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.

Umberto Vitolo, Marco Ladetto, Carola Boccomini, Luca Baldini, Federico De Angelis, Alessandra Tucci, Barbara Botto, Annalisa Chiappella, Annalisa Chiarenza, Antonello Pinto, Amalia De Renzo, Francesco Zaja, Claudia Castellino, Alessia Bari, Isabel Alvarez De Celis, Andrea Evangelista, Guido Parvis, Enrica Gamba, Chiara Lobetti-Bodoni, Giovannino CicconeGiuseppe Rossi

Research output: Contribution to journalArticle

Abstract

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. 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). 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. 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.

Original languageEnglish
Pages (from-to)3351-3359
Number of pages9
JournalJournal of Clinical Oncology
Volume31
Issue number27
Publication statusPublished - Sep 20 2013

ASJC Scopus subject areas

  • Medicine(all)

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    Vitolo, U., Ladetto, M., Boccomini, C., Baldini, L., De Angelis, F., Tucci, A., Botto, B., Chiappella, A., Chiarenza, A., Pinto, A., De Renzo, A., Zaja, F., Castellino, C., Bari, A., Alvarez De Celis, I., Evangelista, A., Parvis, G., Gamba, E., Lobetti-Bodoni, C., ... Rossi, G. (2013). 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. Journal of Clinical Oncology, 31(27), 3351-3359.