The way to address any treatment
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.”