Abstract
This study provides an updated report of the consecutive multicenter Gruppo Italiano Trapianto Midollo Osseo trial employing an intensified, purging-free, total body irradiation-free, high-dose sequential chemotherapy schedule with peripheral blood stem cell autograft (i-HDS) in advanced-stage follicular lymphoma (FL). Special interest has been devoted to late toxicities and outcome in terms of molecular status. Ninety-two untreated FL patients aged ⩽60 were enrolled by 20 Italian centers and evaluated on an intention-to-treat basis. Main findings are as follows: (1) 5.5-years overall survival projection of 80% (median follow-up: 68 months), with no differences related to age-adjusted IPI score; (2) 46 (50%) of 92 patients presently in continuous complete remission; (3) projected long-term progression-free survival exceeding 80% for patients collecting PCR-negative stem cell harvests or achieving molecular remission within the first 2 years from the end of therapy; (4) actuarial 5-years risk of developing secondary myelodysplasia and acute myeloid leukemia of 3.7%, with most of these events occurring in patients re-treated for recurrent lymphoma. These results demonstrate that i-HDS is feasible, effective and safe even in terms of long-term outcome. As the HDS schedule can be easily supplemented with Rituximab, it is one of the best options for random comparison with Rituximab-supplemented conventional chemotherapy.
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Acknowledgements
Investigators from the following Institutions in Italy contributed to the trial: Divisione Universitaria di Ematologia, Cattedra di Ematologia (Torino): M Ladetto, S Vallet, M Boccadoro, C Tarella, I Ricca, M Zanni, F De Marco, C Tarella; Divisione Universitaria di Ematologia, Policlinico Borgo Roma (Verona): F Benedetti, M Sorio, G Pizzolo; Divisione Ospedaliera di Ematologia, AO S Giovanni Battista (Torino): U Vitolo, C Boccomini, A Chiappella, E Gallo; Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza (Roma): M Martelli, MT Petrucci, A Pulsoni, F Mandelli; Dipartimento di Ematologia, AO Bianchi-Melacrino-Morelli (Reggio Calabria): V Callea, C Stelitano, G Messina, M Brugiatelli, F Nobile; Divisione di Ematologia, AO S Maurizio (Bolzano/Bozen): P Coser, S Cortelazzo, N Pescosta; Divisione Universitaria di Ematologia, AO S Eugenio, Università Tor Vergata (Roma): A Perrotti, S Amadori; Divisione di Ematologia, AO V Cervello (Palermo): C Patti, S Mirto, R Scimè, I Majolino; Divisione Universitaria di Ematologia, AO Spirito Santo (Pescara): G Fioritoni, F Angrilli; Divisione di Ematologia-CTMO, Ospedale Maggiore (Cremona): S Morandi, C Bergonzi; Divisione di Oncoematologia e TMO, Ospedale La Maddalena (Palermo): M Musso; Bone Marrow Transplantation Unit, Istituto Scientifico HS Raffaele (Milano): P Corradini, A Pescarollo, M Bregni, Division of Medical Oncology, Istituto Nazionale Tumori, Milano, Italy: P Corradini, F Zallio; Divisione di Ematologia, AO S Bortolo (Vicenza): R Zambello, F Rodeghiero; Divisione di Ematologia, Ospedali Riuniti SS. Giovanni e Paolo, (Venezia): T Chisesi; Divisione di Ematologia, AO Casa Sollievo della Sofferenza (S Giovanni Rotondo): N Di Renzo; Divisione di Ematologia, AO S Chiara (Trento): P Vivaldi; Divisione di Medicina Generale, Ospedale S Giovanni Vecchio antica sede (Torino): A De Crescenzo; Divisione di Ematologia, AO S Croce (Cuneo): A Gallamini, C Castellino; Divisione di Ematologia, AO SS Antonio e Biagio (Alessandria): F Salvi, A Levis; Dipartimento di Ematologia, AO S Martino (Genova): G Santini. This work was supported by Compagnia di San Paolo, Torino, Italy and by Regione Piemonte. IR is a recipient of a fellowship from AIRC.
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Ladetto, M., Vallet, S., Benedetti, F. et al. Prolonged survival and low incidence of late toxic sequelae in advanced follicular lymphoma treated with a TBI-free autografting program: updated results of the multicenter consecutive GITMO trial. Leukemia 20, 1840–1847 (2006). https://doi.org/10.1038/sj.leu.2404346
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DOI: https://doi.org/10.1038/sj.leu.2404346
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