Originally published as JCO Early Release 10.1200/JCO.2009.21.8545 on September 21 2009

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Google Scholar Articles by Wang, M. Articles by Younes, A. PubMed PubMed Citation Articles by Wang, M. Articles by Younes, A. Social Bookmarking                            What's this?

Phase II Study of Yttrium-90–Ibritumomab Tiuxetan in Patients With Relapsed or Refractory Mantle Cell Lymphoma

From the Departments of Lymphoma, Myeloma, and Diagnostic Imaging and Division of Quantitative Science, The University of Texas M. D. Anderson Cancer Center, Houston, TX.

Corresponding author: Anas Younes, MD, Department of Lymphoma and Myeloma, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 429, Houston, TX 77030; e-mail: ayounes{at}mdanderson.org.

Purpose This phase II trial evaluated the safety and efficacy of yttrium-90 (⁹⁰Y)–ibritumomab tiuxetan in patients with relapsed or refractory mantle cell lymphoma (MCL).

Patients and Methods Patients with relapsed or refractory MCL were eligible for the study if they had adequate major organ function and performance status. Those with CNS disease, pleural effusion, circulating lymphoma cells 5,000/µL, or history of stem-cell transplant were ineligible. Patients with a platelet count 150,000/µL received a dose of 0.4 mCi/kg of ⁹⁰Y–ibritumomab tiuxetan, whereas those with a platelet count less than 150,000/µL received a dose of 0.3 mCi/kg.

Results Thirty-four patients with a median age of 68 years (range, 52 to 79 years) received the therapeutic dose. The patients had received a median of three prior treatment regimens (range, one to six treatment regimens), including those that contained rituximab (n = 32) and bortezomib (n = 7). Of the 32 patients with measurable disease, 10 (31%) achieved complete or partial remission. After a median follow-up of 22 months (range, 2 to 72+ months), an intent-to-treat analysis revealed a median event-free survival (EFS) duration of 6 months and an overall survival duration of 21 months. The median EFS for those who achieved partial or complete remission was 28 months, while it was 3 months for those whose disease did not respond (P < .0001); it was 9 months for patients whose tumor measured less than 5 cm in the largest diameter before treatment and 3 months for those whose tumor measured 5 cm (P = .015).

Conclusion The single-agent activity of ⁹⁰Y–ibritumomab tiuxetan and its favorable safety profile warrant its further development for the treatment of MCL.

Presented in part at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Atlanta, GA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00038623 [ClinicalTrials.gov] .

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?