Pegilated Liposomal Doxorubicin in Combination with Cyclophosphamide, Vincristine, Prednisone and Rituximab in Patients with Newly Diagnosed Diffuse Large B Cell NHL: Clinical Efficacy and Related Cardiac Safety.

Pegylated liposomal doxorubicin, (CAELYX; Schering Plough) was introduced because of its low or totally absent cardiotoxicity and greater penetration in tumor tissue. Based on differences in clinical pharmacokinetics and clinical studies, the dose for PLD is lower than the standard dose for doxorubicin and epidoxorubicin. This feature makes it suitable for use in older patients and/or those with previous heart disease suffering from diffuse large B-cell NHL, by including Caelyx in 30 mg/mq doses in the classic CHOP regimen, in place of conventional doxorubicin. In this single-centre study, the endpoint were the therapeutic response and the incidence of cardiotoxicity, assessed by means of echocardiogram (LVEF),before and after chemotherapy and at a later stage following the last chemotherapy cycle. Pegylated liposomal doxorubicin was administered in a dose of 30 mg/mq in association with standard doses of Cyclophosphamide 750 mg/mq, Vincristine 1,4 mg/mq, Prednisone 100 mg/mq p.o. day 1–5, and Rituximab 375 mg/mq at 21 day intervals.The trial enrolled 24 patients, aged between 65 and 83 (average age 75 years), in stage II-IV (15 patients in stage IV, 6 in stage III and 3 in stage II); in 65% of the patients, the International Prognostic Index was high-intermediate. An average of six chemotherapy cycles were administered per patients. No dose-limiting cumulative toxicity was observed. The objective responses observed were 85%, with 70% complete responses and 15% partial responses. The average duration of the response was 14 months (1.7–41.5 months). There was no decrease in LVEF associated with administration of pegylated liposomal doxorubicin. Pegylated liposomal doxorubicin in combination with Cyclophosphamide, Vincristine and Prednisone in addition to Rituximab, was found to be active and safe in this series of patients with diffuse large B-cell lymphoma with complete remission in 70% of the cases, without this affecting cardiac safety.