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Kritiya Butthongkomvong,1 Nilubol Raunroadroong,2 Sirikul Sorrarichingchai,2 Isaraporn Sangsaikae,3 Vichien Srimuninnimit,4 Henrik Harling,5 Stig Larsen6 1Udonthani Cancer Hospital, Udonthani, Thailand; 2Lampang Cancer Hospital, Lampang, Thailand; 3Ubonratchathani Cancer Hospital, Ubonratchathani, Thailand; 4Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand; 5Bispebjerg University Hospital, Department of Gastroenterology, Center for Digestive Disease, Copenhagen, Denmark; 6Digestive Disease Center, Centre for Epidemiology and Biostatistics, Norwegian University of Life Sciences, Oslo, Norway Aims: The aim of this study was to compare the efficacy and tolerability of BP-C1 vs equal-looking placebo in metastatic breast cancer.Materials and methods: A randomized, double-blind, placebo-controlled multi-center study with a semicross-over design was performed. Sixteen patients received daily intramuscular injection of 0.035 mg/kg bodyweight of BP-C1 and 15 patients received equal-looking placebo for 32 days. After 32 days, the placebo patients crossed to BP-C1 with the last observation in the placebo period as baseline. The status of receptors including estrogen receptor (ER), progesterone receptor (PtR), and human EGF receptor 2 (HER2) was analyzed prior to inclusion in the study. Thoracoabdominal CT scan was blindly analyzed by the same independent radiologist in accordance with the RECIST criteria 1.1. Toxicity was assessed according to the NCI Bethesda Version 2.0 (CTC-NCI), and the quality of life (QOL) was assessed according to European Organization for the Research and Treatment of Cancer QOL-C30 and QOL-BR23.Results: The sum of target lesion diameters (sum lesions) after 32 days of treatment increased by 8.9% (P=0.08) in the BP-C1 arm compared to 37.6% (P |
