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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 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 Citation Map 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 CrossRef Google Scholar Articles by Ladetto, M. Articles by Tarella, C. PubMed PubMed Citation Articles by Ladetto, M. Articles by Tarella, C. Related Collections Transplantation Free Research Articles Clinical Trials and Observations Neoplasia Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS 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 overall survival advantage Marco Ladetto1, Federica De Marco1, Fabio Benedetti2, Umberto Vitolo3, Caterina Patti4, Alessandro Rambaldi5, Alessandro Pulsoni6, Maurizio Musso7, Anna M. Liberati8, Attilio Olivieri9, Andrea Gallamini10, Enrico Pogliani11, Delia Rota Scalabrini12, Vincenzo Callea13, Francesco Di Raimondo14, Vincenzo Pavone15, Alessandra Tucci16, Sergio Cortelazzo17, Alessandro Levis18, Mario Boccadoro1, Ignazio Majolino19, Alessandro Pileri1, Alessandro M. Gianni20, Roberto Passera21, Paolo Corradini20, Corrado Tarella1, for Gruppo Italiano Trapianto di Midollo Osseo (GITMO), Intergruppo Italiano Linfomi (IIL) 1 Divisione Universitaria di Ematologia, Cattedra di Ematologia, Torino; 2 Divisione di Ematologia, Policlinico Borgo Roma, Verona; 3 Divisione Ospedaliera di Ematologia, A.O. S. Giovanni Battista, Torino; 4 Divisione di Ematologia, Ospedale V. Cervello, Palermo; 5 Divisione di Ematologia, Ospedali Riuniti, Bergamo; 6 Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza, Roma; 7 Unità operativa di Oncoematologia, Ospedale La Maddalena, Palermo; 8 Istituto di Medicina interna e Scienze oncologiche, Policlinico Monteluce, Perugia; 9 Clinica di oncologia medica, Ospedale Torrette, Ancona; 10 Divisione di Ematologia, A.O. S. Croce, Cuneo; 11 Cattedra di Medicina Interna ed Ematologia, A.O. S. Gerardo de' Tintori, Monza; 12 Cattedra Universitaria di Oncologia ed Ematologia, Istituto per la ricerca e la cura del cancro, Candiolo; 13 Divisione di Ematologia, A.O. Bianchi-Melacrino-Morelli, Reggio Calabria; 14 Cattedra di Ematologia, A.O. Ferrarotto, Catania; 15 Divisione Universitaria di Ematologia, Università degli studi di Bari, Bari; 16 Divisione di Ematologia, Ospedali Civili, Brescia; 17 Divisione di Ematologia, A.O. S. Maurizio, Bolzano/Bozen; 18 Divisione di Ematologia, A.O. S.S. Antonio e Biagio, Alessandria; 19 Divisione di Ematologia, Ospedale S. Camillo, Roma; 20 Divisione di Ematologia, Unità di Trapianto di Midollo Osseo, Istituto Nazionale Tumori, Universitá di Milano, Milano; and 21 Statistical Consultant, A.O. San Giovanni Battista Torino and Università di Torino, Torino, Italy In this randomized multicenter study of 136 patients, 6 courses of CHOP (cyclo-phosphamide/doxorubicin/vincristine/prednisone) followed by rituximab (CHOP-R) were compared with rituximab-supplemented high-dose sequential chemotherapy with autografting (R-HDS) to assess the value of intensified chemo-therapy 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 an 85% CR rate and a 68% 3-year EFS (MFU, 30 months). We conclude that (1) achieving MR is critical for effective disease control, regardless of which treatment is used; (2) R-HDS ensures superior disease control and molecular outcome than CHOP-R, but no OS improvement; and (3) 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 no. NCT00435955 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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