Leukemia & lymphoma · 2021
A randomized phase II study comparing consolidation with a single dose of 90Y 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.
Клиническое исследование II фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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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, Hernández Miguel T, Soler Alfons, García Marco José A, Deben Guillermo, Marín Julián, Tomás José Francisco, PETHEMA/GELTAMO/GELCAB Spanish Intergroup
Аннотация
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.