NICE comments on proposed “new” use for degarelix


According to a media release issued by the National Institute for Clinical Excellence (NICE) in the UK, it has issued new draft guidance recommending treatment with degarelix (Firmagon) as an option for men with prostate cancer-related spinal metastases who are at risk for spinal cord compression.

This seems like an odd indication for degarelix (or any other form of androgen deprivation therapy [ADT]), since the vast majority of such patients would, presumably, already be on ADT, but it is possible that there are some patients with metastatic disease and minimal cancer-related pain who are not on ADT but are, indeed, at relatively higher levels of risk for spinal cord compression.

Spinal cord compression is a relatively common consequence of late stage prostate cancer as the cancer can eat away at the bones in the spine, causing them to collapse into each other and put pressure on the spinal cord, which can result in intense pain.

6 Responses

  1. Yes, I just saw that! Interesting for sure. Anna

  2. A TARGET GROUP WHERE DEGARELIX (FIRMAGON) WOULD BE USEFUL

    One group would be men with newly diagnosed prostate cancer that was already metastatic. Based on the profoundly misleading recommendation by the blundering US Preventive Services Task Force (which failed to adequately understand the disease, the success of existing treatments, the overall research, and active surveillance beyond lip service, to say nothing of trend analysis), a number of leading experts are predicting an expanding proportion of patients in this group. Anecdotal reports from at least one leading clinician are that this is already happening.

    I’m thinking the key advantage of degarelix is that, because it is an LHRH antagonist rather than an agonist, when initially given it does not accelerate secretion of LHRH initially, a surge (flare) which has a substantial risk of enlarging metastatic growth sites; in sharp contrast, the agonists (Lupron, Zoladex, Viadur, etc.) do initially accelerate LHRH secretion unless countered with an anti-androgen. Such enlargement is dangerous if it occurs in the spine. It can produce permanent crippling.

    A second advantage is that degarelix acts very rapidly, thereby offering rapid relief from pain from existing metastases.

    I have read just a brief sampling of the NICE documents, but I’ll bet they are thinking along these lines. One of the patient statements suggests these points which also occurred to me as a veteran of IADT.

  3. Dear Jim:

    Degarelix is already approved in Europe to treat any man with metastatic disease. NICE dealt with that indication in the UK years ago. That’s why I really am having a hard time understanding the point of this new proposed use.

    I would also point out that the recommendations of the USPSTF have no weight in Europe, just as those of NICE have no weight in America, so I think you are “muddling your politics” somewhat.

  4. Have you commented on the recent article published in the European Journal of Urology (Klotz et al. “Disease control outcomes from analysis of pooled individual patient data from five comparative randomised clinical trials of degarelix vs. LHRH agonists”)? It concludes that there was a 53% overall survival benefit, for degarelix, but the underlying data presented is not very clear. Please help! Thank you.

    Richard

  5. Richard:

    Just for you … click here!

  6. Thank you very much! Your analysis was extremely enlightening. I am now considering which agonists/antagonists I should go with, if that is the route I must go, despite, as you said, the fact that it is not even clear that treatment with any form of standard ADT has an overall survival benefit.

    Best regards,

    Richard

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