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Prepublished online as a Blood First Edition Paper on June 7, 2002; DOI 10.1182/blood-2002-02-0621.

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Submitted February 28, 2002
Accepted April 9, 2002

High rate of clinical and molecular remissions in follicular lymphoma patients receiving high-dose sequential chemotherapy and autografting at diagnosis: a multicenter, prospective study by the Gruppo Italiano Trapianto Midolla Osseco (GITMO)

Marco Ladetto*, Paolo Corradini, Sonia Vallet, Fabio Benedetti, Umberto Vitolo, Maurizio Martelli, Maura Brugiatelli, Paolo Coser, Alessio Perrotti, Ignazio Majolino, Giuseppe Fioritoni, Sergio Morandi, Maurizio Musso, Renato Zambello, Teodoro Chisesi, Nicola Di Renzo, Paolo Vivaldi, Alberto De Crescenzo, Alessandro Pileri, Corrado Tarella, Andrea Gallamini, Flavia Salvi, Gino Santini, Carola Boccomini, Marco Sorio, Monica Astolfi, and Daniela Drandi

Cattedra di Ematologia, Universita di Torino, Turin, Italy
Bone Marrow Trasplantation Unit,, Istituto Scientifico H. S. Raffaele, Milan, Italy; Cattedra di Ematologia, Universita di Torino, Turin, Italy
3Divisione Universitaria di Ematologia, Policlinico Borgo Roma, Verona, Italy
Divisione Ospedaliera di Ematologia, Azienda Ospedaliera S. Giovanni Battista, Turin, Italy
Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita La Sapienza, Rome, Italy
Dipartimento di Ematologia, Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, Italy
Divisione di Ematologia, Azienda Ospedaliera S. Maurizio, Bolzano/Bozen, Italy
Divisione Universitaria di Ematologia, Universita Tor Vergata, Rome, Italy
Divisione di Ematologia, Azienda Ospedaliera V. Cervello, Palermo, Italy
Divisione Universitaria di Ematologia, Azienda Ospedaliera Spirito Santo, Pescara, Italy
Divisione di Ematologia-CTMO, Ospedale Maggiore, Cremona, Italy
Divisione di Oncoematologia e TMO, Ospedale La Maddalena, Palermo, Italy
Divisione di Ematologia, Azienda Ospedaliera S. Bortolo, Vicenza, Italy
Divisione di Ematologia, Ospedali Riuniti SS. Giovanni e Paolo, Venice, Italy
Divisione di Ematologia, Azienda Ospedaliera Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
Divisione di Ematologia, Azienda Ospedaliera S. Chiara, Trento, Italy
Divisione di Medicina Generale, Ospedale S. Giovanni Vecchio antica sede, Turin, Italy
Divisione di Ematologia, Azienda Ospedaliera S. Croce, Cuneo, Italy
Divisione di Ematologia, Azienda Ospedaliera SS. Antonio e Biagio, Alexandria, Italy
Dipartimento di Ematologia, Azienda Ospedaliera S. Martino, Genova, Italy

* Corresponding author; email: marco.ladetto{at}unito.it.

Single-center experiences have shown that intensified treatments with autologous transplantation are a promising therapeutic strategy for patients with high-risk follicle-center lymphoma (FCL) at diagnosis, whereas data from prospective multicenter trials are still lacking. This paper describes the results of a prospective multicenter study of an intensified purging-free high-dose sequential (i-HDS) chemotherapy schedule with peripheral blood progenitor cell (PBPC) autografting. The main feature of this program is harvesting stem cells after intensified chemotherapeutic debulking, with no ex vivo manipulation of PBPC. Ninety-two previously untreated patients aged <= 60 with advanced stage FCL were enrolled by 20 Italian Centers and evaluated on an intention-to-treat basis. i-HDS proved feasible with limited toxicity (87% patients completed the planned treatment schedule). i-HDS led to a complete remission rate of 88%. The projected overall survival and disease-free survival (DFS) were respectively 84% and 67% at four years. Centralized molecular analysis showed that PCR-negative harvests could be collected in 47% of cases. Following autograft, 65% of molecularly evaluable patients achieved clinical and molecular remission. The projected DFS at four years of this subgroup is 85%. This result emphasizes the importance of achieving maximal tumor reduction in these patients. In conclusion, our data show that highly effective intensified treatments can now be routinely offered to young patients with poor risk FCL even at small Institutions, with no need for sophisticated and expensive cell manipulation procedures.


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