Bo Zhao1, Nitin K Yerram2, Tianming Gao2, Robert Dreicer3, Eric A Klein3. 1. Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH. Electronic address: zhaob@ccf.org. 2. Glickman Urological Institute, Cleveland Clinic, Cleveland, OH. 3. Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH; Glickman Urological Institute, Cleveland Clinic, Cleveland, OH.
Abstract
BACKGROUND: Patients with locally advanced prostate cancer (PCa) have worse outcomes after radical prostatectomy (RP) than patients with more favorable parameters. We conducted a phase II study of neoadjuvant chemotherapy with docetaxel before RP during 2000 to 2003 in patients with locally advanced disease. We report an updated long-term survival analysis of these patients. MATERIAL AND METHODS: Overall, 28 patients with locally advanced PCa (defined as serum preoperative [initial] prostate-specific antigen level ≥ 15 ng/ml, clinical ≥ T2b disease, or biopsy Gleason score ≥ 8) and no evidence of metastatic disease received 6 weekly doses of intravenous docetaxel (40 mg/m(2)) followed by RP. Disease status was assessed by shared medical records or followed by phone and fax. Biochemical recurrence (BCR) was defined as 2 consecutive prostate-specific antigen level readings ≥ 0.2 ng/ml. A Social Security Death Index search was conducted on all patients to ascertain date of death if unavailable in records. RESULTS: In total, 28 patients completed chemotherapy and underwent RP. At a median follow-up of 130 months (range: 37-166 mo), 10 patients (36%) remained alive and disease free clinically and biochemically with no additional therapy, whereas 18 patients (64%) had BCR. The estimated 10-year BCR-free survival is 33.5%, metastasis-free survival is 68.7%, PCa-specific survival is 92.2%, and overall survival is 79.7%. CONCLUSIONS: The use of neoadjuvant docetaxel chemotherapy in patients with locally advanced PCa undergoing RP remains undefined. Results from this study are informative but only hypothesis generating given the study was not powered for survival. Mature data from the ongoing CALGB 90203 and GETUG-12 studies will shed light on this clinical question.
BACKGROUND:Patients with locally advanced prostate cancer (PCa) have worse outcomes after radical prostatectomy (RP) than patients with more favorable parameters. We conducted a phase II study of neoadjuvant chemotherapy with docetaxel before RP during 2000 to 2003 in patients with locally advanced disease. We report an updated long-term survival analysis of these patients. MATERIAL AND METHODS: Overall, 28 patients with locally advanced PCa (defined as serum preoperative [initial] prostate-specific antigen level ≥ 15 ng/ml, clinical ≥ T2b disease, or biopsy Gleason score ≥ 8) and no evidence of metastatic disease received 6 weekly doses of intravenous docetaxel (40 mg/m(2)) followed by RP. Disease status was assessed by shared medical records or followed by phone and fax. Biochemical recurrence (BCR) was defined as 2 consecutive prostate-specific antigen level readings ≥ 0.2 ng/ml. A Social Security Death Index search was conducted on all patients to ascertain date of death if unavailable in records. RESULTS: In total, 28 patients completed chemotherapy and underwent RP. At a median follow-up of 130 months (range: 37-166 mo), 10 patients (36%) remained alive and disease free clinically and biochemically with no additional therapy, whereas 18 patients (64%) had BCR. The estimated 10-year BCR-free survival is 33.5%, metastasis-free survival is 68.7%, PCa-specific survival is 92.2%, and overall survival is 79.7%. CONCLUSIONS: The use of neoadjuvant docetaxel chemotherapy in patients with locally advanced PCa undergoing RP remains undefined. Results from this study are informative but only hypothesis generating given the study was not powered for survival. Mature data from the ongoing CALGB 90203 and GETUG-12 studies will shed light on this clinical question.
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