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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†‡

  1. Antonio Salar MD1,2,§,*,
  2. Eva Domingo-Domenech MD3,4,
  3. Cristina Estany MD5,
  4. Miguel A. Canales MD6,
  5. Fernando Gallardo MD1,2,
  6. Octavio Servitje MD3,4,
  7. Guadalupe Fraile MD7,
  8. Carlos Montalbán MD7

Article first published online: 11 AUG 2009

DOI: 10.1002/cncr.24605

Issue

Cancer

Cancer

Volume 115, Issue 22, pages 5210–5217, 15 November 2009

Additional Information

How to Cite

Salar, A., Domingo-Domenech, E., Estany, C., Canales, M. A., Gallardo, F., Servitje, O., Fraile, G. and Montalbán, C. (2009), 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. Cancer, 115: 5210–5217. doi: 10.1002/cncr.24605

Author Information

  1. 1

    Department of Clinical Hematology, Hospital Universitari del Mar, Barcelona, Spain

  2. 2

    Department of Dermatology, Hospital Universitari del Mar, Barcelona, Spain

  3. 3

    Department of Clinical Hematology, ICO/Hospital de Bellvitge, L”Hospitalet de Llobregat, Barcelona, Spain

  4. 4

    Department of Dermatology, Institut Català d'Oncologia/Hospital de Bellvitge, L”Hospitalet de Llobregat, Barcelona, Spain

  5. 5

    Department of Hematology, Hospital Mutua de Terrassa, Terrassa, Barcelona, Spain

  6. 6

    Department of Hematology, Hospital La Paz, Madrid, Spain

  7. 7

    Department of Internal Medicine, Ramon y Cajal Hospital, Madrid, Spain

  1. §

    Fax: (011) 34-93-2483343

*Department of Clinical Hematology, Hospital Universitari del Mar, Passeig Marítim 25-29, E-08003 Barcelona, Spain

  1. †

    Presented at the 44th Annual Meeting of the American Society for Clinical Oncology, Chicago, Illinois, May 30-June 3, 2008.

  2. ‡

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

Publication History

  1. Issue published online: 3 NOV 2009
  2. Article first published online: 11 AUG 2009
  3. Manuscript Accepted: 22 JAN 2009
  4. Manuscript Revised: 18 JAN 2009
  5. Manuscript Received: 4 NOV 2008

Funded by

  • Instituto de Salud Carlos III
  • Spanish Ministry of Science and Technology. Grant Number: PI07/0586
  • Institut Municipal de Investigació Médica
  • Hospital del Mar. Grant Number: ASS/2008

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Keywords:

  • B cells;
  • fludarabine;
  • non-Hodgkin lymphoma;
  • mucosa-associated lymphoid tissue;
  • rituximab

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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