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 II). 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.