局部前列腺癌常规分割与适度超分割放射治疗的前瞻性随机试验十年更新。
Ten-Year Update of a Randomized, Prospective Trial of Conventional Fractionated Versus Moderate Hypofractionated Radiation Therapy for Localized Prostate Cancer.
机构信息
Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.
Department of Biostatistics, Fox Chase Cancer Center, Philadelphia, PA.
出版信息
J Clin Oncol. 2020 May 20;38(15):1676-1684. doi: 10.1200/JCO.19.01485. Epub 2020 Mar 2.
PURPOSE
The previously published single institution randomized prospective trial failed to show superiority in the 5-year biochemical and/or clinical disease failure (BCDF) rate with moderate hypofractionated intensity-modulated radiation therapy (H-IMRT) versus conventionally fractionated IMRT (C-IMRT). We now present 10-year disease outcomes using updated risk groups and definitions of biochemical failure.
METHODS
Men with protocol-defined intermediate- and high-risk prostate adenocarcinoma were randomly assigned to receive C-IMRT (76 Gy in 38 fractions) or H-IMRT (70.2 Gy in 26 fractions). Men with high-risk disease were all prescribed 24 months of androgen deprivation therapy (ADT) and had lymph node irradiation. Men with intermediate risk were prescribed 4 months of ADT at the discretion of the treating physician. The primary endpoint was cumulative incidence of BCDF. We compared disease outcomes and overall mortality by treatment arm, with sensitivity analyses for National Comprehensive Cancer Network (NCCN) risk group adjustment.
RESULTS
Overall, 303 assessable men were randomly assigned to C-IMRT or H-IMRT. The median follow-up was 122.9 months. Per updated NCCN risk classification, there were 28 patients (9.2%) with low-risk, 189 (62.4%) with intermediate-risk, and 86 (28.4%) with high-risk prostate cancer. The arms were equally balanced for clinicopathologic factors, except that there were more black patients in the C-IMRT arm (17.8% 7.3%; = .02). There was no difference in ADT use ( = .56). The 10-year cumulative incidence of BCDF was 25.9% in the C-IMRT arm and was 30.6% in the H-IMRT arm (hazard ratio, 1.31; 95% CI, 0.82 to 2.11). The two arms also had similar cumulative 10-year rates of biochemical failure, prostate cancer-specific mortality, and overall mortality; however, the 10-year cumulative incidence of distant metastases was higher in the H-IMRT arm (rate difference, 7.8%; 95% CI, 0.7% to 15.1%).
CONCLUSION
H-IMRT failed to demonstrate superiority compared with C-IMRT in long-term disease outcomes.
目的
先前发表的单中心随机前瞻性试验未能显示中度适形调强放疗（H-IMRT）与常规分割调强放疗（C-IMRT）相比在 5 年生化和/或临床疾病失败（BCDF）率方面具有优越性。我们现在使用更新的风险组和生化失败定义报告 10 年疾病结果。
方法
患有协议定义的中危和高危前列腺腺癌的男性被随机分配接受 C-IMRT（76 Gy 分 38 次）或 H-IMRT（70.2 Gy 分 26 次）。高危疾病的男性均接受 24 个月的雄激素剥夺治疗（ADT）和淋巴结照射。中危疾病的男性可根据治疗医生的判断接受 4 个月的 ADT。主要终点是 BCDF 的累积发生率。我们比较了治疗组的疾病结果和总死亡率，并进行了 NCCN 风险组调整的敏感性分析。
结果
共有 303 名可评估的男性被随机分配到 C-IMRT 或 H-IMRT。中位随访时间为 122.9 个月。根据更新的 NCCN 风险分类，28 名患者（9.2%）为低危，189 名患者（62.4%）为中危，86 名患者（28.4%）为高危前列腺癌。两组在临床病理因素方面平衡，除了 C-IMRT 组黑人患者更多（17.8% 比 7.3%； =.02）。ADT 的使用没有差异（ =.56）。C-IMRT 组的 10 年 BCDF 累积发生率为 25.9%，H-IMRT 组为 30.6%（风险比，1.31；95%CI，0.82 至 2.11）。两组的生化失败、前列腺癌特异性死亡率和总死亡率也相似；然而，H-IMRT 组远处转移的 10 年累积发生率更高（差异率，7.8%；95%CI，0.7%至 15.1%）。
结论
与 C-IMRT 相比，H-IMRT 在长期疾病结果方面没有优势。
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