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Japanese Journal of Clinical Oncology Advance Access published online on September 19, 2005
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyi149
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© 2005 Foundation for Promotion of Cancer Research
Received May 12, 2005
Accepted July 24, 2005

Original Article

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 Sung 1, Dong Hwan Kim 2, Sang Kyun Sohn 2*, Jong Gwang Kim 2, Jin Ho Baek 1, Seok Bong Jeon 1, Joon Ho Moon 1, Byung Min Ahn 1, and Kyu Bo Lee 2

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

* To whom correspondence should be addressed.
Sang Kyun Sohn, E-mail: sksohn{at}knu.ac.kr


  Abstract

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.

Keywords: acute leukemia; salvage therapy; amsacrine; intermediate-dose Ara-C; etoposide.
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