TY - JOUR
T1 - Consolidation and maintenance immunotherapy with rituximab improve clinical outcome in patients with B-cell chronic lymphocytic leukemia
AU - Del Poeta, Giovanni
AU - Del Principe, Maria Ilaria
AU - Buccisano, Francesco
AU - Maurillo, Luca
AU - Capelli, Giovanni
AU - Luciano, Fabrizio
AU - Perrotti, Alessio Pio
AU - Degan, Massimo
AU - Venditti, Adriano
AU - De Fabritiis, Paolo
AU - Gattei, Valter
AU - Amadori, Sergio
PY - 2008/1/1
Y1 - 2008/1/1
N2 - BACKGROUND. Rituximab in sequential combination with fludarabine (Flu) allowed patients with B-cell chronic lymphocytic leukemia (B-CLL) to achieve higher remission rates and longer response duration. Based on their recent experience in indolent non-Hodgkin lymphomas, in this study, the authors attempted to demonstrate whether consolidation/maintenance therapy with rituximab could prolong the response duration in this patient population. METHODS. This Phase II study was based on a consolidation/maintenance therapy with rituximab for patients in complete remission (CR) or partial remission (PR) who were positive for minimal residual disease (MRD), as determined by flow cytometry. Seventy-five symptomatic, untreated patients with B-CLL received 6 monthly cycles of Flu (25 mg/m2 for 5 days) followed by 4 weekly doses of rituximab (375 mg/m2). Then, 28 patients who were positive for MRD were consolidated with 4 monthly cycles of rituximab (375 mg/m 2) followed by 12 monthly low doses of rituximab (150 mg/m 2). RESULTS. Based on National Cancer Institute criteria, 61 of 75 patients (81%) achieved a CR, 10 of 75 patients (13%) had a PR, and 4 of 75 patients (5%) had either no response or disease progression. MRD-positive patients in CR or PR who received consolidation therapy (n = 28 patients) had a significantly longer response duration (87% vs 32% at 5 years; P = .001) compared with a subset of patients who did not receive consolidation therapy (n = 18 patients). All patients experienced a long progression-free survival from the end of induction treatment (73% at 5 years). It was noteworthy that, within the subset of ZAP-70-positive patients, MRD-positive, consolidated patients (n = 12 patients) had a significantly longer response duration (69% vs 0% at 2.6 years; P = .007) compared with MRD-positive, unconsolidated patients (n = 11 patients). CONCLUSIONS. The addition of a consolidation and maintenance therapy with rituximab prolonged response duration significantly in patients with MRD-positive B-CLL.
AB - BACKGROUND. Rituximab in sequential combination with fludarabine (Flu) allowed patients with B-cell chronic lymphocytic leukemia (B-CLL) to achieve higher remission rates and longer response duration. Based on their recent experience in indolent non-Hodgkin lymphomas, in this study, the authors attempted to demonstrate whether consolidation/maintenance therapy with rituximab could prolong the response duration in this patient population. METHODS. This Phase II study was based on a consolidation/maintenance therapy with rituximab for patients in complete remission (CR) or partial remission (PR) who were positive for minimal residual disease (MRD), as determined by flow cytometry. Seventy-five symptomatic, untreated patients with B-CLL received 6 monthly cycles of Flu (25 mg/m2 for 5 days) followed by 4 weekly doses of rituximab (375 mg/m2). Then, 28 patients who were positive for MRD were consolidated with 4 monthly cycles of rituximab (375 mg/m 2) followed by 12 monthly low doses of rituximab (150 mg/m 2). RESULTS. Based on National Cancer Institute criteria, 61 of 75 patients (81%) achieved a CR, 10 of 75 patients (13%) had a PR, and 4 of 75 patients (5%) had either no response or disease progression. MRD-positive patients in CR or PR who received consolidation therapy (n = 28 patients) had a significantly longer response duration (87% vs 32% at 5 years; P = .001) compared with a subset of patients who did not receive consolidation therapy (n = 18 patients). All patients experienced a long progression-free survival from the end of induction treatment (73% at 5 years). It was noteworthy that, within the subset of ZAP-70-positive patients, MRD-positive, consolidated patients (n = 12 patients) had a significantly longer response duration (69% vs 0% at 2.6 years; P = .007) compared with MRD-positive, unconsolidated patients (n = 11 patients). CONCLUSIONS. The addition of a consolidation and maintenance therapy with rituximab prolonged response duration significantly in patients with MRD-positive B-CLL.
KW - B-cell chronic lymphocytic leukemia
KW - CD38
KW - Consolidation and maintenance therapy with rituximab
KW - Cytogenetics
KW - Immunoglobulin heavy-chain variable-region status
KW - Minimal residual disease
KW - Response duration
KW - ZAP-70
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U2 - 10.1002/cncr.23144
DO - 10.1002/cncr.23144
M3 - Article
C2 - 17999417
AN - SCOPUS:37549046061
VL - 112
SP - 119
EP - 128
JO - Cancer
JF - Cancer
SN - 0008-543X
IS - 1
ER -