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Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial / John, Wagstaff

The Lancet

Swansea University Author: John, Wagstaff

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Abstract

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...

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Published in: The Lancet
ISSN: 0140-6736
Published: Elsevier BV 2020
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa53807
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Abstract: 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.