Evaluating the risks and benefits of prednisone

Over the past 20 years or so, the oral corticosteroid prednisone has been used regularly in combination with drugs like mitoxantrone, docetaxel, cabazitaxel, ketoconazole, and abiraterone acetate in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC). Predisone is low-cost, and it is fair to say that, for the majority of patients, it is by no means a risky drug to be taking. What is not well understood, however, is the impact of daily prednisone on the outcomes of men with mCRPC, or on the side effects associated with their treatment.

In another poster presentation at the Geniturinary Cancer Synmposium in San Francisco, Naik et al. offered results from a meta-analysis of data from five randomized clinical trials in which 2,939 men with mCRPC were randomized to treatment regimens which did (n = 1,468) or did not (n = 1,471) include prednisone in one or other of the two trial arms.

The two fundamental findings of this meta-analysis were that:

  • Daily oral use of prednisone in combination therapies for mCRPC had no significant effect on the overall survival of the patients (compared to non-use of prednisone).
  • Daily oral use of prednisone in combination therapies for mCRPC had no significant impact on risk for serious toxicities of Grade 3 or higher.

Having said that, there are still a lot of questions left unanswered by this study, several of which were outlined by two of the study’s senior authors in a commentary on the OncLive web site:

  • Does prednisone have a valuable palliative effect for at least some patients?
  • Could prednisone have a real therapeutic effect in a subset of patients that actually increases overall survival?
  • Could there be some patients, e.g., those with such co-morbidities as diabetes, fluid retention, and/or congestive heart failure, who are actually harmed by this type of corticsteroid therapy and, if so, is it possible to characterize these patients appropriately?
  • Does prednisone treatment increase or decrease risk for lower level (Grade 1/2) toxicities or other side effects of treatment?
  • What is the lowest effective dose of prednisone in specific patients on other specific drugs, and are we managing this appropriately?
    Patients with comorbidities such as diabetes, fluid retention, or congestive heart failure might be among those whose conditions could be worsened by prednisone – See more at: http://www.onclive.com/conference-coverage/gu-2014/With-or-Without-Prednisone-Severe-Toxicities-and-Survival-Are-the-Same-in-Men-Treated-for-mCRPC#sthash.cE3uCZJX.dpuf

Prednisone is an anti-inflammatory agent that also suppresses the activity of patients’ immune systems. It has historically been given to men being treated for mCRPC because it can lower PSA levels; it stimulates appetite; and it has direct and indirect effects on the cancer itself. (It is given in combination with abiraterone acetate and with ketoconazole because it lowers risk for hypertension.) What is becoming a great deal clearer, however, is that the nature of the individual cancer in the individual patient may be a key factor in assessing the real benefit and risk of the use of prednisone in combination with the primary therapeutic agent(s) in that individual patient.

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