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.
Disclosure statement
AL-G: Advisory boards of Roche, Gilead, Celgene, Novartis, Janssen, Abbie, Spectrum and My tomorrows; Grants support from Roche, Bayer-Schering, Gilead and Celgene.
M-AC: Roche, Celgene.
ID: Roche.
SM: Roche, Gilead, Celgene, Novartis, Janssen.
JB: Roche, Gilead, Celgene, Novartis, Janssen.
DC: Advisory boards of Roche, Gilead, Celgene, Novartis, Janssen, Abbie, Spectrum and My tomorrows; Grants support from Roche, Bayer-Schering, Gilead and Celgene.
J-MS: Advisory boards of Roche, Gilead, Celgene, Novartis, Janssen, Abbie, Spectrum and My tomorrows.
J-MM: Advisory boards of Roche, Gilead, Celgene, Novartis, Janssen.
MJT: Roche, Gilead, Celgene, Janssen.
AS: Advisory boards of Roche, Gilead, Celgene, Novartis, Janssen, Abbie; Grants support from Roche, Bayer-Schering, Gilead.
LP: Roche.
IJ: Roche, Celgene, Janssen.
JB: Roche, Gilead, Celgene, Novartis, Janssen.
AL: Roche, Gilead, Celgene, Novartis, Janssen.
CP: Roche, Gilead, Celgene, Novartis, Janssen.
AM: Roche, Gilead, Janssen.
CM: Roche, Gilead, Celgene, Novartis, Janssen.
EC: Roche.
J-AG-M: Roche, Gilead, Celgene, Novartis, Janssen.
JFT: Roche, Janssen, Bayer-Schering.