Since two drugs weren’t better than one
Since two drugs weren’t better than one, then why not try three drugs and see if that’s not better than one? Zapodian and Sella have both reported on a regimen using interleukin-2, interferon and 5-FU. This is a much more intense regimen, has to be given as an inpatient. Less intense regimens are typically given as an outpatient. They both initially reported 47% response rates. We haven’t heard much from the M.D. Anderson regimen since that, but Zapodian has consistently reported response rates in the 40% range. For lack of a better idea, this is what I treat my patients with, with metastatic disease. I use the Zapodian regimen as my initial regimen. If they fail that, then they are candidates for phase I studies. Certainly if you had a phase II trial that was ongoing or access to a phase II trial, that would be extremely appropriate treatment for patients with renal cell carcinoma as an initial treatment, reserving the interleukin-2, interferon approach for later.
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This is a report by a group looking at predictive factors for response to biological response modifiers and this group III here are patients with sarcomatoid histology regardless of their performance status, presence of bone metastases or whatever. In that group they had very poor response to biological based therapies. This is a summary, again from the M.D. Anderson paper, and those two patients who I mentioned earlier were then treated with a doxorubicin-containing chemotherapy and both of them actually received CY-VA-DACT which was the sarcoma regimen du jour back in the 70’s and 80’s when this data was collected. Of these eight patients, two went into complete remissions with chemotherapy and were still alive at the time that this paper was published, and they were in durable complete remission. So while sarcomatoid histology is a rare histology, it’s an important histology to be aware of because I believe some patients will have very dramatic and potentially be cured from their metastatic renal cell carcinoma with this diagnosis. This is an example of one of the patients that we treated when I was at Lombardi. This is a fellow with a sarcomatoid histology, had failed interleukin-2 and interferon and had a large mediastinal mass with pleural effusion and parenchymal lung nodule. And after the MAID chemotherapy, the mediastinal mass is gone as is the parenchymal lung disease. This patient is now – I think it’s about three years out – off treatment and continues in a complete remission.
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I just want to say one word about some patients who have very poorly differentiated tumors at the time of diagnosis and have a clinically demonstrable, very rapidly progressing disease. Those patients I tend not to try to treat with immunotherapy. I think their course is just too aggressive. I’ve had some luck treating them as if they were poorly differentiated carcinomas of unknown primary. I don’t think there is anything in the literature about this yet, but just as a practical matter for you as you are out in practice, it’s something to consider.