Dr. Janice Dutcher, MD is Professor of Medicine at New York Medical College and Associate Director for Clinical Affairs at Our Lady of Mercy Cancer Center, Bronx, NY. She is a founding member of the Cytokine Working Group and served as Chair of the FDA Oncologic Drug Advisory Committee. She is actively involved in patient care and clinical research in renal cell cancer, and is a strong advocate for research into the etiology and treatment of RCC.
I jotted down 5 conclusions the Cytokine Working Group had drawn from the study:
The response rates were 25% for high dose Interleukin-2 vs. 11% for low dose sub q administered IL-2 plus Interferon alpha. The conclusion was that high dose Il-2 should remain the preferred method of treatment where minimum patient performance standards are met. This is a statistically significant difference in response rate. She gave median response durations of 16 months for the high dose and 13 months for the low dose but these are not statistically different.
Dr. Dutcher indicated that the significance of this study was that it is the first true randomized study where patient selection does not influence the data. The only other true random study is a NIH 3-arm study.
She indicated that the response rate approaches 40% in lung-only metastasis with high dose IL-2. Anecdotally, she feels prolonged itching as a result of treatment correlates to a response. She also indicated that each successive cycle of high dose IL-2 gets more difficult for the patient, as the body "remembers", receptors are primed to the IL-2 and respond faster and more vigorously each time.
Responding to a question, she indicated she is aware of no scientific data on a thyroid auto-immune response associated with response to IL-2. There has been anecdotal discussion here on the list suggesting a link.
One final interesting insight she gave, was that data shows that biologic therapies prolong survival even if no objective response is seen. I took this to mean that though the tumors might not shrink substantially, disease progression is slowed.