BACKGROUND: This was a phase I study to find the maximum tolerable dose (MTD) of weekly docetaxel combined with high-dose intensity-modulated radiotherapy (IMRT) and androgen deprivation therapy (ADT).
PATIENTS AND METHODS: Men with localized high-risk prostate cancer (HRPC) were treated with weekly docetaxel at 10 to 30 mg/m2 concurrent with IMRT of 77.4 Gy to the prostate and 45 Gy to the seminal vesicles. ADT consisted of a gonadotropin-releasing hormone agonist (GnRHa) and bicalutamide beginning 2 months before and during chemoradiation. GnRHa was continued for 24 months.
RESULTS: Nineteen patients were enrolled. No dose-limiting toxicity (DLT) was seen with docetaxel doses up to 25 mg/m2. At the 30 mg/m2 level, 2 of 4 patients experienced DLTs of both grade 3 fatigue and dyspepsia. At 41 months' median follow-up, 2 patients had died-1 from metastatic prostate cancer and the other from heart failure. Two other patients experienced biochemical failure. One patient with bladder invasion at diagnosis experienced late grade 2 urinary hesitancy 9 months after completion of radiotherapy, requiring short-term intermittent catheterization. All patients had erectile dysfunction, but no late toxicities worse than grade 2 were identified.
CONCLUSION: Weekly docetaxel may be combined with high-dose IMRT and long-term ADT up to a MTD of 25 mg/m2. Acute toxicities and long-term side effects of this regimen were acceptable. Future studies evaluating the efficacy of docetaxel, ADT, and IMRT for localized HRPC should use a weekly dose of 25 mg/m2 when limiting the irradiated volume to the prostate and seminal vesicles.
Written by:
Marshall DT1, Ramey S2, Golshayan AR2, E Keane T2, Kraft AS2, Chaudhary U3 Are you the author?
1Medical University of South Carolina, Charleston, SC. Electronic address: . 2Medical University of South Carolina, Charleston, SC. 3University of California, San Francisco, Fresno, CA.
Reference: Clin Genitourin Cancer. 2013 Nov 13. pii: S1558-7673(13)00290-5 (Epub ahead of print)
doi: 10.1016/j.clgc.2013.11.019
PubMed Abstract
PMID: 24378335
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