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Evaluation of Minimal Residual Disease Using Reverse-Transcription Polymerase Chain Reaction in t(8;21) Acute Myeloid Leukemia: A Multicenter Study of 51 Patients

From the Service des Maladies du Sang and Laboratoire d’Hématologie A, Centre Hospitalier Universitaire, and Unité L’Institut National de la Santé et de la Recherche Médicale (INSERM) U524, Lille; Laboratoire d’Hématologie Moléculaire, INSERM Unit U462, and Service d’Hématologie Pédiatrique, d’Hématologie Clinique Adulte, and de Greffe Médullaire, Hôpital St Louis, Paris; Service d’Hématologie, Centre Hospitalier Universitaire, Brest, France; and Hématologie, Clinique Universitaire St Luc, Brussels, Belgium.

Address reprint requests to Claude Preudhomme, MD, Laboratoire d’Hématologie, Hôpital Calmette, Centre Hospitalier Universitaire, 59037 Lille, France; email cpreudhomme{at}chru-lille.fr

PURPOSE: Most studies using various reverse-transcription polymerase chain reaction (RT-PCR) techniques reported that the detection of the AML1-ETO fusion transcript was a common finding in long-term complete remission (CR) in acute myeloid leukemia (AML) with t(8;21) translocation. However, larger prospective studies with interlaboratory quality control may be important to investigate more precisely the clinical usefulness of studying minimal residual disease with RT-PCR in t(8;21) AML.

PATIENTS AND METHODS: We collected 223 marrow samples from 51 patients with t(8;21) AML diagnosed in five centers and tested all samples by two different RT-PCR techniques (a nested technique and a one-step technique, with a sensitivity of 10^-6 and 10^-5, respectively) in two different laboratories.

RESULTS: Samples from 14 patients in long persistent CR (median follow-up duration, 112 months) were taken at least twice, and all were PCR-negative by both techniques. Samples were prospectively taken from 37 patients after achievement of first CR and/or second CR, before intensive consolidation treatment, and every 3 to 6 months after completion of therapy. Patients who converted to PCR negativity with the one-step technique (60%) or both techniques (48%) after CR achievement had a longer CR duration than those with persistently positive PCR results (two-sided log-rank test, P = .0001). Patients who became PCR-negative with the one-step technique before intensive consolidation (23%) had a lower relapse rate (11% v 72%) and a longer CR duration than those who remained persistently PCR-positive at that point (two-sided log-rank test, P = .0015).

CONCLUSION: Patients with AML with t(8;21) in long-term remission were all PCR-negative. In prospectively studied patients, a good correlation was found between negative PCR results and absence of relapse. Early negative results with the one-step RT-PCR technique, before consolidation treatment, seemed to carry an especially good prognosis, suggesting that RT-PCR analysis could help in choosing the type of consolidation therapy in patients with t(8;21) AML.

P. Fenaux and C. Preudhomme contributed equally as last authors to this work.

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