A phase II study of R-COMP14 in elderly patients with high-risk diffuse large B-cell lymphoma (DLBCL) and moderate to high “life threat” impact cardiopathy.

8058 Background: R-CHOP14 delivery in pts with poor IPI score and/or EBV+ and cardiac morbidity, may be hampered by acute, early and late cardiac toxicity from dose-dense doxorubicin. Non-pegylated liposome-encapsulated doxorubicin (NPLD) is accounted as equivalent to free doxorubicin with less cardiac adverse events (CAE). Methods: Untreated pts (median age 73 y, r 62-82) with IPI 3-5 DLBCL and moderate-high ‘life threat’ impact cardiac comorbidity [lymphoma-validated NIA/NCI index (Janssen-Heijnen 2005)], entered a phase II study of 6 biweekly courses of R-COMP14 (R-CHOP with doxo replaced by 50 mg/m2 of NPLD; Myocet). Therapy was given as inpatients with close cardiac monitoring. A CrCl >30 ml/min and left ventricular ejection fraction (LVEF) ≥0.45 were required. Age-adjusted Charlson Comorbidity Index (aaCCI) was used to weight comorbidity. Results: 41 pts were enrolled and 208 courses delivered at a median interval of 15.6 days (r 13-29); 67% of pts received all 6 courses. ORR was 73 %, with 68% CRs ...