Now an alternative approach to patients with stage I non-seminoma is surveillance. This is a look at multiple studies in which patients with non-seminomas were observed, subsequently may have relapsed, and ultimately treated with chemotherapy. In this conglomerate of studies, as one would anticipate, about 28% of patients relapsed and ultimately with chemotherapy the majority of those patients are cured. Overall the results of surveillance, if done well, are very similar to a retroperitoneal lymph node dissection. Viagra super active works faster and lasts longer than you’ve ever known. Typically if one watches a patient with stage I seminoma and they relapse, they will do so very quickly; 50% by five months, 80% by two years. You rarely see a relapse beyond two years, although it has been reported. Typically if they are watched closely, as they should be, they will relapse in a good-risk fashion and are highly likely to be cured. In general, they will relapse in the retroperitoneum more frequently than the chest and more frequently in both places. About 20% of patients will relapse with markers only and if they do, it’s appropriate to treat them with chemotherapy at that point.
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Now on the basis of the surveillance studies and the retroperitoneal lymph node dissection studies that have been published over the last 20 years, one can stratify patients into two basic subgroups; good risk patients and poor risk patients. Good risk patients are those patients that in their orchiectomy specimen have no lymphatic or venous invasion and have a relatively low proportion of embryonal carcinoma. Poorest patients are those with lymphatic invasion or a venous invasion and/or a high proportion of embryonal carcinoma. These patients will relapse with surveillance about 60% of the time. Patients without lymphatic or venous invasion and lower proportions of embryonal carcinoma will relapse about 20% of the time on surveillance.
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An alternative therapy for patients with stage I seminoma, which might be appropriate for patients who are in the high risk group is adjuvant chemotherapy. That is, chemotherapy when the markers are normal after orchiectomy. Now for high risk features, if patients have high risk features and a greater than 50% relapse, this is an appropriate alternative therapy. This has been proven now in three studies, one of which is shown here. This is a study from Great Britain in which 123 patients who had high risk features were treated with two cycles of platinum, VP-16 and bleomycin – which we will talk about – and ultimately 98% of the patients were cured in this particular study. Similar results were seen in the other two studies.
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The story is a lot more complicated for stage I non-seminomas where there are several choices involved in the treatment of these patients. And I just want to go through these briefly in some amount of detail. Surveillance, retroperitoneal lymph node dissection and chemotherapy are the three alternatives. The standard in the United States for many years, particularly before effective chemotherapy was developed for non-seminomas, was a so-called on-block peritoneal lymph node dissection. You can see the borders of this particular surgery, which involved a dissection of lymph nodes from above the renal hila to below the aortic bifurcation bilaterally. This was effective at staging patients and was also effective, in some cases, in actually curing patients. But it left all patients with retrograde ejaculation and infertility. So procedures were developed over the last 20 years to modify the procedures, to allow the contralateral nerve supply involved in ejaculation to be maintained. Ether a template procedure like this or a nerve identification procedure such that one can spare the nerves. With those procedures about 90% of patients with stage I testicular cancer will maintain antegrade ejaculation.
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Now how effective is the retroperitoneal lymph node dissection in curing patients with stage I testicular cancer? The largest study ever conducted was a multi-institution study called the Testicular Cancer Intergroup Study, conducted between 1979 and 1984 in which over 500 patients from multiple institutions underwent a retroperitoneal lymph node dissection. In that study 284 patients were found to have pathological stage I disease. That is, they were found to have no involvement of the lymph nodes. In those patients, about 10% of the patients ultimately recurred, generally with supradiaphragmatic recurrences, pulmonary metastases and most of those patients were ultimately cured with chemotherapy. For stage I pathological testicular cancer, the mortality rate is 2%. Similar results are seen for patients who undergo a lymph node dissection, who are found to have involved lymph nodes. Pathological stage II disease. These patients subsequently may need chemotherapy and the cure rates in these patients is similarly 98%. So the results of retroperitoneal lymph node dissection are outstanding, 98% of patients with stage I disease will be cured.
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But if we look at how effective retroperitoneal lymph node dissection is at actually curing disease, one has to look at the studies in a little more detail. Look at the studies in which a retroperitoneal lymph node dissection was performed, disease was found in the lymph nodes, and no subsequent therapy was undertaken. What was the cure rate in those patients? Overall, the retroperitoneal lymph node dissection with no subsequent chemotherapy is curative about 50-60% of the time. The remainder of the time the patients will require chemotherapy. So if you think about the patients coming into the clinic with stage I non-seminomas, this is sort of what it looks like. Order canadian levitra 20 mg visa at cheap online pharmacy. If 100 patients come in with stage I non-seminoma and undergo retroperitoneal lymph node dissection, 70 of those patients will be found to have no evidence of disease. When they are found not to have any evidence of disease they are observed. Most of those patients will remain NED and cured of their disease. Seven or 10% of the patients will relapse, usually in the lung and will be cured with chemotherapy. There will be 30 patients out of 100 in whom disease will be detected in the lymph nodes and half of them will be cured with surgery alone. The remainder of patients will be cured with subsequent or immediate chemotherapy. We think that the patients who are best suited for no further chemotherapy are those patients who have minimal metastatic disease. That is, less than 5 lymph nodes involved with cancer and less than 2 cm of disease in any one lymph node.
The staging process involves some assessment of the abdomen, usually a CT scan. Some assessment of the chest which could be a chest x-ray or a chest CT scan, as well as serum markers. There’s probably no other disease where serum markers are as useful as in testicular cancer. One of the markers is the alpha-fetoprotein is elevated in about 50% of the cases. After an orchiectomy is performed, if the person has no residual disease, the alpha-fetoprotein will return to normal. It’s half life is anywhere between 5-7 days. The HCG is elevated in about 60% of tumors. In contrast to the alpha-fetoprotein the half life of HCG is much shorter, with a half life of about 24 hours. One or both of these markers are elevated in about 80% of tumors.
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This is the staging of testicular cancer. Stage I tumors are those tumors that are confined to within the testes, no evidence of metastatic disease and normal markers after orchiectomy. Stage II tumors are those in which there are involved retroperitoneal lymph nodes and the sub-staging of stage II is dependent upon the size of the lymph nodes involved. Stage III tumors are those that involve any other areas beyond the lymph nodes, particularly above the diaphragm.
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Now let’s talk about treatment of different subtypes of testicular cancer. First of all, stage I seminoma. Orchiectomy is performed. The pathologist says this is a pure seminoma. The alpha-fetoprotein has never been elevated. If the alpha-fetoprotein is elevated in the context of a seminoma it is categorically considered a non-seminoma. So for pure seminoma, stage I – that is, radiographically no evidence of disease – markers, HCG, have returned to normal – which can be elevated in about 10% of patients. The standard of care for these patients is infradiaphragmatic radiation in a hockey-stick distribution, to anywhere between 2500 and 3000 rads. Observation is an alternative to infradiaphragmatic radiation, although considering the high cure rate with radiation and low morbidity associated with radiation, it is considered a second alternative to radiation.
For stage II seminomas, that is, involvement of the lymph nodes, the treatment is dependent on the size of the lymph nodes. If the lymph node mass is solitary and is 5 cm or less the standard of care in the United States is radiation in a hockey-stick distribution with a boost of radiation to the lymph node mass of about 1,000 rads. For masses that are greater than 5 cm, chemotherapy is the standard of care.