Effect of Talactoferrin Alfa on the Immune System in Adults With Non‐Small Cell Lung Cancer |
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| Authors: | Ravi A. Madan Kwong‐Yok Tsang Marijo Bilusic Matteo Vergati Diane J. Poole Caroline Jochems Jo A. Tucker Jeffrey Schlom Giuseppe Giaccone James L. Gulley |
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| Affiliation: | 1. Laboratory of Tumor Immunology and Biology and;2. Medical Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA;3. Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA;4. Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA |
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| Abstract: | Background.Talactoferrin alfa (talactoferrin), an agent with immune-stimulating properties, has demonstrated safety and preliminary efficacy in clinical trials.Methods.Ten patients (five males and five females) with stage IV non-small cell lung cancer (NSCLC) in a single-arm pilot study received orally administered talactoferrin (1.5 g, b.i.d.) for up to 24 weeks. Radiographic and immunologic studies were performed at baseline and at weeks 6 and 12. Circulating immune cells (natural killer cells [NKCs], CD4+, CD8+, and regulatory T cells) and systemic cytokine levels were measured to assess immune response.Results.Patients enrolled in the study had received a median of four prior chemotherapy regimens, and all patients were symptomatic. Talactoferrin was well tolerated, with no grade 3 or 4 toxicities. Median time to progression (TTP) and overall survival were 6 weeks and 14.5 weeks, respectively. The four patients with ≥9 weeks TTP had evidence of immunologic activity (three with increased NKC activity).Conclusions.The median of four previous chemotherapy regimens, with elevated levels of interleukin (IL) 6 and tumor necrosis factor-alfa in most patients, suggests these patients were poor candidates for immunotherapy. |
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