Rituximab plus dose-dense CHOP (RCHOP-14) for the treatment of patients with aggressive lymphoma

Introduction: Standard first line therapy for aggressive NHL consists of CHOP chemotherapy. The addition of Rituximab to CHOP shows a survival benefit. Moreover the dose dense CHOP recently has shown an improvement in response and survival rate of pts with aggressive NHL. Methods: To evaluate the efficacy and feasibility of dose-dense CHOP plus Rituximab we planned a schedula with Rituximab 375 mg/m 2 and CHOP therapy on day + 1 given every 2 weeks, with G-CSF starting from day + 7 to + 11. We administered prophylaxis with sulfamethoxazole and trimethoprim and itraconazole. From January 2002, we enrolled 44 patients (pts) with aggressive NHL (FL grade III = 13, DLBCL = 31). The mean age was 62 years (range 29–76).Two pts were stage I, 8 stage II, 7 stage III and 27 stage IV. Eighteen/44(41%) pts presented B symptoms,18 bone marrow involvement, increased LDH value in 28 (64%) pts and 31(71%) presented at least one extranodal station involved. According to IPI score 24 pts were Low Risk (IPI = 0–1) and 24 High Risk (IPI = 2–3). Results: All pts completed the programmed 6 cycles and were evaluable for response. Thirteen (29%) pts delayed the treatment (anemia = 1, neutropenia = 11, thrombocytopenia = 1). No remarkable extrahematological toxicity was observed, in particular we focused our attention on mucositis and cardiotoxicity. Thirty-six (82%) obtained a CR and 8 (18%) a PR (overall response rate was 100%). After a median follow-up of 20 months (range 3–36), 6 (14%) pts relapsed. The 2-yrs OS and DFS were 89% and 78% respectively. Conclusions: R-CHOP-14 was feasible, active and lack of severe toxicity in pts with aggressive NHL.