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)
Year: 2008
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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/m(2)/day for 4 days followed 5 days later by 1.6 million units/m(2)/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.
Source: Blood
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G1033243903, G1063390784, G1216887118, G1257575315, G1312097577, G1375689152, G1469275664, G1545560008, G1790576020, G1958973285, G1985252453, G1990518739, G20028727, G2064543036, G2435896781, G2485941414, G2734683319, G2750730928, G313314762, G3337849518, G3350348941, G3411601502, G3484997517, G3497039781, G3584953356, City of Hope Southwest Oncology Group Clinical Trials, G36541222, G3737421695, G379387698, G425646771, Southwest Oncology Group, Southwest Oncology Group, G4916734862, G4935167430, G5519497345, G5653597704, G5761683024, G5805678965, G6109875642, G6290519354, G7061256793, G712978930, G7222907299, G7520596819, Virginia Mason Community Clinical Oncology Program, G763325562, G7926913928, G7939453469, G8006406963, G8413228103, G971274320
OpenAlex ID: W2034834856