How Is Rectal Cancer Care Being Improved by New National Standards?

Podcast Transcript

Scott Steele: Butts & Guts, a Cleveland Clinic podcast exploring your digestive and surgical health from end to end.

So welcome everybody to another episode of Butts & Guts. I'm your host, Scott Steele, Chairman of Colorectal Surgery here in beautiful Cleveland, Ohio at the Cleveland Clinic. And today we're gonna talk about rectal cancer but from a slightly different angle. Today we're gonna talk about the program that's out there, through the American College of Surgeons, called the National Accreditation Program for Rectal Cancer or NAPRC. And we're very thrilled today to have Dr. Steven Wexner, who's the director of the Digestive Disease Center at Cleveland Clinic Florida, and the Chairman of the Department of Colorectal Surgery. Steve, welcome to Butts & Guts.

Steven Wexner: Thank-you very much, Scott. Happy to be on the program, honored to be on the program.

Scott Steele: So, Steve, you were instrumental in starting this process and really one of the main stalwarts and the person who spearheaded this program. First start off by telling us a little bit about what exactly is NAPRC?

Steven Wexner: We know, historically, over the last 30 years, that rectal cancer outcomes are very much related to surgical technique as well as the ability to accurately pre-operatively stage, as well as the ability to accurately look at the excised specimen to give appropriate, optimal, prognostic information. And the imaging and pathology components of those aspects of rectal cancer care really dictate whether or not neoadjuvant or adjuvant therapy is used. So the combination of the five disciplines: radiation oncology, medical oncology, imaging, surgery, pathology working together gave better outcomes. And in many countries in Europe, all of the Scandinavian countries, plus the UK, Belgium, Germany, Ireland, elsewhere, it was proven that by having centers in which rectal cancer care was focused with expertise and a multi-disciplinary team approach, outcomes improved.

That means lower rates of local recurrence, lower rates of permanent colostomy, and better long-term survival than had previously been experienced in those countries when the care was done by anybody who chose to do the care of those patients. So, a group formed at Cleveland Clinic in August 2011, subsequently November 2011 at Cleveland Clinic Florida, representing about 11 different programs throughout the country. And we deliberately chose

(a) to focus on the perioperative period: surgery, pathology, radiology; and

(b) to choose people who had a voice in many major societies: College for American Pathology, American College for Radiology, American Colleges of Surgeons, Commission on Cancer, American Society of Colorectal Surgeons, Society of American Gastrointestinal and Endoscopic Surgeons, Society for Surgical Oncology, Society for Surgery of the Alimentary Tract. To try and ensure representation of clinics, universities, urban, suburban, all kinds of settings.

And we tried to identify the problem, which we did. We then, over the course of the next several years, came up with some peer-reviewed publications highlighting that this problem existed in the U.S. That there was tremendous variability in care, that there was suboptimal care in the U.S. overall as compared to the countries in Europe and the UK where these centers had been created. So two issues: tremendous discrepancy in the U.S. and the U.S. not up to par with the other side of the Atlantic Ocean.

So, we then presented this issue to the Commission on Cancer, the Accreditation Committee, subsequently the Executive Committee, and separately to the Board of Regents and Officers of the American College of Surgeons, for approval to move forward with creating a program in the U.S. as had been successful in multiple countries in Europe and UK.

We got the green light and then we spend from 2015-17 working on a standards manual to try to codify evidence-based guidelines for the process and performance, which should lead to those improved outcomes. The programs were beta tested at 6 sites in the U.S. first quarter of 2017, including both Cleveland Clinic, Main Campus, and Cleveland Clinic Florida. Then fleshed out some more by the ACS, the COC and all the societies I mentioned, and then rolled out for the initial site visits during the second quarter of 2018. And we're delighted that both Cleveland Clinic Florida and Cleveland Clinic Ohio are amongst the first, two out of the first four sites, accredited in the United States as NAPRC Centers.

