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Clinical Trial
. 2009 Nov 15;115(22):5210-7.
doi: 10.1002/cncr.24605.

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

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Clinical Trial

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

Antonio Salar et al. Cancer. .
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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/m(2) intravenously on Day 1 and fludarabine 25 mg/m(2) 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/m(2) 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.

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