Long Term Follow up of the Patients with Non-Hodgkin's Lymphoma Treated with Rituximab in Combination with CHOP Regimen.

Abstract

Objectives: We performed this prospective study with single arm to evaluate the long term efficacy and safety of rituximab in combination with CHOP regimen in B cell non-Hodgkin's Lymphoma (NHL) patient.Methods: All patients received 4~8 cycles of CHOP plus rituximab. For each cycle, Rituximab (375 mg/m2 per dose) was given on day 1 and CHOP regimen on day 3. CHOP regimen consisted of cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and vincristine 1.4 mg/m2 (maximum dose, 2.0 mg/d) given intravenously on day 3, and oral prednisone 60 mg given from day 3 to 7.Results: 102 patients were enrolled in this trial, 65 of them are males and 37 are females, with the median age of 47.5 (range 16–76). The main subtypes were diffuse large B cell lymphoma (DLBCL, 82/102), follicular lymphoma (FL, 9/102), mucosa associated lymphoma (MALT, 3/102), marginal zone lymphoma (MZL, 3/102), lymphoplasmacytic lymphoma (LPL, 2/102) and mantle cell lymphoma (MCL, 3/102). The overall response (OR) rate was 91.2% and complete response (CR) rate was 71.6%. The OR and CR of DLBCL were 90.2% and 70.7%, respectively; and the OR and CR of indolent lymphoma (MALT, FL, and LPL) were 100.0% and 82.4%, respectively. The patients with lower (0,1) and higher (≥2) IPI score achieved CR rate and OR rate of 87.88% and 59.18%, and 100.00% and 83.67%, respectively. International prognosis index (IPI) score showed significant impact on both CR and OR rate (P=0.006 and 0.019, respectively). The patients with and without bulky disease achieved CR rate and OR rate of 50.00% and 74.29%, and 83.33% and 91.43%, respectively, and there was no statistical significance (P=0.100 and 0.332, respectively). The patients were followed after achieving objective response (CR+PR) for 2–64 months (median 20 months). Estimated 5 year progress free survival (PFS) rate and estimated 5 year overall survival (OS) rate was 60.33%±6.94% and 75.88%±6.94%, respectively. In DLBCL patients, PFS and OS rate was reached at 56.45%±8.26% and 74.12%±7.48%, respectively. 4 year PFS rate and OS rate of the patients with indolent lymphoma was 86.15%±9.11% and 100%, respectively. IPI score showed significant survival impact on OS and PFS in DLBCL patients, respectively (P=0.0339 and 0.0122, respectively); however, the bulky disease showed impact on PFS but not on OS (P=0.0472 and 0.106, respectively).Conclusions: The results suggested that the rituximab in combination with chemotherapy regimen in most B cell NHL patient was effective and safe.