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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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Blood, 1 September 2002, Vol. 100, No. 5, pp. 1559-1565
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
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 Midollo Osseo (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,
Andrea Gallamini,
Flavia Salvi,
Gino Santini,
Carola Boccomini,
Marco Sorio,
Monica Astolfi,
Daniela Drandi,
Alessandro Pileri, and
Corrado Tarella
From the Divisione Universitaria di Ematologia,
Cattedra di Ematologia, Divisione Ospedaliera di Ematologia, Azienda
Ospedaliera S. Giovanni Battista, and Divisione di Medicina Generale,
Ospedale S. Giovanni Vecchio antica sede, Torino, Italy; Bone Marrow
Transplantation Unit, Istituto Scientifico H. S. Raffaele, and
Division of Medical Oncology, Istituto Nazionale Tumori, Milano, Italy;
Divisione Universitaria di Ematologia, Policlinico Borgo Roma, Verona,
Italy; Dipartimento di Biotecnologie Cellulari ed Ematologia,
Università La Sapienza, and Divisione Universitaria di
Ematologia, Azienda Ospedaliera S. Eugenio, Università Tor
Vergata, Roma, Italy; Dipartimento di Ematologia, Azienda Ospedaliera
Bianchi-Melacrino-Morelli, Reggio Calabria, Italy; Divisione di
Ematologia, Azienda Ospedaliera S. Maurizio, Bolzano/Bozen, Italy;
Divisione di Ematologia, Azienda Ospedaliera V. Cervello, and Divisione
di Oncoematologia e TMO, Ospedale La Maddalena, Palermo, Italy;
Divisione Universitaria di Ematologia, Azienda Ospedaliera Spirito
Santo, Pescara, Italy; Divisione di Ematologia-CTMO, Ospedale Maggiore,
Cremona, Italy; Divisione di Ematologia, Azienda Ospedaliera S. Bortolo, and Divisione di Ematologia, Ospedali Riuniti SS. Giovanni e
Paolo, Venezia, Italy; Divisione di Ematologia, Azienda Ospedaliera
Casa Sollievo della Sofferenza, S. Giovanni Rotondo, Italy; Divisione
di Ematologia, Azienda Ospedaliera S. Chiara, Trento, Italy;
Divisione di Ematologia, Azienda Ospedaliera S. Croce, Cuneo,
Italy; Divisione di Ematologia, Azienda Ospedaliera SS. Antonio e
Biagio, Alessandria, Italy; and Dipartimento di Ematologia, Azienda
Ospedaliera S. Martino, Genova, Italy.
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 PBPCs. Ninety-two previously untreated patients aged 60 or younger 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 4 years. Centralized molecular analysis
showed that polymerase chain reaction-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 4 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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