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Blood, 15 January 2002, Vol. 99, No. 2, pp. 443-449
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Real-time quantitation of minimal residual disease in
inv(16)-positive acute myeloid leukemia may indicate risk for
clinical relapse and may identify patients in a curable state
Silvia Buonamici,
Emanuela Ottaviani,
Nicoletta Testoni,
Vittorio Montefusco,
Giuseppe Visani,
Francesca Bonifazi,
Marilina Amabile,
Carolina Terragna,
Deborah Ruggeri,
Pier Paolo Piccaluga,
Alessandro Isidori,
Michele Malagola,
Michele Baccarani,
Sante Tura, and
Giovanni Martinelli
From the Institute of Hematology and Medical Oncology
L. e A. Seràgnoli, University of Bologna, Italy.
The inv(16) cytogenetic subtype of acute myeloid leukemia (AML) has
a relatively good prognosis. Many patients achieve complete remission
(CR). The prognostic uncertainty of negative qualitative reverse
transcription-polymerase chain reaction (RT-PCR) assays suggests the
need to identify prognostically significant critical thresholds by
real-time RT-PCR. A reliable and sensitive (10 5)
real-time RT-PCR assay was set up for the evaluation of relevant CBF -MYH11/ABL transcript ratios and was applied to the 21 patients with inv(16) AML routinely referred for cytogenetic and molecular monitoring in Seràgnoli Institute (Bologna, Italy) since
1990. Among the 18 patients who underwent ablative chemotherapy, all achieved CR with a 3-year disease-free survival probability of 63%
(95% CI, 40%-87%) and no recorded events after 26 months. Five
patients had relapses; 2 died of disease and 3 entered second CR.
Analysis of the 125 bone marrow (or peripheral blood) samples studied
by real-time RT-PCR showed that transcript ratios of samples taken
during CR at any time before a relapse were always greater than 0.12%,
whereas those of samples taken during first or second CR from patients
who did not subsequently have relapses were always less than 0.25%.
This suggests that transcript ratios greater than 0.25% may correspond
to high risk for relapse, whereas ratios below 0.12% might indicate
the patient is in a curable state. If confirmed, such thresholds could
open the way to a new phase in post-CR therapeutic decision making for
patients with inv(16) AML.
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