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Japanese Journal of Clinical Oncology Advance Access originally published online on September 19, 2005
Japanese Journal of Clinical Oncology 2005 35(10):612-616; doi:10.1093/jjco/hyi149
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© 2005 Foundation for Promotion of Cancer Research

Phase II Trial of Amsacrine Plus Intermediate-dose Ara-C (IDAC) with or without Etoposide as Salvage Therapy for Refractory or Relapsed Acute Leukemia

Woo Jin Sung1, Dong Hwan Kim1,2, Sang Kyun Sohn1,2, Jong Gwang Kim1,2, Jin Ho Baek1, Seok Bong Jeon1, Joon Ho Moon1, Byung Min Ahn1 and Kyu Bo Lee1,2

1 Department of Hematology/Oncology, 2 Stem Cell Transplantation Center, Kyungpook National University Hospital, Daegu, Korea

For reprints and all correspondence: Sang Kyun Sohn, Department of Hematology/Oncology, Kyungpook National University Hospital, 50 Samduk 2-ga, Jung-gu, Daegu 700-721, Korea. E-mail: sksohn{at}knu.ac.kr

Received May 12, 2005; accepted July 24, 2005

Objective: The current trial attempted to evaluate the efficacy and toxicity of a salvage therapy consisting of amsacrine plus intermediate-dose Ara-C (IDAC) with or without etoposide for acute leukemia patients in refractory or relapsed states.

Methods: A total of 51 patients with refractory or relapsed acute leukemia were included in the current trial. Twenty-nine patients with acute myeloid leukemia (AML) received a salvage therapy of amsacrine plus IDAC and etoposide, while 22 patients with acute lymphoblastic leukemia (ALL) received amsacrine plus IDAC.

Results: The overall complete remission rate was 55% (45% for AML, 68% for ALL) and the median duration of overall survival was 144 days (95% confidence interval = 101–186 days). Grade 3, 4 infectious toxicities were observed in 43 patients (87%), while treatment-related toxicity, excluding infectious causes, included heart failure from myocarditis (n = 1) and central nervous system toxicity (n = 1).

Conclusion: A salvage therapy consisting of amsacrine plus IDAC with or without etoposide appears to be safe and an effective bridge therapy into a stem cell transplantation programme for patients with refractory or relapsed acute leukemia.

Key Words: acute leukemia • salvage therapy • amsacrine • intermediate-dose Ara-C • etoposide


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