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Annals of Oncology Advance Access published online on September 12, 2005
Annals of Oncology, doi:10.1093/annonc/mdi399
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© 2005 European Society for Medical Oncology
Received March 14, 2005
Revised April 28, 2005
Accepted July 21, 2005

Original article

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. Olivieri 1*, G. Santini 2, C. Patti 3, T. Chisesi 4, C. De Souza 5, A. Rubagotti 6, S. Aversa 7, A. Billio 8, A. Porcellini 9, M. Candela 10, R. Centurioni 11, A. M. Congiu 2, M. Brunori 1, S. Nati 2, M. Spriano 2, R. Vimercati 2, G. Marino 2, A. Contu 12, L. Tedeschi 13, I. Majolino 14, M. Crugnola 15, and M. R. Sertoli 16

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

* To whom correspondence should be addressed.
A. Olivieri, E-mail: a.olivieri{at}ao-umbertoprimo.marche.iy


  Abstract

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.

Keywords: autologous stem cell transplantation; high-dose sequential therapy; high-grade NHL; VACOP-B.
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