Study Finds Weekly Treatment Reduces Pain and Disease in Patients With Advanced Prostate Cancer

05/25/00  New Orleans, La.

Chemotherapy Agent Works to Alleviate Bone Pain and Improve PSA Levels

Weekly treatment with the chemotherapeutic agent Taxotere® (docetaxel) significantly reduces bone pain resulting from progressive prostate cancer while also decreasing prostate-specific antigen, or PSA, levels. These results enhance the quality of life for patients, according to researchers at Oregon Health Sciences University. Prostate cancer is the second-leading cancer-killer among men, after lung cancer. The results were presented May 20, at the 36th Annual Meeting of the American Society of Clinical Oncology in New Orleans.

"When prostate cancer metastasizes, it most often spreads to the bones of these patients. The disabling pain associated with this spread is the predominant symptom that occurs in this disease,&qout; said Tomasz Beer, M.D., an oncologist at the OHSU School of Medicine and lead investigator of the study. "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."

The 25 men who participated in the trial had an advanced form of cancer known as hormone-refractory prostate cancer and also experienced bone pain. These patients all had progressive disease despite standard hormonal therapy including anti-androgen withdrawal. Patients received weekly infusions of approximately 70 mg (based on height and weight) of docetaxel for six weeks, followed by a two-week rest period. The eight-week regimen was continued until there was evidence of disease progression, unacceptable toxicity or the patient requested to be withdrawn from the study.

Forty-four percent of patients achieved a palliative response. In this study, palliative response was defined as either significant relief of pain without an increase in use of pain medication or a significant (50 percent or greater) decrease in the need for pain medication without any increase in pain.

Of the 23 patients evaluated for PSA response, 43 percent responded to the treatment. A PSA response was defined as a PSA decline of 50 percent or more that was sustained on two consecutive evaluations at least four weeks apart. The study also found that a measurable increase in quality of life was observed in the PSA responders, though not in the entire study population.

All patients were evaluated for toxicity. Leukopenia (a decrease in the number of white blood cells) and neutropenia (leukopenia in which the decrease in white blood cells is mainly in the white blood cells that fight infection) occurred in 16 percent of patients. Other side effects were moderate and uncommon. They included, in various patients, anemia, diarrhea, nausea, allergic reaction, skin ulceration, photosensitivity dermatitis (skin inflammation due to extreme sensitivity to the sun), bone pain, shortness of breath, fluid accumulation around the lungs, mouth sores and neuropathy (malfunction of a nerve, often causing numbness or weakness). All side effects resolved when the treatment was stopped.

Prostate cancer is the most common malignancy among men, and the American Cancer Society estimates that more than 31,900 men will die of this disease this year. In the U.S., one out of every ten males will develop the disease during his lifetime. If detected early, however, treatment can be very effective.