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.

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 / Vitolo, Umberto; Ladetto, Marco; Boccomini, Carola; Botto, Barbara; Chiappella, Annalisa; Evangelista, Andrea; Lobetti-Bodoni, Chiara; Ciccone, Giovannino; Baldini, Luca; De Angelis, Federico; Tucci, Alessandra; Rossi, Giuseppe; Chiarenza, Annalisa; Pinto, Antonello; De Renzo, Amalia; Zaja, Francesco; Castellino, Claudia; Bari, Alessia; De Celis, Isabel Alvarez; Parvis, Guido; Gamba, Enrica. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 0732-183X. - 31:27(2013), pp. 3351-3359. [10.1200/JCO.2012.44.8290]

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

Bari, Alessia;
2013

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.
2013
31
27
3351
3359
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 / Vitolo, Umberto; Ladetto, Marco; Boccomini, Carola; Botto, Barbara; Chiappella, Annalisa; Evangelista, Andrea; Lobetti-Bodoni, Chiara; Ciccone, Giovannino; Baldini, Luca; De Angelis, Federico; Tucci, Alessandra; Rossi, Giuseppe; Chiarenza, Annalisa; Pinto, Antonello; De Renzo, Amalia; Zaja, Francesco; Castellino, Claudia; Bari, Alessia; De Celis, Isabel Alvarez; Parvis, Guido; Gamba, Enrica. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 0732-183X. - 31:27(2013), pp. 3351-3359. [10.1200/JCO.2012.44.8290]
Vitolo, Umberto; Ladetto, Marco; Boccomini, Carola; Botto, Barbara; Chiappella, Annalisa; Evangelista, Andrea; Lobetti-Bodoni, Chiara; Ciccone, Giovan...espandi
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