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Adjuvant Weekly Docetaxel Shows Promise in High-Risk Prostate Cancer Patients After Radical Prostatectomy

By Jill Stein

SAN ANTONIO, TX -- May 27, 2005 -- Postoperative adjuvant weekly docetaxel appears to be a feasible treatment that is associated with mild reversible toxicity among patients with localized prostate cancer at high risk for recurrence after radical prostatectomy.

The results were reported by Adam Kibel, MD, assistant professor of urology, Washington University Medical Center, St. Louis, Missouri, on May 23^rd at the American Urological Association (AUA) Annual Meeting.

"Although radical prostatectomy has proven to be an effective treatment for localized prostate cancer, about a third of patients may develop a recurrence within 10 years of follow-up," Dr. Kibel said. "The risk increases to about three quarters in patients with significant adverse pathologic features. For this reason, active systemic compounds should be evaluated in the adjuvant setting in an attempt to reduce these recurrence rates."

Studies in patients with metastatic hormone refractory prostate cancer have demonstrated that single-agent docetaxel or its combination with estramustine is effective for the treatment of prostate cancer, he continued.

In an attempt to improve outcomes with adjuvant chemotherapy postradical prostatectomy in patients at high risk of recurrence, Dr. Kibel and colleagues conducted a pilot study in 75 high-risk patients. Weekly docetaxel was selected for the adjuvant study based on the efficacy and favorable adverse effects profile as known at the time the study was designed.

All subjects had confirmed prostate cancer, status postradical prostatectomy within 3 months without distant metastases, organ dysfunction, prior radiotherapy, or systemic treatment.

The primary objective of the study was to assess the preliminary effects of 6 cycles of adjuvant docetaxel (35mg/m² on days 1, 8, and 15 of a 28-day cycle) on progression-free survival at 2 and 3 years.

After a median follow-up of 21.6 months in 77 patients who enrolled between June 2002 and December 2003, results show the regimen to be feasible and to have moderate reversible toxicity according to National Cancer Institute Common Toxicity Criteria, Dr. Kibel said. All patients have completed treatment.

There was 1 grade-5 toxicity involving an intra-abdominal catastrophe that was considered possibly related to docetaxel.

Treatment was stopped early in 3 patients due to toxicity (recurrent hypersensitivity, atrial fibrillation, and grade-2 peripheral neuropathy), and in 2 additional patients due to progressive disease (distant metastases).

Delays were required in 2 patients due to toxicity (grade 3 paroxysmal tachycardia/dyspnea/lightheadedness and grade 1 stomatitis) and in 4 patients due to errors with pretreatment dexamethasone dosing.

Two patients needed dose reductions due to toxicity (grade 2 peripheral neuropathy and elevated SGTP).

Dr. Kibel said that plans are underway for a multicenter phase 3 study evaluating the role of adjuvant hormonal therapy with and without docetaxel given immediately at the time of recurrence.

The study was funded by Aventis, maker of Taxotere (docetaxel).


[Presentation title: Adjuvant Weekly Docetaxel for High-Risk Prostate Cancer Patients After Radical Prostatectomy. Abstract 821]

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