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Treatment of refractory Hodgkin's disease with high‐dose cytosine arabinoside and mitoxantrone in combination. Results of a clinical phase II study of the German Hodgkin study group
Author(s) -
Hiddemann Wolfgang,
Schmitz Norbert,
Pfreundschuh Michael,
Pflüger KarlHeinz,
OllechChwoyka Jürgen,
Tirier Christian,
Maschmeyer Georg,
Kirchner Hartmut,
Wagner Thomas,
Koch Peter,
Dahmen Elmar,
Fiedler Walter,
Trümper Lorenz,
Diehl Volker
Publication year - 1990
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19900901)66:5<838::aid-cncr2820660504>3.0.co;2-r
Subject(s) - medicine , mitoxantrone , cytopenia , refractory (planetary science) , gastroenterology , surgery , progressive disease , disease , bone marrow , chemotherapy , physics , astrobiology
Abstract In the present study, the activity and side effects of high‐dose cytosine arabinoside (HD‐Ara‐C) in combination with mitoxantrone (mitox) (HAM) was evaluated in 32 heavily pretreated patients with refractory Hodgkin's disease. Therapy consisted of HD‐Ara‐C 3 g/m 2 every 12 hours days 1 and 2 and mitox 10 mg/m 2 /d days 3 to 5. In subsequent steps, HD‐Ara‐C was escalated to six and eight doses for 3 and 4 days, respectively, and mitox to four doses on days 2 to 5. Thirty‐two patients 17 to 55 years of age entered the study. Twenty‐five cases presented with extranodal disease and disseminated organ involvement and 21 revealed systemic (B) symptoms. Eighteen patients (56%) responded with five complete and 13 partial remissions, ten patients (31%) had refractory disease, and four patients died from infections during treatment‐induced cytopenia. The predominant toxicity was severe myelosuppression in all patients with major infections occurring during 55% of treatment courses. Ten of the responding 18 patients underwent subsequent autologous (n = 9) or allogeneic bone marrow transplant (BMT). Seven of these cases are currently alive at 5+ to 22+ months, six of them without evidence of disease. Among the remaining eight patients not receiving BMT, three are alive at 6+ to 19+ months from the initiation of HAM, two of them in ongoing remissions of 2+ and 5+ months' duration. Two patients died from transplant‐related complications and six patients succumbed to progressive disease following relapse. The median survival for all treated patients is 6.2 months. These data indicate that HAM has a significant activity in refractory Hodgkin's disease. However, the substantial side effects and the lack of an obvious superiority to alternative, less intensive regimens limits the further application of the two‐drug combination in its present form. Modifications in timing and dosage and the addition of hematopoietic growth factors will be evaluated in subsequent trials.