Phase I study of transforming growth factor-beta 3 mouthwashes for prevention of chemotherapy-induced mucositis
作者： W Timens , H Timmer-Bosscha , NH Mulder , Anm Wymenga , Ege de Vries
DOI:
关键词: Internal medicine 、 Gastroenterology 、 Buccal swab 、 Epirubicin 、 Mucositis 、 Chemotherapy 、 Cyclophosphamide 、 Surgery 、 Medicine 、 Carboplatin 、 ThioTEPA 、 Tolerability
摘要: The purpose of this study was to establish the safety and tolerability recombinant transforming growth factor-β3 (TGF-β3; CGP 46614) mouthwashes intended for prevention chemotherapy-induced mucositis. Local effects were especially analyzed by objective subjective measurements Secondary aims analysis potential systemic exposure development anti-TGF-β3-antibodies. Eleven breast cancer patients received chemotherapy with 1.5 g/m 2 cyclophosphamide i.v., 80 mg/m epirubicin 1.0 5-fluorouracil i.v. ( n = 8) or 1.6 carboplatin 480 thiotepa 6 divided over 4 days 3). TGF-β3 (10 ml; provided Novartis, Basel, Switzerland) administered days, four times a day, starting 1 day before chemotherapy. dose escalated in following from 25 μg/ml 3) 50 100 5). Clinically, mucosa scored objectively according WHO criteria. percentage viable oral epithelial cells determined trypan blue dye exclusion. Morphology assessed buccal smears. Plasma samples collected determination levels Adverse events recorded patient diary. Mouthwashes well tolerated. Three mucositis > grade 0 (WHO grading criteria). treated stable, whereas an increase observed. morphology showed transient shift mature immature first week. Neither absorption nor TGF-β3-antibodies tolerated deserve further preventing
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