The PeriOperative chemotheraphy or sUrveillance in upper Tract urothelial cancer, also known as POUT (CRUK/11/027; NCT01993979, NIHR portfolio) is the largest clinical trial in upper tract urothelial cancer (UTUC) with findings supporting the use of adjuvant platinum based chemotherapy as a new standard of care. Dr. Alison Birtle, Consultant Oncologist of the Rosemere Cancer Centre at the Royal Preston Hospital, will present the study’s key findings and updates at the upcoming 10th European Multidisciplinary Congress on Urological Cancers (EMUC18) in Amsterdam, The Netherlands.
“The POUT trial is the first randomised trial in this niche area. It has shown an absolute improvement of 16% (95% CI:2-30%) in disease free survival (DFS) at two years in favour of chemotherapy and a similar benefit for metastasis-free survival (MFS). Data collection for overall survival is ongoing. We have had retrospective data in this area; now we have robust data to guide treatment and to change practice,” said Dr. Birtle.
The study won the first prize for Best Abstract in Oncology at the 33rd Annual EAU Congress held in Copenhagen, Denmark early this year.
The POUT study
The POUT trial was coordinated by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU) and between May 2012 and November 2017, 261 patients were randomised to receive either chemotherapy (131) or surveillance (129) at 57 hospitals across the UK. POUT examined the role of post nephro-ureterectomy (NU) treatment for UTUC and whether adjuvant chemotherapy improves DFS for patients with histologically confirmed TCC pT2-pT4 pN0-3 M0 or pTany N1-3 M0, WHO PS 0-1 who were fit to receive chemotherapy.
The POUT findings concluded that adjuvant platinum based chemotherapy should be considered as a new standard of care; it is tolerable for patients and improved MFS in UTUC. Recruitment to the POUT trial was terminated early because of efficacy was met in favour of chemotherapy; follow up for overall survival continues.
Potential and possibilities
In terms of possible new breakthroughs in the coming years, Dr. Birtle anticipates that there could be data on adjuvant treatment with checkpoint inhibitors: “We will have data on adjuvant treatment with checkpoint inhibitors in bladder cancer – the studies are not powered sufficiently for the UTUC cohorts as these were added post hoc so they won’t truly answer how effective check point inhibitors are in UTUC adjuvantly. Similarly, studies in metastatic urothelial cancer will read out, comparing immuno-oncology (IO) versus chemotherapy versus a combination.” Dr. Birtle is currently working on a successor trial to POUT.
According to Dr. Birtle, the lack of access to data is crucial for researchers since it leads to bottlenecks and delays the progress of current trials, which in turn affects the speed of offering curative therapies to cancer patients. She added, “The barriers among countries (even pre-Brexit) makes true collaborations challenging. We don’t want competing trials, we want to run studies together across countries to give us data to move onto the next trial. Pooling our individual biobanks so that we can mine the wealth of translational work is vital.”
“POUT is a triumph of UK collaboration. 71 UK sites were opened and 57 recruited at least one patient. We need to make sure that other countries can join together and reduce bureaucracy so that we can recruit to important trials quickly and improve options for patients. We should all view research as the core business as it improves what we can do for patients. It should never be seen as an optional extra.”
On multidisciplinary team (MDT) work, she commented that forums and events like the EMUC significantly contributes to a more effective network among cancer specialists. “Meetings like this are so important – not just to keep up to date but to hear what is going on, what the next stages might be, and to network with colleagues so that we can join in cutting-edge research at an early stage.”
EMUC as a platform
At EMUC18, the POUT update will be taken up during the session “New trials update: What we need to know.” Also to be presented during this session are key updates on the CARMENA, STAMPEDE, PRECISION and HORRAD trials. Biostatistician Laurence Collette (BE), surgical oncologist Ganesh Palapattu (US), and radiation oncologist Alberto Bossi (FR) will chair the session which will be held on Saturday, 10 November.
Annually held as a platform for scientific updates and professional networking for urological cancers experts, EMUC focuses on improving MDT work and is organised by three of Europe’s frontline professional associations – the European Society for Medical Oncology (ESMO), the European Association of Urology (EAU), and the European SocieTy for Radiotherapy & Oncology (ESTRO).
EMUC18’s Scientific Programme will address clinical and research issues with the interactive sessions to be led by opinion leaders, expert lecturers and speakers from across Europe and North America. From decision-making dilemmas to future prospects in drug development, participants will not only contribute to the discussion through direct voting but can also join workshops, special courses, hands-on training and other specialist forums.
Want to know more about EMUC18? For additional information on the Scientific Programme, Venue and Registration, visit the meeting website.