Of course, the way to address any treatment option issue is to do a controlled randomized trial. And controlled randomized trials of surgery are quite difficult. They tend to be complicated and you are depending on a surgeon to do what he or she is told to do when the patient is under anesthesia and you are not there, essentially. So sometimes it doesn’t get done. But there has been a controlled randomized trial reported. This was in the New England Journal. It was in March, late March, I think March 25th of 2006. A very interesting clinical trial. It was done in Holland, it was done in the Netherlands and what they did was they randomized patients between the D2 dissection, where they took only the N1 nodes, and the D2 dissection where they took the N1 and the N2 nodes. The total number of patients in this study was over 700 patients and they showed the survival, overall survival was no different. The complications were greater in the D2 dissections and postoperative deaths were greater in the D2 dissections. These were quite interesting data. Many surgeons immediately responded and said that in their hands the D2 dissection can be done very safely and that these D2 dissections were biased towards problems because the protocol required that a distal pancreatectomy be done along with the D2 dissection and that isn’t really appropriate. So whenever you have a technique you can always get arguments back and forth about how well the technique is executed. But in any event, overall it looked like there was no benefit in overall survival for doing the extensive D2 dissection.
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Now there is a benefit for doing a D2 dissection and these are interesting data. This is probably, in regard to surgery, this will probably be the most important thing in regard to the primary treatment of gastric cancer that I will show you. This is a very interesting paper that was published in January of 1995 and it was from the Dutch group again. What they did was a real interesting thing. They took their patients who were having D2 dissections and they said, Okay, to their pathologists, they said, “Stage these patients as if they only had a D1 dissection.” In other words, only look at the nodes within 3 cm of the primary tumor and give us a stage, and then go on and stage the rest of the specimen. This was relatively early on in the study, 1993-1994, and so they had this number of patients here. For example, in stage IIIa they had 49 patients, who when you looked at the N1 nodes were IIIa patients. When you looked at the N2 nodes 61% of those patients had a worse stage. In IIIb, 24 patients and when you looked at the N2 nodes, 75% of these patients had a worse stage. So it is clear that if you look at the patients who only have an N1 or D1 dissection then those patients are under-staged about 50-70% of the time. So there is a real staging benefit for doing the more extensive dissection. Interestingly enough, if you look at the Dutch study – and what I did was pull out the stage IIIa patients who were randomized to D1 and D2 dissections – and what you see here is that the patients with the D2 dissections did significantly better than the D1 dissections. Probably because what’s happened here is about 60% of these patients actually aren’t stage IIIa but they are IIIb or stage IV because they’ve been under-staged. So even buried within the randomized study you see the benefit, the staging benefit.
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It basically shows that his feeling is that if you are D2, if you are a good surgeon you can do the D2 dissection, you have less relapse with the D2 dissection and surgeons who do it can do it with low morbidity. This is a typically egocentric surgical statement, “The patient can only be harmed when a D2 dissection is performed by an incompetent surgeon.” So what he was essentially saying was “Send your patients to Memorial and avoid the rest of them.”
The treatment of gastric cancer is really surgical resection. This just shows you the stomach. Again, as a general rule, in the GI tract the organs are – except for the liver and the pancreas – are really hollow visci. In mammals hollow visci are hung on a lymphovascular pedicle. So you have this lymphovascular pedicle and surgical management of gastric cancer entails removing the tumor wherever it happens to be, with a wide margin and also taking some of the lymph nodes. Now how many lymph nodes you take and whether or not you increase the cure by taking a more extensive lymph node dissection is one of the areas of real contention in gastric cancer. One of the areas where, within the last year for example, there’s been important literature published to discuss this problem. Basically, with gastric cancer you can refer to the N1 nodes. And if tumor, for example, were here in the distal stomach the N1 nodes would be nodes within 3 cm of the tumor. The N2 nodes are nodes greater than 3 cm and are typically the celiac access nodes or the hepatic portal nodes or the splenic nodes. You will hear about a R1 resection or a D1 or D2 dissection, and what that means; a R1 or D1 dissection takes the N1 nodes. A D2 dissection would take the N2 nodes in continuity with the tumor. So an en bloc resection. This just shows you a U.S. data from about 10 years ago, American College of Surgery data, on gastric cancer survival with surgery. If you had very early disease, and Ia is essentially mucosal gastric cancer – rarely seen in this country – surgery is highly curative. If you have the typical gastric cancers seen in this country, which are node-positive, IIIa, IIIb, the chance of survival with surgery alone is somewhere around 20%. So there is a high risk of recurrence and that of course is the treatment of microscopic residual disease with curative intent, of course it is adjuvant therapy. But surgery for the typical patient who is diagnosed in this country, who has relatively locally advanced gastric cancer, surgery may cure at best 20% of patients.
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This just shows you what I went over before. The literature has changed so this slide is a little bit old. These should really be D0, D1, D2 rather than R1, but what it refers to is the type of nodal dissections. This is the one that is of quite interest. The D2 or R2 dissection because worldwide, particularly in the Far East and particularly in Japan, this has been the standard of care for 30 years. That you do an extensive en bloc nodal dissection, taking the nodes down to the celiac access. You skeletonize the celiac access. There have been data presented over the years, and this is from about ten years ago, from a Japanese surgeon – Dr. Moriama – comparing United States survival and Japanese survival after gastric cancer surgery. As you see here, if you look at particularly stage III node-positive patients, you see significant differences with the Japanese patients appearing to do significantly better. Now when you see that kind of data you can say, “Well, it’s probably because the operation is better and cures more people.” Or you could say that if you don’t do the right kind of operation, what can happen is that you under-stage the patient and therefore the patients that you think are stage II are actually mostly stage III. Therefore you don’t have correct staging and you would expect the patients to do worse, stage for stage. That question is being addressed now in a number of clinical trials. These are data, more recent data, from a U.S. surgeon in Hawaii, Scott Hundal – who is a very meticulous gastric cancer surgeon and does the Japanese D2 dissection – and he just looked at data on survival from Japan, from Germany and the U.S. Again, when you look out here that’s where you see the difference, in the stage IIIa and IIIb, which are the patients who are node-positive. And it appears that the Japanese and the German patients – and in Europe the D2 dissection is more commonly done – appear to do better.
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