The other drug that has been tried in renal cell carcinoma
The other drug that has been tried in renal cell carcinoma is alpha interferon and a large number of investigators have looked at a large number of interferon preparations. Generally, in the regimens that you can give as an outpatient and are tolerated by the patients, I think a response rate of about 10-15% is a reasonable number to carry around in your head. Most of these response durations are fairly short-lived although there are a very rare occasional patient who will have a prolonged good response to interferon. But generally, as you know, interferon is a fairly toxic treatment and really does not result in an improved quality of life for the patients, suffering from the side effects of the interferon. So it’s difficult to get very excited about interferon as a single agent, especially for any kind of prolonged treatment course. Patients who tend to respond to interferon are the ones who have a good performance status prior to nephrectomy, non-bulky pulmonary and soft tissue metastases and patients who are asymptomatic or who have minimal symptomatology. So it is exactly the group that you would be most hesitant to make sick from the interferon, that would be likely to respond. So you need to come to grips with this problem philosophically on your own.
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The other thing I need to touch upon is the frequency of spontaneous remissions. There’s been a lot of talk about this in the literature and when Bloom reviewed 1,100 patients back in 1973 – his own group of 195 patients and then six other studies – and reported on the times that spontaneous regressions were reported in these studies. He found two in his own series where he was specifically looking for it and then one in the other series where they were not specifically looking for it and concluded that the incidence of spontaneous remissions was 0.3%. I think probably a better figure, although this is really virtue among thieves, is two out of 195 where he was specifically looking for it. So the incidence is probably around 1%. But I think that carrying a figure of 0.3% to 1% incidence of spontaneous remissions is probably an accurate number. So clearly you would not be doing nephrectomies trying to get that kind of a response rate. Interestingly, when the natural history of the spontaneous remissions is reviewed, 19 out of 51 of these cases that were reviewed were histologically confirmed. Most of them were in the lung. Thirty-seven of the responses came after nephrectomy and four came after radiation to the kidney. So about 80% of these spontaneous remissions occurred after some treatment to the kidney. And of these 51 patients, 29 had a duration of response and follow-up greater than two years. So when these occur they can sometimes be very significant. But you certainly don’t want to plan your treatment regimen around the development of this. It is worthwhile though, in patients who present with a renal cell carcinoma that’s metastatic, it’s sometimes very useful to just observe those patients especially if they are elderly and couldn’t tolerate treatment, and get some sense of the pace of their disease. It can be very variable. I’ve had patients whose tumors have grown over a three-month period, we were concerned that we were going to have to start chemo or some kind of treatment for their metastatic disease, decided to follow them – mostly because of usually personal reasons, they wanted to wait for a little bit, they were asymptomatic – so three months later there was no change in the lesions that had previously been progressing. So if I’ve put somebody, put those people on treatment, at that point I would have said, “Wow, we’ve interrupted the growth of your tumor.” So you really do need to get a sense of the pace of the disease that you are dealing with.
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Now it was in this context that interleukin-2 came on the scene and as you know, interleukin-2 is a T-cell growth factor. The clinical material is a 15.5 kilodalton peptide and obviously in vivo it’s produced by the helper T-cells. In May of 1992 the FDA approved interleukin-2 for the treatment of metastatic renal cell carcinoma. This is the only FDA-approved treatment for metastatic renal cell carcinoma, or for renal cell carcinoma in general. The regimen was a very high dose regimen that was developed at the National Cancer Institute in the surgery branch by Steve Rosenberg and that regimen was developed in the context of giving adoptive immunotherapy. The clinical trials that supported approval were using that same IL-2 regimen but without the adoptive immunotherapy. So evaluated in 255 patients both at the surgery branch and in some extramural studies, and there was an overall response rate of 15%. Not strikingly different from that of the interferon. So why has interleukin-2 been approved and interferon has not been approved for renal cell carcinoma? It’s because the median duration of these responses was about two years and some of these patients had apparently extremely durable complete responses and probably are cured from their renal cell carcinoma. These are just the response data.