Division of Urology, Oregon Health and Science University, Portland Veterans Administration Medical Center, Portland, Oregon, USA.
Cancer. 2010 Apr 1;116(7):1699-708. doi: 10.1002/cncr.24960.
: A study was conducted to determine the 5-year recurrence-free survival in patients with high-risk prostate cancer after neoadjuvant combination chemotherapy followed by surgery. Secondary endpoints included safety, pathologic effects of chemotherapy, and predictors of disease recurrence.
: Fifty-seven patients were enrolled in a phase 1/2 study of weekly docetaxel 35 mg/m(2) and escalating mitoxantrone to 4 mg/m(2) before prostatectomy. Patients were treated with 16 weeks of chemotherapy administered weekly on a 3 of every 4 week schedule. A tissue microarray, constructed from the prostatectomy specimens, served to facilitate the exploratory evaluation of biomarkers. The primary endpoint was recurrence-free survival. Disease recurrence was defined as a confirmed serum prostate-specific antigen (PSA) >0.4 ng/mL.
: Of the 57 patients, 54 received 4 cycles of docetaxel and mitoxantrone before radical prostatectomy. Grade 4 toxicities were limited to leukopenia, neutropenia, and hyperglycemia. Serum testosterone levels remained stable after chemotherapy. Negative surgical margins were attained in 67% of cases. Lymph node involvement was detected in 18.5% of cases. With a median follow-up of 63 months, 27 of 57 (47.4%) patients recurred. The Kaplan-Meier recurrence-free survival at 2 years was 65.5% (95% confidence interval [CI], 53.0%-78.0%) and was 49.8% at 5 years (95% CI, 35.5%-64.1%). Pretreatment serum PSA, lymph node involvement, and postchemotherapy tissue vascular endothelial growth factor expression were independent predictors of early recurrence.
: Preoperative chemotherapy with docetaxel and mitoxantrone is feasible. Approximately half of the high-risk patients remain free of disease recurrence at 5 years, and clinical and molecular predictors of early recurrence were identified. Cancer 2010. (c) 2010 American Cancer Society.
一项研究旨在确定新辅助联合化疗后行手术治疗的高危前列腺癌患者的 5 年无复发生存率。次要终点包括安全性、化疗的病理效应以及疾病复发的预测因素。
57 例患者参与了每周 docetaxel 35mg/m2 联合递增剂量 mitoxantrone（4mg/m2）的 1/2 期研究，在前列腺切除术前行新辅助化疗。患者接受 16 周化疗，每周 1 次，每 4 周为 1 个周期。从前列腺切除术标本构建组织微阵列，用于促进生物标志物的探索性评估。主要终点是无复发生存率。疾病复发定义为确认的血清前列腺特异性抗原（PSA）>0.4ng/mL。
57 例患者中，54 例在根治性前列腺切除术前行 4 个周期的 docetaxel 和 mitoxantrone 治疗。4 级毒性仅限于白细胞减少、中性粒细胞减少和高血糖。化疗后血清睾酮水平保持稳定。67%的病例获得了阴性手术切缘。18.5%的病例检测到淋巴结受累。中位随访 63 个月时，57 例患者中有 27 例（47.4%）复发。2 年Kaplan-Meier 无复发生存率为 65.5%（95%置信区间[CI]，53.0%-78.0%），5 年为 49.8%（95% CI，35.5%-64.1%）。治疗前血清 PSA、淋巴结受累和化疗后组织血管内皮生长因子表达是早期复发的独立预测因素。
术前用 docetaxel 和 mitoxantrone 化疗是可行的。大约一半的高危患者在 5 年内无疾病复发，并且确定了早期复发的临床和分子预测因素。癌症 2010. （c）2010 美国癌症协会。
