Liposomal doxorubicin-liposomal doxorubicin-rituximab for the treatment of elderly patients with diffuse large B-cell lymphoma

Abstract

6687 Background: At present CHOP plus rituximab (CHOP-R) appears to be the golden standard treatment for elderly patients with diffuse large B-cell lymphoma (B-DLCL). Treatment related toxicity, in particular infectious complications and cardiac toxicity, however, still represent a major cause of morbidity and mortality. Here we report the preliminary results of a pilot study performed to evaluate the efficacy and tolerability of a Caelyx-modified CHOP-R regimen (COP-Caelyx-R). Methods: Thirty consecutive untreated patients, 60 years or older, with CD20 positive B-DLCL, stage II-IV or bulky stage I, were enrolled in the study. Caelyx 30 mg/m2 was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) and rituximab every 21 days for 6 courses. G-CSF was administered as appropriate. Patients with initial bulky disease or localized residual disease received consolidation-involved field radiotherapy. The procedures planned for cardiac toxicity evaluation were echography with ejection fraction (EF) and serum troponin dosage. Hematological and extra-hematological toxic effects were graded according to the WHO classification. Results: Patients’ median age was 69 (range 60–75 years); the distribution according to International Prognostic Index (IPI) was: low 13.3%, low-intermediate 20%, high-intermediate 43.3%, high 23.3%. Twenty-nine patients are valuable for response and toxicity. Overall response (OR) and CR rate are 75.8% and 58.6%. The projected one year EFS and OS are 65% and 79%. No treatment-related mortality was documented. WHO grade III-IV neutropenia and thrombocytopenia were 86% and 3.5%. Extra-hematological WHO III-IV toxicity was represented by a single case of infection, mucositis and bleeding. None of the patients had clinical, instrumental and laboratory signs of cardiac toxicity; none developed hand-foot syndrome. Conclusions: COP-Caelyx-R regimen is an active regimen for the treatment of elderly B-DLCL. The replacement of conventional doxorubicin with Caelyx seems to reduce the incidence of extra-hematological toxicity, in particular cardiac and infectious complications. No significant financial relationships to disclose.