NEW ORLEANS—In a phase II study, weekly docetaxel(Drug information on docetaxel) (Taxotere) significantly reduced bone pain and PSA levels in men with hormone-refractory prostate cancer, and these results led to enhanced quality of life. Lead investigator Tomasz Beer, MD, of Oregon Health Sciences University, reported the results at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO).
The 25 patients in the study received weekly infusions of docetaxel, 36 mg/m², for 6 weeks of an 8-week cycle. Oral dexamethasone(Drug information on dexamethasone) 8 mg was given 12 hours and 1 hour before and 12 hours after the docetaxel infusion.
Treatment was continued until there was evidence of disease progression or unacceptable toxicity, or the patient requested to be withdrawn from the study.
Of the 25 patients evaluable for pain, 44% achieved a palliative response, Dr. Beer said. Palliative response was defined as either significant pain relief without an increase in the use of pain medication or a significant (50% or more) decrease in the need for pain medication without any increase in pain.
Of the 23 patients evaluable for PSA response, 43% responded to the treatment. A PSA response was defined as a PSA decline of 50% or more that was sustained on two consecutive evaluations at least 4 weeks apart. The results also showed a measurable increase in quality of life in the PSA responders.
All 25 patients were evaluated for toxicity. Leukopenia and neutropenia occurred in 16% of patients, Dr. Beer said. Other side effects were moderate and uncommon, including anemia, diarrhea, nausea, allergic reaction, skin ulceration, photosensitivity dermatitis, bone pain, dyspnea, fluid accumulation around the lungs, mouth sores, and neuropathy.
“Our results suggest that weekly docetaxel not only represents an effective and well-tolerated agent for relieving bone pain in these patients but also reduces disease activity by means of a decrease in PSA levels,” Dr. Beer said.
