FN And CHOP Combined With And Without CD20 Monoclonal Antibody Randomized Controlled First Line Treatment Of MALT Lymphoma

OBJECTIVE To study the efficacy and the toxicities of rituximab (R) plus FND chemotherapy and rituximab plus CHOP chemotherapy for MALT lymphoma. and examine the feasibility of FND chemotherapy for MALT lymphoma. To provide a reference for determining a standard first-line treatment for MALT lymphoma.Methods54inpatients with MALT lymphoma between July1,2008and December1,2012were identified the studied group. There were24cases of male,30cases of female,55meta-age of onset years old. There were15patients with gastric MALT lymphoma and39patients with Non-gastric MALT lymphoma. We conducted an open-label, randomized trial among adult patients with previously untreated MALT to compare efficacy of six doses of R associated with six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or six cycles of fludarabine,mitoxantrone and dexamethasone(FND). The principal end point of the study was Failure Free Survival(FFS) and Overall Survival(OS).RESULTS1. Overall response rates were57.1%、46.2%for FND and CHOP (P=.25),92.3%and84.6%for R-FND and R-CHOP(p=.19).2. After a median follow-up of32.4months,3-year FFS were35.9%、34.7%for FND and CHOP (p=0.39). And69.8%、75.5%for R-FND and R-CHOP groups(p=0.01). 3. In the studied group, overall major grade3to4toxicities comprised neutropenia(35.14%), including2cases of grade4febrile neutropenia(5.41%)and There were22(82%) cases comprised febrile neutropenia, including6cases of grade IV and16cases of grade Ⅱ-Ⅲ febrile neutropenia in FND group (FND+R-FND).In CHOP group (R-CHOP+CHOP),10(40%) cases comprised febrile neutropenia, in which2cases comprised grade IV and8cases comprised grade Ⅱ-Ⅲ.CONCLUSION1. FND had same efficacy to CHOP in Overall response rates and FFS.2. Chemotherapy associated with rituximab were superior to chemotherapy alone group in Overall response rates and FFS, respectively, especially in CHOP/R-CHO group.3. R-CHOP were superior to R-FND in terms of3-year FFS. In addition, R-CHOP had a better risk-benefit ratio compared with R-FND.