Combination therapy with rituximab and intravenous or oral fludarabine in the first-line, systemic treatment of patients with extranodal marginal zone B-cell lymphoma of the mucosa-associated lymphoid tissue type

Authors

  • Antonio Salar MD,

    Corresponding author
    1. Department of Clinical Hematology, Hospital Universitari del Mar, Barcelona, Spain
    2. Department of Dermatology, Hospital Universitari del Mar, Barcelona, Spain
    • Department of Clinical Hematology, Hospital Universitari del Mar, Passeig Marítim 25-29, E-08003 Barcelona, Spain
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    • Fax: (011) 34-93-2483343

  • Eva Domingo-Domenech MD,

    1. Department of Clinical Hematology, ICO/Hospital de Bellvitge, L”Hospitalet de Llobregat, Barcelona, Spain
    2. Department of Dermatology, Institut Català d'Oncologia/Hospital de Bellvitge, L”Hospitalet de Llobregat, Barcelona, Spain
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  • Cristina Estany MD,

    1. Department of Hematology, Hospital Mutua de Terrassa, Terrassa, Barcelona, Spain
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  • Miguel A. Canales MD,

    1. Department of Hematology, Hospital La Paz, Madrid, Spain
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  • Fernando Gallardo MD,

    1. Department of Clinical Hematology, Hospital Universitari del Mar, Barcelona, Spain
    2. Department of Dermatology, Hospital Universitari del Mar, Barcelona, Spain
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  • Octavio Servitje MD,

    1. Department of Clinical Hematology, ICO/Hospital de Bellvitge, L”Hospitalet de Llobregat, Barcelona, Spain
    2. Department of Dermatology, Institut Català d'Oncologia/Hospital de Bellvitge, L”Hospitalet de Llobregat, Barcelona, Spain
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  • Guadalupe Fraile MD,

    1. Department of Internal Medicine, Ramon y Cajal Hospital, Madrid, Spain
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  • Carlos Montalbán MD

    1. Department of Internal Medicine, Ramon y Cajal Hospital, Madrid, Spain
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  • Presented at the 44th Annual Meeting of the American Society for Clinical Oncology, Chicago, Illinois, May 30-June 3, 2008.

  • We thank Marta Pulido, MD, for editing the article and for editorial assistance.

Abstract

BACKGROUND:

Currently, there are no consensus guidelines regarding the best therapeutic option for patients with extranodal marginal zone lymphomas of the mucosa-associated lymphoid tissue (MALT) type.

METHODS:

Patients with systemically untreated or de novo extranodal MALT lymphoma received rituximab 375 mg/m2 intravenously on Day 1 and fludarabine 25 mg/m2 intravenously on Days 1 through 5 (Days 1-3 in patients aged >70 years) every 4 weeks, for 4 to 6 cycles. After the first cycle, oral fludarabine could be given orally at 40 mg/m2 on the same schedule. After 3 cycles, a workup was done. Patients who achieved a complete remission (CR) received an additional cycle, and patients who achieved a partial remission (PR) received a total of 6 cycles.

RESULTS:

Twenty-two patients were studied, including 12 patients with gastric lymphoma and 10 patients with extragastric MALT lymphoma. Six patients (27%) had stage IV disease. In total, 101 cycles were administered (median, 4 cycles per patients). After the third cycle, 13 patients (62%) achieved a CR, and 8 patients (38%) achieved a PR. Primary extragastric disease was an adverse factor to achieve CR after 3 cycles of chemotherapy (hazard ratio, 23.3; 95% confidence interval, 2.0-273.3). At the end of treatment, the overall response rate was 100%, and 90% of patients achieved a CR. The progression-free survival rate at 2 years in patients with gastric and extragastric MALT lymphoma was 100% and 89%, respectively. Toxicities were mild and mainly were hematologic.

CONCLUSIONS:

Combination therapy with rituximab and fludarabine is a very active treatment with favorable safety profile as first-line systemic treatment for patients with extranodal MALT lymphoma. Cancer 2009. © 2009 American Cancer Society.

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