Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the Royal Marsden Hospital experience

Sir,

The evaluation made by Arkenau et al (2008) on the impact of progression free and overall survival of 29 phase I trials performed on 212 consecutive patients is noteworthy. However, it is necessary to emphasise that 54 (25%) of these patients are affected by prostate cancer and 37 (68%) of them were not pretreated with chemotherapy. The fact that patients with such urological cancers have had a significant better outcome compared with those with non-urological cancers, P=0.001, as reported by the authors, can be justified by the fact that, after phase I trials, these patients not pretreated with chemotherapy were probably treated with Docetaxel regimens, which are known to be efficacious forms of therapy in hormone-resistant prostate cancer. It would be very interesting to compare the outcome of these two groups of patients with prostate cancer, that is, those not pretreated vs those pretreated with chemotherapy. In case of no differences in the outcome, it could be stated that patients whose prognosis is poor, despite chemotherapy, could be safely given phase I chemotherapy trials upfront without having been pretreated with any chemotherapy regimen, with obvious advantages for the assessment of new therapeutic drugs.