Rituximab or rituximab plus chlorambucil for translocation (11;18)-negative gastric mucosa-associated lymphoid tissue lymphoma: a monocentric non-randomized observational study.

To assess the effectiveness and safety of rituximab alone or in combination with chlorambucil for the treatment of translocation (11;18)-negative gastric MALT lymphoma, we included 71 patients in a retrospective case-control study, 54 treated with rituximab alone and 17 with combination therapy. There was no difference between the groups in complete remission or overall response rates at weeks 25 and 52. After a median follow-up period of 5.8 years (range, 3.3 - 9.7 years), the 5-year progression-free survival probabilities were 60% and 88% in patients treated with rituximab monotherapy and combination therapy, respectively (p = .05). Adverse events were reported in 13 (18%) patients and were more frequent in the combination therapy group (p < .001). Combination therapy may be a preferable choice in patients with gastric MALT lymphoma irrespective of t(11;18) status. Further studies should assess benefit of stopping chlorambucil in early good-responder patients.