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Blood, 15 April 2008, Vol. 111, No. 8, pp. 4048-4054. Prepublished online as a Blood First Edition Paper on February 6, 2008; DOI 10.1182/blood-2007-09-111708. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2007-09-111708v1 111/8/4048    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via CrossRef Google Scholar Articles by Thompson, J. A. Articles by Fefer, A. PubMed PubMed Citation Articles by Thompson, J. A. Articles by Fefer, A. Related Collections Transplantation Free Research Articles Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Total body irradiation, etoposide, cyclophosphamide, and autologous peripheral blood stem-cell transplantation followed by randomization to therapy with interleukin-2 versus observation for patients with non-Hodgkin lymphoma: results of a phase 3 randomized trial by the Southwest Oncology Group (SWOG 9438) John A. Thompson1, Richard I. Fisher2, Michael LeBlanc3, Stephen J. Forman4, Oliver W. Press1, Joseph M. Unger3, Auayporn P. Nademanee4, Patrick J. Stiff5, Stephen H. Petersdorf1, and Alexander Fefer1 1 Puget Sound Oncology Consortium, Seattle, WA; 2 James P. Wilmot Cancer Center, University of Rochester School of Medicine, NY; 3 Southwest Oncology Group Statistical Center, Seattle, WA; 4 City of Hope National Medical Center, Duarte, CA; and 5 Loyola University Stritch School of Medicine, Maywood, IL To determine the effect of posttransplantation immunotherapy with IL-2 on the progression-free survival (PFS) and overall survival (OS) of patients with non-Hodgkin lymphoma (NHL) after autologous stem-cell transplantation (PBSCT), patients with previously treated NHL were treated with cyclophosphamide, etoposide, total body irradiation (TBI), and PBSCT. Twenty-eight to 80 days after PBSCT, patients were randomized to IL-2 versus observation. Three hundred seventy-six eligible patients were registered (with 4-year PFS of 34% and 4-year OS of 52%), and 194 eligible patients were randomized to continuous infusion intravenous IL-2 (9 million units/m2/day for 4 days followed 5 days later by 1.6 million units/m2/day for 10 days) versus observation. In randomized patients, there was no significant difference in PFS (hazard ratio of IL-2 to observation = 0.90; P =.56) or in OS (hazard ratio of IL-2 to observation = 0.88; P =.55). There were no deaths related to IL-2 treatment. Grade 4 IL-2–related toxicities (n = 14) were reversible. These results confirm earlier SWOG findings that cyclophosphamide, etoposide, TBI, and PBSCT can be administered to patients with relapsed/refractory NHL with encouraging PFS and OS. Posttransplantation IL-2 given at this dose and schedule of administration had no significant effect on PFS or OS. This study is registered at www.clinicaltrials.gov as NCT00002649 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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