Department of Radiation Oncology, Hospital Clinico San Carlos, Madrid, Spain; Investigation Institute, Clinico San Carlos Hospital, Madrid, Spain.
Department of Radiation Oncology, The Ottawa Hospital, Ottawa, Ontario, Canada.
Clin Oncol (R Coll Radiol). 2023 Apr;35(4):262-268. doi: 10.1016/j.clon.2023.01.006. Epub 2023 Jan 20.
To report long-term oncological outcomes of men treated prospectively as part of the American College of Surgeons Oncology Group phase III Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial (SPIRIT) at our institution.
In 2003-2004, patients eligible for SPRIT attended a multidisciplinary educational session, following which they could choose radical prostatectomy, low dose rate brachytherapy (LDR-BT) or randomisation to SPIRIT. Biochemical failure was determined by the accepted definitions of a prostate-specific antigen (PSA) level ≥0.2 ng/ml after radical prostatectomy and the Phoenix definition of PSA ≥2 ng/ml above the nadir after LDR-BT. A sensitivity analysis, using a PSA >0.5 ng/ml to define biochemical failure after LDR-BT and a threshold PSA ≥0.2 ng/ml, was carried out to test the robustness of the results. To account for the competing risk of death, Gray's test was used to test the equality of the cumulative incidence function of biochemical failure between treatment groups. The Kaplan-Meier method was used to estimate overall survival and prostate cancer-specific survival. A P-value ≤0.05 was considered statistically significant.
Of 156 patients, 100 received LDR-BT (15 after randomisation) and 56 underwent radical prostatectomy (15 after randomisation). The median follow-up was 12.6 and 14.7 years for LDR-BT and radical prostatectomy, respectively. The median age was 60 years; the median pre-treatment PSA was 5.5 (interquartile range 4.3-7.1). No significant differences in patient characteristics were found between groups. Two patients received adjuvant radiotherapy after radical prostatectomy. The cumulative incidence function of biochemical failure was 0%, 1.1% and 2.4% at 5, 10 and 15 years, respectively, in the LDR-BT arm versus 8.5%, 15.8% and 15.8% in the radical prostatectomy arm (P < 0.001). These results were consistent when varying the definition of biochemical failure defined as PSA ≥0.5 ng/ml (P = 0.01). At 15 years, overall survival was higher in patients treated with radical prostatectomy compared with those treated with LDR-BT; however, no statistical difference was found in prostate cancer-specific survival.
In low-risk prostate cancer patients, LDR-BT offers excellent long-term oncological outcomes comparable with radical prostatectomy, in addition to the previously reported advantage for LDR-BT in urinary and sexual quality of life domains and patient satisfaction.
报告本机构前瞻性纳入美国外科医师学院肿瘤学组 III 期前列腺切除术与间质内放疗干预试验（SPIRIT）的男性患者的长期肿瘤学结果。
2003-2004 年，符合 SPRIT 条件的患者参加了多学科教育会议，之后他们可以选择前列腺根治切除术、低剂量率近距离放射治疗（LDR-BT）或随机分配至 SPIRIT 组。生化失败通过以下公认的定义来确定：前列腺根治切除术后 PSA 水平≥0.2ng/ml，LDR-BT 后 PSA 水平高于最低点≥2ng/ml。使用 PSA>0.5ng/ml 定义 LDR-BT 后的生化失败，并使用阈值 PSA≥0.2ng/ml 进行敏感性分析，以检验结果的稳健性。为了考虑死亡的竞争风险，使用 Gray 检验来检验治疗组之间生化失败累积发生率函数的均等性。使用 Kaplan-Meier 方法估计总生存和前列腺癌特异性生存。P 值≤0.05 被认为具有统计学意义。
在 156 例患者中，100 例接受 LDR-BT（随机分配后 15 例），56 例接受前列腺根治切除术（随机分配后 15 例）。LDR-BT 和前列腺根治切除术的中位随访时间分别为 12.6 年和 14.7 年。中位年龄为 60 岁；中位治疗前 PSA 为 5.5（四分位间距 4.3-7.1）。两组患者的特征无显著差异。前列腺根治切除术后有 2 例患者接受辅助放疗。LDR-BT 组的生化失败累积发生率分别为 0%、1.1%和 2.4%，前列腺根治切除术组分别为 8.5%、15.8%和 15.8%（P<0.001）。当将生化失败定义为 PSA≥0.5ng/ml 时，结果一致（P=0.01）。15 年时，与 LDR-BT 组相比，接受前列腺根治切除术的患者总体生存率更高，但前列腺癌特异性生存率无统计学差异。
在低危前列腺癌患者中，LDR-BT 提供了出色的长期肿瘤学结果，与前列腺根治切除术相当，此外，LDR-BT 在尿控和性功能质量以及患者满意度方面也具有先前报道的优势。
