Phase Ⅱ trial of granulocyte-macrophage colony-stimulating factor plus thalidomide in older patients with castration-resistant prostate cancer
- Authors:
- Lei Song
- Xijian Zhou
- Xiangyong Li
View Affiliations
Affiliations: Department of Hematology and Oncology, The 101th Hospital of The People's Liberation Army, Wuxi, Jiangsu 214044, P.R. China
- Published online on: May 15, 2015 https://doi.org/10.3892/mco.2015.571
-
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865-868
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Abstract
The objective of this study was to assess the efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) in combination with thalidomide for prostate-specific antigen (PSA) reduction in older patients (aged ≥70 years, life expectancy of >1 year) with castration‑resistant prostate cancer (CRPC). A total of 11 CRPC patients were treated with 300 µg GM‑CSF administered subcutaneously on days 1, 3 and 6 of weeks 1 and 2 of each cycle. Thalidomide was gradually increased to reach the study dose of 100 mg̸day. The patients were assessed every 4 weeks with therapy continuing to 4 months. All 11 patients exhibited a decrease in PSA levels and 3 patients (27.2%) exhibited a PSA decrease of >50% in cycle 1. In cycle 2, 8 patients exhibited decreasing PSA levels. A total of 3 patients (27.2%) had a PSA rebound, with 1 patient exhibiting a PSA rebound of >50%. In cycle 3, 10 patients exhibited continuously decreasing PSA levels, with 2 patients (18.2%) exhibiting a PSA decrease of >50%; 1 patient (27.2%) had a PSA rebound of <50%. In cycle 4, 9 patients exhibited continuously decreasing PSA levels and 2 patients (18.2%) had a PSA rebound of >50%. all 11 patients in this study exhibited a decrease in PSA levels, with a median decrease of 92.2%. Therapy was well tolerated, with the majority of the patients experiencing only one adverse event. In conclusion, the combination of GM‑CSF with thalidomide was found to be clinically effective and well tolerated by elderly CRPC patients. Therefore, GM‑CSF plus thalidomide may be considered a viable treatment option for such patients.
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