Early prediction of effect remains an unsolved problem in cytostatic treatment of malignant tumors. The aim of the present study was to analyze the potential relationship between immune activity as measured by the NK Vue® system and response in patients with different tumors and different cytostatic regimens.
The study included six different trials encompassing patients with breast, prostate, ovarian and colorectal cancer. All protocols are still recruiting and so far 108 patients have been included. The preliminary results are based on 54 patients with response data available from the first evaluation. Blood samples were collected at baseline and prior to each treatment cycle into NK Vue™ Promoca tubes and placed in an incubator at 37 °C within 15 minutes of sampling. Following 24 hours of stimulation the plasma in each tube was harvested and analyzed for the level of interferon-gamma, as a surrogate for immune activity, by enzyme-linked immunosorbent assay using the NK Vue® Gold Kit.
Similar results were seen between immune response and tumor types receiving different treatments. Consequently, data were pooled for preliminary evaluation. The outcome suggested a classification into three groups. The interferon-gamma dropped to an abnormal level (500 pg/ml), while in group 3 (15 patients) it was raised from an abnormal to a normal level. The response rates were 11%, 42%, and 80% in the three groups, respectively. The difference was highly significant (p
The results suggest a relationship between the ability to mount an immune response upon stimulation and treatment effect comparable among different tumor types and treatments. Increasing levels of interferon-gamma shortly after initiation of treatment seems to predict treatment effect. Updated results will be presented at the meeting.
Clinical trial identification
Legal entity responsible for the study
Vejle Hospital, Department of Oncology
All authors have declared no conflicts of interest.