Phase III Intergroup Study of Fludarabine Phosphate Compared With Cyclophosphamide, Vincristine, and Prednisone Chemotherapy in Newly Diagnosed Patients With Stage III and IV Low-Grade Malignant Non-Hodgkin's Lymphoma

To compare the efficacy and safety of fludarabine phosphate with cyclophosphamide, vincristine, and prednisone (CVP) in 381 previously untreated, advanced-stage, low-grade (lg) non-Hodgkin's lymphoma (NHL) patients in a phase III, multicenter study. Between 1993 and 1997, patients were randomly...

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Published inJournal of clinical oncology Vol. 24; no. 10; pp. 1590 - 1596
Main Authors HAGENBEEK, Anton, EGHBALI, Houchingue, TEODOROVIC, Ivana, NEGROUK, Anastassia, VAN GLABBEKE, Martine, MARCUS, Robert, MONFARDINI, Silvio, VITOLO, Umberto, HOSKIN, Peter J, DE WOLF-PEETERS, Christiane, MACLENNAN, Ken, STAAB-RENNER, Elvira, KALMUS, Joachim, SCHOTT, Astrid
Format Journal Article
LanguageEnglish
Published Baltimore, MD American Society of Clinical Oncology 01.04.2006
Lippincott Williams & Wilkins
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Abstract To compare the efficacy and safety of fludarabine phosphate with cyclophosphamide, vincristine, and prednisone (CVP) in 381 previously untreated, advanced-stage, low-grade (lg) non-Hodgkin's lymphoma (NHL) patients in a phase III, multicenter study. Between 1993 and 1997, patients were randomly assigned to treatment with either fludarabine (25 mg/m2 intravenously [IV] daily for 5 days every 4 weeks) or CVP (cyclophosphamide 750 mg/m2 IV on day 1; vincristine, 1.4 mg/m2 IV on day 1; and prednisone, 40 mg/m2 orally on days 1 through 5 every 4 weeks). Results Overall response (OR) rates were significantly improved in the fludarabine arm versus the CVP arm, both for the intent-to-treat (ITT) population and assessable patients (P < .001). Complete response (CR) rates in the ITT population were also higher after fludarabine treatment. The CR rate was 38.6% for fludarabine compared with 15.0% for CVP. There were no statistically significant differences in time to progression (TTP), time to treatment failure (TTF), and overall survival (OS) between treatment groups. WHO grades 3 and 4 hematologic adverse events were more common in the fludarabine arm. However, concerning the higher incidence of granulocytopenia, this did not translate to more infections in fludarabine-treated patients. Newly diagnosed lgNHL patients who received fludarabine achieved higher OR and CR rates compared with CVP-treated patients. No differences in TTP, TTF, and OS were noted. Fludarabine is a highly active single agent in lgNHL. Combination therapies incorporating fludarabine are now being further evaluated as first-line therapy in follicular NHL.
AbstractList To compare the efficacy and safety of fludarabine phosphate with cyclophosphamide, vincristine, and prednisone (CVP) in 381 previously untreated, advanced-stage, low-grade (lg) non-Hodgkin's lymphoma (NHL) patients in a phase III, multicenter study. Between 1993 and 1997, patients were randomly assigned to treatment with either fludarabine (25 mg/m2 intravenously [IV] daily for 5 days every 4 weeks) or CVP (cyclophosphamide 750 mg/m2 IV on day 1; vincristine, 1.4 mg/m2 IV on day 1; and prednisone, 40 mg/m2 orally on days 1 through 5 every 4 weeks). Results Overall response (OR) rates were significantly improved in the fludarabine arm versus the CVP arm, both for the intent-to-treat (ITT) population and assessable patients (P < .001). Complete response (CR) rates in the ITT population were also higher after fludarabine treatment. The CR rate was 38.6% for fludarabine compared with 15.0% for CVP. There were no statistically significant differences in time to progression (TTP), time to treatment failure (TTF), and overall survival (OS) between treatment groups. WHO grades 3 and 4 hematologic adverse events were more common in the fludarabine arm. However, concerning the higher incidence of granulocytopenia, this did not translate to more infections in fludarabine-treated patients. Newly diagnosed lgNHL patients who received fludarabine achieved higher OR and CR rates compared with CVP-treated patients. No differences in TTP, TTF, and OS were noted. Fludarabine is a highly active single agent in lgNHL. Combination therapies incorporating fludarabine are now being further evaluated as first-line therapy in follicular NHL.
Author Christiane de Wolf-Peeters
Anton Hagenbeek
Ivana Teodorovic
Ken MacLennan
Martine van Glabbeke
Silvio Monfardini
Elvira Staab-Renner
Peter J. Hoskin
Astrid Schott
Joachim Kalmus
Houchingue Eghbali
Umberto Vitolo
Anastassia Negrouk
Robert Marcus
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  surname: SCHOTT
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  organization: European Organisation for Research and Treatment of Cancer (EORTC) Lymphoma Group, the British National Lymphoma investigation Group, and the Dutch-Belgian Working Party on Hemato-Oncology, Academic Medical Center Amsterdam, Amsterdam, Netherlands
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Issue 10
Keywords Antineoplastic agent
Phase III trial
Phosphates
Early stage
Alkaloid
Cancerology
Lymphoproliferative syndrome
Malignant lymphoma
Advanced stage
Antimitotic
Low grade
Human
Corticosteroid
Purine nucleotide
Malignant hemopathy
Prednisone
Non Hodgkin lymphoma
Vincristine
Alkylating agent
Oxazaphosphinane derivatives
Chemotherapy
Cyclophosphamide
Fludarabine
Treatment
Antimetabolic
Nitrogen mustard
Adrenal hormone
Fluorine Organic compounds
Language English
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Snippet To compare the efficacy and safety of fludarabine phosphate with cyclophosphamide, vincristine, and prednisone (CVP) in 381 previously untreated,...
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SubjectTerms Adult
Aged
Antimetabolites, Antineoplastic - therapeutic use
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Cyclophosphamide - therapeutic use
Female
Hematologic and hematopoietic diseases
Humans
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Lymphoma, Non-Hodgkin - drug therapy
Male
Medical sciences
Middle Aged
Neoplasm Staging
Prednisone - therapeutic use
Prospective Studies
Tumors
Vidarabine Phosphate - analogs & derivatives
Vidarabine Phosphate - therapeutic use
Vincristine - therapeutic use
Title Phase III Intergroup Study of Fludarabine Phosphate Compared With Cyclophosphamide, Vincristine, and Prednisone Chemotherapy in Newly Diagnosed Patients With Stage III and IV Low-Grade Malignant Non-Hodgkin's Lymphoma
URI http://jco.ascopubs.org/content/24/10/1590.abstract
https://www.ncbi.nlm.nih.gov/pubmed/16575010
Volume 24
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