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Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial / Alison Birtle, Mark Johnson, John Chester, Robert Jones, David Dolling, Richard T Bryan, Christopher Harris, Andrew Winterbottom, Anthony Blacker, James W F Catto, Prabir Chakraborti, Jenny L Donovan, Paul Anthony Elliott, Ann French, Satinder Jagdev, Benjamin Jenkins, Francis Xavier Keeley, Roger Kockelbergh, Thomas Powles, John Wagstaff, Caroline Wilson, Rachel Todd, Rebecca Lewis, Emma Hall
The Lancet, Volume: 395, Issue: 10232, Pages: 1268 - 1277
Swansea University Author: John Wagstaff
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This paper reports the results of an open label phase III trial of Chemotherapy with platinum based chemotherapy versus observation in patients who had undergone nephrectomy for a transitional carcinoma of the upper urinary tract. Patients received four cycles of cisplatin/carboplatin at three weekl...
|Published in:||The Lancet|
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This paper reports the results of an open label phase III trial of Chemotherapy with platinum based chemotherapy versus observation in patients who had undergone nephrectomy for a transitional carcinoma of the upper urinary tract. Patients received four cycles of cisplatin/carboplatin at three weekly intervals. 261 patients were randomised from 71 centres across the United Kingdom. At a median follow-up of 30.3 months chemotherapy significantly improved disease-free survival (hazard ratio 0·45, 95% CI 0·30–0·68; p=0·0001). Three year event free estimates were 71 and 46% for chemotherapy and observation respectively. 55 (43%) of patients given chemotherapy had grade 3 adverse events whilst 5 of 129 (4%) subjected to observation had grade 3 adverse events. Platinum based chemotherapy given within 90 days of nephrouretectomy significantly improved disease-free survival and should be offered to patients as a standard of care.