Schmidt J D, Gibbons R P, Murphy G P, Bartolucci A
Division of Urology, University of California, San Diego School of Medicine, La Jolla 92103-8897, USA.
Prostate. 1996 Jan;28(1):51-7. doi: 10.1002/(SICI)1097-0045(199601)28:1<51::AID-PROS7>3.0.CO;2-R.
In 1978 the National Prostate Cancer Project launched two protocols evaluating adjuvant therapy following surgery (Protocol 900) or irradiation (Protocol 1,000) for clinically localized prostate cancer. All patients underwent staging pelvic lymphadenectomy. Following definitive treatment, patients were randomized to either cyclophosphamide 1 gram/m2-IV every 3 weeks for 2 years, estramustine phosphate 600 mg/m2-po daily for up to 2 years, or to observation only. Patient accession closed in 1985 and includes 184 to Protocol 900 (170 evaluable) and 253 to Protocol 1,000 (233 evaluable). Lymph node involvement was identified in 198 patients (49% of total), 29% in Protocol 900, 63% in Protocol 1,000. Median progression-free survival (PFS) for patients with nodal involvement in Protocol 1,000 receiving estramustine phosphate adjuvant was longer (37.3 mo) compared to cyclophosphamide (30.9 mo) and to no treatment (20.9 mo). Median PFS for patients with limited nodal disease in Protocol 1,000 was longer (39.9 mo), regardless of adjuvant, compared to extensive nodal disease (20.7 mo). However for patients with extensive nodal involvement, those receiving adjuvant estramustine phosphate experienced a significantly longer median PFS (32.8 mo) compared to adjuvant cyclophosphamide (22.7 mo) and no adjuvant (12.9 mo). We conclude that adjuvant estramustine phosphate is of benefit in prostate cancer patients with extensive pelvic node involvement receiving irradiation as definitive treatment.
1978年，国家前列腺癌项目启动了两项方案，评估针对临床局限性前列腺癌手术（方案900）或放疗（方案1000）后的辅助治疗。所有患者均接受分期盆腔淋巴结清扫术。在确定性治疗后，患者被随机分为三组，分别接受每3周静脉注射1克/平方米环磷酰胺，持续2年；每天口服600毫克/平方米磷酸雌莫司汀，持续2年；或仅进行观察。患者入组于1985年结束，方案900纳入184例患者（170例可评估），方案1000纳入253例患者（233例可评估）。198例患者（占总数的49%）发现有淋巴结受累，方案900中为29%，方案1000中为63%。接受磷酸雌莫司汀辅助治疗的方案1000中淋巴结受累患者的无进展生存期（PFS）中位数（37.3个月）长于接受环磷酰胺治疗的患者（30.9个月）和未接受治疗的患者（20.9个月）。方案1000中淋巴结疾病局限的患者，无论是否接受辅助治疗，其PFS中位数（39.9个月）均长于淋巴结疾病广泛的患者（20.7个月）。然而，对于淋巴结广泛受累的患者，接受磷酸雌莫司汀辅助治疗的患者PFS中位数（32.8个月）显著长于接受环磷酰胺辅助治疗的患者（22.7个月）和未接受辅助治疗的患者（12.9个月）。我们得出结论，对于接受放疗作为确定性治疗且盆腔淋巴结广泛受累的前列腺癌患者，磷酸雌莫司汀辅助治疗有益。
