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ABMT vs. Chemotherapy in Adults: A Multicenter Study
AUTOLOGOUS BONE MARROW TRANSPLANTATION VERSUS
CHEMOTHERAPY FOR ADULT ACUTE MYELOBL ASTIC LEUKEMIA
IN FIRST REMISSION: PRELIMINARY RESULTS OF A
MULTICENTER RANDOMIZED STUDY
J.Y. Cohn, J.L. Harousseau, B. Pignon, M. Mercier, F. Witz, P. Colombat,
F. Oberling, C. Ghandour, N. Ifrah, D. Caillot, M. Jeffredo, B. Desablens,
B. Audhuy, P. Casassus and P. Hurteloup
For the GOELAM Study Group, France; Hôpital Minjoz Bd Fleming, Besancon,
France
INTRODUCTION
Complete remission is now expected in the majority of previously
untreated adults with de novo acute myeloid leukemia (AML). Patients under
age 60 enter complete remission in 70-75% of cases (1). Treatment strategies
are directed on mamtaining these remissions by intensification chemotherapy (2)
or very intensive chemotherapy or chemo-radiotherapy followed by autologous
or allogeneic bone marrow transplantation.
To evaluate the relative value of each approach, the GOELAM group
decided, in November 1987, to initiate a prospective randomized study
comparing early autologous BMT to a second intensification chemotherapy for
all patients less than 50 years old. Patients less than 40 with an HLA identical
sibling were randomized at diagnosis and received allogeneic BMT after
achieving CR without consolidation or intensification therapy.
PATIENTS AND PROTOCOLS
All patients aged less than 50 years old with untreated de novo AML
were randomized at diagnosis between two induction therapies: regimen A
consisting of idarubicin (8 mg/m 2 /d x 5 days) and cytarabine (200 mg/m 2 /d x
7 days) or regimen B consisting of zorubicin (200 mg/m 2 /d x 4 days) and
cytarabine (same dose than regimen A).
Patients under age 40 who had an HLA identical sibling donor
proceeded to allogeneic bone marrow transplantation without other
intensification therapy. Conditioning regimen and graft-versus-host disease
prophylaxis were chosen according to each center's protocol.
The other patients attaining complete remission received a first
intensification with high-dose Ara-C (3 g/nr q 12 h from Dl to D4) followed