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Blood, Vol. 93 No. 12 (June 15), 1999:
pp. 4131-4143
Presenting White Blood Cell Count and Kinetics of Molecular Remission
Predict Prognosis in Acute Promyelocytic Leukemia Treated With
All-Trans Retinoic Acid: Result of the Randomized MRC Trial
Alan K. Burnett,
David Grimwade,
Ellen Solomon,
Keith Wheatley, and
Anthony H. Goldstone on behalf of the MRC Adult Leukaemia
Working Party
From the Department of Haematology, University of Wales College of
Medicine, Cardiff, UK; the Cancer Genetics Laboratory, Division of
Medical and Molecular Genetics, Guy's Hospital, London, UK; the
Clinical Trial Service Unit, Radcliffe Infirmary, Oxford, UK; and the
Department of Haematology, University College Hospital, London,
UK.
All-trans retinoic acid (ATRA) is an essential component of
the treatment of acute promyelocytic leukemia (APL), but the optimal timing and duration remain to be determined. Molecular characterization of this disease can refine the diagnosis and could be potentially useful in monitoring response to treatment. Patients defined
morphologically to have APL were randomized to receive a 5-day course
of ATRA before commencing chemotherapy or to receive daily ATRA
commencing with chemotherapy and continuing until complete remission
(CR). The chemotherapy was that used in current MRC
Leukaemia Trials. Outcome comparisons were by intention to treat with
additional analysis for relevant risk factors. Patients were
characterized by molecular techniques for the fusion products of the
t(15;17) and monitored by reverse transcriptase-polymerase chain
reaction (RT-PCR) during and after treatment. Two hundred thirty-nine
patients were randomized. Treatment with extended ATRA resulted in a
superior remission rate (87% v 70%, P < .001), due
to fewer early and induction deaths (12% v 23%, P = .02), and less resistant disease (2% v 7%, P = .03), which was associated with a significantly more rapid recovery of
neutrophils and platelets. Extended ATRA reduced relapse risk (20%
v 36% at 4 years, P = .04) and resulted in superior survival (71% v 52% at 4 years, P = .005).
Presenting white blood cell count (WBC) was a key
determinant of outcome. The 70% of patients who presented with a WBC
less than 10 × 109/L had a better CR (85% v
62%, P = .0001) and reduced relapse risk (22% v
42%, P = .002) and superior survival (69%
v 43%, P < .0001). Within the low count group,
extended ATRA resulted in a better CR (94% v 76%, P
= .001), reduced relapse risk (13% v 35%, P = .04), and improved survival (80% v 57%, P = .0009).
There was no evidence of benefit in patients presenting with a higher WBC (>10 × 109/L). Molecular monitoring after the third
chemotherapy course had a correlation with risk of relapse. The relapse
risk was 57% if the RT-PCR was positive versus 27% if the RT-PCR was
negative (P = .006). APL patients who present
with a low WBC derive substantial benefit from combining ATRA with
induction chemotherapy until remission is achieved, whereas patients
with a higher WBC did not benefit. Molecular characterization of
disease can improve diagnostic precision and a positive RT-PCR after
consolidation identifies patients at a higher risk of relapse.
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