Ibandronate as a treatment for bone pain in men with metastatic prostate cancer

A new report in the Journal of the National Cancer Institute suggests that a single intravenous injection of the drug ibandronate has a very similar ability to relieve prostate cancer-related bone pain as a single treatment with external beam radiation therapy.

These new data, just published by Hoskin et al., are based on a randomized, multi-center, Phase III clinical trial carried out in the UK. They are also discussed in a report on the Medscape Onoclogy web site.

Hoskin et al. enrolled 470 men with metastatic prostate cancer and associated bone pain. All patients were potentially eligible for treatment with local radiation therapy (using a single 8-Gy dose of radiation) to alleviate this pain. However, the patients were actually randomized to either that single dose of radiation or to a single IV infusion of ibandronate (6 mg).

The trial was designed as a “non-inferiority” trial, with patients’ pain levels being measured through the use of the Brief Pain Inventory at baseline and then at 4, 8, 12, 26, and 52 weeks post-treatment. Pain response was also measured, through use of the  World Health Organization (WHO) criteria and the Effective Analgesic Score (EAS); the maximum allowable difference was ± 15 percent.

If patients failed to respond to their assigned treatment at 4 weeks of follow-up, they were then were offered re-treatment with the alternative treatment. The patients’ quality of life (QoL) was assessed at baseline and at 4 and 12 weeks post-treatment.

Here is a summary of the study results:

  • The 470 patients were enrolled at 58 medical centers within the UK between 2003 and 2009.
  • Patients were mostly > 65 years and had a life expectancy of > 3 months.
  • Pain response, overall, was not statistically different at 4 or 12 weeks, based on the WHO criteria and on the EAS.
  • Compared to responses to the single dose of radiation therapy, responses to ibandronate were
    • − 3.7 percent at 4 weeks using the WHO criteria
    • + 6.7 percent at 12 weeks using the WHO criteria
    • − 7.5 percent at 4 weeks using the EAS
    • − 3.5 percent at 12 weeks using the EAS.
  • Similar results were seen at 26 and 52 weeks.
  • There was a more rapid response to a single dose of radiation therapy than to a single dose of ibandronate.
  • There was no overall difference in toxicity between the two treatments (but each treatment did have different side effects).
  • At 4 and 12 weeks post-treatment, there was no difference in the patients’ quality of life.
  • Overall survival was similar between the two groups but was better among patients having re-treatment than those who did not.

Hoskin et al. conclude that:

A single infusion of ibandronate had outcomes similar to a single dose of radiotherapy for metastatic prostate bone pain. Ibandronate could be considered when radiotherapy is not available.

While a single dose of external beam radiation therapy will likely remain the “gold standard” for initial treatment of metastatic bone pain, it is clearly helpful to know that a drug such as ibandronate can be used to induce a very analogous response to treatment.

One Response

  1. For men who have pain, as did someone I met with this afternoon and showed this to, the question that comes to mind is whether a combination of ibandronate + radiation is better than either one alone?

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