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Prepublished online as a Blood First Edition Paper on July 5, 2002; DOI 10.1182/blood-2002-02-0352.
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Blood, 1 November 2002, Vol. 100, No. 9, pp. 3141-3146
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Induction therapy with idarubicin alone significantly influences
event-free survival duration in patients with newly diagnosed
hypergranular acute promyelocytic leukemia: final results of the GIMEMA
randomized study LAP 0389 with 7 years of minimal
follow-up
Giuseppe Avvisati,
Maria Concetta Petti,
Francesco Lo-Coco,
Maria Luce Vegna,
Sergio Amadori,
Michele Baccarani,
Nicola Cantore,
Eros Di Bona,
Felicetto Ferrara,
Giuseppe Fioritoni,
Eugenio Gallo,
Rosangela Invernizzi,
Mario Lazzarino,
Vincenzo Liso,
Guglielmo Mariani,
Francesco Ricciuti,
Carmine Selleri,
Simona Sica,
Dino Veneri, and
Franco Mandelli for the Italian Cooperative Group
GIMEMA (Gruppo Italiano Malattie Ematologiche
dell'Adulto)
From Ematologia, Università Campus-Bio-Medico,
Rome; SC Ematologia, Istituto Regina Elena, Rome; Dipartimento di
Biotecnologie Cellulari ed Ematologia, Università la Sapienza,
Policlinico Umberto I, Rome; Ematologia, Università Tor Vergata,
Ospedale S. Eugenio, Rome; Istituto di Ematologia ed Oncologia Medica
L.e A. Seràgnoli, Università di Bologna; Divisione di
Ematologia Ospedale Civile, Avellino; Divisione di Ematologia Ospedale
S. Bortolo, Vicenza; Divisione di Ematologia, Ospedale A. Cardarelli,
Napoli; Divisione di Ematologia Ospedale Civile, Pescara; Divisione di
Ematologia Ospedale S. Giovanni Battista, Torino; Istituto di Clinica
Medica Università di Pavia, Policlinico Universitario, IRCCS S. Matteo, Pavia; Cattedra di Ematologia Università di Pavia,
Policlinico Universitario, IRCCS S. Matteo, Pavia; Ematologia,
Università degli Studi, Policlinico Universitario, Bari; Cattedra
di Ematologia, Università degli Studi, Palermo; Divisione di
Ematologia, Ospedale S. Carlo, Potenza; Ematologia, Università
Federico II, Policlinico Universitario, Napoli; Ematologia,
Università Cattolica del Sacro Cuore, Policlinico Gemelli, Rome;
Ematologia, Università degli Studi, Ospedale Policlinico Borgo
Roma, Verona, Italy.
Shortly before the all-trans retinoic acid (ATRA) era,
the GIMEMA cooperative group initiated a randomized study comparing idarubicin (IDA) alone with IDA plus arabinosylcytosine (Ara-C) as
induction treatment in patients with newly diagnosed hypergranular acute promyelocytic leukemia (APL). Of the 257 patients evaluable for
induction treatment, 131 were randomized to receive IDA alone (arm A)
and 126 to receive IDA + Ara-C (arm B). Treatment in arm A
consisted of 10 mg/m2 IDA daily for 6 consecutive days,
whereas in arm B it consisted of 12 mg/m2 IDA daily for 4 days combined with 200 mg/m2 Ara-C daily in continuous
infusion for 7 days. Once in complete remission (CR), patients received
3 consolidation courses of standard chemotherapy, and those still in CR
at the end of the consolidation were randomized to receive or not
receive 1 mg/kg 6-mercaptopurine daily and intramuscular injections of
0.25 mg/kg methotrexate weekly for 2 years. Overall, 100 (76.3%)
patients in arm A and 84 (66.6%) patients in arm B achieved CR
(P = NS). Event-free survival (EFS) rates were 35% and
23% for patients in arm A and arm B, respectively
(P = .0352). Multivariate analysis revealed that EFS was
favorably influenced by induction treatment with IDA alone
(P = .0352) and unfavorably influenced by white blood cell
(WBC) counts greater than 3000/µL (P = .0001) and
increasing age (P = .0251). These results indicate that
anthracycline monochemotherapy with IDA favorably influences the EFS of
patients with newly diagnosed hypergranular APL.
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