Fludarabine, cyclophosphamide, and rituximab in patients with advanced, untreated, indolent B-cell nonfollicular lymphomas: Phase 2 study of the Italian Lymphoma Foundation

Andrea Ferrario, Alessandro Pulsoni, Barbara Olivero, Giuseppe Rossi, Umberto Vitolo, Alessandra Tedeschi, Francesco Merli, Luigi Rigacci, Caterina Stelitano, Maria Goldaniga, Donato Mannina, Pellegrino Musto, Francesca Rossi, Enrica Gamba, Luca Baldini

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Abstract

BACKGROUND: Indolent nonfollicular non-Hodgkin B-cell lymphomas (INFLs) are clonal mature B-cell proliferations for which treatment has not been defined to date. METHODS: In this phase 2 study of patients with advanced INFL, the authors evaluated the efficacy and safety of first-line rituximab, fludarabine, and cyclophosphamide (FCR) as induction immunochemotherapy (rituximab 375 mg/m 2 intravenously on day 1 of each cycle and on days 1 and 14 of cycles 4 and 5; fludarabine 25 mg/m 2 intravenously on days 2-4, cyclophosphamide 250 mg/m 2 intravenously on Days 2-4) every 28 days for 6 cycles followed by a maintenance phase with 4 infusions of rituximab (375 mg/m 2 intravenously on day 1) every 2 months for responders. RESULTS: Forty-seven patients were enrolled. Among 46 evaluable patients (28 men; median age, 59 years), 19 were diagnosed with lymphoplasmacytic lymphoma, 21 were diagnosed with small lymphocytic lymphoma, and 6 were diagnosed with nodal marginal zone lymphoma. The overall response rate after maintenance was 89.1% with a 67.4% complete remission (CR) rate (CR/unconfirmed CR) and a 21.7% partial response rate. After a median follow-up of 40.9 months, the failure-free survival and progression-free survival rates both were 90.1%, and the overall survival rate was 97.4%. The main toxicity was hematologic, and related grade 3 and 4 neutropenia was observed in 55.3% of patients. CONCLUSIONS: FCR induction therapy followed by a short maintenance phase is a highly effective regimen with acceptable toxicity. Cancer 2012. © 2011 American Cancer Society. Indolent nonfollicular non-Hodgkin B-cell lymphomas are clonal mature B-cell proliferations for which treatment has not been defined to date. The combination of rituximab, fludarabine, and cyclophosphamide as induction immunochemotherapy followed by a short maintenance phase with rituximab is a highly effective regimen with acceptable toxicity in this subset of lymphomas.

Original languageEnglish
Pages (from-to)3954-3961
Number of pages8
JournalCancer
Volume118
Issue number16
DOIs
Publication statusPublished - Aug 15 2012

Fingerprint

B-Cell Lymphoma
Cyclophosphamide
Lymphoma
Maintenance
Non-Hodgkin's Lymphoma
B-Lymphocytes
Survival Rate
Cell Proliferation
B-Cell Chronic Lymphocytic Leukemia
Neutropenia
Disease-Free Survival
Therapeutics
fludarabine
Rituximab
Safety
Neoplasms

Keywords

  • chemotherapy
  • cyclophosphamide
  • fludarabine
  • indolent nonfollicular lymphomas
  • rituximab

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Fludarabine, cyclophosphamide, and rituximab in patients with advanced, untreated, indolent B-cell nonfollicular lymphomas : Phase 2 study of the Italian Lymphoma Foundation. / Ferrario, Andrea; Pulsoni, Alessandro; Olivero, Barbara; Rossi, Giuseppe; Vitolo, Umberto; Tedeschi, Alessandra; Merli, Francesco; Rigacci, Luigi; Stelitano, Caterina; Goldaniga, Maria; Mannina, Donato; Musto, Pellegrino; Rossi, Francesca; Gamba, Enrica; Baldini, Luca.

In: Cancer, Vol. 118, No. 16, 15.08.2012, p. 3954-3961.

