Satraplatin as second-line chemotherapy for CRPC

Satraplatin is an oral platinum analog that was tested (in combination with prednisone) in a multinational, double-blind, randomized, placebo-controlled, Phase III clinical trial in patients with metastatic castrate-refractory prostate cancer (CRPC) who had progressed after one prior chemotherapy regimen.

The data from this trial were originally presented some time ago at a variety of urology and oncology conferences, and it is widely understood that satraplatin failed to demonstrate any impact on the overall survival of the patients in this trial. However, a recent paper by Sternberg et al. has now provided a complete report on the results of the trial.

A total of 950 patients were randomly assigned — in a 2:1 ratio — to receive either oral satraplatin (n = 635) 80 mg/m2 on days 1 to 5 of a 35-day cycle + prednisone 5 mg twice daily or placebo (n = 315) and prednisone 5 mg twice daily. The primary end points of the trial were progression-free survival (PFS) and overall survival (OS). The secondary end point was time to pain progression (TPP).

The trial actually showed the following:

  • There was a 33 percent reduction in the risk of progression or death with satraplatin compared placebo.
  • This effect was observed whether or not the patients had received prior docetaxel treatment.
  • There was no observable difference in OS between the patients on the satraplatin and placebo arms of the trial.
  • Compared with placebo, satraplatin significantly reduced TPP.
  • Satraplatin was generally well tolerated, although myelosuppression and gastrointestinal disorders did occur more frequently in patients treated with satraplatin.

It seems very clear that satraplatin does have activity in patients with CRPC who experience progression after initial chemotherapy. However, whether we will ever see a trial of satraplatin used before docetaxel (i.e., as first-line chemotherapy) is now doubtful — particularly given the advent of newer agents such as abiraterone and MDV3100.

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