So what we did about eight years ago
So what we did about eight years ago was design this study, which is SWOG-9008 or intergroup 0116, which is a randomized study of resected gastric cancer patients to surgery alone or 5FU plus leucovorin and radiation therapy after surgery. We accrued 610 patients in this study. It was closed to accrual in July of ’98. It is actually just about to undergo analysis. In fact, next week we are having the SWOG meeting in San Diego and we will be looking at some data on this. We don’t have full data on it. It is interesting that if you look at the kinds of patients that you get in the United States, 84% of these patients were node positive in both arms, so it’s relatively advanced patients who get referred for adjuvant therapy. We also have some interesting data on the issue of what kind of surgery was done. One of my colleagues, Norm Estes who is a surgical oncologist at the University of Kansas, looked at the first 400 patients who had been operated and it was recommended to U.S. surgeons that they do a D2 or Japanese style dissection. As you see, the recommendation was taken quite seriously and 6.2% of cases were done. I don’t mean this in a… the facts are that we all train in institutions and we all presumably listen to our chairpersons and our chiefs of service and in the United States it has sort of been surgical dogma for the last 50 years that doing the extensive dissection is not valuable, so people are not trained in their residencies to do D2 dissections. They are told by their chairmen and chairpersons that it is not a good thing to do, so they don’t know how to do it and they don’t want to learn how to do it. So they didn’t do it and interestingly enough you have here about 50% of patients didn’t even have a complete N1 node dissection. Now one of the things that’s kind of interesting to me is that I think that this kind of surgery is going to bias for positivity in this study. I think what you are going to find is – because if there is one thing that we know about radiation and 5FU is it’s very effective therapy in sterilizing microscopic residual cancer – if you do these kinds of operations there is a very high likelihood that you are leaving microscopic residual cancer. So I wouldn’t be a bit surprised if this study isn’t positive. It may be that if people do only D2 dissections, you don’t need adjuvant therapy. But it may be that in the United States we do.
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The other thing that was interesting that Norm looked at just as sort of more evidence towards the value of the extensive dissections; he looked at the number of nodes dissected and the positivity of the nodes. In other words, when you do up to 10 nodes, 45% of them are positive. If you do over 40 nodes, only 13%. So what this tells you is that you have a high likelihood if you dissect a breast, a modified mastectomy and you a have five out of five nodes positive, you always worry that the sixth node was also positive but it’s still in there. It’s the same situation here. The more nodes you take the lower the positivity, and that’s probably because you are “clearing the nodes” and getting out. So in any event, you are going to be able to see in the next year some interesting data on adjuvant therapy in gastric cancer.
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What about the clinical management of patients and what are we going to do next? This is an endoscopic picture of a large fungating gastric cancer. And this is quite common, as I said. They symptoms are relatively non-specific. Patients present with locally advanced disease. Many times – I don’t know what it’s like in your institutions – but many times the surgeons come to you and sort of say, “Can’t you do something to make this tumor shrink down? I don’t want to operate on this big tumor and I want to see whether we can get it to shrink down.” Of course, that opens the way to neoadjuvant therapy. There are some important issues in neoadjuvant therapy. Of course neoadjuvant therapy is the jargon term used for using radiation or radiation plus chemotherapy, or chemotherapy before a definitive surgical resection. One of the issues is, is the patient resectable? Surgical judgment becomes an important issue. If one of the endpoints of the neoadjuvant study is to make a patient, who is not resectable, resectable then you have to have some judgment that the patient was indeed un-resectable. The best way to do this of course would be to do an exploratory laparotomy and define by criteria that it is un-resectable. Because as you know, un-resectability is really a judgment call nowadays. I mean, at my current institution we have surgeons who we refer to as “fainting at the sight of blood” who would not touch something if it was going to bleed a little bit, and we have other surgeons who, if you told them to do a hemi-corpectomy, they would do it and say, “Which part do you want sent to the ICU?” So it really is judgment.