Research output: Contribution to journalArticle

Ferrario, A, Pulsoni, A, Olivero, B, Rossi, G, Vitolo, U, Tedeschi, A, Merli, F, Rigacci, L, Stelitano, C, Goldaniga, M, Mannina, D, Musto, P, Rossi, F, Gamba, E & Baldini, L 2012, 'Fludarabine, cyclophosphamide, and rituximab in patients with advanced, untreated, indolent B-cell nonfollicular lymphomas: Phase 2 study of the Italian Lymphoma Foundation', Cancer, vol. 118, no. 16, pp. 3954-3961. https://doi.org/10.1002/cncr.26708
Ferrario, Andrea ; Pulsoni, Alessandro ; Olivero, Barbara ; Rossi, Giuseppe ; Vitolo, Umberto ; Tedeschi, Alessandra ; Merli, Francesco ; Rigacci, Luigi ; Stelitano, Caterina ; Goldaniga, Maria ; Mannina, Donato ; Musto, Pellegrino ; Rossi, Francesca ; Gamba, Enrica ; Baldini, Luca. / Fludarabine, cyclophosphamide, and rituximab in patients with advanced, untreated, indolent B-cell nonfollicular lymphomas : Phase 2 study of the Italian Lymphoma Foundation. In: Cancer. 2012 ; Vol. 118, No. 16. pp. 3954-3961.
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abstract = "BACKGROUND: Indolent nonfollicular non-Hodgkin B-cell lymphomas (INFLs) are clonal mature B-cell proliferations for which treatment has not been defined to date. METHODS: In this phase 2 study of patients with advanced INFL, the authors evaluated the efficacy and safety of first-line rituximab, fludarabine, and cyclophosphamide (FCR) as induction immunochemotherapy (rituximab 375 mg/m 2 intravenously on day 1 of each cycle and on days 1 and 14 of cycles 4 and 5; fludarabine 25 mg/m 2 intravenously on days 2-4, cyclophosphamide 250 mg/m 2 intravenously on Days 2-4) every 28 days for 6 cycles followed by a maintenance phase with 4 infusions of rituximab (375 mg/m 2 intravenously on day 1) every 2 months for responders. RESULTS: Forty-seven patients were enrolled. Among 46 evaluable patients (28 men; median age, 59 years), 19 were diagnosed with lymphoplasmacytic lymphoma, 21 were diagnosed with small lymphocytic lymphoma, and 6 were diagnosed with nodal marginal zone lymphoma. The overall response rate after maintenance was 89.1{\%} with a 67.4{\%} complete remission (CR) rate (CR/unconfirmed CR) and a 21.7{\%} partial response rate. After a median follow-up of 40.9 months, the failure-free survival and progression-free survival rates both were 90.1{\%}, and the overall survival rate was 97.4{\%}. The main toxicity was hematologic, and related grade 3 and 4 neutropenia was observed in 55.3{\%} of patients. CONCLUSIONS: FCR induction therapy followed by a short maintenance phase is a highly effective regimen with acceptable toxicity. Cancer 2012. {\circledC} 2011 American Cancer Society. Indolent nonfollicular non-Hodgkin B-cell lymphomas are clonal mature B-cell proliferations for which treatment has not been defined to date. The combination of rituximab, fludarabine, and cyclophosphamide as induction immunochemotherapy followed by a short maintenance phase with rituximab is a highly effective regimen with acceptable toxicity in this subset of lymphomas.",
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T1 - Fludarabine, cyclophosphamide, and rituximab in patients with advanced, untreated, indolent B-cell nonfollicular lymphomas

