Fractionated ⁹⁰Y-ibritumomab tiuxetan radioimmunotherapy as an initial therapy of follicular lymphoma: an international phase II study in patients requiring treatment according to GELF/BNLI criteria.
| Autor: | Illidge TM; Tim M. Illidge, Sam Mayes, John A. Radford, W. David J. Ryder, Manchester Academic Health Science Centre, University of Manchester; Jill Tipping, Maureen Zivanovic, Christie Hospital NHS Foundation Trust, Manchester; Ruth Pettengell, St. George's, University of London, London; Andrew T. Bates, Southampton University Hospitals NHS Foundation Trust, Southampton; Mike Bayne, Poole Hospital NHS Foundation Trust, Dorset, United Kingdom; Steven Le Gouill, Centre Hospitalier Universitaire Nantes; Françoise Kraeber-Bodere, Caroline Bodet-Milin, University Hospital-ICO-CRCNA INSERM U892, Nantes; Emmanuel Malek, Damien Huglo, Hospitalier Universitaire Lille; Franck Morschhauser, Centre Hospitalier Universitaire, Lille; Fabrice Jardin, Centre Henri Becquerel, Rouen; Manuel Bardies, Centre de Recherche en Cancérologie de Toulouse, Faculté de Médecine de Toulouse-Rangueil, Toulouse, France., Mayes S, Pettengell R, Bates AT, Bayne M, Radford JA, Ryder WD, Le Gouill S, Jardin F, Tipping J, Zivanovic M, Kraeber-Bodere F, Bardies M, Bodet-Milin C, Malek E, Huglo D, Morschhauser F |
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| Jazyk: | angličtina |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2014 Jan 20; Vol. 32 (3), pp. 212-8. Date of Electronic Publication: 2013 Dec 02. |
| DOI: | 10.1200/JCO.2013.50.3110 |
| Abstrakt: | Purpose: We report an international, multicenter phase II trial to evaluate the efficacy and toxicity of fractionated (90)Y-ibritumomab tiuxetan ((90)Y-IT) as initial therapy of follicular lymphoma (FL). Patients and Methods: A total of 74 patients, with a median age of 61 years (range, 28 to 80 years), were recruited requiring initial therapy by Groupe d'Etude des Lymphomes Folliculaires (GELF)/British National Lymphoma Investigation (BNLI) criteria. Among them, 78% had stage III-IV disease, 32% intermediate, and 44% high-risk (according to FL International Prognostic Index). Treatment consisted of two doses of (90)Y-IT (11.1 MBq/kg) administered 8 to 12 weeks apart. Patients with more than 20% lymphoma infiltration of bone marrow (BM) received one infusion per week for 4 consecutive weeks of rituximab (375 mg/m(2)) and proceeded to fractionated radioimmunotherapy (RIT) only if a repeat BM biopsy demonstrated clearing of lymphoma to less than 20% involvement. The primary end point was end of treatment response of the intention-to-treat population. Secondary objectives were safety and progression-free survival (PFS). Results: Initial overall response rate (ORR) was 94.4% (68 of 72 patients) with combined complete response (CR/CRu) of 58.3% (42 of 72 patients). Nine patients subsequently improved response making an ORR of 95.8% (69 of 72 patients) and CR/CRu of 69.4% (50 of 72 patients). At a median follow-up of 3.1 years (range, 0.2 to 5.2 years) estimated 3-year PFS is 58%, treatment-free survival 66%, and overall survival 95%. Median PFS is 40.2 months. Thirty patients have experienced disease progression and 24 have required further treatment. The treatment was well tolerated with few (2.8%) grade 3 or 4 infectious episodes or adverse events and manageable hematologic toxicity. Conclusion: Fractionated RIT using (90)Y-IT is an effective initial treatment for advanced-stage FL in patients with higher tumor burden requiring treatment. |
| Databáze: | MEDLINE |
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