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The International Watch and Wait Database (IWWD) for rectal cancer, an update

Interview with Dr. Maxime van der Valk and Prof Cornelis van der Velde

Interview Maxime van der Valk und Cornelis van de Velde 1

Dr. Maxime van der Valk and Prof Cornelis van der Velde – Leiden University Medical Center, Leiden, Netherlands

ECCO 2017 Poster 450: The International Watch and Wait Database (IWWD) for rectal cancer, an update -  Download poster - ECCO 2017 abstract

Video Summary:

Dr Maxime van der Valk and Professor Cornelis van de Velde, mentioned that there are some differences internationally but in most cases for locally advanced rectal cancer a combination of chemotherapy and radiotherapy (chemo-radiotherapy), is used as an induction treatment followed by TME surgery. About 0-25% patients have a complete pathological response, which is established after surgery. However the watch and wait approach is about identifying complete response before surgery, mostly based on imaging modalities such as endoscopy, MRI or CT scans. The International Watch and Wait database has evaluated whether it is oncologically safe to omit surgery in patients who have a complete clinical response. The data from this registry has been presented at ECCO2017, for example the RAPIDO trial, a trial evaluating locally advanced rectal cancer randomized patients to either standard chemo-radiotherapy or short course radiotherapy followed by chemotherapy. It was reported that 20% of patients have a pathological complete response but surgery was omitted in only 4%, so the watch and wait approach cannot be a standard practice yet. The Watch and Wait Registry is part of the European Registration of Cancer Care (EURECCA) which is a database focussing on treatments of patient groups consisting of special populations like elderly patients with comorbidities that are not included into clinical trials. The reason to establish this Watch and Wait database was to have it as a standard practice and an option for patients in the future. So the change in 20 years’ time of enormous operations is to have a good option of not to operate at all. Certain fluorescent markers have already been developed that can be administered intravenously and can indicate where there is regrowth of tumour.  Hence there are more specific techniques to detect regrowth of tumour at an early stage, but are still at an experimental stage. What has been learned from the International Watch and Wait database so far is that, the patients that experienced a local regrowth, 96% of the regrowth is located intraluminally and hence for diagnosing and follow-up of this local regrowth endoscopy should be the most important imaging modality. More data on the patients who have been operated on, had a pathologic complete response and recommendations from the international team of experts connected to the Watch and Wait Registry what patients should be referred to such a treatment will be available. Additionally e-learning is being developed for all the disciplines involved so that patients can also access and learn about their cancers and will become a standard of care with very strict regulations and conditions and preferably also in centres of expertise.

Video transcript:

How is rectal cancer usually treated? Is ‘Watch-and-Wait’ a standard approach for these patients?

Dr van der Valk:  We know that there are some differences internationally but in most cases for locally advanced rectal cancer a combination of chemotherapy and radiotherapy, mostly chemoradiotherapy is used as an induction treatment followed by TME surgery and we see that in about 20-25% patients have a pathological complete response, so that is established after surgery but the watch and wait approach, it’s about identifying a complete response before surgery, mostly based on imaging modalities such as endoscopy, MRI or CT scans.

And what we tried to investigate with the International Watch and Wait database is whether it is oncologically safe to omit surgery in patients that have a clinical complete response and we know from the data that is presented at this conference, for example the RAPIDO trial which is a trial for locally advanced rectal cancer randomising between standard chemoradiotherapy or short course radiotherapy followed by chemotherapy, we know that 20% of patients have a pathological complete response but surgery was omitted in only 4%, so we can say that watch and wait is not standard yet.

Can you tell us about EURECCA? What have we learned regarding the 'Watch-and-Wait' approach following chemoradiotherapy which was presented at ECCO2017 today?

Professor van de Velde:  The Watch and Wait Registry is part of EURECCA colorectal.  EURECCA is the European Registration of Cancer Care which is a database focussing on peculiar treatments of patient groups like elderly patients with comorbidities that are not included into clinical trials to learn from that and to learn from the different policies in different countries.

Watch and Wait is the aimed at, a prospective database so it’s now mainly retrospective but also to prospectively follow those patients who have been selected for a watch and wait strategy, usually in centres with some experience in that and we want also to produce through this EURECCA guidelines, recommendations with an expert group we have formed throughout the world when we have enough patients and data also from randomised trials what are the ideal candidates for such a policy, and not only locally advanced where in the past we had to do huge operations and of course I call it a triumph and a tragedy.  The triumph is there is no tumour there, the patient has had an abdominal perineal resection, an enormous resection with a stoma and 40% complications and when you say to the patients ‘The pathologist didn’t find a single tumour cell’, that’s a bit of a tragedy; was this operation really necessary? 

But it must not be a strategy of watch and worry.  No, you have to have confidence and so far we found there is confidence because 96%, what we call regrowth, patients have not been operated, have a regrowth of the tumour, it’s intraluminal and can be successfully treated surgically thereafter.

So it’s not a lost case when you have this regrowth, but of course the prognosis is better of those who will not have a regrowth of the tumour and they have an excellent prognosis.

So it’s an enormous change in 20 years’ time of enormous operations now having a good option not to operate at all, but in order to have it as a standard practice and an option for patients for the future was the reason to establish this Watch and Wait database, including also a surgeon who is quite old already from São Paulo, Angelita Habr-Gama who propagated and started this treatment in 2004, so it’s relatively new but still as Maxime indicated, in trials it is still the standard of care is still surgery.

How do we select the best patients for a 'Watch-and-Wait' approach following chemotherapy for rectal cancer?

Professor van de Velde:  But of course it’s the bioprobe.  I call this the bioprobe, feeling if there is tumour and secondly it’s endoscopy, so to see is there any suspicion and we are developing right now, we already have developed certain fluorescent markers that you can give intravenously and they indicate where there is regrowth of tumour.  So it becomes more specific to detect regrowth of tumour at an early stage, but this is still experimental, it’s only in Phase I and II studies now and also data from randomised trials that Maxime explained will become more known in the coming years so that we can come with recommendations for patients.

Dr van der Valk:  What we have learned from the International Watch and Wait database so far is that from the patients that experienced a local regrowth, 96% of the regrowths are located intraluminally so for follow-up and diagnosing this local regrowth, endoscopy should be the most important imaging modality.

Professor van de Velde:  So it’s not the lymph nodes, it’s not where the tumour recurs and again we try to say ‘regrowth’ because it’s not a recurrence but a regrowth of tumour cells and that’s surprising and of course very pleasant that it is intraluminal rather than in lymph nodes you cannot easily detect and also discriminate with an MRI which is a standard investigation for rectal cancer.  The MRI does not indicate ‘This enlarged lymph node contains tumour or does not’ and of course also targeted agents can give more reliability on where the regrowth is.

Should 'Watch-and-Wait' become a standard of care for selected patients with rectal cancer after chemoradiotherapy?

Professor van de Velde: For the future...so it’s not a standard approach but soon we will have now Maxime has assembled more than 800 patients in the Watch and Wait Registry, we will perhaps go to 1,000 but also randomised trials like the RAPIDO trial on locally advanced will be known in the coming year and then we will produce data on those patients who have been operated, had a pathologic complete response and come with recommendations together with the international team of experts connected to the Watch and Wait Registry what patients should be recommended for such a treatment. 

And of course we also are developing e-learning for all the disciplines involved so that also patients can access and can learn that they do not have this need in all cases to have an abdominal perineal, a very large operation but perhaps can ask ‘This is a new development; is this suitable for my tumour and my person?’ and of course that’s the development for the coming years, that it will become a standard of care but under very strict regulations and conditions and preferably also in centres of expertise.

- Ends -

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