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Fixed-dose-rate gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas
Authors:David Goldstein  M. Corona Gainford  Chris Brown  Niall Tebbutt  Stephen P. Ackland  Guy van Hazel  Michael Jefford  Ehtesham Abdi  Sid Selva-Nayagam  Val Gebski  Danielle Miller  Jenny Shannon
Affiliation:1. Department of Medical Oncology, Prince of Wales Hospital, Barker Street, Randwick, NSW, 2031, Australia
2. NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia
3. Austin Health, Melbourne, VIC, Australia
4. Department of Medical Oncology, Calvary Mater Newcastle Hospital, Hunter Medical Research Institute Cancer Research Program, Newcastle, NSW, Australia
5. Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia
6. Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
7. Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia
8. Tweed Cancer Care Centre, Tweed Heads, NSW, Australia
9. Department of Medical Oncology, Royal Adelaide Hospital, Adelaide, SA, Australia
10. Sydney West Cancer Network, Nepean Cancer Care Centre, Sydney, NSW, Australia
Abstract:

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 fixed-dose-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?C40.4) had a partial response, and 12 (24%) had stable disease. The median RD was 8.3?months (95% CI 6.91?C9.99); median PFS 4?months (95% CI 2.5?C6.77); and median OS 6.8?months (95% CI 5.0?C8.7). 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.
Keywords:
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