Early Primary Gastric Lymphoma with Adverse Prognosis Factors. Is it Benefit Adding Rituximab to CHOP-14?

Objective: Assess if the addition of rituximab to a dose-dense chemotherapy regimen in patients with primary gastric diffuse large B-cell lymphoma (PGL) in early stage, but, associated with worse prognostic factors. Patients and Methods: Patients with pathological diagnosis of PGL and early stages, but, with elevated levels of beta 2 microglobulin and lactic dehydrogenase, age > 18 years age without upper limit, no gender differences, previously untreated, were recruit in an open label clinical trial, to received CHOP-14 (cyclophosphamide, vincristine, doxorubicin and prednisone, dose dense, every 14 days) and compare with patients that received R-CHOP14 (rituximab + CHOP-14). Results: Between March 2011 to December 2016, 141 patients were taken entry to the study: no statistical differences were observed in clinical and laboratory characteristics. Complete response (CR) was observed in 68 out of 72 (94.4%) patients in the CHOP-R14, and 67 out of 69 (95.1%) patients in the CHOP14 regimen. Actuarial curves at 5-years show that progression-free survival (PFS) was 89% (95%Confidence Interval (CI) in the CHOP-R14, that did not have statistical differences in the CHOP-14 arm: 92% (95%CI: 83% -97%) (p 0.887); the overall survival were: 90% (95% CI:86%-97%) and 93.4% (95% CI: 86% to 97%) (p 0,665). Toxicities were severe granulocytopenia and infection-related, but no dead were observed. Until now, late toxicities as acute leukemia, second neoplasms and cardiac damage has not been observed. Conclusion: The use of dose dense regimen (CHOP-14) confirm that is useful in the treatment of PGL associated to worse prognosis factors, the addition of rituximab did not show any benefit.