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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.
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Submitted September 11, 2007
Accepted January 17, 2008
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's lymphoma: results of a phase III randomized trial by the Southwest Oncology Group (SWOG 9438)
John A Thompson*, Richard I Fisher, Michael LeBlanc, Stephen J. Forman, Oliver W. Press, Joseph M Unger, Auayporn P Nademanee, Patrick J Stiff, Stephen H Petersdorf, and Alexander Fefer
Puget Sound Oncology Consortium, Seattle, WA, United States
James P Wilmot Cancer Center, University of Rochester School of Medicine, Rochester, NY, United States
Statistical Center, Southwest Oncology Group, Seattle, WA, United States
Hematology and Hematopoietic Stem Cell Transplantation, City of Hope National Medical Center, Duarte, CA, United States
Cardinal Bernardin Cancer Center, Loyola University Stritch School of Medicine, Maywood, IL, United States
* Corresponding author; email: jat{at}u.washington.edu.
To determine the effect of post-transplant immunotherapy with IL-2 on the progression-free survival (PFS) and overall survival (OS) of patients with non-Hodgkin's 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 four days followed five 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=0.56) nor in OS (hazard ratio of IL-2 to observation=0.88; p=0.55). There were no deaths related to IL-2 treatment. Grade IV IL-2-related toxicities (n=14) were reversible in all cases. 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. Post-transplant IL-2 given at this dose and schedule of administration had no significant effect on post-transplant PFS or OS. This study is registered at www.ClinicalTrials.gov as NCT00002649.

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