High antileukemic activity of sequential high dose cytosine arabinoside and mitoxantrone in patients with refractory acute leukemias : Results of a clinical Phase II study

✍ Scribed by Wolfgang Kern; Eberhard Schleyer; Michael Unterhalt; Bernhard Wörmann; Thomas Büchner; Wolfgang Hiddemann

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 147 KB
• Volume: 79
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/(sici)1097-0142(19970101)79:1<59::aid-cncr9>3.0.co;2-h

✦ Synopsis

Department of Heremission whereas 5 patients (23%) succumbed to early death and 3 patients (14%) matology and Oncology, Go ¨ttingen, Germany.

did not respond. Blood counts recovered at a median of 33.5 days after the start 2 Westfa ¨lische Wilhelms University, Department of treatment and complete remission was achieved after a median of 38 days. of Hematology and Oncology, Mu ¨nster, Ger-

The median duration of complete remission was 4 months (range, 1-14 months) many.

whereas overall survival time lasted for a median of 4.5 months (range, 1-30/ months). Treatment-associated toxicity was comprised predominantly of infection and diarrhea that reached World Health Organization Grades 3 and 4 in 64% and 32% of patients, respectively. Complementary pharmacokinetic evaluations of plasma AraC and AraU levels revealed no impact of initial AraC administration on the pharmacokinetics of subsequent AraC administrations and failed to demonstrate any evidence of self-potentiation.

CONCLUSIONS.

The clinical data show the S-HAM regimen to be a promising approach for the treatment of patients with advanced acute leukemias. However, further evaluation at earlier stages of treatment is needed.