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

Anton Hagenbeek, Houchingue Eghbali, Silvio Monfardini, Umberto Vitolo, Peter J. Hoskin, Christiane De Wolf-Peeters, Ken MacLennan, Elvira Staab-Renner, Joachim Kalmus, Astrid Schott, Ivana Teodorovic, Anastassia Negrouk, Martine Van Glabbeke, Robert Marcus

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Abstract

Purpose: To compare the efficacy and safety of fludarabine phosphate with cyclophosphamide, vincristine, and prednisone (CVP) in 381 previously untreated, advanced-stage, low-grade (Ig) non-Hodgkin's lymphoma (NHL) patients in a phase III, multicenter study. Patients and Methods: 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. Conclusion: Newly diagnosed IgNHL 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 IgNHL. Combination therapies incorporating fludarabine are now being further evaluated as first-line therapy in follicular NHL.

Original languageEnglish
Pages (from-to)1590-1596
Number of pages7
JournalJournal of Clinical Oncology
Volume24
Issue number10
DOIs
Publication statusPublished - Apr 1 2006

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fludarabine phosphate
Vincristine
Prednisone
Non-Hodgkin's Lymphoma
Cyclophosphamide
Drug Therapy
Treatment Failure
Therapeutics
fludarabine
Follicular Lymphoma
Agranulocytosis
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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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. / Hagenbeek, Anton; Eghbali, Houchingue; Monfardini, Silvio; Vitolo, Umberto; Hoskin, Peter J.; De Wolf-Peeters, Christiane; MacLennan, Ken; Staab-Renner, Elvira; Kalmus, Joachim; Schott, Astrid; Teodorovic, Ivana; Negrouk, Anastassia; Van Glabbeke, Martine; Marcus, Robert.

In: Journal of Clinical Oncology, Vol. 24, No. 10, 01.04.2006, p. 1590-1596.

Research output: Contribution to journalArticle

Hagenbeek, A, Eghbali, H, Monfardini, S, Vitolo, U, Hoskin, PJ, De Wolf-Peeters, C, MacLennan, K, Staab-Renner, E, Kalmus, J, Schott, A, Teodorovic, I, Negrouk, A, Van Glabbeke, M & Marcus, R 2006, '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', Journal of Clinical Oncology, vol. 24, no. 10, pp. 1590-1596. https://doi.org/10.1200/JCO.2005.03.7952
Hagenbeek, Anton ; Eghbali, Houchingue ; Monfardini, Silvio ; Vitolo, Umberto ; Hoskin, Peter J. ; De Wolf-Peeters, Christiane ; MacLennan, Ken ; Staab-Renner, Elvira ; Kalmus, Joachim ; Schott, Astrid ; Teodorovic, Ivana ; Negrouk, Anastassia ; Van Glabbeke, Martine ; Marcus, Robert. / 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. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 10. pp. 1590-1596.
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abstract = "Purpose: To compare the efficacy and safety of fludarabine phosphate with cyclophosphamide, vincristine, and prednisone (CVP) in 381 previously untreated, advanced-stage, low-grade (Ig) non-Hodgkin's lymphoma (NHL) patients in a phase III, multicenter study. Patients and Methods: 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. Conclusion: Newly diagnosed IgNHL 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 IgNHL. Combination therapies incorporating fludarabine are now being further evaluated as first-line therapy in follicular NHL.",
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T1 - 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

AU - Hagenbeek, Anton

AU - Eghbali, Houchingue

AU - Monfardini, Silvio

AU - Vitolo, Umberto

AU - Hoskin, Peter J.

AU - De Wolf-Peeters, Christiane

AU - MacLennan, Ken

AU - Staab-Renner, Elvira

AU - Kalmus, Joachim

AU - Schott, Astrid

AU - Teodorovic, Ivana

AU - Negrouk, Anastassia

AU - Van Glabbeke, Martine

AU - Marcus, Robert

PY - 2006/4/1

Y1 - 2006/4/1

N2 - Purpose: To compare the efficacy and safety of fludarabine phosphate with cyclophosphamide, vincristine, and prednisone (CVP) in 381 previously untreated, advanced-stage, low-grade (Ig) non-Hodgkin's lymphoma (NHL) patients in a phase III, multicenter study. Patients and Methods: 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. Conclusion: Newly diagnosed IgNHL 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 IgNHL. Combination therapies incorporating fludarabine are now being further evaluated as first-line therapy in follicular NHL.

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