Rituximab maintenance for a maximum of 5 years after single-agent rituximab induction in follicular lymphoma: Results of the randomized controlled phase III trial SAKK 35/03

Christian Taverna, Giovanni Martinelli, Felicitas Hitz, Walter Mingrone, Thomas Pabst, Lidija Cevreska, Auro Del Giglio, Anna Vanazzi, Daniele Laszlo, Johann Raats, Daniel Rauch, Daniel A. Vorobiof, Andreas Lohri, Christine Biaggi Rudolf, Stéphanie Rondeau, Corinne Rusterholz, Ingmar A F M Heijnen, Emanuele Zucca, Michele Ghielmini

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Abstract

Purpose: Rituximab maintenance therapy has been shown to improve progression-free survival in patients with follicular lymphoma; however, the optimal duration of maintenance treatment remains unknown. Patients and Methods: Two hundred seventy patients with untreated, relapsed, stable, or chemotherapy-resistant follicular lymphoma were treated with four doses of rituximab monotherapy in weekly intervals (375 mg/m2). Patients achieving at least a partial response were randomly assigned to receive maintenance therapy with one infusion of rituximab every 2 months, either on a short-term schedule (four administrations) or a long-term schedule (maximum of 5 years or until disease progression or unacceptable toxicity). The primary end point was event-free survival (EFS). Progression-free survival, overall survival (OS), and toxicity were secondary end points. Comparisons between the two arms were performed using the log-rank test for survival end points. Results: One hundred sixty-five patients were randomly assigned to the short-term (n = 82) or long-term (n = 83) maintenance arms. Because of the low event rate, the final analysis was performed after 95 events had occurred, which was before the targeted event number of 99 had been reached. At a median follow-up period of 6.4 years, the median EFS was 3.4 years (95% CI, 2.1 to 5.3) in the shortterm arm and 5.3 years (95% CI, 3.5 to not available) in the long-term arm (P = .14). Patients in the long-term arm experienced more adverse effects than did those in the short-term arm, with 76% v 50% of patients with at least one adverse event (P

Original languageEnglish
Pages (from-to)495-500
Number of pages6
JournalJournal of Clinical Oncology
Volume34
Issue number5
DOIs
Publication statusPublished - Feb 10 2016

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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    Taverna, C., Martinelli, G., Hitz, F., Mingrone, W., Pabst, T., Cevreska, L., Del Giglio, A., Vanazzi, A., Laszlo, D., Raats, J., Rauch, D., Vorobiof, D. A., Lohri, A., Rudolf, C. B., Rondeau, S., Rusterholz, C., Heijnen, I. A. F. M., Zucca, E., & Ghielmini, M. (2016). Rituximab maintenance for a maximum of 5 years after single-agent rituximab induction in follicular lymphoma: Results of the randomized controlled phase III trial SAKK 35/03. Journal of Clinical Oncology, 34(5), 495-500. https://doi.org/10.1200/JCO.2015.61.3968