First-line treatment with rituximab combined with intravenous or oral fludarabine for patients with extranodal mucosa associated lymphoid tissue (MALT) lymphoma

Abstract

8608 Background: The addition of rituximab to other drugs has improved outcomes in several types of NHL without a significant addition of toxicity. Our aim was to evaluate the safety and efficacy of rituximab combined with fludarabine in first-line therapy for extranodal MALT lymphoma. Methods: This study enrolled adult patients with untreated extranodal MALT lymphoma who were candidate to receive systemic treatment. Patients received rituximab 375 mg/m2 intravenously (IV) on day 1 and fludarabine 25 mg/m2 (IV) given on days 1–5 (days 1–3 in > 60 years), every 4 weeks; after the first cycle, oral fludarabine was allowed to be given orally at 40 mg/m2 with the same schedule. After three cycles, a work-up was done. Patients in CR received an additional cycle and, if PR, a total of 6 cycles was recommended. Use of G-CSF and prophylactic antibiotics was optional. Results: 22 patients have been included and started on therapy. Characteristics of the first 18 pts: median age: 59 years (range: 32–83); 7 male, 11 female; PS 0 (94%); site of lymphoma origin: stomach (61%), skin (16%), lung (11%), parotid gland (11%); stage: I (66%), II (16%) and IV (16%). A total of 82 cycles of R-F were administered; 2 pts received 2 cycles, 9 pts 4 cycles, 7 pts 6 cycles. 17 pts are evaluable for response. Overall response rate was 100% with 94% achieving CR. One pt relapsed. Median follow-up from starting treatment is 15 m (range: 17–27). PFS rate is 93% (CI95%: 79–100%) at 12 m and OS rate is 100% at 12 m. Tolerance to oral fludarabine was excellent with most patients preferring this formulation. Mild neutropenia was the most common toxicity, usually presenting after the third cycle. No blood transfusions were required. 3 pts developed grade 2 respiratory infection, but none pt had to be admitted. Conclusions: These preliminary data indicate that the RF regimen, either with intravenous or oral fludarabine, was well tolerated even in elderly patients. This combination is very active for the treatment of untreated extranodal MALT lymphoma, even with fewer cycles than initially planned. Updated data will be presented. No significant financial relationships to disclose.