期刊
CANCER CHEMOTHERAPY AND PHARMACOLOGY
卷 67, 期 3, 页码 519-525出版社
SPRINGER
DOI: 10.1007/s00280-010-1351-8
关键词
Biliary tract cancer; Cancer antigen 19-9; Cisplatin; Fixed-dose-rate gemcitabine; Phase II trial
资金
- Eli Lilly
- Cancer Institute NSW
- National Health and Medical Research Council Clinical Trials Centre
Biliary tract cancers (BTC) have a poor prognosis, and there is no consensus on the best chemotherapy regimen. This study determined the response rate for fixed-dose-rate (FDR) gemcitabine combined with cisplatin. This multicentre phase II trial enrolled 50 patients with inoperable locally advanced or metastatic BTC. Treatment consisted of FDR gemcitabine 1,000 mg/m(2) (10 mg/m(2)/min) and cisplatin 20 mg/m(2) on days 1 and 8 of a 21-day cycle. The primary endpoint was response rate. Secondary endpoints included safety, response duration (RD), progression-free (PFS) and overall survival (OS), and cancer antigen 19-9 response. Thirteen patients (26%, 95% CI 14.6-40.4) had a partial response, and 12 (24%) had stable disease. The median RD was 8.3 months (95% CI 6.91-9.99); median PFS 4 months (95% CI 2.5-6.77); and median OS 6.8 months (95% CI 5.0-8.7). Treatment was well tolerated. Grade 3 and grade 4 nausea, vomiting, and fatigue were uncommon. Thirty-eight per cent of patients discontinued treatment because of toxicity, patient or clinician preference. This treatment combination had moderate activity with acceptable toxicity, supporting previous results that this combination has a role to play. The study does not suggest that FDR gemcitabine is superior to bolus infusion.
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