A randomized phase II study comparing consolidation with a single dose of Y-90 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
Por:
López-Guillermo A, Canales MÁ, Dlouhy I, Mercadal S, Briones J, Martín García-Sancho A, Sancho JM, Moraleda JM, Terol MJ, Salar A, Palomera L, Gardella S, Jarque I, Ferrer S, Bargay J, López A, Panizo C, Muntañola A, Montalbán C, Conde E, Hernández MT, Soler A, García Marco JA, Deben G, Marín J and Tomás JF
Publicada:
2 ene 2022
Ahead of Print:
1 ago 2021
Resumen:
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 Y-90-ibritumomab-tiuxetan 0.4 mCi/kg (arm A) vs. rituximab 375 mg/m(2) 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 Y-90-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.
Filiaciones:
López-Guillermo A:
Hematopathology Department, Hospital Clinic de Barcelona, Barcelona, Spain
Canales MÁ:
Hematology Department, Hospital La Paz, Madrid, Spain
Dlouhy I:
Hematopathology Department, Hospital Clinic de Barcelona, Barcelona, Spain
Mercadal S:
Catalan Institute of Oncology, Hospital Bellvitge, Barcelona, Spain
Briones J:
Hospital de la Santa Creu y Sant Pau, Barcelona, Spain
Martín García-Sancho A:
Hospital Clinico, Salamanca, Spain
Sancho JM:
Hematology Department, ICO-IJC-Hospital Germans Trias i Pujol, Badalona, Spain
Moraleda JM:
Hematology Department, Hospital V. Arraixaca, Murcia, Spain
Terol MJ:
Department of Haematology and Medical Oncology, Hospital Clinico, Valencia, Spain
Salar A:
Hematology Department, Hospital del Mar, Barcelona, Spain
Palomera L:
Hematology Department, Hospital Clínico Lozano Blesa, Zaragoza, Spain
Gardella S:
Catalan Institute of Oncology, Hospital Josep Trueta, Girona, Spain
Jarque I:
Hematology Department, Hospital La Fe, CIBERONC - Instituto Carlos III, Valencia, Spain
:
Hematology Department, Hospital Dr. Peset, Valencia, Spain
Bargay J:
Hospital Son Llatzer, Mallorca, Spain
López A:
Hematology Department, Hospital Vall d'Hebron, Barcelona, Spain
Panizo C:
Hematology Department, Clínica Universidad de Navarra, Pamplona, Spain
Muntañola A:
Hematology Department, Hospital Universitari Mutua de Terrassa, Terrassa, Spain
Montalbán C:
Internal Medicine, Hospital Ramón y Cajal, Madrid, Spain
Conde E:
Department of Hematology, Hospital Universitario Marqués de Valdecilla, Santander, Spain
Hernández MT:
Hematology Department, Hospital Universitario de Canarias, Tenerife, Spain
Soler A:
Hematology Department, Hospital Parc Taulí, Sabadell, Spain
García Marco JA:
Hospital Puerta de Hierro, Madrid, Spain
Deben G:
Hematology Department, Hospital Juan Canalejo, La Coruña, Spain
Marín J:
Hematology Department, Hospital Nuestra Señora de Aránzazu, San Sebastián, Spain
Tomás JF:
Hematology Department, MD Anderson Cancer Center, Madrid, Spain
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