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Phase III Trial of Consolidation Therapy With Yttrium-90–Ibritumomab Tiuxetan Compared With No Additional Therapy After First Remission in Advanced Follicular Lymphoma
Abstract
Purpose: We conducted an international, randomized, phase III trial to evaluate the efficacy and safety of consolidation with yttrium-90 ( 90 Y)–ibritumomab tiuxetan in patients with advanced-stage follicular lymphoma in first remission. Patients and Methods: Patients with CD20 + stage III or IV follicular lymphoma, who achieved a complete response (CR)/unconfirmed CR (CRu) or partial response (PR) after first-line induction treatment, were randomly assigned to receive 90 Y-ibritumomab tiuxetan (rituximab 250 mg/m 2 on day −7 and day 0 followed on day 0 by 90 Y-ibritumomab tiuxetan 14.8 MBq/kg; maximum of 1,184 MBq) or no further treatment (control). The primary end point was progression-free survival (PFS), which was calculated from the time of random assignment. Results: A total of 414 patients (consolidation, n = 208; control, n = 206) were enrolled at 77 centers. 90 Y-ibritumomab tiuxetan consolidation significantly prolonged median PFS (after a median observation time of 3.5 years) in all patients (36.5 v 13.3 months in control arm; hazard ratio [HR] = 0.465; P < .0001) and regardless of whether patients achieved PR (29.3 v 6.2 months in control arm; HR = 0.304; P < .0001) or CR/CRu (53.9 v 29.5 months in control arm; HR = 0.613; P = .0154) after induction treatment. Median PFS with consolidation was prolonged in all Follicular Lymphoma International Prognostic Index risk subgroups. After 90 Y-ibritumomab tiuxetan consolidation, 77% of patients in PR after induction converted to CR/CRu, resulting in a final CR rate of 87%. The most common toxicity with 90 Y-ibritumomab tiuxetan was hematologic, and grade 3 or 4 infections occurred in 8% of patients. Conclusion: Consolidation of first remission with 90 Y-ibritumomab tiuxetan in advanced-stage follicular lymphoma is highly effective with no unexpected toxicities, prolonging PFS by 2 years and resulting in high PR-to-CR conversion rates regardless of type of first-line induction treatment.
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Metadata
- Authors
- Morschhauser, F., Radford, J., Van Hoof, A., Vitolo, U., Soubeyran, P., Tilly, H., Huijgens, P. C., Kolstad, A., d’Amore, F., Diaz, M. G., Petrini, M., Sebban, C., Zinzani, P. L., van Oers, M. H. J., van Putten, W., Bischof-Delaloye, A., Rohatiner, A., Salles, G., Kuhlmann, J., & Hagenbeek, A.
- Venue
- Journal of Clinical Oncology
- Published
- 2008-11-10
- Volume
- 26
- Issue
- 32
- Pages
- 5156-5164
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2132443196
- Cited by
- 460
- References
- 0
- FWCI
- 32.86
- Type
- journal article
- Language
- en
- Open access
- closed
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- The paper
- Morschhauser, F., Radford, J., Van Hoof, A., Vitolo, U., Soubeyran, P., Tilly, H., Huijgens, P. C., Kolstad, A., d’Amore, F., Diaz, M. G., Petrini, M., Sebban, C., Zinzani, P. L., van Oers, M. H. J., van Putten, W., Bischof-Delaloye, A., Rohatiner, A., Salles, G., Kuhlmann, J., & Hagenbeek, A. (2008). Phase III Trial of Consolidation Therapy With Yttrium-90–Ibritumomab Tiuxetan Compared With No Additional Therapy After First Remission in Advanced Follicular Lymphoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2008.17.2015
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