Purpose

Hypofractionated radiation therapy (HFRT) may offer treatment advantages for patients with prostate cancer. However, HFRT may also increase the risk of gastrointestinal (GI) or genitourinary (GU) toxicity compared with conventionally fractionated radiation therapy (CFRT). Several large trials have found that HFRT is well tolerated in mixed risk population studies. Here, we report on a phase II, randomized controlled study conducted to evaluate these endpoints in exclusively high-risk patients with prostate cancer treated with prostate and pelvic nodal radiation.

Methods and Materials

After giving informed consent, patients with high-risk prostate cancer were randomly assigned to prostate plus pelvic nodal radiation therapy with either HFRT (68 Gy in 25 fractions) or CFRT (78 Gy in 39 fractions) and 18 months of androgen suppression therapy. Toxicity was scored using the Common Terminology Criteria for Adverse Events (version 4.0). Biochemical failure was determined by the Phoenix definition. Patients were analyzed on an intention-to-treat basis.

Results

From 2012 to 2018, 111 patients with high-risk prostate cancer were enrolled and 109 patients were treated. The cumulative incidence of grade 2 or higher acute GI toxicity was not significantly different between the arms (HFRT 18.9% vs CFRT 21.8%; P = .812). Similarly, acute GU (HFRT 30.2% vs CFRT 30.9%; P = 1.00), late GI (HFRT 16.0% vs CFRT 10.0%; P = .554), and late GU (HFRT 16.0% vs CFRT 6.0%; P = .200) were not significantly different between the arms. Median follow-up was 38.0 months (4.8-77.8 months). The 3-year biochemical recurrence-free survival was not significantly different between the 2 arms (97.3% for HFRT vs 91.0% for CFRT; P = .606). The 3-year overall survival was 94.8% in the HFRT arm and 100.0% in the CFRT arm (P = .116).

Conclusions

HFRT and CFRT using intensity modulated radiation therapy were both well tolerated for patients with high-risk prostate cancer and resulted in similar 3-year biochemical recurrence-free survival and overall survival.

中文翻译：

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CHIRP 试验的临床结果：对高危前列腺癌患者进行常规分割与中等大分割前列腺和盆腔淋巴结放射治疗的 II 期前瞻性随机试验

目的

大分割放射治疗 (HFRT) 可能为前列腺癌患者提供治疗优势。然而，与传统的分割放疗 (CFRT) 相比，HFRT 也可能增加胃肠 (GI) 或泌尿生殖系统 (GU) 毒性的风险。几项大型试验发现，在混合风险人群研究中，HFRT 具有良好的耐受性。在这里，我们报告了一项 II 期随机对照研究，该研究旨在评估接受前列腺和盆腔淋巴结放射治疗的前列腺癌高危患者的这些终点。

方法和材料

在给予知情同意后，高危前列腺癌患者被随机分配接受前列腺加盆腔淋巴结放疗，HFRT（25 次分割 68 Gy）或 CFRT（39 次分割 78 Gy）和 18 个月的雄激素抑制治疗。使用不良事件通用术语标准（4.0 版）对毒性进行评分。生化失败由凤凰定义确定。在意向治疗的基础上对患者进行分析。

结果

2012年至2018年共纳入高危前列腺癌患者111例，治疗109例。2 级或更高级别急性胃肠道毒性的累积发生率在两组之间没有显着差异（HFRT 18.9% 与 CFRT 21.8%；P = .812）。同样，急性 GU（HFRT 30.2% 与 CFRT 30.9%；P = 1.00）、晚期 GI（HFRT 16.0% 与 CFRT 10.0%；P = .554）和晚期 GU（HFRT 16.0% 与 CFRT 6.0%；P = . 200）在手臂之间没有显着差异。中位随访时间为 38.0 个月（4.8-77.8 个月）。2 组之间的 3 年生化无复发生存率无显着差异（HFRT 为 97.3%，CFRT 为 91.0%；P= .606）。HFRT 组的 3 年总生存率为 94.8%，CFRT 组为 100.0% ( P = .116)。

结论

使用调强放射治疗的 HFRT 和 CFRT 对高危前列腺癌患者均具有良好的耐受性，并导致类似的 3 年生化无复发生存率和总生存率。