically judged improvement) or ultra-low dose treatment (1.2 X 10(5) IU/m2, s.c. daily increasing to a well-tolerated dose) with Hr IFn-2c (arg). Induction therapy was limited to 84 days. Patients who reached the clinical stage Jansen I or A were then randomized to 2 arms either to receive further IFn (1.2 X 10(6) IU/m2 s.c.) twice a week or to be taken off treatment. For both arms induction therapy was reinstituted whenever a patient lost the criteria of Jansen stage A or I. The study included obligatory central diagnostic procedures and several special investigations. During the first year of the study a special problem evolved in the group of 34 patients with recurrent disease after splenectomy. Ten of them died, 9 of septicemia and 1 of bleeding complications, whereas only 1 death occurred in those patients who received IFn before splenectomy. The risk factors and the response to therapy in the two groups will be analyzed in order to define the criteria that will be needed for the proper choice of primary treatment for HCL. It appears important to us to restrict splenectomy to selected patients.
Pralle
H
H
Zwingers
T
T
Boedewadt
S
S
Bross
K
K
Dörken
B
B
Gamm
H
H
Ho
A D
AD
Parwaresch
R M
RM
Schmitz
N
N
Papendick
U
U
D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006801:Humans; D007370:Interferon Type I / Q000627:therapeutic use*; D007943:Leukemia, Hairy Cell / Q000628:therapy*; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012306:Risk; D013156:Splenectomy
D007370:Interferon Type I; D011994:Recombinant Proteins
Primäre Behandlung der Haarzelleukämie mit niedrigdosiertem humanem rekombinantem Interferon-Alpha-2c (Hr-IFn Alpha 2c) im Vergleich zur Therapie nach Splenektomie. Interferon (IFn-Alpha 2c) bei HCL vor oder nach Splenektomie.