Abstract

19500 Background: The potentially curative rate in patients with failure to first line shown to be only from 5 to 10%, and the 2 years survival rate about 25% without haematopoietic stem cell transplantation (HSCT). We evaluate the efficacy and safety of EPID plus Rituximab (EPID-R) vs. EPID as second line treatment in patients with Lymphoma (NHL). Methods: Retrospective study in Patients with NHL and EPID (Etoposide 80/100 mg/m2 d1–3, q3w, Cisplatin 80/100 mg/m2 delivery in 3 days q3w, Ifosfamide (plus MESNA) 5 grs/m2 delivery in 3 days q3w and Dexamethasone 24 mg/m2 d1–3 q3w) or EPID-R (Rituximab 375 mg/m2 d1 q3w) as second line treatment and not candidates for HSCT between 1999–2005. Results: We included 50 patients (20 pts EPID-R/30 pts EPID). Pts characteristics (EPID-R vs. EPID respective): Median age 47.8 (range 39–75) vs. 52 years (range 21–76), >64 years 23% vs. 23% Female 55% vs 57%, Stage III/IV 40% vs. 46%, extra nodal 10% vs. 8% ECOG 0–1 80% vs. 77%, histological type (WF) I/HG 90% vs. 80%, First line chemotherapy CHOP 70% and CHOP-R 25% vs. CHOP 70% and CHOP-R 0%, Overall Response rate (ORR) first line chemotherapy 80% vs. 73% and time to progression (TTP) first line 11 vs 8.3 months.Efficacy: N of cycles EPID-R 4.15 (1–6) vs. EPID 4.4 (1–7), ORR: EPID-R 75% (CR 55%/PR 20%) vs. EPID 73% (CR 35%/PR 38%), TTP EPID-R 22 months vs. EPID 10 months, 2 years Overall Survival (OS) EPID-R 65% vs. EPID 26.9 %, Pts. EPID-R with CR OS 2 years 90% vs. 44% (OS EPID 22 months - less than 2 years-), Rituximab maintenance or after failure to EPID/EPID-R: EPID-R 70%, EPID 0%. Toxicity G3/4(EPID-R vs. EPID respective): Neutropenia 75% vs. 56%, neutropenia febrile 45% vs. 15%, anaemia 25% vs. 18%, Thrombocytopenia 20% vs. 15%, nausea and vomiting 10% vs 30%, mucositis 5% vs. 7%, diarrhea 5% vs. 3%, renal 5% vs. 7%, treatment death associated 0% vs. 3%. Conclusion: An unexpected increase in hematologic toxicity was shown with EPID-R, however, in our study the addition of Rituximab to EPID improves ‘dramatically‘ the OS. Further and prospective studies are required to evaluate the therapeutic potential of EPID-R, and may be to revaluate the HSCT indications. No significant financial relationships to disclose.

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