Alan Pollack, Gail Walker, and Radka Stoyanova, University of Miami Miller School of Medicine, Miami, FL; Eric M. Horwitz, Robert Price, Richard E. Greenberg, Robert G. Uzzo, Charlie Ma, and Mark K. Buyyounouski, Fox Chase Cancer Center, Philadelphia, PA; Steven Feigenberg, University of Maryland, Baltimore, MD; Andre A. Konski, Wayne State University Medical Center; and Benjamin Movsas, Henry Ford Hospital, Detroit, MI.
J Clin Oncol. 2013 Nov 1;31(31):3860-8. doi: 10.1200/JCO.2013.51.1972. Epub 2013 Oct 7.
To determine if escalated radiation dose using hypofractionation significantly reduces biochemical and/or clinical disease failure (BCDF) in men treated primarily for prostate cancer.
Between June 2002 and May 2006, men with favorable- to high-risk prostate cancer were randomly allocated to receive 76 Gy in 38 fractions at 2.0 Gy per fraction (conventional fractionation intensity-modulated radiation therapy [CIMRT]) versus 70.2 Gy in 26 fractions at 2.7 Gy per fraction (hypofractionated IMRT [HIMRT]); the latter was estimated to be equivalent to 84.4 Gy in 2.0 Gy fractions. High-risk patients received long-term androgen deprivation therapy (ADT), and some intermediate-risk patients received short-term ADT. The primary end point was the cumulative incidence of BCDF. Secondarily, toxicity was assessed.
There were 303 assessable patients with a median follow-up of 68.4 months. No significant differences were seen between the treatment arms in terms of the distribution of patients by clinicopathologic or treatment-related (ADT use and length) factors. The 5-year rates of BCDF were 21.4% (95% CI, 14.8% to 28.7%) for CIMRT and 23.3% (95% CI, 16.4% to 31.0%) for HIMRT (P = .745). There were no statistically significant differences in late toxicity between the arms; however, in subgroup analysis, patients with compromised urinary function before enrollment had significantly worse urinary function after HIMRT.
The hypofractionation regimen did not result in a significant reduction in BCDF; however, it is delivered in 2.5 fewer weeks. Men with compromised urinary function before treatment may not be ideal candidates for this approach.
确定采用大分割放疗是否能显著降低前列腺癌初治患者的生化和/或临床疾病失败（BCDF）。
2002 年 6 月至 2006 年 5 月，将具有中高危特征的前列腺癌患者随机分配，分别接受 76 Gy/38 次（常规分割调强放疗[CIMRT]）或 70.2 Gy/26 次（大分割调强放疗[HIMRT]），后者的剂量估计相当于 2.0 Gy/次分割的 84.4 Gy。高危患者接受长期雄激素剥夺治疗（ADT），部分中危患者接受短期 ADT。主要终点为 BCDF 的累积发生率。次要终点为毒性。
共有 303 例患者可评估，中位随访 68.4 个月。在临床病理或治疗相关因素（ADT 使用和时间）方面，两组患者的分布无显著差异。CIMRT 和 HIMRT 组的 5 年 BCDF 率分别为 21.4%（95%CI，14.8%至 28.7%）和 23.3%（95%CI，16.4%至 31.0%）（P=.745）。两组间晚期毒性无统计学差异；但亚组分析显示，入组前有尿路功能受损的患者，HIMRT 后尿路功能明显恶化。
大分割放疗方案并未显著降低 BCDF，但治疗时间缩短 2.5 周。治疗前尿路功能受损的患者可能不是该方法的理想人选。
