First Efficacy Assessment Of A Phase Ii Study With Cyclophosphamide, Vincristine, Liposomal Doxorubicin, And Prednisone Plus Rituximab, Administered Every Two Weeks (R-Comp-14) As Primary Treatment For Nhl

18519 Background: R-CHOP is the standard treatment for CD20+ aggressive B-cell non-Hodgkin lymphoma (DLBCL). Dose dense regimens have shown better outcome and acceptable tolerability compared to standard. Liposomal doxorubicin has demonstrated significant less cardiotoxicity and acute toxicity when compared with standard doxorubicin. The aim of the study is to assess the efficacy and safety of the R- COMP-14 (Myocet™-modified CHOP) in newly diagnosed aggressive DLBCL. Pegfilgrastim was used to provide prophylactic bone marrow support. Methods: Patients (Pts) with stages III, IV or I, II (IPI = 1) were included in this single arm, multicentric, 2-step (Simon design) phase II trial. Treatment: eight biweekly cycles of liposomal doxorubicin 50 mg/m2, cyclophosphamide 750mg/m2, vincristine 1.4 mg/m2 (max. 2mg), rituximab 375 mg/m2 and prednisone 100 mg/d d1–5. Pegfilgrastim was administered on day 2 at standard dose. Interim analysis shows: Twenty-six out of 28 Pts were evaluable for efficacy. Median age: 51 y (28 - 64). Ann Arbor stage: I-II (IPI = 1) 42%, III 29%, IV 29%. Extranodal involvement: 50%. Median basal LVEF was 66% (range 44 - 80). Results: The overall response rate was 84% (CR 64% and PR 20%). Three (12%) Pts had PD and 1 (4%) SD. Median n° cycles was 8 (2-8); the median relative dose intensity per week was 93.5%. Only 4.8% of cycles were delayed and 4.2% of the cycles were administered with dose reduction due to related adverse events. Grade 3–4 neutropenia and thrombocytopenia were observed in 4.0% and 0.6% of cycles respectively. Febrile neutropenia experienced in 3.3% of cycles. Non-hematological G3–4 toxicities per cycles were hepatic (1.7%), emesis (1.2%) and G3 neurotoxicity, asthenia and infection (0.6% each). No other relevant toxicities were observed. Median LVEF after completion of treatment was 63% (range 52 - 76), there was no cardiac clinical event related to the treatment, nor irreversible toxicities. Conclusions: This Interim analysis confirmed the efficacy and safety of the dose-dense regimen in order to continue with the second step of the study. R-COMP-14 treatment with pegfilgrastim bone marrow support warrants further exploration. No significant financial relationships to disclose.