Survival of glioma patients after complementary treatment with galactoside-specific lectin from mistletoe.
Malignant glioma patients were prospectively enrolled into a clinical trial. All the patients were provided with the internationally recommended oncologic standard treatment (neurosurgery, radiation, basic clinical care according to protocol and indication) and randomly divided into a treatment group (receiving complementary immunotherapy with a galactoside-specific lectin from mistletoe, ML-1) and a control group (without additional complementary treatment). Whereas the beneficial effects of ML-1 treatment on immunological rescue and quality of life have been recently shown, evaluation of relapse free/overall survival was performed after a 50 months follow up time. Non-stratified analysis of all the patients revealed non-relevant prolongation of relapse-free intervals/overall survival time for the treatment group. However, analysis of stratified stage III/IV glioma patients demonstrated: 1. a tendency for a prolongation of relapse-free survival for patients of the treatment group (17.43 +/- 8.2 months) vs. the control group (10.45 +/- 3.9 months) 2. a statistically significant (BRESLOW p = 0.035) prolongation of the overall survival for the treatment group (20.05 +/- 3.5 months) as compared to the control group (9.90 +/- 2.1 months). These promising data warrant confirmation in a GCP-based prospectively randomized (multicenter) study, which is currently under consideration.
Lenartz
D
D
Städtische Kliniken, Department of Neurosurgery, Cologne, Germany.
Dott
U
U
Menzel
J
J
Schierholz
J M
JM
Beuth
J
J
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000401:mortality / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D015331:Cohort Studies; D003131:Combined Modality Therapy; D016371:Cranial Irradiation; D003399:Craniotomy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D005909:Glioblastoma / Q000401:mortality / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy; D015993:Life Tables; D008297:Male; D008866:Microsurgery; D008875:Middle Aged; D028321:Plant Preparations; D010940:Plant Proteins; D011446:Prospective Studies; D011788:Quality of Life; D054790:Ribosome Inactivating Proteins, Type 2; D016019:Survival Analysis; D014118:Toxins, Biological / Q000627:therapeutic use*; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D028321:Plant Preparations; D010940:Plant Proteins; D054790:Ribosome Inactivating Proteins, Type 2; D014118:Toxins, Biological; C009674:ribosome inactivating protein, Viscum