Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment.
作者： M D Pegram , A Lipton , D F Hayes , B L Weber , J M Baselga
DOI: 10.1200/JCO.1998.16.8.2659
关键词: Trastuzumab 、 Metastatic breast cancer 、 Pathology 、 Internal medicine 、 Phases of clinical research 、 HER2/neu 、 Chemotherapy 、 Cancer 、 Cisplatin 、 Oncology 、 Medicine 、 Metastasis
摘要: PURPOSETo determine the toxicity, pharmacokinetics, response rate, and duration of intravenous (i.v.) administration recombinant, humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) plus cisplatin (CDDP) in a phase II, open-label, multicenter clinical trial for patients with HER2/neu-overexpressing metastatic breast cancer.PATIENTS AND METHODSThe study population consisted extensively pretreated advanced cancer HER2/neu overexpression disease progression during standard chemotherapy. Patients received loading dose rhuMAb HER2 (250 mg i.v.) on day 0, followed by weekly doses 100 i.v. 9 weeks. CDDP (75 mg/m2) days 1, 29, 57.RESULTSOf 37 assessable response, nine (24.3%) achieved PR, had minor or stable disease, occurred 19 (51.3%). The median was 5.3 months (range, 1.6-18). Grade III IV toxicity observed 22 39 (56%). T...
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