Imatinib plus Peginterferon Alfa-2a in Chronic Myeloid Leukemia.

被引：308

作者：

Preudhomme, Claude ^{[2
,3
]}

Guilhot, Joelle ^{[1
]}

Nicolini, Franck Emmanuel ^{[4
]}

Guerci-Bresler, Agnes ^{[5
]}

Rigal-Huguet, Francoise ^{[6
]}

Maloisel, Frederic ^{[7
]}

Coiteux, Valerie ^{[8
]}

Gardembas, Martine ^{[9
]}

Berthou, Christian ^{[10
]}

Vekhoff, Anne ^{[11
]}

Rea, Delphine ^{[12
]}

Jourdan, Eric ^{[13
]}

Allard, Christian ^{[14
]}

Delmer, Alain ^{[15
]}

Rousselot, Philippe ^{[16
]}

Legros, Laurence ^{[17
]}

Berger, Marc ^{[18
]}

Corm, Selim ^{[19
]}

Etienne, Gabriel ^{[20
]}

Roche-Lestienne, Catherine ^{[2
,3
]}

Eclache, Virginie ^{[21
]}

Mahon, Francois-Xavier ^{[22
,23
,24
]}

Guilhot, Francois ^{[1
]}

机构：

[1] CHU Poitiers, INSERM, U935, CIC 802, F-86021 Poitiers, France

[2] CHU Lille, Hematol Lab, F-59037 Lille, France

[3] INSERM, U837, F-59045 Lille, France

[4] Hop Edouard Herriot, Hematol Clin, Lyon, France

[5] CHU Brabois, Serv Hematol, Vandoeuvre Les Nancy, France

[6] Hop Purpan, Serv Hematol, Toulouse, France

[7] Clin St Anne, Serv Oncohematol, Strasbourg, France

[8] Hop Claude Huriez, Serv Malad Sang, Lille, France

[9] CHU Angers, Serv Malad Sang, Angers, France

[10] CHU Brest, Serv Hematol, F-29285 Brest, France

[11] Hop Hotel Dieu, Serv Hematol Clin, Paris, France

[12] Hop St Louis, INSERM, CIC 9504, Paris, France

[13] Grp Hosp Univ Caremeau, Nimes, France

[14] Ctr Hosp Meaux, Serv Hematol, Meaux, France

[15] CHU Reims, Serv Hematol Clin, Reims, France

[16] Hop Versailles, Versailles, France

[17] Hop Archet 1, Serv Hematol Clin, Nice, France

[18] CHU Estaing, Clermont Ferrand, France

[19] CHU, Serv Hematol Clin, Chambery, France

[20] Inst Bergonie, Bordeaux, France

[21] Hop Avicenne, Hematol Lab, F-93009 Bobigny, France

[22] CHU Bordeaux, Hematol Lab, Bordeaux, France

[23] CHU Bordeaux, Serv Malad Sang, Bordeaux, France

[24] Univ Victor Segalen, INSERM, U876, Bordeaux, France

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2010年 / 363卷 / 26期

关键词：

CHRONIC MYELOGENOUS LEUKEMIA; PATIENTS RECEIVING IMATINIB; HEMATOPOIETIC STEM-CELLS; ABL TYROSINE KINASE; FOLLOW-UP; INTERFERON; CYTARABINE; QUIESCENT; CML; CHROMOSOME;

D O I：

10.1056/NEJMoa1004095

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: Imatinib (400 mg daily) is considered the best initial therapy for patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase. However, only a minority of patients treated with imatinib have a complete molecular remission. Methods: We randomly assigned 636 patients with untreated chronic-phase CML to receive imatinib alone at a dose of 400 mg daily, imatinib (400 mg daily) plus cytarabine (20 mg per square meter of body-surface area per day on days 15 through 28 of each 28-day cycle) or pegylated interferon (peginterferon) alfa-2a (90 microg weekly), or imatinib alone at a dose of 600 mg daily. Molecular and cytogenetic responses, time to treatment failure, overall and event-free survival, and adverse events were assessed. An analysis of molecular response at 12 months was planned. A superior molecular response was defined as a decrease in the ratio of transcripts of the tyrosine kinase gene BCR-ABL to transcripts of ABL of 0.01% or less, corresponding to a reduction of 4 log(sub 10) units or more from the baseline level, as assessed by means of a real-time quantitative polymerase-chain-reaction assay. Results: At 12 months, the rates of cytogenetic response were similar among the four groups. The rate of a superior molecular response was significantly higher among patients receiving imatinib and peginterferon alfa-2a (30%) than among patients receiving 400 mg of imatinib alone (14%) (P=0.001). The rate was significantly higher among patients treated for more than 12 months than among those treated for 12 months or less. Gastrointestinal events were more frequent among patients receiving cytarabine, whereas rash and depression were more frequent among patients receiving peginterferon alfa-2a. Conclusions: As compared with other treatments, the addition of peginterferon alfa-2a to imatinib therapy resulted in significantly higher rates of molecular response in patients with chronic-phase CML. (Funded by the French Ministry of Health and others; ClinicalTrials.gov number, NCT00219739.) N Engl J Med 2010;363:2511-21.

引用

页码：2511 / 2521

页数：11

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