17506 Background: The majority of patients (pts) with diffuse large B-cell lymphoma (DLBCL) are elderly and may have limited tolerance to intense chemotherapy. Myocet has an improved therapeutic index in comparison to doxorubicin, resulting in less myelosuppresion, lower GI toxicity and reduced risk of cardiotoxicity. The aim of this study was to assess the efficacy and safety of the R-CHOP modified by replacing doxorubicin with Myocet (R-COMP) in pts ≥ 60 years with newly diagnosed, advanced DLBCL. Methods: Sample size was defined with the level of no interest P0 = 40% of CRs and the level of interest P1 = 60% of CRs. After assessment of the first 25 evaluable pts accrual continued to 75 pts, sample size estimated to include 66 evaluable pts. R-COMP regimen: d1 every 3 wks Myocet 50 mg/m2, cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 (max. 2 mg), rituximab 375 mg/m2 (d3 C1, d1 thereafter) and prednisone 100 mg/d d1–5. After 3 cycles pts with an objective response received 5 additional cycles. Results: Between Oct 2002 and Apr 2005, 75 pts were registered. This analysis includes the first 51 evaluable pts: median age was 71 (60–83); 56% of pts had an intermediate or high risk IPI score (≥ 3); median LVEF at baseline was 60% (50–89). Relative dose intensity was 89.8%. Median treatment of 8 cycles (1–8). Thirty-four pts (67%) achieved CR (95% CI = 51, 5–79,3) and 10 pts (20%) PR; Five percent of cycles were delayed and 9% were dose reduced due to toxicity. Toxicity: Grade (G) 3–4 neutropenia in 22% of cycles (52% of pts), febrile neutropenia in 3% of cycles (12% of pts), G 3–4 thrombocytopenia in 2 cycles, one episode of neutropenic sepsis, mucositis and related infections in 1% of the cycles each. Median final LVEF was 60% (40–79). Four pts were withdrawn due to decrease in LVEF. One pt had acute pulmonary oedema (considered related to the drug in absence of other reasons). No pts had congestive heart failure related to study drug. Conclusions: The R-COMP regimen is a well-tolerated and effective treatment for aggressive NHL in elderly pts. Both, the general tolerability and the low incidence of cardiac events warrants further studies in order to confirm the clinical benefit of R-COMP in elderly population. [Table: see text]
Aggressive chemotherapy in frail patients with diffuse large B-cell lymphoma: The role of pegylated liposomal doxorubicin