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.

Keywords:

• Follicular lymphoma
• 90Y ibritumomab tiuxetan
• maintenance

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.

Additional information

Funding

Grants: the study was carried out thanks to a specific grant of SCHERING/BAYER.