Originally published as JCO Early Release 10.1200/JCO.2007.14.4204 on May 19 2008

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Rituximab Improves the Efficacy of High-Dose Chemotherapy With Autograft for High-Risk Follicular and Diffuse Large B-Cell Lymphoma: A Multicenter Gruppo Italiano Terapie Innnovative nei Linfomi Survey

Corrado Tarella, Manuela Zanni, Michele Magni, Fabio Benedetti, Caterina Patti, Tiziano Barbui, Alessandro Pileri, Mario Boccadoro, Fabio Ciceri, Andrea Gallamini, Sergio Cortelazzo, Ignazio Majolino, Salvo Mirto, Paolo Corradini, Roberto Passera, Giovanni Pizzolo, Alessandro M. Gianni, Alessandro Rambaldi

From the Dipartimento Medicina-Oncologia Sperimentale, Divisione Universitaria di Ematologia, and Divisione Universitaria di Medicina Nucleare, Azienda Ospedaliera S. Giovanni B., Torino; Divisione Universitaria di Oncologia, Istituto Nazionale Tumori; Hematology Division and Bone Marrow Transplantation Unit, Istituto Scientifico H.S. Raffaele; and Divisione di Ematologia, Istituto Nazionale Tumori, Università di Milano, Milano; Dipartimento di Medicina Clinica e Sperimentale, Sezione e Divisione di Ematologia, Università e Azienda Ospedaliera di Verona, Verona; Divisione Ospedaliera Ematologia, Ospedali Riuniti di Bergamo, Bergamo; Divisione Ospedaliera di Ematologia, Azienda Ospedaliera V. Cervello, Palermo; Divisione di Ematologia, Azienda Ospedaliera S. Croce, Cuneo; Divisione di Ematologia, Azienda Ospedaliera S. Maurizio, Bolzano; and Divisione di Ematologia, Azienda Ospedaliera S. Camillo/Forlanini, Roma, Italy

Corresponding author: Corrado Tarella, MD, Divisione Universitaria di Ematologia, Az. Osp. S. Giovanni Battista, Via Genova 3, 10126 Torino, Italy; e-mail: corrado.tarella{at}unito.it

Purpose To investigate the impact of adding rituximab to intensive chemotherapy with peripheral-blood progenitor cell (PBPC) autograft for high-risk diffuse large B-cell lymphoma (DLB-CL) and follicular lymphoma (FL).

Patients and Methods Data were collected from 10 centers associated with Gruppo Italiano Terapie Innnovative nei Linfomi for 522 patients with DLB-CL and 223 patients with FL (median age, 47 years) who received the original or a modified high-dose sequential (HDS) chemotherapy regimen. HDS was delivered to 396 patients without (R–) and to 349 patients with (R+) rituximab; 154 (39%) and 178 patients (51%) in the R– and R+ subsets, respectively, underwent HDS for relapsed/refractory disease.

Results A total of 355 R– (90%) and 309 R+ patients (88%) completed the final PBPC autograft. Early treatment-related mortality was 3.3% for R– and 2.8% for R+ (P = not significant). Two parameters significantly influenced the outcome: disease status at HDS, with 5-year overall survival (OS) projections of 69% versus 57% for diagnosis versus refractory/relapsed status, respectively, and rituximab addition, with 5-year OS of 69% versus 60% in the R+ versus R– groups, respectively. In the multivariate analysis, these two variables maintained an independent prognostic value. The marked benefit of rituximab was evident in patients receiving HDS as salvage treatment: the 5-year OS projections for R+ versus R– were, respectively, 64% versus 38%, for patients with refractory disease or early relapse and 71% versus 57%, for patients with late relapse, partial response, or second/third relapse.

Conclusion The results of this large series indicate that rituximab should be included in the current practice of PBPC autograft for DLB-CL and FL.

published online ahead of print at www.jco.org on May 19, 2008.

Supported in part by grants from the Ministero dell’Istruzione, dell’Università e della Ricerca; the Michelangelo Foundation for Advances in Cancer Research and Treatment; and the Piedmont Regional Government (Regione Piemonte).

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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