Surgery and chemotherapy versus chemotherapy as treatment of high-grade MALT gastric lymphoma

Background and Objectives: Treatment of high-grade MALT (mucosa-associated lymphoid tissue) gastric lymphoma remains uncertain. To assess efficacy and toxicity of the most common therapies-surgery followed by chemotherapy or chemotherapy alone-we began a controlled clinical trial in patients in early stage (I and III). Methods: One hundred and two patients were randomized to be treated with surgery followed by six cycles of CEOP-Bleo (cyclophosphamide, epirubicin, vincristine, prednisone, and bleomycin at standard doses) (52 cases) or with chemotherapy alone (49 cases). Results: Complete response rates were 94% [95% confidence interval (CI): 88-99%] and 96% (93-100%), respectively. Actuarial curves at 5 yr showed that event-free survival were 70% (95% CI: 59-74%) in patients treated with surgery and chemotherapy, that were not statistically significant to 67% (95% CI: 51-69%) in the patients who received chemotherapy (p = 0.5). Also, overall survival that was not statistically significant: 78% (95% CI: 70-88%) in the combined treatment and 76% (95% CI: 70-87%) in chemotherapy (p = 0.8). Acute and late toxicity were mild and well controlled. No acute leukemia or second neoplasm has been observed. Conclusions: The use of surgery and chemotherapy did not improve outcome in patients with early-stage high-grade gastric MALT lymphoma. It is apparent that chemotherapy alone is sufficient treatment in this select group of patients.