A phase II trial of rituximab as adjuvant to intensive sequential chemotherapy in patients under 60 years with untreated poor-prognosis diffuse large B-cell lymphoma.

The potential benefit of rituximab as adjuvant to highdose therapy(HDT) has been investigated in patients under 60 years with poor-risk (age-adjusted international prognostic index at 2–3) CD20 þ diffuse large B-cell lymphoma (DLBCL). The treatment consisted of four cycles of high-dose CEOP (cyclophosphamide, epirubicin, vincristine, prednisone), plus etoposide and cisplatin during the two last cycles. Peripheral blood stem cells were collected after cycle 1, and reinfused after cycles 3 and 4. Four weeklyrituximab infusions were subsequently delivered. Among the 36 patients included, 30 could complete chemotherapyschedule, and 24/36 received rituximab. A complete response occured in 26/36 patients (72%). With a median follow-up of 30 months, the estimated 5-year overall survival (OS) and event-free survival (EFS) rates (mean7s.d.) were 65716 and 63715%, respectively. For the 24 patients who received both chemotherapyand rituximab, the estimated 5-y ear OS and EFS rates were 86714 and 82715%. These data suggest that rituximab after HDT is feasible. Both complete remission rate and survival curves compare favorablywith the poor outcome usuallyobserved in high-risk DLBCL patients managed with HDT without rituximab.