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Blood, 15 April 2008, Vol. 111, No. 8, pp. 4004-4013. Prepublished online as a Blood First Edition Paper on January 31, 2008; DOI 10.1182/blood-2007-10-116749. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2007-10-116749v1 111/8/4004    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Ladetto, M. Articles by Tarella, C. Search for Related Content PubMed PubMed Citation Articles by Ladetto, M. Articles by Tarella, C. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted October 19, 2007 Accepted January 3, 2008 Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an over-all survival advantage Marco Ladetto*, Federica De Marco, Fabio Benedetti, Umberto Vitolo, Caterina Patti, Alessandro Rambaldi, Alessandro Pulsoni, Maurizio Musso, Anna M Liberati, Attilio Olivieri, Andrea Gallamini, Enrico Pogliani, Delia Rota Scalabrini, Vincenzo Callea, Francesco Di Raimondo, Vincenzo Pavone, Alessandra Tucci, Sergio Cortelazzo, Alessandro Levis, Mario Boccadoro, Ignazio Majolino, Alessandro Pileri, Alessandro M Gianni, Roberto Passera, Paolo Corradini, and Corrado Tarella Divisione Universitaria di Ematologia,Cattedra di Ematologia, Universita degli Studi, Torino, Italy Divisione di Ematologia, Policlinico Borgo Roma, Verona, Italy Divisione Ospedaliera di Ematologia, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy Divisione di Ematologia, Ospedale V.Cervello, Palermo, Italy Divisione di Ematologia, Ospedali Riuniti, Bergamo, Italy Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita La Sapienza, Roma, Italy Unita Operativa di Oncoematologia, Ospedale La Maddalena, Palermo, Italy Istituto di Medicina Interna e Scienze Oncologiche, Policlinico Monteluce, Perugia, Italy Clinica di Oncologia Medica, Ospedale Torrette, Ancona, Italy Divisione di Ematologia, Azienda Ospedaliera S.Croce, Cuneo, Italy Cattedra di Medicina Interna ed Ematologia, Azienda Ospedaliera S.Gerardo de' Tintori, Monza, Italy Cattedra Univarsitaria di Oncologia ed Ematologia, Istituto per la ricerca e la cura del cancro, Candiolo, Italy Divisione Di Ematologia, Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, Italy Cattedra di Ematologia, Azienda Ospedaliera S. Ferrarotto, Catania, Italy Divisione Universitaria di Ematologia, Universita degli Studi di Bari, Bari, Italy Divisione di Ematologia, Ospedali Civili, Brescia, Italy Divisione di Ematologia, Azienda Ospedaliera S. Maurizio, Bolzano/Bozen, Italy Divisione di Ematologia, Azienda Ospedaliera S.S. Antonio e Biagio, Alessandria, Italy Divisone di Ematologia, Ospedale S.Camillo, Roma, Italy Divisione di Ematologia, Unita di Trapianto di Midollo Osseo, Istituto Nazionale Tumori, Milano, Italy Statistical Consultant, Azienda Ospedaliera San Giovanni Battista Torino and Universita di Torino, Torino, Italy * Corresponding author; email: marco.ladetto{at}unito.it. In this randomized multicenter study of 136 patients, six courses of CHOP followed by rituximab (CHOP-R) were compared with rituximab-supplemented high-dose sequential chemotherapy with autografting (R-HDS), to assess the value of intensified chemotherapy as a first-line treatment for high-risk follicular lymphoma (FL) after the introduction of monoclonal antibodies. The analysis was intention to treat with event-free survival (EFS) as the primary endpoint. Complete remission (CR) was 62% with CHOP-R and 85% with R-HDS (P<.001). At a median follow-up (MFU) of 51 months, the 4-year EFS was 28% and 61% respectively (P<.001) with no difference in overall survival (OS). Molecular remission (MR) was achieved in 44% of CHOP-R and 80% of R-HDS patients (P<.001) and was the strongest independent outcome predictor. Patients relapsing after CHOP-R underwent salvage R-HDS in 71% of cases. Salvage R-HDS had 85% CR rate and 68% three-year EFS (MFU: 30 months). We conclude that: a) achieving MR is critical for effective disease control, regardless of which treatment is used; b) R-HDS ensures superior disease control and molecular outcome than CHOP-R, but no OS improvement; c) CHOP-R failures have a good outcome after salvage R-HDS suggesting that relapsed/refractory FL could be the most appropriate setting for R-HDS-like treatments. This trial was registered at www.clinicaltrials.gov as #NCT00435955. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: Y. L. Kasamon, R. J. Jones, R. A. Brodsky, E. J. Fuchs, W. Matsui, L. Luznik, J. D. Powell, A. L. Blackford, A. Goodrich, C. D. Gocke, et al. Immunologic recovery following autologous stem-cell transplantation with pre- and posttransplantation rituximab for low-grade or mantle cell lymphoma Ann. Onc., October 30, 2009; (2009) mdp484v1. [Abstract] [Full Text] [PDF] A. J. Moskowitz and C. H. Moskowitz Controversies in the Treatment of Lymphoma with Autologous Transplantation Oncologist, September 1, 2009; 14(9): 921 - 929. [Abstract] [Full Text] [PDF] M. Foster, D. A. Gabriel, and T. Shea Role of Hematopoietic Stem Cell Transplant in the Management of Follicular Lymphoma Oncologist, July 1, 2009; 14(7): 726 - 738. [Abstract] [Full Text] [PDF] H. Hochster, E. Weller, R. D. Gascoyne, T. M. Habermann, L. I. Gordon, T. Ryan, L. Zhang, N. Colocci, S. Frankel, and S. J. Horning Maintenance Rituximab After Cyclophosphamide, Vincristine, and Prednisone Prolongs Progression-Free Survival in Advanced Indolent Lymphoma: Results of the Randomized Phase III ECOG1496 Study J. Clin. Oncol., April 1, 2009; 27(10): 1607 - 1614. [Abstract] [Full Text] [PDF] M. Kornacker, J. Stumm, C. Pott, S. Dietrich, S. Sussmilch, M. Hensel, M. Nickelsen, M. Witzens-Harig, M. Kneba, N. Schmitz, et al. Characteristics of relapse after autologous stem-cell transplantation for follicular lymphoma: a long-term follow-up Ann. Onc., April 1, 2009; 20(4): 722 - 728. [Abstract] [Full Text] [PDF] E. Gyan, C. Foussard, P. Bertrand, P. Michenet, S. Le Gouill, C. Berthou, H. Maisonneuve, V. Delwail, R. Gressin, P. Quittet, et al. High-dose therapy followed by autologous purged stem cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by the GOELAMS with final results after a median follow-up of 9 years Blood, January 29, 2009; 113(5): 995 - 1001. [Abstract] [Full Text] [PDF] S. J. Horning Follicular Lymphoma, Survival, and Rituximab: Is It Time to Declare Victory? J. Clin. Oncol., October 1, 2008; 26(28): 4537 - 4538. [Full Text] [PDF] M. Bendandi Aiming at a Curative Strategy for Follicular Lymphoma CA Cancer J Clin, September 1, 2008; 58(5): 305 - 317. [Abstract] [Full Text] [PDF]

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