Treatment of seminomas with chemotherapy
One of the issues that comes up in the treatment of seminomas with chemotherapy is the presence of a residual mass after treatment. In distinction to non-seminomas where teratoma is an issue, teratoma is not an issue with seminoma, and the issue here is whether there is residual seminoma or carcinoma in the residual mass or is it all just fibrosis. The vast majority of the time the mass is residual fibrosis. There have been strategies in the United States, and Europe as well, of resecting the residual mass or giving radiation for the residual mass, but I think that in 2006 the standard of care in general is observation. This is a non-randomized study from England that looked at the utility of giving radiation to these masses after chemotherapy. This is a study of 302 consecutive men with metastatic seminoma, treated with chemotherapy. Over 50% of the patients had residual masses, so this is a common scenario in seminoma. Half the patients received radiation, half the patients were observed. There were no differences in the subgroups of patients who received radiation or did not, although this was not randomized. The only difference was which hospital was doing the treating, since there were some hospitals in this study where the standard of care was no radiation. Others where it was radiation. Overall the cure rate was very high and there was no difference in relapse rates or overall survival, whether or not radiation was given. So once again, the standard for post chemotherapy masses after seminoma treatment is observation.
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Now shifting over to non-seminomas; the sub-grouping is a little more complex. This is now the consensus, the world consensus, in terms of stratification. These are good risk non-seminomas. These patients have to have testicular primaries or retroperitoneal primaries, no non- pulmonary visceral metastases and low markers. These patients are cured over 90% of the time. Intermediate risk patients; no non-pulmonary visceral metastases, retroperitoneal or testicular primaries, intermediate levels of markers. These patients are cured 80% of the time. Finally, poor prognosis patients; these are patients with mediastinal primaries or non-pulmonary visceral metastases, or high markers. Fifty percent of these patients are cured with chemotherapy. Now the standard of care in the United States for many years for advanced disease had been treatment with the so-called Einhorn regimen, three drugs; platinum, Velban and bleomycin until this study was done about 15 years ago, when it was recognized that VP-16 was an effective salvage treatment. It was incorporated into the front line therapy in a regimen called BEP and compared to PVB. The results of BEP were superior to that of PVB as shown in this particular Kaplan-Meyer curve, and also the morbidity associated with BEP was less than PVB. So four cycles of BEP became the standard of care in the United States for all risk groups with testicular cancer.
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The past 10-15 years have been a series of randomized studies, attempting to minimize therapy for good risk patients. I just want to briefly go through these studies but ultimately get back to the main point, which is; in the United States, at the present time, the standard of care for patients with good risk or intermediate risk non-seminomas or seminomas is three cycles of platinum, VP-16 and bleomycin. Memorial Sloan-Kettering still adheres to the standard of treatment being four cycles of platinum, VP-16 and I’ll address that in a second. The first randomized study was done at Memorial for good risk patients comparing a complex five-drug regiment called BAB-6, to four cycles of platinum and VP-16. In good risk patients these appeared to be equivalent. So this regimen has been a standard of care at Memorial since that time. There was a study, an Intergroup study, that compared four cycles of BEP to three cycles of BEP and these two proved to be equivalent for good risk patients. Since that time there have been a number of other studies which have failed to demonstrate any ability to decrease the amount of cycles or to eliminate bleomycin from the regimen, or to substitute carboplatin for platinum. Here’s one study that compared three cycles of BEP, now the standard, to three cycles of EP. There were 23% failures with EP versus 14% with BEP. A statistically significant difference in survival with inferiority in three cycles of EP. So three cycles of EP should certainly not be given. How about four cycles of EP versus BEP? There is going to be a caveat for these two particular European studies because in Europe the dose of VP-16 is lower than the VP-16 dose that’s given in the United States. With that caveat in mind, in this European study 419 men were randomized to either four cycles of BEP or four cycles of EP. There was a difference in complete response rates, statistically significant, but with salvage therapy, no ultimate difference in survival. Another smaller study comparing four cycles of EP to three cycles of BEP, 58 men randomized. There was a difference in relapse free survival, no difference in survival, with median follow-up of three years. So there appeared to be superiority of BEP over EP but once again, the caveat here is that of the lower VP-16 doses in these European regimens.
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