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Annals of Oncology Advance Access originally published online on September 12, 2005
Annals of Oncology 2005 16(12):1941-1948; doi:10.1093/annonc/mdi399
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© 2005 European Society for Medical Oncology

Upfront high-dose sequential therapy (HDS) versus VACOP-B with or without HDS in aggressive non-Hodgkin's lymphoma: long-term results by the NHLCSG

A. Olivieri1,*, G. Santini2, C. Patti3, T. Chisesi4, C. De Souza5, A. Rubagotti6, S. Aversa7, A. Billio8, A. Porcellini9, M. Candela10, R. Centurioni11, A. M. Congiu2, M. Brunori1, S. Nati2, M. Spriano2, R. Vimercati2, G. Marino2, A. Contu12, L. Tedeschi13, I. Majolino14, M. Crugnola15 and M. R. Sertoli16

1 Department of Hematology, University of Ancona; 2 Department of Hematology, San Martino Hospital, Genova; 3 Department of Hematology, Cervello Hospital, Palermo; 4 Division of Hematology, San Giovanni Hospital, Venezia; 5 Department of Hematology, University of Campinas, Brasil; 6 Department of Medical Oncology-Biostatistics Unit, Genova University and National Cancer Institute, Genova; 7 Division of Oncology, General Hospital, Padova; 8 Division of Hematology, San Maurizio Hospital, Bolzano; 9 Division of Hematology, General Hospital, Noale; 10 Institute of Medicine, University of Ancona; 11 Division of Medicine, General Hospital, Civitanova Marche; 12 Division of Oncology, General Hospital, Sassari; 13 Division of Oncology, San Carlo Borromeo Hospital, Milano; 14 Division of Hematology, San Camillo Hospital, Roma; 15 Institute of Hematology, Parma University, Parma; 16 Department of Medical Oncology, Genova University and National Cancer Institute, Genova, Italy

* Correspondence to: Dr A. Olivieri, Department of Hematology, University of Ancona-Italy, Via Conca n.1 – Torrette, 60020 Ancona, Italy. Tel +39-07-15964736; Fax +39-071-2183448; E-mail: a.olivieri{at}ao-umbertoprimo.marche.iy

Background: There is not univocal concordance for using high-dose sequential therapy (HDS) as first-line treatment for aggressive non-Hodgkin's lymphoma (NHL). We designed this study to evaluate the usefulness of HDS followed by high-dose therapy (HDT) with autologous stem cell transplantation as front-line treatment in different subsets of aggressive NHL.

Patients and methods: Among 223 patients aged 15–60 years with aggressive, advanced stage NHL, 106 patients were randomized to VACOP-B (etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin) for 12 weeks (plus HDS/HDT in case of persistent disease) (arm A), and 117 patients to VACOP-B for 8 weeks plus upfront HDS/HDT (arm B).

Results: According to the intention-to-treat analysis, the complete response rate was 75% for arm A and 72.6% for arm B. With a median follow-up of 62 months there was no difference in 7-year probability of survival (60% and 57.8%; P = 0.5), disease-free survival (DFS) (62% and 71%; P = 0.2) and progression-free survival (PFS) (44.9% and 40.9%; P = 0.7) between the two arms. Subgroup analyses confirmed that the best results in terms of survival, DFS and PFS were achieved by patients with large B-cell NHL without bone marrow (BM) involvement, independently of the treatment arm. Results were poorer in other categories of patients and poorest in patients with BM involvement.

Conclusions: Aggressive NHL patients do not benefit from upfront HDS/HDT.

Key words: autologous stem cell transplantation, high-dose sequential therapy, high-grade NHL, VACOP-B


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