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

Autor: John D. Chester, Anthony Blacker, Mark Johnson, Thomas Powles, David Dolling, Satinder Jagdev, Andrew Winterbottom, Alison Birtle, Chris Harris, Paul Anthony Elliott, John Wagstaff, Richard T. Bryan, Robert Jones, Rebecca Lewis, Emma Hall, Francis X. Keeley, Caroline Wilson, Rachel Todd, Benjamin Jenkins, Ann French, James W.F. Catto, Jenny L Donovan, Prabir Chakraborti, Roger Kockelbergh
Rok vydání: 2020
Předmět:
Zdroj: Birtle, A, Johnson, M, Donovan, J L & al., E 2020, ' Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial) : a phase 3, open-label, randomised controlled trial ', Lancet, vol. 395, no. 10232, pp. 1268-1277 . https://doi.org/10.1016/S0140-6736(20)30415-3
Lancet (London, England)
ISSN: 1474-547X
0140-6736
Popis: Background:\ud Urothelial carcinomas of the upper urinary tract (UTUCs) are rare, with poorer stage-for-stage prognosis than urothelial carcinomas of the urinary bladder. No international consensus exists on the benefit of adjuvant chemotherapy for patients with UTUCs after nephroureterectomy with curative intent. The POUT (Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer) trial aimed to assess the efficacy of systemic platinum-based chemotherapy in patients with UTUCs.\ud \ud Methods:\ud We did a phase 3, open-label, randomised controlled trial at 71 hospitals in the UK. We recruited patients with UTUC after nephroureterectomy staged as either pT2–T4 pN0–N3 M0 or pTany N1–3 M0. We randomly allocated participants centrally (1:1) to either surveillance or four 21-day cycles of chemotherapy, using a minimisation algorithm with a random element. Chemotherapy was either cisplatin (70 mg/m2) or carboplatin (area under the curve [AUC]4·5/AUC5, for glomerular filtration rate
Databáze: OpenAIRE