AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance

被引：169

作者：

Avvisati, Giuseppe ^{[1
]}

Lo-Coco, Francesco ^{[2
,3
]}

Paoloni, Francesca Paola ^{[4
]}

Petti, Maria Concetta ^{[5
]}

Diverio, Daniela ^{[6
]}

Vignetti, Marco ^{[6
]}

Latagliata, Roberto ^{[6
]}

Specchia, Giorgina ^{[7
]}

Baccarani, Michele ^{[8
]}

Di Bona, Eros ^{[9
]}

Fioritoni, Giuseppe ^{[10
]}

Marmont, Filippo ^{[11
]}

Rambaldi, Alessandro ^{[12
]}

Di Raimondo, Francesco ^{[13
]}

Kropp, Maria Grazia ^{[14
]}

Pizzolo, Giovanni ^{[15
]}

Pogliani, Enrico M. ^{[16
]}

Rossi, Giuseppe ^{[17
]}

Cantore, Nicola ^{[18
]}

Nobile, Francesco ^{[19
]}

Gabbas, Attilio ^{[20
]}

Ferrara, Felicetto ^{[21
]}

Fazi, Paola ^{[4
]}

Amadori, Sergio ^{[2
]}

Mandelli, Franco ^{[4
]}

机构：

[1] Univ Campus Biomed, Unita Operat Complessa Ematol & Terapia Cellulare, I-00128 Rome, Italy

[2] Univ Tor Vergata, Dipartimento Bipatol, Rome, Italy

[3] Fdn Santa Lucia, Lab Neurooncoematol, Rome, Italy

[4] Fdn GIMEMA ONLUS, Rome, Italy

[5] Ist Nazl & Tumori Regina Elena, Div Ematol, Rome, Italy

[6] Univ Roma La Sapienza, Dipartimento Biotecnol Cellulari & Ematol, Rome, Italy

[7] Univ Bari, Unita Operat Ematol 1, Bari, Italy

[8] Univ Bologna, Ist Ematol & Oncol Med L&A Seragnoli, Bologna, Italy

[9] Osped S Bortolo, Div Ematol, Vicenza, Italy

[10] Azienda USL, Unita Operat Ematol, Pescara, Italy

[11] Osped Maggiore SG Battista, Div Ematol Molinette, Turin, Italy

[12] Osped Riuniti Bergamo, Div Ematol, I-24100 Bergamo, Italy

[13] Univ Catania, Osped Ferrarotto, Div Ematol, Catania, Italy

[14] Azienda Osped Pugliese Ciaccio, Unita Operat Ematol, Catanzaro, Italy

[15] Univ Verona, Policlin GB Rossi, Div Ematol, I-37100 Verona, Italy

[16] Univ Milano Bicocca, Clin Ematol, Nuovo Osped S Gerardo dei Tintori, Monza, Italy

[17] Spedali Civil Brescia, Div Ematol, I-25125 Brescia, Italy

[18] Azienda Osped SG Moscati, Div Ematol, Avellino, Italy

[19] Azienda Osped Bianchi Melacrino Morelli, Dipartimento Ematol Oncol, Reggio Di Calabria, Italy

[20] Osped S Francesco, Div Ematol, Nuoro, Italy

[21] Azienda Osped Rilievo Nazl A Cardarelli, Div Ematol, Naples, Italy

来源：

BLOOD | 2011年 / 117卷 / 18期

关键词：

TRANS-RETINOIC ACID; MOLECULAR REMISSION; TRANSRETINOIC ACID; CONSOLIDATION; IDARUBICIN; INDUCTION; THERAPY; GIMEMA; CHEMOTHERAPY; MULTICENTER;

D O I：

10.1182/blood-2010-08-302950

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

All-trans-retinoic acid (ATRA) has greatly modified the prognosis of acute promyelocytic leukemia; however, the role of maintenance in patients in molecular complete remission after consolidation treatment is still debated. From July 1993 to May 2000, 807 genetically proven newly diagnosed acute promyelocytic leukemia patients received ATRA plus idarubicin as induction, followed by 3 intensive consolidation courses. Thereafter, patients reverse-transcribed polymerase chain reaction-negative for the PML-RARA fusion gene were randomized into 4 arms: oral 6-mercaptopurine and intramuscular methotrexate (arm 1); ATRA alone (arm 2); 3 months of arm1 alternating to 15 days of arm 2 (arm 3); and no further therapy (arm 4). Starting from February 1997, randomization was limited to ATRA-containing arms only (arms 2 and 3). Complete remission was achieved in 761 of 807 (94.3%) patients, and 681 completed the consolidation program. Of these, 664 (97.5%) were evaluated for the PML-RARA fusion gene, and 586 of 646 (90.7%) who tested reverse-transcribed polymerase chain reaction-negative were randomized to maintenance. The event-free survival estimate at 12 years was 68.9% (95% confidence interval, 66.4%-71.4%), and no differences in disease-free survival at 12 years were observed among the maintenance arms. (Blood. 2011; 117(18): 4716-4725)

引用

页码：4716 / 4725

页数：10

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