Powell Isaac J, Tangen Catherine M, Miller Gary J, Lowe Bruce A, Haas Gabriel, Carroll Peter R, Osswald Michael B, DeVERE WHITE Ralph, Thompson Ian M, Crawford E David
Wayne State University Medical Center, Detroit, Michigan, USA.
J Urol. 2002 Nov;168(5):2016-9. doi: 10.1016/S0022-5347(05)64285-1.
Several investigators have examined the role of hormonal therapy before definitive local therapy for locally advanced prostate cancer to improve outcome. We evaluated the resectability rate and clinical response rate to 16 weeks of total androgen blockage therapy for clinically locally prostate cancer before radical prostatectomy, and progression-free survival in this multi-institutional study.
Southwest Oncology Group 9109 was a phase II feasibility study designed to treat patients with clinical stage C prostate cancer (T3, T4, N0 and M0). Cases were classified by stage T3 versus T4 and bulky (greater than 4 cm.) versus nonbulky (or less 4 cm.) disease. The neoadjuvant agents used were goserelin and flutamide before radical prostatectomy.
A total of 62 patients were accrued to the study and 1 patient was ineligible. There were 2 protocol deviations and these patients refused to undergo prostatectomy after hormonal therapy. Four patients went off protocol treatment because they were not considered surgical candidates. The racial distribution was 72% white, 20% black, 7% Hispanic and 2% Asian. Clinical stage at diagnosis was T3 in 97% and T4 in 3% of cases. Of the patients 39% were diagnosed with bulky disease. Of the 61 eligible patients 55 (90%) underwent a prostatectomy. The 5-year progression-free survival estimate was 70% (24 of 61 cases failed) and the 5-year survival estimate was 90% (11 of 61 deaths). Most of the patients in this trial would have been considered inoperable and referred to radiation oncology.
Neoadjuvant hormonal therapy followed by radical prostatectomy is reasonable and appropriate for clinical stage T3 prostate cancer. A progression-free and overall 5-year survival of 70% and 90%, respectively, compares favorably to Radiation Therapy Oncology Group neoadjuvant trial outcomes for this stage of prostate cancer.
几位研究者探讨了激素治疗在局部晚期前列腺癌确定性局部治疗前的作用，以改善治疗效果。在这项多机构研究中，我们评估了临床局部前列腺癌在根治性前列腺切除术前行16周全雄激素阻断治疗后的可切除率和临床缓解率，以及无进展生存期。
西南肿瘤协作组9109是一项II期可行性研究，旨在治疗临床C期前列腺癌（T3、T4、N0和M0）患者。病例按T3期与T4期以及肿块较大（大于4厘米）与肿块较小（或小于4厘米）疾病进行分类。新辅助治疗药物为根治性前列腺切除术前行戈舍瑞林和氟他胺。
共有62例患者纳入本研究，1例不符合条件。有2例违反方案，这2例患者在激素治疗后拒绝接受前列腺切除术。4例患者退出方案治疗，因为他们不被认为是手术候选者。种族分布为72%白人、20%黑人、7%西班牙裔和2%亚裔。诊断时临床分期T3期占97%，T4期占3%。39%的患者被诊断为肿块较大的疾病。61例符合条件的患者中，55例（90%）接受了前列腺切除术。5年无进展生存期估计为70%（61例中有24例失败），5年生存率估计为90%（61例中有11例死亡）。该试验中的大多数患者原本会被认为无法手术，并转诊至放射肿瘤学。
新辅助激素治疗后行根治性前列腺切除术对于临床T3期前列腺癌是合理且合适地。5年无进展生存率和总生存率分别为70%和90%，与放射肿瘤学组针对该期前列腺癌的新辅助试验结果相比更具优势。
