title: Adjuvant immunotherapy with whole-cell lysate dendritic cells vaccine for glioblastoma multiforme: a phase II clinical trial.
abstract: BACKGROUND
  This study sought to evaluate effectiveness of autologous dendritic cell vaccine (immunotherapy) for glioblastoma multiforme (GBM).
  
  
  METHODS
  Patients 14 to 70 years of age with newly diagnosed GBM and Karnofsky Performance Scale (KPS) score >70 who were receiving initial treatment were enrolled and were randomized into 2 groups during the 5-year study period. Eighteen patients underwent conventional treatment (surgery, radiotherapy, and chemotherapy) and received adjuvant autologous dendritic cell vaccine, and 16 patients (control group) underwent conventional treatment only. Administration of the vaccine was begun within 1 to 2 months postoperatively, with 10 inoculations given over 6 months. Outcome measures were overall survival (OS); progression-free survival (PFS); 1-, 2-, and 3-year survival rates, and quality of life (QoL).
  
  
  RESULTS
  Follow-up time ranged from 14 to 56 months (median, 33 months). The 1-, 2-, and 3-year survival rates were 88.9%, 44.4%, and 16.7% for the vaccine group, respectively, and 75.0%, 18.8%, and 0%, respectively, for the control group, (P = 0.299, 0.0035, 0.0014, respectively). The median OS for the vaccine group was 31.9 months and for the control group was 15.0 months (P < 0.002). The median progression-free survival (PFS) for the vaccine group was 8.5 months, and 8.0 months for the control group (P = 0.075). The surviving fraction was significantly higher in the vaccine group based on Kaplan-Meier analysis.
  
  
  CONCLUSIONS
  Adjuvant immunotherapy with whole-cell lysate dendritic cell vaccine may improve short-term survival. It seems to be safe, and its long-term effectiveness is worthy of further investigation.
authors: Department of Neurosurgery, Neuropsychiatric Center, China Medical University, Taichung, Taiwan, People's Republic of China.
authors: Der-Yang
authors: DY
authors: Cho
authors: Wen-Kuang
authors: WK
authors: Yang
authors: Han-Chung
authors: HC
authors: Lee
authors: Den-Mei
authors: DM
authors: Hsu
authors: Hung-Lin
authors: HL
authors: Lin
authors: Shinn-Zong
authors: SZ
authors: Lin
authors: Chun-Chung
authors: CC
authors: Chen
authors: Horng-Jyh
authors: HJ
authors: Harn
authors: Chun-Lin
authors: CL
authors: Liu
authors: Wen-Yuan
authors: WY
authors: Lee
authors: Li-Hui
authors: LH
authors: Ho
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001932:Brain Neoplasms / Q000401:mortality / Q000628:therapy*; D019496:Cancer Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D045744:Cell Line, Tumor; D003131:Combined Modality Therapy; D003713:Dendritic Cells / Q000276:immunology*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D005909:Glioblastoma / Q000401:mortality / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D053208:Kaplan-Meier Estimate; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures; D011788:Quality of Life; D016634:Radiosurgery; D013534:Survival; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D019496:Cancer Vaccines