Department of Radiation Oncology.
Department of Radiation Oncology.
Pract Radiat Oncol. 2021 Nov-Dec;11(6):527-533. doi: 10.1016/j.prro.2021.03.006. Epub 2021 Apr 10.
There remains limited data as to the feasibility, safety, and efficacy of higher doses of elective radiation therapy to the pelvic lymph nodes in men with high-risk prostate cancer. We conducted a phase II study to evaluate moderate dose escalation to the pelvic lymph nodes using a simultaneous integrated boost to the prostate.
Patients were eligible with biopsy-proven adenocarcinoma of the prostate, a calculated lymph node risk of at least 25%, Karnofsky performance scale ≥70, and no evidence of M1 disease. Acute and late toxicity were prospectively collected at each follow-up using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). The pelvic lymph nodes were treated to a dose of 56 Gy over 28 fractions with a simultaneous integrated boost to the prostate to a total dose of 70 Gy over 28 fractions using intensity-modulated radiation therapy.
Thirty patients were prospectively enrolled from October 2010 to August 2014. Median patient age was 70 years (57-83), pretreatment prostate-specific antigen was 11.5 ng/mL (3.23-111.5), T stage was T2c (T1c-T3b), and Gleason score was 9 (6-9). CTCAE v4.0 rate of any grade 1 or 2 genitourinary and gastrointestinal toxicity were 55% and 44%, respectively, and there was 1 reported acute grade 3 genitourinary and gastrointestinal toxicity, both unrelated to protocol therapy. With a median follow-up of 6.4 years, the biochemical failure free survival rate was 80.2%, and mean biochemical progression free survival was 8.3 years (95% confidence interval [CI], 7.2-9.4). The prostate cancer specific survival was 95.2%, and mean prostate cancer specific survival was 8.7 years (95% CI, 8.0-9.4). Five-year distant metastases free survival was 96%. Medians were not reached.
In this single arm, small, prospective feasibility study, nodal radiation therapy dose escalation was safe, feasible, and seemingly well tolerated. Rates of progression free survival are highly encouraging in this population of predominately National Comprehensive Cancer Network very high-risk patients.
对于高危前列腺癌患者，选择对盆腔淋巴结进行更高剂量的放疗的可行性、安全性和疗效数据有限。我们开展了一项 II 期研究，旨在通过对前列腺进行同步整合式增敏放疗来评估对盆腔淋巴结进行中度剂量递增。
符合条件的患者为经活检证实的前列腺腺癌，预计淋巴结风险至少为 25%，Karnofsky 表现状态评分≥70，无 M1 疾病证据。使用不良事件通用术语标准第四版（CTCAE v4.0）在每次随访时前瞻性收集急性和晚期毒性。盆腔淋巴结接受 56 Gy/28 次分割的剂量照射，同时对前列腺进行同步整合式增敏放疗，总剂量为 70 Gy/28 次分割，采用调强放疗。
2010 年 10 月至 2014 年 8 月，前瞻性纳入 30 例患者。中位患者年龄为 70 岁（57-83 岁），治疗前前列腺特异性抗原为 11.5ng/ml（3.23-111.5），T 分期为 T2c（T1c-T3b），Gleason 评分为 9（6-9）。根据 CTCAE v4.0，任何 1 或 2 级泌尿生殖系统和胃肠道毒性的发生率分别为 55%和 44%，报告了 1 例急性 3 级泌尿生殖系统和胃肠道毒性，均与方案治疗无关。中位随访 6.4 年后，生化无失败生存率为 80.2%，平均生化无进展生存率为 8.3 年（95%置信区间[CI]：7.2-9.4）。前列腺癌特异性生存率为 95.2%，平均前列腺癌特异性生存率为 8.7 年（95%CI：8.0-9.4）。5 年远处转移无复发生存率为 96%。中位数尚未达到。
在这项单臂、小样本、前瞻性可行性研究中，淋巴结放疗剂量递增是安全、可行的，且似乎耐受性良好。在以国家综合癌症网络高危为主的患者人群中，无进展生存率令人鼓舞。
