Rituximab maintenance after first-line therapy with rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) for chronic lymphocytic leukemia

被引：52

作者：

Abrisqueta, Pau ^{[1
]}

Villamor, Neus ^{[2
]}

Jose Terol, Maria ^{[3
]}

Gonzalez-Barca, Eva ^{[4
]}

Gonzalez, Marcos ^{[5
]}

Ferra, Christelle ^{[6
]}

Abella, Eugenia ^{[7
]}

Delgado, Julio ^{[8
,9
]}

Garcia-Marco, Jose A. ^{[10
]}

Gonzalez, Yolanda ^{[11
]}

Carbonell, Felix ^{[12
]}

Ferrer, Secundino ^{[13
]}

Monzo, Encarna ^{[14
]}

Jarque, Isidro ^{[15
]}

Muntanola, Ana ^{[16
]}

Constants, Mireia ^{[17
]}

Escoda, Lourdes ^{[18
]}

Calvo, Xavier ^{[2
]}

Bobillo, Sabela ^{[1
]}

Bruno Montoro, Jose ^{[19
]}

Montserrat, Emili ^{[9
]}

Bosch, Francesc ^{[1
]}

机构：

[1] Univ Autonoma Barcelona, Univ Hosp Vall dHebron, Dept Hematol, Barcelona, Spain

[2] Hosp Clin Barcelona, Hematopathol Unit, Barcelona, Spain

[3] Hosp Clin Univ Valencia, Dept Hematol, Hosp Clin, Inst Invest, Valencia, Spain

[4] Inst Invest Biomed Bellvitge, Inst Catala Oncol, Barcelona, Spain

[5] Hosp Clin Univ, Salamanca, Spain

[6] Hosp Badalona Germans Trias & Pujol, Badalona, Spain

[7] Hosp Mar, Barcelona, Spain

[8] Hosp Santa Creu & Sant Pau, Barcelona, Spain

[9] Hosp Clin Barcelona, Inst Invest Biomed August Pi & Sunyer, Dept Hematol, Barcelona, Spain

[10] Hosp Univ Puerta de Hierro, Madrid, Spain

[11] Hosp Josep Trueta, Girona, Spain

[12] Hosp Gen Univ, Valencia, Spain

[13] Hosp Dr Peset, Valencia, Spain

[14] Hosp Arnau Vilanova, Valencia, Spain

[15] Hosp La Fe, Valencia, Spain

[16] Hosp Mutua Terrassa, Terrassa, Spain

[17] Althaia, Xarxa Assistencial Manresa, Manresa, Spain

[18] Hosp Joan 23, Tarragona, Spain

[19] Hosp Valle De Hebron, Dept Pharm, Barcelona, Spain

来源：

BLOOD | 2013年 / 122卷 / 24期

关键词：

PROGRESSION-FREE SURVIVAL; PREVIOUSLY UNTREATED PATIENTS; STEM-CELL TRANSPLANTATION; LOW-DOSE FLUDARABINE; PHASE-III TRIAL; RESIDUAL DISEASE; INITIAL THERAPY; SUBCUTANEOUS ALEMTUZUMAB; RESPONSE DURATION; 1ST REMISSION;

D O I：

10.1182/blood-2013-05-502773

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The effectiveness of rituximab maintenance therapy in the treatment of chronic lymphocytic leukemia has been investigated in a phase 2 clinical trial that included an initial treatment with rituximab 500 mg/m2 on day 1 (375 mg/m2 the first cycle), fludarabine 25 mg/m2 on days 1 to 3, cyclophosphamide 200 mg/m2 on days 1 to 3, and mitoxantrone 6 mg/m2 on day 1 (R-FCM), for 6 cycles, followed by a maintenance phase with rituximab 375 mg/m2 every 3 months for 2 years. Sixty-seven patients having achieved complete response (CR) or partial response (PR) with R-FCM were given maintenance therapy. At the end of maintenance, 40.6% of patients were in CR with negative minimal residual disease (MRD), 40.6% were in CR MRD-positive, 4.8% remained in PR, and 14% were considered failures. Six of 29 patients (21%) who were in CR MRD-positive or in PR after R-FCM improved their response upon rituximab maintenance. The 4-year progression-free survival (PFS) and overall survival rates were 74.8% and 93.7%, respectively. MRD status after R-FCM induction was the strongest predictor of PFS. Maintenance with rituximab after R-FCM improved the quality of the response, particularly in patients MRD-positive after initial treatment, and obtained a prolonged PFS. This trial was registered at www.clinicaltrialsregister.eu as identifier #2005-001569-33. (Blood. 2013;122(24):3951-3959)

引用

页码：3951 / 3959

页数：9