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J Clin Oncol. 2013 Sep 20;31(27):3351-9. doi: 10.1200/JCO.2012.44.8290. Epub 2013 Aug 19.

Rituximab maintenance compared with observation after brief first-line R-FND chemoimmunotherapy with rituximab consolidation in patients age older than 60 years with advanced follicular lymphoma: a phase III randomized study by the Fondazione Italiana Linfomi.

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1
Umberto Vitolo, Marco Ladetto, Carola Boccomini, Barbara Botto, Annalisa Chiappella, Andrea Evangelista, Chiara Lobetti-Bodoni, and Giovannino Ciccone, Città della Salute e della Scienza Hospital and University, Turin; Luca Baldini, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Università di Milano, Milan; Federico De Angelis, Sapienza University, Rome; Alessandra Tucci and Giuseppe Rossi, Spedali Civili Hospital and University, Brescia; Annalisa Chiarenza, Ferrarotto Hospital, Catania; Antonello Pinto, National Institute for Study and Cure of Tumors, Pascale Foundation; Amalia De Renzo, Federico II University, Napoli; Francesco Zaja, Santa Maria della Misericordia Hospital and University, Udine; Claudia Castellino, Santa Croce and Carle Hospital, Cuneo; Alessia Bari, University of Modena and Reggio Emilia, Modena; Isabel Alvarez De Celis, Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia; Guido Parvis, San Luigi Gonzaga Hospital and University, Orbassano; and Enrica Gamba, Roche Italia, Monza, Italy.

Abstract

PURPOSE:

To evaluate the efficacy of rituximab maintenance in 60- to 75-year-old patients with advanced follicular lymphoma responding to brief first-line chemoimmunotherapy followed by rituximab consolidation.

PATIENTS AND METHODS:

A total of 234 treatment-naive 60- to 75-year-old patients began chemoimmunotherapy with four monthly courses of rituximab, fludarabine, mitoxantrone, and dexamethasone (R-FND) followed by four weekly cycles of rituximab consolidation. Of these, 210 patients completed the planned treatment, and 202 responders were randomly assigned to rituximab maintenance (arm A) for 8 months, once every 2 months for a total of four doses, or to observation (arm B).

RESULTS:

Median ages in arms A and B were 66 and 65 years, respectively. After induction and consolidation therapy, the overall response rate was 86%, with 69% complete remissions (CR). After a 42-month median follow-up from diagnosis, 3-year progression-free survival (PFS; the primary end point) and overall survival (OS) were 66% (95% CI, 59% to 72%) and 89% (95% CI, 85% to 93%), respectively. After randomization, 2-year PFS was 81% for rituximab maintenance versus 69% for observation, with a hazard ratio of 0.74 (95% CI, 0.45 to 1.21; P = .226), although this was not statistically significant. No differences between the two arms were detected for OS. Overall, the regimen was well-tolerated. The most frequent grade 3 to 4 toxicity was neutropenia (25% of treatment courses), with 13 infections. Two toxic deaths (0.8%) occurred during induction treatment.

CONCLUSION:

A brief R-FND induction plus rituximab consolidation achieved excellent results with high CR and PFS rates, supporting the feasibility of this regimen in patients older than 60 years. A short rituximab maintenance did not achieve a statistically significant PFS improvement over observation.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01144364.

PMID:
23960180
DOI:
10.1200/JCO.2012.44.8290
[Indexed for MEDLINE]
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