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A Phase II Trial of Front-Line Double High Dose Chemotherapy with DICEP Then BEAM and Autologous Stem Cell Transplantation as Induction Therapy for Poor Prognosis Aggressive Non-Hodgkins Lymphoma

A Phase II Trial of Front-Line Double High Dose Chemotherapy with DICEP Then BEAM and Autologous Stem Cell Transplantation as Induction Therapy for Poor Prognosis Aggressive Non-Hodgkins Lymphoma

Blood 100(11): Abstract No 2539

A single treatment with early induction HDCT has not been shown to improve survival of patients (pts) with poor prognosis aggressive NHL. However, the strategy of late remission-consolidation HDCT cannot improve the outcome of those pts who do not respond and develop resistance to standard dose induction chemotherapy. We, therefore, have conducted a prospective phase II study evaluating the use of two cycles of induction HDCT for high-intermediate and high risk aggressive-histology NHL. Eligibility criteria included age 18-65 years, 2 or 3 of the AAIPI risk factors (uparwLDH, ECOG performance status 2-4, stage 3-4), and no serious co-morbid disease. The treatment protocol involved a single cycle of standard CHOP chemotherapy followed 3 weeks later by non-myeloablative DICEP (dose-intensive cyclophosphamide 5.25g/m2, etoposide 1.05g/m2, cisplatin 105mg/m2) for tumor cytoreduction and stem cell mobilization, and then in a further 5-8weeks by BEAM (BCNU 300mg/m2, etoposide 800mg/m2, Ara-C 1600mg/m2, melphalan 140mg/m2) and ASCT. Since June 1998, 41 pts aged 20-65 years (median 48) with diffuse large B-cell NHL (n=38) or other NHL histologies (n=3) were accrued. Patient characteristics included stage 4 (n=33), uparwLDH (n=33), ECOG 2-4 (n=30), tumor bulkgtoreq10cm (n=25), marrow involvement (n=13). A median of 20.3 x106 CD34 cells/kg (10.6-54.9) were collected following DICEP. All but 2 pts achieved at least a partial lymphoma response to DICEP, and all 13 pts with morphological evidence of bone marrow infiltration pre-DICEP had normal marrow biopsies post-DICEP. Three pts did not receive BEAM/ASCT because of progressive lymphoma post-DICEP (n=2) or reactivated pulmonary tuberculosis (n=1). Time to ANC>0.5 was 9-15 days (median 11) and to platelets>20 was 8-15 days (median 11) post-ASCT. No pt experienced grade 3 or 4 regimen-related toxicity or treatment-related death from DICEP or BEAM. Post-ASCT radiotherapy to sites of prior disease bulk was given to 16 pts. With a median follow-up of 20 months (1-50) 10 pts experienced lymphoma progression (3 in meninges) and 7 have died, all from lymphoma. The 2 year event-free (EFS) and overall (OS) survival rates for all 41 pts are 72% and 76%, respectively. In conclusion, CHOP-DICEP-BEAM induction HDCT is feasible and is associated with encouraging early EFS and OS rates for these pts with poor prognosis aggressive NHL. Further study of multi-cycle induction HDCT is warranted for poor prognosis NHL.

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