Archive for December, 2008.
Posted on December 17th, 2008 by Canadian Health in
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About 5% of all cancer patients will present with neck masses. About 12% of head and neck cancer patients present with neck masses. So it is a fairly common presenting symptom.Unfortunately it just about has your prognosis for almost any site when you see a neck mass, but it is frequently the first symptom that we will see. Especially for head and neck cancers. If at all possible you should avoid an open biopsy of a neck mass. There are a lot of reasons oncologically. It does compromise where we can put our incisions if you have an incision in the neck. It does obstruct the lymphatics and it may indicate a poor prognosis for the patient who has had an open neck biopsy. It usually is not necessary. We almost always can find a primary site or we almost always can do it either with a fine needle aspiration or something like that, prior to an open neck biopsy. So try to do all these other things first, prior to an open neck biopsy.
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Any neck mass in an adult is malignant until proven otherwise. Some of the statistics as we go through them are really kind of shocking, at least they were to me. At what a high percentage of malignancies you will find in your adult patients. At biopsy, the primary site is always best and before we launch on any type of treatment, whether it’s chemotherapy, radiation or surgical approach, we have to have a diagnosis. So that patient is going to have to have a biopsy at some point. Again, the history and physical directs what we do. It really is the way that you go through it. And I won’t insult you by going through how to do a history and physical, but I will just emphasize those points that I think it is so tempting to overlook when you see somebody walk through the door with a 10 cm mass in their neck. You want to get that diagnosis, and we do the same thing too. We find primary sites in the oral cavity all the time in patients who have had open neck biopsies. It’s really best to avoid.
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The jugular nodes along the internal jugular vein, especially the junctional nodes up here are the most important nodes that you are going to find in them, and really from a head/neck oncologists standpoint, those nodes are involved in almost all cancers that we treat up there. Also lots of lymphomas as well. Submandibular nodes and then posterior triangle nodes, supraclavicular nodes and that’s the way I would break them down. Remember, when you get that patient in the chair when you are examining for a neck mass, those nodes lie right underneath the sternocleidomastoid muscle so I always keep my hand on the top of their head and kind of turn their head so that you kind of loosen up that muscle. You can really feel those nodes, in most patients, down to about a centimeter. That’s probably the point at which they become significant. When you start picking up nodes smaller than that we don’t know what to do with them anyway and they are frequently not significant. Don’t forget your bimanual palpation for anyplace that you can do it. When we put the patient to sleep for our direct laryngoscopes, you can get your hand clear down to the vallecula and you can feel, you can bimanually palpate nodes all the way down. It’s really a good technique and an easy way to feel them. Of course, it’s not too easy in the clinic but when you do feel the base of the tongue and those things, make sure it’s the last thing you do for the patient because they won’t let you do much else after you do that. Canadian pharmacy news
The other thing that appears to be important is cisplatin. Not carboplatin, but cisplatin used in about every three weeks, every month. Larry Leishman at Roswell Park uses a regimen that uses continuous infusion 5FU plus monthly platinum at 100 mg per meter square. This regimen, ECF, is from David Cunningham at the Royal Marsden and he included epirubicin. Of course epirubicin is a anthracycline analog that was available in Europe up until three weeks ago when it was approved by the FDA for breast cancer. So actually it will be available here to test. I don’t have a great deal of confidence in anthracyclines in gastric cancer.
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I don’t know whether this adds anything. But in any event, a randomized study was performed by Cunningham, Webb and their associates, published in January of ’97 in the Journal of Clinical Oncology. It was FAM-TX, which is a standard chemotherapy regimen in advanced gastric cancer, versus ECF. Over 100 patients in each arm. And if you look here you can see that the CR and PR rate, including complete responses, were substantially higher in the patients who received the ECF regimen. This was locally advanced cardioesophageal junction adenocarcinoma. When one looks at survival, the survival was also beneficial. There also was a quality of life done with this and the quality of life on the ECF patients was benefit. But again, when you look out here you see that this is a temporary fix. We are not curing patients but it’s useful to see that we are actually doing controlled randomized studies and that we seem to be making some advances. I think that cisplatin plus 5FU regimens of some sort will be around for a long while and will be of interest in this disease.
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There are a variety of other regimens in gastric cancer that are being looked at. The Taxol/platinum regimens are interesting. Taxotere needs to be explored more. CPT-11 clearly has some activity in this disease. At Memorial they are doing a Taxotere/CPT-11. We’ve gotten very interested in this combination of CPT-11 and cisplatin, which is quite tolerable and is an effective regimen in gastric cancer. Of course gemcitabine is also beginning to come on line, and there is some evidence of gemcitabine/platinum synergies.
There are some exciting neoadjuvant protocols that are available. These are data that were presented at ASCO from Tony Greco’s group in Nashville. This is a Taxol, carbo, 5FU radiation in distal esophageal cancer, so it’s cardioesophageal junction cancer. These are patients treated preoperatively. About two-thirds of them were able to be resected and when they looked at the patients who were resected after treatment, in other words they have 56 who were resected and 30 – or 59% of those resected patients – had clinical CR’s. There was no evidence of clinical disease in the tumor. And pathologically there was about a 20-25% evidence of complete pathologic response with a good survival. So these are all … this is all essentially oncologic phenomenology. What you are seeing are phase II studies, and I think the thing that’s interesting here – and I think many of you in the audience have probably had some experience with these kinds of regimens in upper GI cancer – but you can expect most of the patients to have a substantially good response. So that tells us something. That tells us that this is obviously a strategy to build upon.
