期刊
ONKOLOGIE
卷 33, 期 6, 页码 295-299出版社
KARGER
DOI: 10.1159/000313598
关键词
Capecitabine; Oxaliplatin; Irinotecan; Colorectal cancer; Phase I
类别
资金
- Pfizer AG
- Sanofi-Aventis (Suisse) SA
- Roche Pharma (Schweiz) AG
- Oncosuisse
- Swiss federal government
Background: A phase I multicentre trial was conducted to define the recommended dose of capecitabine in combination with oxaliplatin and irinotecan (OCX) in metastatic colorectal cancer. Patients and Methods: Patients with performance status (PS) < 2 and adequate haematological, renal and liver function received oxaliplatin 70 mg/m(2) on days 1 and 15, irinotecan 100 mg/m(2) on days 8 and 22 and one of five dose levels (DL 1-5, between 800 and 1,600 mg/m(2)) of capecitabine on days 1-29 every 5 weeks. Results: 23 patients received a median of 3 cycles. 3 dose-limiting toxicities occurred (DL 1: grade 3 (G3) elevated alkaline phosphatase; DL 5: 1 patient G4 hyperglycaemia/G3 diarrhoea and 1 sudden death). The most common severe adverse event was G3 diarrhoea (13%). Severe haematotoxicity was rare. Therapy was stopped mainly due to metastasectomy or tumour progression (7 patients each). 8 patients reached a partial response. Median time to progression and overall survival (OS) were 8.0 and 21.9 months, respectively. Conclusions: The recommended capecitabine dose in this schedule is 1,400 mg/m(2) daily. The OCX regimen is well tolerated. The response rate was surprisingly low with progression-free survival (PFS) and OS within the range of a triple combination. Further studies in combination with targeted agents are warranted.
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