NAPRC is the first COC program, and the COC for those who don't know is the organization which represents about 1700 hospitals at which about 80% of all new cancers are cared for each year, and all of the data feed into the National Cancer Database which is the world's largest national cancer database. So, this is the first type of cancer that has its own accreditation program. There is the National Accreditations Program for Breast Centers, but that program does not require COC certification, so you could be NABPC certified without being COC certified. This program is the first one requiring COC certification so the baseline is already higher, not to in any way denigrate NABPC Centers, but our centers must first meet the bar of COC accreditation and then can add on NAPRC.

The thought is, this model might potentially be a template for other cancers down the road for which, like rectal cancer, there is significant body of evidence that who does it, how it's done, and the setting in which it's done, significantly impacts outcomes.

Scott Steele: Wow, what a massive undertaking. Lots to unpack there, especially for our patients out there who are listening. So, Steve, let's take a quick step back and just talk a little bit about “What does this mean?” I'm a patient, I'm listening out there and I say “Cleveland Clinic, Cleveland Clinic Florida, one of the other institutions out there are NAPRC accredited.” What does that mean to me as a patient?

Steven Wexner: Basically, what it means is if you're going to seek care, as a patient, you would be strongly advised to look at the evidence out there that your outcomes will be better at an NAPRC accredited center based upon what's gone on in the rest of the world. That you should get your care at a place where you're going to have a high quality MR done and interpreted by an imager who has been through the educational module, which the American College of Radiology has beautifully created, it's a masterpiece educational module for MR imagers. That those images will be looked at by a big group of people including, potentially your surgeon, potentially your medical oncologist, potentially your radiation oncologist, and potentially your pathologist, who's going to subsequently look at the excised tumor.

It means your surgery is going to be done by a surgeon who has completed the educational module that is being created under the direction of Conor Delaney, our DDSI Chair in Ohio, on behalf of the ASCRS. And it means that the surgeon will have completed that module, and that surgeon is willing to have his or her excised specimen, i.e. my tumor as the patient, put up on a big screen for that whole multi-disciplinary tumor board to look at. And that means that surgeon wants to achieve a fantastic result because that image is gonna be magnified multifold and looked at to ensure it's of the highest possible quality. Nothing can be swept under the rug or hidden or ignored.

It means that the pathologist has been trained by doing the educational module that Mariana Berho, the Chair of Pathology at Cleveland Clinic Florida, Associate Chief of Staff at Cleveland Clinic Florida, that she created with others from the College of American Pathologists. That your pathologist who's gonna look at your rectal cancer, has completed that educational module, and will be in the room with the other people, along with medical and radiation oncology.

So it is a team, it is a skilled team, it is an up-to-the-minute team who's gonna be taking care of you. They talk to each other on a frequent basis. You, as the patient, are gonna have your particulars presented to that group at least twice: first, when you come in, prior to a decision being made as to the optimal treatment, and again after the definitive treatment presumably surgery, not necessarily, and discussed. And those results will be communicated to any physician who you want to get those results as well as to yourself. So tremendous amount of interaction and communication is ensured and, again, as has been said by somebody far smarter than me, the wisdom of the crowd, as opposed to one person.

No matter how good or how smart that person is, a group of people can far better and more information. And we know that from a study that was published recently in Journal of the American College of Surgeons by Matt Kalady, who spearheaded this effort in Cleveland Clinic Ohio. And Matt shows that in roughly between a quarter and a third of cases, no matter how senior the surgeon was, his or her idea of how the patient was to be treated going into this multi-disciplinary team conference changed in between a third and a quarter of cases so regardless of seniority, again the wisdom of the crowd cannot be underestimated in the context of rectal cancer care.

