A phase II study of liposomal daunorubicin, in combination with cyclophosphamide, vincristine and prednisolone, in elderly patients with previously untreated aggressive non-Hodgkin lymphoma

Liposomal daunorubicin (DaunoXome) was substituted for doxorubicin in the CHOP regimen, aiming to reduce toxicity and maintain or improve efficacy in elderly patients. Eligibility criteria included: age ≥60 years; previously untreated aggressive non-Hodgkin Lymphoma (NHL) and performance status (PS) 0–2. Treatment was cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 (maximum 2 mg), and DaunoXome 100 mg/m2 iv on day 1, prednisolone 100 mg po on days 1–5 and G-CSF 5 µg/kg/day sc, for 6–8 cycles. For the 51 patients, median age was 70 years (range 60–88), 94% had diffuse large B-cell lymphoma (DLBCL) and 55% were high-intermediate or high-risk according to the age-adjusted international prognostic index. A mean of 6 cycles was delivered, with dose reductions of DaunoXome in 8.3% of cycles. The combined CR and CRu rate was 65.2%, survival was 566 days and 5-year survival 35%. Three deaths occurred during treatment and may have been related to COP-X. Only 4 (7.8%) of the remaining patients had ≥10% reduction ...