Publication of final data from the TRAPEZE trial

Some 2½ years ago, James presented data from the TRAPEZE trial at the annual meeting of the American Society of Clinical Oncology in Chicago. At the time, we described these data as “unsurprising.”

The final report on the data from this trial have now been published by James et al. in JAMA Oncology — and they remain “unsurprising.” The addition of either zoledronic acid (Zometa) or strontium-89 (Metastron) to treatment with docetaxel-based chemotherapy had no really meaningful survival benefit in men with metastatic, castration-resistant prostate cancer (mCRPC). There was, however, benefit from the zoledronic acid in terms of a reduction in risk for fractures and skeletal-related events (SREs).

To a large extent the data from this trial have, in any case, been made irrelevant by changes in the patterns of treatment for men with mCRPC. The discovery that early use of docetaxel-based chemotherapy in conjunction with androgen deprivation therapy in androgen-sensitive men with metastatic disease has indicated that chemotherapy probably needs to be initiated prior to the onset of castration resistance in most patients. In addition, the use of strontium-89 as an agent for the treatment of bone pain has largely been superseded by the availability of the more effective radium-223 (Xofigo), which palliates bone pain and also provides a small overall survival benefit.

On the other hand, it is worth bearing in mind that the development of the TRAPEZE trial in the UK was a step towards the development of the far larger STAMPEDE trial that has provided categorical evidence for the early use of docetaxel-based chemotherapy in combination with ADT in men with metastatic prostate cancer or with a high probability of micrometastatic disease.

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