The addition of rituximab to fludarabine improves clinical outcome in untreated patients with ZAP-70-negative chronic lymphocytic leukemia.

Abstract:

BACKGROUND:Clinical trials of monoclonal antibodies in combination with chemotherapy have reported previously unattained response rates in patients with B-cell chronic lymphocytic leukemia (B-CLL); however, the analysis of ZAP-70 protein and/or CD38 may explain better the discordant outcomes independent of treatment. METHODS:The authors conducted a Phase II study, in which rituximab was added to fludarabine for patients with symptomatic, untreated CLL, to evaluate clinical outcomes. Sixty patients with B-CLL received 6 monthly courses of fludarabine (25 mg/m(2) for 5 days) followed by 4 weekly doses of rituximab (375 mg/m(2)). RESULTS:On the basis of National Cancer Institute criteria, 47 of 60 patients (78%) achieved a complete remission, 9 of 60 patients (15%) achieved a partial remission, and 4 of 60 patients (7%) had no response or progressive disease. It is noteworthy that the patients experienced a long progression-free survival (PFS) from treatment (68% at 3 yrs). A significantly shorter PFS was observed in ZAP-70-positive patients (25% vs. 100% at 3 yrs; P = 0.00005), in CD38-positive patients (18% vs. 91% at 3 yrs; P = 0.0002), and in patients who had more minimal residual disease (36% vs. 77% at 2.5 yrs; P = 0.001). CONCLUSIONS:With the addition of rituximab to fludarabine, improved clinical outcomes were obtained, and the stratification of patients by using ZAP-70 and CD38 may help clinicians offer more aggressive and/or experimental approaches to the treatment of patients with high-risk B-CLL subtypes.

journal_name

Cancer

journal_title

Cancer

authors

Del Poeta G,Del Principe MI,Consalvo MA,Maurillo L,Buccisano F,Venditti A,Mazzone C,Bruno A,Gianní L,Capelli G,Lo Coco F,Cantonetti M,Gattei V,Amadori S

doi

10.1002/cncr.21535

subject

Has Abstract

pub_date

2005-12-15 00:00:00

pages

2743-52

issue

12

eissn

0008-543X

issn

1097-0142

journal_volume

104

pub_type

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