The biology of cancers is important
Then the issue of the biology of cancers is important. Is there a difference in the intrinsic biology of the distal intestinal metaplasia-type cancers and the more proximum Barrett’s type of thing? That’s important. There’s a blur between, nowadays, between esophageal and gastric cancer. Order Propecia 5 mg online at licensed canadian pharmacy. The distal adenocarcinomas of the esophagus and the proximal gastric cancers really get into the same protocols, are probably very much the same disease. Then what type of surgery? We talked about this relatively exhaustively. I think what we know now is that across the board it doesn’t appear, there isn’t data, that doing a D2 dissection will result in improved survival. I have effective adjuvant therapy, for example radiation and chemotherapy, does the performance of the D2 dissection obviate the need for postoperative therapy? I think you will see, when you hear about rectal cancer later today, that’s a very interesting question there because of this total mesorectal excision which is a very careful, meticulous excision of the rectum, developing surgical planes. The data reported from that show the relapse rate is much lower if you do that than if you do the typical resection. It may be that patients with TME’s, total mesorectal excisions, you don’t need postoperative radiation therapy. Phase III trials are obviously the way to go.
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I can show you a little bit about neoadjuvant therapy because the next clinical trial in gastric cancer, the intergroup gastric study, will be a neoadjuvant therapy study. This is an older study and I show it to you because it is a good example of what’s been done in neoadjuvant therapy. This was a study done in Germany and what they did was they took patients to laparotomy and they did determine that they were non-resectable. They treated them with a regimen that we don’t do anymore – etoposide, Adriamycin, platinum – because it’s a little bit toxic. If they didn’t respond they were off study. If the patients responded either with a clinical complete response or a clinical partial response, they went to second look operation. Non-resectable, they were off study. If they were resectable they were resected to achieve no evidence of disease and these were pathologic clinical responses or they rendered no evidence of disease, and then they received chemotherapy afterwards. What was seen in 33 patients from Hans Joachim Wilke and colleagues at Essen was that there was a complete clinical response. In other words, no evidence of tumor at the time of surgery in 21% of them, and there was no evidence of tumor pathologically in 5 of the 33 patients. They were able to take essentially two-thirds of the patients who were un-resectable and resect them. There was a high relapse rate of about 60% after some 20 months of follow-up. Most of these relapses were local, which means that perhaps if you had added postoperative radiation therapy or done something particularly innovative – like maybe intraperitoneal therapy or perhaps intraoperative radiation therapy – one could decrease the local relapse rate. But anyway, these are the sorts of data that are seen so it appears that neoadjuvant therapy is effective in causing a tumor to shrink down. The question that hasn’t been addressed in randomized fashion is, is it indeed – when you look at all the patient selection factors – is it indeed per primum surgical therapy? The next study we will do in the intergroup is just that. Is neoadjuvant therapy versus standard resection followed by radiation chemotherapy, if that has shown in the last study to be the effective postoperative adjuvant.
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You are going to see actually, in the esophageal presentation, David Kelson’s study which was published in the New England Journal about December of last year, which was a randomized study of 5FU/platinum in patients with esophageal cancer. Very nice preoperative study that was an appropriate phase III study. Now these are kind of dangerous but interesting data. These are data from the German group that were presented at one of the Tucson adjuvant meetings about four years ago, four or five years ago. What they did is they looked at their patients who were resected for cure after neoadjuvant therapy, looked at their survival, versus patients who never received neoadjuvant therapy but were resected for cure. You can see that these patients appear to do better, and these curves were significant. The conclusion that one could draw is that neoadjuvant therapy is better. However, the danger here in interpreting these data is that of course this is not a randomized study. These are historical controls, and to get to neoadjuvant therapy – to get through the neoadjuvant therapy, to get to the second operation to get resected – requires patients to go through all sorts of hoops, and these patients may just actually be better protoplasm. They may have more indolent tumors. There may be a variety of things that need to be answered in a randomized study. But when you do look at patients who have had neoadjuvant therapy and have been resected, generally across the board, stage for stage, they do better than historical controls.