Adjuvant degarelix in combination with radiation therapy (instead of an LHRH agonist + an antiandrogen)

According to an announcement from the European Association for Urology (EAU) earlier today, data from a recently completed trial demonstrate that degarelix is “non-inferior” to the LHRH agonist goserelin acetate + the antiandrogen bicalutamide at reducing prostate volume in men with advanced hormone- dependent prostate cancer.

The results of this trial, announced by the EAU in advance of presentation of the actual data, are scheduled for presentation by Prof. Malcolm Mason of Cardiff University at a late-breaking news lecture scheduled for tomorrow (Tuesday).

According to Dr. Mason, as quoted in the European Urology Times, “This was a non-inferiority study with the primary measure being the reduction of prostate volume at 3 months — which is a very important measure of efficacy from the point of view of planning radiotherapy, but of course this has to be seen against the context that radiotherapy in this setting is much more important than a way of reducing the prostate volume.”

Now “non-inferior” does not necessarily mean “just as good as.” It means that, within the limits of the trial, there was no statistically significant difference (even if there was a numerical difference) between the outcomes observed using degarelix as opposed to the LHRH agonist + bicalutamide. We also don’t know (yet) whether the combination of degarelix + radiation therapy is as effective and as safe as the combination of an LHRH agonist + bicalutamide + radiation therapy in the treatment of men who need this type of combination therapy. (It took about 5 years to initially demonstrate that the combination of radiation therapy + an LHRH agoniost + an antiandrogen was really significantly better than radiation therapy alone!)

It is hardly surprising that the LHRH antagonist degarelix would have similar activity to a combination of an LHRH agonist and antiandrogen in this type of clinical use. The important question is actually going to be whether there are other real and measurable benefits associated with LHRH antagonist therapy that would make the LHRH antagonist the treatment of choice for use in combination with radiation therapy for men needing adjuvant, salvage, or first line treatment of this type.

There appear to be some suggestions that this might be the case. Dr. Mason has suggested that — in this trial — degarelix offered better control of lower urinary tract symptoms (LUTS) such as frequency, urgency, and hesitancy in urination than the combination of an LHRH agonist and an antiandrogen. Whether these benefits are of sufficient signifciance to actually change the form of adjuvant or neoadjuvant androgen deprivation therapy being given to men scheduled for radiation therapy is going to be hard to assess.

The available information — as of today — does not (yet) provide us with any detailed data on which we are able to comment regarding the significance of these preliminary claims.

2 Responses

  1. As noted by Sitemaster, pretty lame “trial.” Expense of “trial” could have been put to better use.

  2. Chuck:

    This trial was undoubtedly designed and paid for by the manufacturers of degarelix. To be fair to them, if they want to be able to get their product used for this aspect of prostate cancer therapy, they do need to generate and make available data that would support such a use. It may not further the overall advances in the treatment of prostate cancer, but for the manufacturer it would be essential to expand the data about the effectiveness and safety of the product.

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