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Intensive chemotherapy with idarubicin, ara-C, etoposide, and m-AMSA followed by immunotherapy with interleukin-2 for myelodysplastic syndromes and high-risk Acute Myeloid Leukemia (AML)
Authors:A Ganser  G Heil  G Seipelt  W Hofmann  J T Fischer  W Langer  W Brockhaus  K Kolbe  T H Ittel  N Brack  H G Fuhr  P Knuth  K Höffken  L Bergmann  D Hoelzer
Institution:Medizinische Klinik III, Klinikum der Universit?t Frankfurt, Germany, DE
Medizinische Klinik III, Klinikum der Universitat Ulm, Germany, DE
II. Medizinische Klinik, St?dtisches Klinikum Karlsruhe, Germany, DE
Abteilung für H?matologie-Onkologie, Ev. Krankenhaus Essen-Werden, Germany, DE
2. Medizinische Klinik, Klinikum Nürnberg, Germany, DE
Abteilung für H?matologie, III. Medizinische Klinik der Universit?t Mainz,Germany, DE
Medizinische Klinik II, Klinikum der RWTH Aachen, Germany, DE
Abteilung für H?matologie-Onkologie, München-Harlaching, Germany, DE
Medizinische Klinik B, Klinikum Wiesbaden, Germany, DE
Medizinische Klinik, Krankenhaus Nordwest, Frankfurt, Germany, DE
Klinik für Innere Medizin II, Klinikum der Universit?t Jena, Germany, DE
Abstract: Intensive chemotherapy followed by treatment with interleukin-2 (IL-2) was evaluated in a prospective, randomized, multicenter trial including 18 patients with refractory anemia with excess of blasts in transformation (RAEB-T), 86 patients with acute myeloid leukemia (AML) evolving from myelodysplastic syndromes, and six patients with secondary AML after previous chemotherapy. Median age was 58 years (range: 18–76 years). Forty-nine patients (45%) achieved a complete remission (CR) after two induction cycles with idarubicin, ara-C, and etoposide, 52% of them aged ≤60 years and 35% aged >60 years (p=0.06). After two consolidation courses, patients were randomized to four cycles of either high- or low-dose IL-2. Patients aged up to 55 years with an HLA-identical sibling donor were eligible for allogeneic bone marrow transplantation. The median relapse-free survival was 12.5 months, with a probability of ongoing CR at 6.5 years of 19%. Overall survival of all patients was 8 months, and 21 months for the CR patients. Median survival was significantly longer among patients aged ≤60 years than among the older patients (16 vs 6 months, p<0.001). Median duration of survival and relapse-free survival were not statistically different in the two IL-2 treatment arms. Received: March 23, 1999 / Accepted: June 23, 1999
Keywords:  Acute myeloid leukemia  Myelodysplastic syndrome  Secondary leukemia  Interleukin-2  G-CSF
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