Impact of bone marrow involvement on outcome of young patients with high-risk diffuse large B-cell lymphoma (DLBCL) treated in the phase III randomized trial (DLCL04) with rituximab dose-dense chemotherapy followed by intensified high-dose chemotherapy and autologous stem cell transplantation (HDC+ASCT) or standard rituximab dose dense chemotherapy: A study of the fondazione Italiana linfomi (FIL) in Blood
2013
AOU Città della Salute di Torino
Tipo pubblicazione
Conference Abstract
Autori/Collaboratori (29)Vedi tutti...
Vitolo U
Chiappella A
Brusamolino E
et alii...
Abstract
Introduction The role of bone marrow (BM) involvement as prognostic factor in untreated young patients with diffuse large B-cell lymphoma at poor prognosis is still a matter of debate. Recent data showed an adverse prognostic role of BM involvement in DLBCL including patients both at low and high IPI score (Sehn L et al, J Clin Oncol 2011). On this basis, FIL analyzed the impact of BM involvement in the prospective randomized phase III trial DLCL04 (Vitolo U et al, Blood, ASH annual Meeting 2012) that included only young patients at high-risk age-adjusted IPI (aa-IPI) score 2 or 3. Patients and Methods Inclusion criteria were: age 18-65; untreated DLBCL or follicular grade IIIb; aa-IPI score 2 or 3. Patients were stratified according to aa-IPI and randomized at diagnosis to receive: R-CHOP14 x 8 cycles; R-MegaCHOP14 (1200 mg/sqm Cyclophosphamide, 70 mg/sqm Doxorubicin, standard dose Vincristine and Prednisone) x 6; R-CHOP14 x 4 + R-HDC (Rituximab + High Dose Cytarabine + Mitoxantrone + Dexamethasone) followed by BEAM and ASCT; R-MegaCHOP14 x 4 + R-HDC + BEAM and ASCT. BM biopsy and aspirate were mandatory at diagnosis; at the end of treatment, BM assessment was mandatory only in case of positivity at baseline. BM involvement was defined as concordant if marrow was involved by large B-cell and discordant if involved by small B-cells. Flow cytometry, immunohistochemistry, and/or molecular studies were utilized to confirm a clonal B-cell population. Results From June 2005 to September 2010, 399 patients were randomized to receive: 199 R-HDC+ASCT and 200 R-dose-dense chemotherapy without ASCT. All patients were evaluable for analysis. BM involvement was reported in 84 patients (21%): 39 (20%) in the R-HDC+ASCT group and 45 (22%) in the R-dose-dense chemotherapy group. Pattern of involvement was: concordant in 63 patients, discordant in 14 and not specified in 7 patients. Patients with BM involvement (BM positive: 84) compared to those without BM involvement (BM n
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Keywords
rituximab; dexamethasone; mitoxantrone; salicylate sodium; cytarabine; prednisone; vincristine; doxorubicin; cyclophosphamide; lactate dehydrogenase; dose densification; risk; human; bone marrow; large cell lymphoma; society; patient; drug megadose; chemotherapy; autologous stem cell transplantation; hematology; B lymphocyte; prognosis; proportional hazards model; diagnosis; blood; high risk patient; histology; gender; follow up; normal value; cell population; immunohistochemistry; flow cytometry; aspiration; hazard; sample size; biopsy;