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Abstracts
13
5 - Results of POUT - A phase III randomised
trial of peri-operative chemotherapy versus
surveillance in upper tract urothelial cancer
(UTUC)
Figure 4a. Best Academic Paper 4
Figure 4b. Best Academic Paper 4
Figure 4c. Best Academic Paper 4
Birtle A1, Johnson M2, Kocklebergh R3, Keeley F4, Catto
J5, Bryan R6, Jones R7, Chester J8, Hill M9, Donovan J10,
French A11, Harris C12, Powles T13, Todd R9, Tregellas
L9, Wilson C10, Winterbottom A14, Lewis R9, Hall E9
1Royal Preston Hospital, Preston, United Kingdom, 2Newcastle
upon Tyne Hospitals NHS Trust, Newcastle, United Kingdom,
3University Hospitals Leicester, Leicester, United Kingdom, 4North
Bristol NHS Trust, Bristol, United Kingdom, 5The University of
Sheffield, Sheffield, United Kingdom, 6University of Birmingham,
Birmingham, United Kingdom, 7Beatson West of Scotland Cancer
Centre, Glasgow, United Kingdom, 8Cardiff University, Cardiff,
United Kingdom, 9Clinical Trials and Statistics Unit, Institute
of Cancer Research, London, United Kingdom, 10University of
Bristol, Bristol, United Kingdom, 11Southend University Hospital
NHS Foundation Trust, Southend, United Kingdom, 12Consumer
Representative, London, United Kingdom, 13St Barts & the London
NHS Trust, London, United Kingdom, 14Fight Bladder Cancer,
Chinnor, United Kingdom
Background: The role of chemotherapy post nephroureterectomy (NU) for UTUC is unclear. POUT
(CRUK/11/027; NCT01993979) addresses whether adjuvant chemotherapy improves disease free survival (DFS)
for patients (pts) with histologically confirmed pT2-T4
N0-3 M0 UTUC.
Methods: Pts (max n=345), d90 days post NU, randomised (1:1) to 4 cycles gemcitabine-cisplatin (gemcitabine-carboplatin if GFR 30-49ml/min) or surveillance.
Primary endpoint was DFS. The trial was powered to
detect a hazard ratio (HR) of 0.65 (i.e. improvement in
3yr DFS from 40% to 55%; 2-sided alpha 5%, 80% power)
with Peto-Haybittle early stopping rules for efficacy &
inefficacy.
Secondary endpoints included toxicity (CTCAE v4), quality of life, metastasis-free (MFS) & overall survival (OS).
Results: 261pts (127 surveillance; 134 chemotherapy)
were randomised between 31/05/2012-10/11/2017,
across 57 centres. In Oct 2017, independent trial oversight committees recommended POUT recruitment
closed; as data collected thus far (data snapshot
05/09/2017) met early stopping rule for efficacy in favour
of chemotherapy.
At time of interim analysis, median follow-up was
17.6mths (IQR 7.5-33.6). Median age 69yrs (range 36-88),
30% pT2, 65% pT3; 91% pN0. Most common grade t3
toxicities for chemotherapy pts during treatment were
neutropenia 29% (0% surveillance) & thrombocytopenia
7% (0%). 47/123 (surveillance) & 29/125 (chemotherapy)
Table of Contents for the Digital Edition of JCU - Abstracts of the BAUS 2018 Scientific Meeting - June 2018
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