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.

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.

• Authors: Armando López-Guillermo, Miguel Ángel Canales, Ivan Dlouhy, Santiago Mercadal, Javier Briones, Alejandro Martín García-Sancho, Juan Manuel Sancho, José María Moraleda, María José Terol, Antonio Salar, Luis Palomera, Santiago Gardella, Isidro Jarque, Secundino Ferrer, Joan Bargay, Andrés López, Carlos Panizo, Anna Muntañola, Carlos Montalbán, Eulogio Conde, Miguel T Hernández, Alfons Soler, José A García Marco, Guillermo Deben, Julián Marín, José Francisco Tomás, PETHEMA/GELTAMO/GELCAB Spanish Intergroup
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 63 Issue 1 Pg. 93-100 (01 2022) ISSN: 1029-2403 [Electronic] United States
• PMID: 34459702 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Murine-Derived
• Yttrium Radioisotopes
• Rituximab
• ibritumomab tiuxetan

Topics

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Murine-Derived (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Disease-Free Survival
• Follow-Up Studies
• Humans
• Lymphoma, Follicular (diagnosis, drug therapy, etiology)
• Radioimmunotherapy (methods)
• Rituximab (adverse effects)
• Treatment Outcome
• Yttrium Radioisotopes (therapeutic use)