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Blood, Vol. 95 No. 1 (January 1), 2000:
pp. 96-101
A prospective study of residual-disease monitoring of the
ALL1/AF4 transcript in patients with t(4;11) acute
lymphoblastic leukemia
Giuseppe Cimino,
Loredana Elia,
Maria Cristina Rapanotti,
Teresa Sprovieri,
Marco Mancini,
Antonio Cuneo,
Cristina Mecucci,
Giuseppe Fioritoni,
Mario Carotenuto,
Enrica Morra,
Vincenzo Liso,
Luciana Annino,
Giuseppe Saglio,
Giulio De Rossi,
Robin Foà, and
Franco Mandelli
From the Dipartimento di Biotecnologie Cellulari ed Ematologia,
University La Sapienza, Rome; Dipartimento di Scienze Biomediche,
Hematology Unit, University of Ferrara; Dipartimento di Ematologia,
University of Perugia; Ematologia Clinica, Ospedale Civile Spirito
Santo, Pescara; IRCCS Casa Sollievo della Sofferenza, S Giovanni
Rotondo; Divisione di Ematologia, Azienda Ospedaliera
Niguarda Cà Grande, Milan; Cattedra di Ematologia I°,
University of Bari; Dipartimento di Scienze Biomediche, University of
Turin; Divisione di Ematologia, Ospedale Pediatrico Bambino
Gesù, Vatican City; and Dipartimento di Scienze Biomediche ed
Oncologia Umana, University of Turin, Italy.
Twenty-five patients (22 adults and 3 infants) with
ALL1/AF4-positive acute lymphoblastic leukemia (ALL) were
prospectively monitored by reverse transcriptase-polymerase chain
reaction (RT-PCR) between January 1992 and July 1999. After high-dose
induction and consolidation chemotherapy without bone marrow
transplantation, all patients had a complete hematologic remission.
Using nested RT-PCR (sensitivity 10 4), we
observed conversion to PCR negativity in 11 (44%) of the patients.
Thirteen of the 14 patients who did not have a molecular remission had
a relapse at a median time of 4 months (range, 1 - 20 months). Of the
11 patients who had a conversion to PCR negativity, 5 reconverted to
PCR positivity within 1 to 14 months. These 5 patients all
progressed to hematologic relapse after 2, 3, 4, 4, and 7 months,
respectively. Of the remaining 6 patients, 4 are in persistent
hematologic and molecular remission at 12, 14, 88, and 96 months,
whereas 2 are early in their follow-up. Actuarial probabilies of
relapse and overall survival were 100% and 0% at 14 and 24 months and
67% and 43% at 96 and 100 months, respectively, in patients who had
persistent RT-PCR positivity and in those who had a molecular
remission. For both relapse and survival, the differences observed
between the two groups were significant (P = .003 and
P < .005, respectively). This study, which represents the
first prospective analysis of residual-disease monitoring carried out
in a substantial series of patients with t(4;11)-positive ALL,
emphasizes the clinical relevance of RT-PCR-based methods to monitor
minimal residual disease in this leukemia subset. (Blood. 2000;95:96-101)
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