T2 - Phase 2 study of the Italian Lymphoma Foundation

AU - Ferrario, Andrea

AU - Pulsoni, Alessandro

AU - Olivero, Barbara

AU - Rossi, Giuseppe

AU - Vitolo, Umberto

AU - Tedeschi, Alessandra

AU - Merli, Francesco

AU - Rigacci, Luigi

AU - Stelitano, Caterina

AU - Goldaniga, Maria

AU - Mannina, Donato

AU - Musto, Pellegrino

AU - Rossi, Francesca

AU - Gamba, Enrica

AU - Baldini, Luca

PY - 2012/8/15

Y1 - 2012/8/15

N2 - BACKGROUND: Indolent nonfollicular non-Hodgkin B-cell lymphomas (INFLs) are clonal mature B-cell proliferations for which treatment has not been defined to date. METHODS: In this phase 2 study of patients with advanced INFL, the authors evaluated the efficacy and safety of first-line rituximab, fludarabine, and cyclophosphamide (FCR) as induction immunochemotherapy (rituximab 375 mg/m 2 intravenously on day 1 of each cycle and on days 1 and 14 of cycles 4 and 5; fludarabine 25 mg/m 2 intravenously on days 2-4, cyclophosphamide 250 mg/m 2 intravenously on Days 2-4) every 28 days for 6 cycles followed by a maintenance phase with 4 infusions of rituximab (375 mg/m 2 intravenously on day 1) every 2 months for responders. RESULTS: Forty-seven patients were enrolled. Among 46 evaluable patients (28 men; median age, 59 years), 19 were diagnosed with lymphoplasmacytic lymphoma, 21 were diagnosed with small lymphocytic lymphoma, and 6 were diagnosed with nodal marginal zone lymphoma. The overall response rate after maintenance was 89.1% with a 67.4% complete remission (CR) rate (CR/unconfirmed CR) and a 21.7% partial response rate. After a median follow-up of 40.9 months, the failure-free survival and progression-free survival rates both were 90.1%, and the overall survival rate was 97.4%. The main toxicity was hematologic, and related grade 3 and 4 neutropenia was observed in 55.3% of patients. CONCLUSIONS: FCR induction therapy followed by a short maintenance phase is a highly effective regimen with acceptable toxicity. Cancer 2012. © 2011 American Cancer Society. Indolent nonfollicular non-Hodgkin B-cell lymphomas are clonal mature B-cell proliferations for which treatment has not been defined to date. The combination of rituximab, fludarabine, and cyclophosphamide as induction immunochemotherapy followed by a short maintenance phase with rituximab is a highly effective regimen with acceptable toxicity in this subset of lymphomas.

AB - BACKGROUND: Indolent nonfollicular non-Hodgkin B-cell lymphomas (INFLs) are clonal mature B-cell proliferations for which treatment has not been defined to date. METHODS: In this phase 2 study of patients with advanced INFL, the authors evaluated the efficacy and safety of first-line rituximab, fludarabine, and cyclophosphamide (FCR) as induction immunochemotherapy (rituximab 375 mg/m 2 intravenously on day 1 of each cycle and on days 1 and 14 of cycles 4 and 5; fludarabine 25 mg/m 2 intravenously on days 2-4, cyclophosphamide 250 mg/m 2 intravenously on Days 2-4) every 28 days for 6 cycles followed by a maintenance phase with 4 infusions of rituximab (375 mg/m 2 intravenously on day 1) every 2 months for responders. RESULTS: Forty-seven patients were enrolled. Among 46 evaluable patients (28 men; median age, 59 years), 19 were diagnosed with lymphoplasmacytic lymphoma, 21 were diagnosed with small lymphocytic lymphoma, and 6 were diagnosed with nodal marginal zone lymphoma. The overall response rate after maintenance was 89.1% with a 67.4% complete remission (CR) rate (CR/unconfirmed CR) and a 21.7% partial response rate. After a median follow-up of 40.9 months, the failure-free survival and progression-free survival rates both were 90.1%, and the overall survival rate was 97.4%. The main toxicity was hematologic, and related grade 3 and 4 neutropenia was observed in 55.3% of patients. CONCLUSIONS: FCR induction therapy followed by a short maintenance phase is a highly effective regimen with acceptable toxicity. Cancer 2012. © 2011 American Cancer Society. Indolent nonfollicular non-Hodgkin B-cell lymphomas are clonal mature B-cell proliferations for which treatment has not been defined to date. The combination of rituximab, fludarabine, and cyclophosphamide as induction immunochemotherapy followed by a short maintenance phase with rituximab is a highly effective regimen with acceptable toxicity in this subset of lymphomas.

KW - chemotherapy

KW - cyclophosphamide

KW - fludarabine

KW - indolent nonfollicular lymphomas

KW - rituximab

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