- Title
- Fixed-dose-rate gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas
- Creator
- Goldstein, David; Gainford, M Corona; Miller, Danielle; Shannon, Jenny; Brown, Chris; Tebbutt, Niall; Ackland, Stephen P.; van Hazel, Guy; Jefford, Michael; Abdi, Ehtesham; Selva-Nayagam, Sid; Gebski, Val
- Relation
- Cancer Chemotherapy and Pharmacology Vol. 67, Issue 3, p. 519-525
- Publisher Link
- http://dx.doi.org/10.1007/s00280-010-1351-8
- Publisher
- Springer
- Resource Type
- journal article
- Date
- 2011
- Description
- Background: 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 Wxeddose-rate (FDR) gemcitabine combined with cisplatin. Methods: This multicentre phase II trial enrolled 50 patients with inoperable locally advanced or metastatic BTC. Treatment consisted of FDR gemcitabine 1,000 mg/m² (10 mg/m²/min) and cisplatin 20 mg/m² 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. Results: 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. Conclusions: 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.
- Subject
- biliary tract cancer; cancer antigen 19-9; cisplatin; fixed-dose-rate gemcitabine; phase II trial
- Identifier
- http://hdl.handle.net/1959.13/936525
- Identifier
- uon:12335
- Identifier
- ISSN:0344-5704
- Language
- eng
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