Umberto Vitolo1, 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 Ciccone, Giuseppe Rossi. 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 beganchemoimmunotherapy 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.
RCT Entities:
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.
Authors: Loretta J Nastoupil; Peter McLaughlin; Lei Feng; Sattva S Neelapu; Felipe Samaniego; Fredrick B Hagemeister; Ana Ayala; Jorge E Romaguera; Andre H Goy; Eleanor Neal; Michael Wang; Luis Fayad; Michelle A Fanale; Yasuhiro Oki; Jason R Westin; Maria A Rodriguez; Fernando Cabanillas; Nathan H Fowler Journal: Br J Haematol Date: 2017-03-24 Impact factor: 6.998
Authors: C Madsen; M R Clausen; T L Plesner; A Pasanen; T Kuismanen; H H Bentzen; J M Jørgensen; I B Sillesen; B M Himmelstrup; D Rønnov-Jessen; K R Jensen; A M Pettinger; M Ludvigsen; S Leppä; F A d'Amore Journal: Blood Adv Date: 2018-07-10