The section of Cytokines & Supportive Oncology conducts clinical and translational research in the area of supportive oncology to reduce the toxicity and complications of disease and treatment and to improve quality of life of our patients. We have continued to work with many effective novel therapeutic agents including agents to reduce mucositis, bone disease, transfusions and agents that can be used to prevent or treat oncologic emergencies such as tumor lysis syndrome.
The patient populations include multidisciplinary referrals to the Cytokines & Supportive Oncology Clinic. The reduction in treatment complications such as mucositis, thrombocytopenia, and nausea/vomiting are just some examples of patient benefits and positive impact on their quality of life.
The clinical trials involve novel agents in the area of unmet need and are integrated with correlative laboratory studies that can help better understand the biology and nature of response to these agents. For example, mucositis is a significant dose-limiting toxicity of doxorubicin-based regimens. Based on prior experience with biology of growth factors, we designed a randomized, double-blind, placebo-controlled clinical trial of rhuKGF (palifermin) in patients with sarcoma receiving multi-cycle, high dose adriamycin-based chemotherapy which is associated with severe mucositis in nearly half of the patients and > grade 2 over 75%.
Results of this study demonstrated that a single dose of palifermin given 3 days prior to chemotherapy, can results in reduction in mucositis. Furthermore, all patients who experienced severe mucositis on placebo arm when received open-label palifermin in the next cycle, avoided severe mucositis. These clinical results were supported by our laboratory studies which showed a significant proliferative response in mucosa with increase in Ki-67, and thickening of the tissue by non-optical imaging studies, providing insight into biology and nature of response. The reduction in mucositis was associated with significant reduction in mouth and throat soreness, and improvement in the patient-reported outcome including ability to drink, eat, and talk.
A number of studies are ongoing in other areas, including:
- Prevention of thrombocytopenia
- Nausea and vomiting