Scott Steele: And I think it's important to bring up that the goal here with everything is to raise everybody in the boat, and raise the standard of care and not to be exclusion or anything but Steve the U.S. does have some geographical limitations in terms of its massive size and remote areas that people live in that Europe doesn't. Where do you see NAPRC headed in the future, and what does that mean to some of the rural surgeons? I grew up in Northern Wisconsin where we had a great group of surgeons, but it was small town USA.

Steven Wexner: Well, it's an interesting phenomenon, and it is meant to be inclusive, but you know the American College of Surgeons is there to improve patient outcomes and that is our main goal is improving outcomes for patients. We have to be honest as well, and if I as a surgeon knew that I was gonna take care of one rectal cancer a year, I don't think I could look myself in the mirror and say “I'm gonna do that to a patient, and I'm doing it in isolation, without this entire support team.” And I think at that point I'd have to talk to my patient and say, “You know something, you're better to go to XYZ whatever that center is, not necessarily for your chemotherapy and radiation, but absolutely for your surgery. You know, you should get this done at a center where this is done day in and day out.”

And I often think of the fact, some person's willing to travel to go get a great price on a car, or a living room set, or a refrigerator. They go to the nearest big city 'cause there's a great outlet store there. People will travel for that. They certainly should travel for their own health care, when it relates to a permanent colostomy and survival from cancer. And this is a cancer where that travel is worthwhile. And I just think that people have to be honest with their patients about it. Now there may be a way people can amalgamate in rural areas and one person in this area say “Okay, you're the rectal cancer person, and the other person is the breast cancer person.” Perhaps that's feasible, but honesty is the best policy.

Scott Steele: Steve, you know we're focused on rectal cancer here, but what about pancreas cancer, or any cancer, gastric cancer, do you see the wave of the future going in this direction?

Steven Wexner: I definitely do for pancreas because that's one of the areas where these data exist. As a privilege of being on the Executive Committee of the Commission on Cancer, and there is definitely some discussion that I've heard in the hallways that this perhaps might be looked at. I'm certainly not making any official statement on behalf of the COC, but suffice to say there is absolutely interest expressed to the COC by HPB surgeons to have that be the next area of focus.

I haven't heard anybody asking about gastric yet or esophagus but quite a lot of HPB surgeons said “Are you gonna be looking at pancreatic cancer next?” So, perhaps.

Scott Steele: So final thoughts on the NAPRC program or rectal cancer care in the United States in general.

Steven Wexner: I think that this program is going to be immensely successful. COC already has 30 hospitals who've applied for accreditation, and many, many more who claim that they are interested and are going to apply. But it's not just a matter of ticking the boxes, it's a matter of having all of those processes and performance metrics in place and complying with the minimum standards for the COC to reach accreditation. And therefore, people aren't applying until they think they are gonna be accredited.

So there are 30 that think they're ready. I would hazard a guess that there are another 100-150 that will follow suit, just my own personal guess, will follow suit soon thereafter. So I think the 45000 patients per year in the U.S., roughly 45000, who get rectal cancer, are soon gonna be able to benefit from the same improvements in care that have been introduced in Europe and the UK and are soon gonna be afforded the lower rates of local recurrence, the lower rates of permanent colostomy, and the higher rates of survival that are seen across the ocean, due to the inception and continuation of this program.

Scott Steele: Well, just a public thank-you to you and the many others that were involved in the vision, in the leadership, of making this multi-year and multi-institutional, multi-disciplinary process come forward in an effort to raise the global care for those patients with rectal cancer, that is absolutely outstanding.

And to our listeners, for more information about NAPRC or about Cleveland Clinic's Digestive Disease and Surgery Institute, visit clevelandclinic.org/digestive, that's clevelandclinic.org/digestive. And to make an appointment with the Cleveland Clinic digestive specialists, please call 216-444-7000 that's 216-444-7000.

Steve, again congratulations on being one of the early accredited programs and leading this effort.

Steven Wexner: Thank-you very much.

Scott Steele: That wraps things up here at Cleveland Clinic. Until next time, thanks for listening to Butts & Guts.