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Blood, Vol. 94 No. 9 (November 1), 1999:
pp. 3015-3021
A Modified AIDA Protocol With Anthracycline-Based
Consolidation Results in High Antileukemic Efficacy and Reduced
Toxicity in Newly Diagnosed PML/RAR -Positive Acute
Promyelocytic Leukemia
Miguel A. Sanz,
Guillermo Martín,
Consuelo Rayón,
Jordi Esteve,
Marcos González,
Joaquín Díaz-Mediavilla,
Pascual Bolufer,
Eva Barragán,
María J. Terol,
José D. González,
Dolors Colomer,
Carmen Chillón,
Concha Rivas,
Teresa Gómez,
José M. Ribera,
Rafael Bornstein,
José Román,
María J. Calasanz,
Jesus Arias,
Carmen Álvarez,
Fernando Ramos, and
Guillermo Debén for the PETHEMA Group
From Hospital Universitario La Fe, Valencia, Spain; Hospital Central
de Asturias, Oviedo, Spain; Hospital Clínico San Carlos,
Madrid, Spain; Hospital Clínico Universitario, Valencia, Spain;
Hospital Insular de Las Palmas, Las Palmas, Spain; Hospital Clinic,
Barcelona, Spain; Hospital General, Alicante, Spain; Hospital U. Germans Trias i Pujol, Badalona, Spain; Complexo Hospitalario
Xeral-Calde, Lugo, Spain; Hospital Universitario, Salamanca, Spain;
Hospital de Cruces, Baracaldo, Spain; Complejo Hospitalario,
León, Spain; and Hospital Juan Canalejo, La Coruña, Spain.
The Spanish PETHEMA group designed a protocol for newly
diagnosed PML/RAR -positive acute promyelocytic leukemia
(APL) in which induction and consolidation followed the original
AIDA regimen, except for the omission of cytarabine and
etoposide from consolidation. Induction consisted of 45 mg/m2 all-trans retinoic acid (ATRA) daily until
complete remission (CR) and 12 mg/m2 idarubicin on days 2, 4, 6, and 8. Patients in CR received 3 monthly chemotherapy courses:
idarubicin 5 mg/m2/d × 4 (course no. 1), mitoxantrone 10 mg/m2/d × 5 (course no. 2), and idarubicin 12 mg/m2/d × 1 (course no. 3). Maintenance therapy consisted
of 90 mg/m2/d mercaptopurine orally, 15 mg/m2/wk methotrexate intramuscularly, and, intermittently,
45 mg/m2/d ATRA for 15 days every 3 months. Between
November 1996 and December 1998, 123 patients with newly diagnosed
PML/RAR-positive APL from 39 centers were enrolled. A total of 109 patients achieved CR (89%; 95% confidence interval [CI], 83 to 95),
12 died of early complications, and the remaining 2 were resistant.
Consolidation treatment was associated with very low toxicity and no
deaths in remission were recorded. Molecular assessment of response by reverse transcriptase-polymerase chain reaction (RT-PCR) showed conversion to PCR-negative in 48 of 99 (51%) and 82 of 88 patients (93%) after induction and consolidation, respectively. The 2-year Kaplan-Meier estimates of overall survival and event-free survival were
82% ± 4% and 79% ± 4%, respectively. For patients who achieved CR, the 2-year disease-free survival (DFS) was 92% ± 3%. These data
indicate that a significant reduction in toxicity might be obtained in
APL using a less intensive consolidation without apparently compromising the antileukemic effect. These results also suggest a
minor role for cytarabine and etoposide in the treatment of newly
diagnosed PML/RAR-positive APL patients.
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