Atlanta-Based on the landmark TAX-327 study, which showed a survival benefit of treatment every 3 weeks with docetaxel (Taxotere)/prednisone over mitoxantrone hydrochloride/prednisone, the every-3-weeks docetaxel regimen has now become a standard of care for men with metastatic hormone-refractory prostate cancer.
But the study left important questions unanswered: Can minimally symptomatic patients benefit from this mainly palliative treatment? Which regimen is more likely to deteriorate quality of life?
A new analysis of the data has provided answers to some of those questions.
"In addition, quality of life deteriorates much more with the weekly docetaxel/prednisone regimen than with the 3-weekly regimen," said Dr. Dawson, who led a session on genitourinary cancer at the American Society of Clinical Oncology annual meeting, where the new findings were presented.
"Especially looking at the data on quality of life deterioration, this 3-weekly dosage should be favored over the weekly docetaxel, except in a few special clinical scenarios," added study presenter Dominik R. Berthold, MD, clinical research fellow in the department of medical oncology, Princess Margaret Hospital, Toronto, working with Ian F. Tannock, MD, PhD.
Pain was measured by using the Present Pain Intensity (PPI) scale, scored from 0 to 5, or an analgesic score, represented by the daily dose of pain medication. Pain response was defined by at least a two-point reduction in PPI with no increase in analgesic score or by a 50% or greater reduction in analgesic score with no concomitant increase in PPI.
Patients with minimal symptoms at baseline were defined as those who had a FACT-P score >128 on a scale from 0 to 156 (higher is better) or by a PPI <2 and an analgesic score <10. Quality of life response required at least a 16-point increase in FACT-P score. Deterioration was defined by at least a 16-point decrease from the baseline score.
Effect of treatment
At the start of the study, quality of life was impaired in 92% of patients who were assessable for pain and 72% of those who were not. Quality of life improved for 22.3% of the 278 patients on the every-3-weeks docetaxel regimen and for 23% of the 270 patients on the weekly regimen, significantly more than the 13.1% of the 267 patients on the mitoxantrone regimen (p=.009). In patients with minimal symptoms, quality of life improved for 18.5% of the 157 patients on the every-3-weeks docetaxel regimen and for 17.3% of the 156 patients on the weekly regimen, but for only 10.2% of the 157 patients on the mitoxantrone regimen.