Vaccination With Patient-Specific Tumor-Derived Antigen in First Remission Improves Disease-Free Survival in Follicular Lymphoma

作者：Stephen J. Schuster, Sattva Swarup Neelapu, Barry L. Gause, John Edward Janik, Franco M. Muggia, Jon P. Gockerman, Jane N. Winter, Christopher R. Flowers, Daniel A. Nikcevich, Eduardo M. Sotomayor, Dean S. McGaughey, Elaine S. Jaffe, Elise A. Chong, Craig W. Reynolds, Donald A. Berry, Carlos Ferreira Santos, Mihaela A. Popa, Amy M. McCord, Larry W. Kwak · 发表于：Journal of Clinical Oncology · 年份：2011 · DOI：10.1200/jco.2010.33.3005 · 被引用次数：247 · 研究领域：Lymphoma Diagnosis and Treatment、Immunotherapy and Immune Responses、Lymphadenopathy Diagnosis and Analysis

PURPOSE: Vaccination with hybridoma-derived autologous tumor immunoglobulin (Ig) idiotype (Id) conjugated to keyhole limpet hemocyanin (KLH) and administered with granulocyte-monocyte colony-stimulating factor (GM-CSF) induces follicular lymphoma (FL) -specific immune responses. To determine the clinical benefit of this vaccine, we conducted a double-blind multicenter controlled phase III trial. PATIENTS AND METHODS: Treatment-naive patients with advanced stage FL achieving complete response (CR) or CR unconfirmed (CRu) after chemotherapy were randomly assigned two to one to receive either Id vaccine (Id-KLH + GM-CSF) or control (KLH + GM-CSF). Primary efficacy end points were disease-free survival (DFS) for all randomly assigned patients and DFS for randomly assigned patients receiving at least one dose of Id vaccine or control. RESULTS: Of 234 patients enrolled, 177 (81%) achieved CR/CRu after chemotherapy and were randomly assigned. For 177 randomly assigned patients, including 60 patients not vaccinated because of relapse (n = 55) or other reasons (n = 5), median DFS between Id-vaccine and control arms was 23.0 versus 20.6 months, respectively (hazard ratio [HR], 0.81; 95% CI, 0.56 to 1.16; P = .256). For 117 patients who received Id vaccine (n = 76) or control (n = 41), median DFS after randomization was 44.2 months for Id-vaccine arm versus 30.6 months for control arm (HR, 0.62; 95% CI, 0.39 to 0.99; P = .047) at median follow-up of 56.6 months (range, 12.6 to 89.3 mont...