Tabata Ken-Ichi, Satoh Takefumi, Matsumoto Kazumasa, Fujita Tetsuo, Irie Akira, Iwamura Masatsugu, Yanagisawa Nobuyuki, Matsuda Daisuke, Muramoto Masatoshi, Kadowaki Kazuomi, Suyama Kazuho, Shoji Kiyoshi, Koh Hideshige, Kawakami Tatsuo, Okayasu Isao, Egawa Shin, Baba Shiro
Department of Urology, Kitasato University, School of Medicine.
Nihon Hinyokika Gakkai Zasshi. 2006 Jul;97(5):712-8. doi: 10.5980/jpnjurol1989.97.712.
To evaluate the clinicopathological outcomes of 8 months of neoadjuvant hormonal therapy (NHT) prior to radical prostatectomy for high-risk prostate cancer.
A multi-institutional prospective trial was performed between July 2000 and May 2003 involving high-risk prostate cancer patients without metastasis, including 21 who received 8 months of NHT before radical prostatectomy. High-risk group was defined as clinical stage > or =T2c and/or prostate-specific antigen (PSA) >20 ng/ml and/or Gleason score > or =8. PSA values were considered elevated (biochemical failure) if values of 0.1 ng/ml or greater were obtained.
Median of initial PSA levels before prostate biopsy was 27.6 ng/ml (8.5-80.7 ng/ml), and median of pre-operative PSA levels after NHT was 0.28 ng/ml (0.02-4.2 ng/ml). There were 5 patients (23.8%) with lower limit of PSA detection (less than 0.02 ng/ml) in 8 months after NHT. The clinical T stage was T1c in 9 patients (42.9%), T2a-b in 8 patients (38.1%), T2c in 3 patients (14.3%), and T3a in 1 patient (4.8%). The median follow-up was 25 months (range 4 to 37). There were 2 patients (9.5%) in pT0, 5 patients (23.8%) with positive surgical margin, 5 patients (23.8%) with extracapsular extension (ECE) and 3 patients (14.3%) with seminal vesicle involvement (SVI). Biochemical failure was occurred in 9 of 21 (42.9%) including of one pT0. Range of time to postoperative biochemical failure was 2 to 25 months (median 6 months) and most of biochemical failure was found within 12 months after surgery. Biochemical failure rate was significantly higher in patient with positive SVI (p = 0.0308) and higher in patients with pre-operative PSA levels of more than 0.1 ng/ml (p = 0.0836), positive ECE (p = 0.0545) and positive surgical margin (p = 0.0545).
Biochemical failure was frequent after this combined treatment, even in a pT0 case. Long-term follow-up of patients is needed to assess the impact of this therapy on mortality.
评估高危前列腺癌患者在根治性前列腺切除术前行8个月新辅助激素治疗(NHT)的临床病理结果。
2000年7月至2003年5月进行了一项多机构前瞻性试验,纳入无转移的高危前列腺癌患者,其中21例在根治性前列腺切除术前行8个月的NHT。高危组定义为临床分期≥T2c和/或前列腺特异性抗原(PSA)>20 ng/ml和/或Gleason评分≥8。如果PSA值≥0.1 ng/ml,则认为PSA值升高(生化失败)。
前列腺活检前初始PSA水平中位数为27.6 ng/ml(8.5 - 80.7 ng/ml),NHT后术前PSA水平中位数为0.28 ng/ml(0.02 - 4.2 ng/ml)。NHT后8个月有5例患者(23.8%)PSA检测下限(低于0.02 ng/ml)。临床T分期为T1c的有9例患者(42.9%),T2a - b的有8例患者(38.1%),T2c的有3例患者(14.3%),T3a的有1例患者(4.8%)。中位随访时间为25个月(范围4至37个月)。pT0的有2例患者(9.5%),手术切缘阳性的有5例患者(23.8%),包膜外侵犯(ECE)的有5例患者(23.8%),精囊受累(SVI)的有3例患者(14.3%)。21例中有9例(42.9%)发生生化失败,其中包括1例pT0患者。术后生化失败时间范围为2至25个月(中位时间6个月),大多数生化失败发生在术后12个月内。SVI阳性患者的生化失败率显著更高(p = 0.0308),术前PSA水平>0.1 ng/ml的患者(p = 0.0836)、ECE阳性患者(p = 0.0545)和手术切缘阳性患者(p = 0.0545)的生化失败率也更高。
即使在pT0病例中,这种联合治疗后生化失败也很常见。需要对患者进行长期随访以评估该治疗对死亡率的影响。