Department of Radiation Oncology, Robert Wood Johnson School of Medicine and Cooper University Hospital, Camden, NJ 08103, USA.
Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):732-6. doi: 10.1016/j.ijrobp.2010.06.042. Epub 2010 Oct 30.
We report the long-term results of a prospective, Phase II study of long-term androgen deprivation (AD), pelvic radiotherapy (EBRT), permanent transperineal prostate brachytherapy boost (PB), and adjuvant docetaxel in patients with high-risk prostate cancer.
Eligibility included biopsy-proven prostate adenocarcinoma with the following: prostate-specific antigen (PSA) > 20 ng/ml; or Gleason score of 7 and a PSA >10 ng/ml; or any Gleason score of 8 to 10; or stage T2b to T3 irrespective of Gleason score or PSA. Treatment consisted of 45 Gy of pelvic EBRT, followed 1 month later by PB with either iodine-125 or Pd-103. One month after PB, patients received three cycles of docetaxel chemotherapy (35 mg/m(2) per week, Days 1, 8, and 15 every 28 days). All patients received 2 years of AD. Biochemical failure was defined as per the Phoenix definition (PSA nadir + 2).
From August 2000 to March 2004, 42 patients were enrolled. The median overall and active follow-ups were 5.6 years (range, 0.9-7.8 years) and 6.3 years (range, 4-7.8 years), respectively. Grade 2 and 3 acute genitourinary (GU) and gastrointestinal (GI) toxicities were 50.0% and 14.2%, respectively, with no Grade 4 toxicities noted. Grade 3 and 4 acute hematologic toxicities were 19% and 2.4%, respectively. Of the patients, 85.7% were able to complete the planned multimodality treatment. The 5- and 7-year actuarial freedom from biochemical failures rates were 89.6% and 86.5%, and corresponding rates for disease-free survival were 76.2% and 70.4%, respectively. The 5- and 7-year actuarial overall survival rates were 83.3% and 80.1%, respectively. The 5- and 7-year actuarial rates of late Grade 2 GI/GU toxicity (no Grade 3-5) was 7.7%.
The trimodality approach of using 2 years of AD, external radiation, brachytherapy, and upfront docetaxel in high-risk prostate cancer is well tolerated, produces encouraging long-term results, and should be validated in a multi-institutional setting.
我们报告了一项前瞻性、Ⅱ期研究的长期结果，该研究评估了长期雄激素剥夺（AD）、盆腔放疗（EBRT）、经会阴前列腺近距离放射治疗（PB）加辅助多西他赛治疗高危前列腺癌患者的效果。
入选标准包括经活检证实的前列腺腺癌，符合以下条件：前列腺特异性抗原（PSA）>20ng/ml；或 Gleason 评分 7 分且 PSA>10ng/ml；或任何 Gleason 评分 8 至 10 分；或无论 Gleason 评分或 PSA 如何，T2b 至 T3 期。治疗包括 45Gy 盆腔 EBRT，1 个月后行 PB，使用碘-125 或 Pd-103。PB 后 1 个月，患者接受 3 个周期多西他赛化疗（35mg/m2，每周 1 次，第 8 和 15 天，每 28 天 1 个周期）。所有患者均接受 2 年 AD。生化失败定义为 Phoenix 定义（PSA 最低点+2）。
2000 年 8 月至 2004 年 3 月，共纳入 42 例患者。中位总随访和活跃随访时间分别为 5.6 年（范围：0.9-7.8 年）和 6.3 年（范围：4-7.8 年）。急性泌尿生殖（GU）和胃肠道（GI）毒性的 2 级和 3 级发生率分别为 50.0%和 14.2%，无 4 级毒性。3 级和 4 级急性血液学毒性的发生率分别为 19%和 2.4%。85.7%的患者能够完成计划的多模式治疗。5 年和 7 年无生化失败的估计生存率分别为 89.6%和 86.5%，相应的无疾病生存估计率分别为 76.2%和 70.4%。5 年和 7 年的总生存率分别为 83.3%和 80.1%。5 年和 7 年迟发性 2 级 GI/GU 毒性（无 3-5 级）的发生率分别为 7.7%。
高危前列腺癌中使用 2 年 AD、外照射、近距离放射治疗和先期多西他赛的三联疗法耐受性良好，可产生令人鼓舞的长期结果，应在多机构环境中进行验证。