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What about chemotherapy of advanced disease? This is the FAM regimen. The only reason I show you the FAM regimen is that FAM started something in gastric cancer and that was the feeling among oncologists that combination chemotherapy was better than single agents. I think initially for ten years there was a big debate as to whether that was indeed the truth or whether we were jumping to conclusions with FAM. But now I think we can agree that combination chemotherapy is better but FAM is also useful to look at because it’s an example of what the problem is with chemotherapy of advanced solid tumors. I put this together, it must be 15 years ago now, looking at studies in the literature with FAM, 302 patients. The point here is that sure, there was 35% response rate. The tumor shrank down in one third of the patients, but only 2% of patients actually had a complete response. That’s why some of the neoadjuvant data is so exciting now. If you look at tumors that we do well with – in other words, disseminated cancers that we cure like leukemia, lymphoma, testicular cancer, ovarian cancer to some extent – the only people who ever get cured are people who have complete responses. So this really represents half-way technology. What we need to look at in gastric cancer is our studies that are able to produce high orders of complete response. Now we are not getting there yet but we really have the mechanisms set up to do that, in that you are seeing in the literature in gastric cancer more and more controlled randomized studies, prospective phase III studies.
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This is one regimen. There are lots of chemotherapy regimens to use for gastric cancer. This is one regimen that sort of combines the principles of a lot of them. If you look at the regimens that are of significant benefit in gastric cancer, most of them have continuous infusion 5FU as part of the regimen. Actually Jim Algren here has been one of the national leaders in developing the concept of continuous infusion 5FU. Continuous infusion 5FU is of particular interest now because, as you know, what we are talking about now is a Port-A-Cath or a Hickman and a pump and the patient carrying the pump around. Of course, the oral fluorinated pyrimidines that are coming on line – capecitabine, UFT, 5FU plus 776, S1 – all of those mimic pharmaco-kinetically continuous infusion 5FU. So if continuous infusion 5FU works in gastric cancer, we may be able to switch over to oral therapies soon in this disease. Zithromax online at canadian health mall.
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.
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.
What about adjuvant therapy? If you look at … we can talk about staging. Interestingly enough, in the United States in an adjuvant study that I am going to report to you shortly, about 80% of the patients that were referred for adjuvant therapy were node-positive. So they were IIIa or IIIb patients essentially. We know that 80-85% of those patients relapse after surgery. So what about adjuvant chemotherapy, for example? This is really the largest adjuvant chemotherapy study that’s been reported in the United States, a prospectively randomized study of the Southwest Oncology Group. And it used FAM. Started of course, 7804, started in 1978 where FAM was sort of a standard of care and there were 193 patients. If you look here, we presented this at ASCO about four years ago and there’s absolutely no difference for FAM adjuvant therapy. It did not help. This is a relatively small study and one way of looking at relatively small studies in trying to sort out whether there may be benefit buried within them is to do a metaanalysis. And this is a metaanalysis that was published I think in June of 1993 in JCO looking at the papers, the randomized papers, published in the English language literature. Essentially what this shows is that there was a tendency toward some benefit for adjuvant chemotherapy, but when you look at the combined results it was not statistically significant.
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If adjuvant chemotherapy with the combinations we have now is not adequate adjuvant therapy, what might be reasonable adjuvant strategies? One thing that makes a lot of sense when you are dealing with solid tumors, is to understand the pattern of relapse. Because you might be able to design adjuvant therapy using modalities of therapy that are targeted towards that particular pattern of relapse. This just looks at the sites of failure in patients with gastric cancer. Old data from Len Gunderson, who is now at the Mayo Clinic – and this was actually done when he was at the University of Minnesota – and at the University of Minnesota in the 50’s and 60’s they had a re-operation protocol then. You can imagine what your case manager with managed care would think of this. The patient after nine months was taken back to the OR to have another look, another two weeks in the hospital just to see what was going on. I also think that actually Minnesota citizens must be particularly compliant because they basically all agreed to this. So what they did is they looked for evidence of failure. And what they found was that local failure was an important aspect of failure in about 90% of patients. So where the resection is done, the patient is likely to fail. And that’s not surprising because the tumor goes through the wall of the stomach, frequently involves the serosa. That’s a T3 tumor and nodes are involved. So even though you do an en block resection you are very likely to leave microscopic residual disease. So local failure is important. Distant metastases only occur about 25% of the time.
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So with these data in mind, one would say, “What are the local modalities that we have?” and of course one of the major local modalities of therapy available is radiation. So what about the use of radiation as a postoperative therapy in gastric cancer? Well one thing, as a general rule in gastrointestinal cancer – and this is what I call a poor man’s metaanalysis – and what I did was to look at a variety of sites, of reports published over the last 20 years or so in GI cancers and look at whether or not when you use radiation therapy, either in advanced disease or resected disease and when you add 5FU as a radiation sensitizer whether there is benefit for the combined modality therapy. Basically, there is benefit in all the sites that have been looked at. Of course, adjuvant rectal cancer, we know that the combination of 5FU plus radiation is really the heart of the standard of care for postoperative therapy for resected rectal cancer. But there is benefit in these patients by combining radiation and chemotherapy.