학술논문
A randomized phase II study comparing consolidation with a single dose of 90 Y ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results
Document Type
Article
Author
López-Guillermo, Armando; Canales, Miguel Ángel; Dlouhy, Ivan; Mercadal, Santiago; Briones, Javier; Martín García-Sancho, Alejandro; Sancho, Juan Manuel; Moraleda, José María; Terol, María José; Salar, Antonio; Palomera, Luis; Gardella, Santiago; Jarque, Isidro; Ferrer, Secundino; Bargay, Joan; López, Andrés; Panizo, Carlos; Muntañola, Anna; Montalbán, Carlos; Conde, Eulogio
Source
Subject
*FOLLICULAR lymphoma
*ANTINEOPLASTIC combined chemotherapy protocols
*RITUXIMAB
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Language
ISSN
1042-8194
Abstract
This is a randomized phase-2 trial aimed to compare consolidation vs. maintenance in untreated patients with follicular lymphoma (FL) responding to induction. 146 patients were enrolled from 25 Spanish institutions (ZAR2007; ClinicalTrials.gov #NCT00662948). Patients in PR or CR/CR[u] after R-CHOP were randomized 1:1 to 90Y-ibritumomab-tiuxetan 0.4 mCi/kg (arm A) vs. rituximab 375 mg/m2 every 8 weeks for 2 years (arm B). After a median follow-up of 10.55 years, 53 patients eventually progressed with a 10-year PFS of 50% vs. 56% for patients in arm A and B, respectively (HR = 1.42; p > 0.1). No significant differences were seen in OS (10-year OS 78% vs. 84.5%; HR = 1.39, p >.1). Patients receiving 90Y-ibritumomab-tiuxetan showed higher incidence of second neoplasms than those in arm B (10-year cumulative incidence 18.5 vs. 2%, respectively; p =.038). In conclusion, in FL patients responding to R-CHOP, no significant differences were found between consolidation and maintenance, although with higher late toxicity for consolidation. [ABSTRACT FROM AUTHOR]