• 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, and Michele Ghielmini.
• Christian Taverna, Kantonsspital Münsterlingen, Münsterlingen; Felicitas Hitz, Kantonsspital St Gallen, St Gallen; Walter Mingrone, Kantonsspital Aarau/Olten, Olten; Thomas Pabst, Inselspital Bern; Christine Biaggi Rudolf, Stéphanie Rondeau, and Corinne Rusterholz, Swiss Group for Clinical Cancer Research SAKK, Bern; Daniel Rauch, Spital Thun Simmental, Thun; Andreas Lohri, Kantonsspital Liestal, Liestal; Ingmar A.F.M. Heijnen, University Hospital Basel, Basel; Emanuele Zucca and Michele Ghielmini, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland; Giovanni Martinelli, Anna Vanazzi, and Daniele Laszlo, Istituto Europeo di Oncologia, Milan, Italy; Lidija Cevreska, University Clinic for Hematology, Skopje, Macedonia; Auro del Giglio, ABC Fondation School of Medicine, Sao Paulo, Brazil; Johann Raats, Panorama Oncology Unit, Cape Town; and Daniel A. Vorobiof, Sandton Oncology Center, Johannesburg, South Africa. christian.taverna@stgag.ch.
• J. Clin. Oncol. 2016 Feb 10; 34 (5): 495-500.

PurposeRituximab 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 MethodsTwo 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/m(2)). 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.ResultsOne 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 short-term 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 < .001), five versus one patient with grade 3 and 4 infections, and three versus zero patients discontinuing treatment because of unacceptable toxicity, respectively. There was no difference in OS between the two groups.ConclusionLong-term rituximab maintenance therapy does not improve EFS, which was the primary end point of this trial, or OS, and was associated with increased toxicity.© 2015 by American Society of Clinical Oncology.

30 keywords...

hide…