Martin Jarad M, Rosewall Tara, Bayley Andrew, Bristow Robert, Chung Peter, Crook Juanita, Gospodarowicz Mary, McLean Michael, Ménard Cynthia, Milosevic Michael, Warde Padraig, Catton Charles
Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, ON, Canada.
Int J Radiat Oncol Biol Phys. 2007 Nov 15;69(4):1084-9. doi: 10.1016/j.ijrobp.2007.04.049. Epub 2007 Jul 2.
To assess in a prospective trial the feasibility and late toxicity of hypofractionated radiotherapy (RT) for prostate cancer.
Eligible patients had clinical stage T1c-2cNXM0 disease. They received 60 Gy in 20 fractions over 4 weeks with intensity-modulated radiotherapy including daily on-line image guidance with intraprostatic fiducial markers.
Between June 2001 and March 2004, 92 patients were treated with hypofractionated RT. The cohort had a median prostate-specific antigen value of 7.06 ng/mL. The majority had Gleason grade 5-6 (38%) or 7 (59%) disease, and 82 patients had T1c-T2a clinical staging. Overall, 29 patients had low-risk, 56 intermediate-risk, and 7 high-risk disease. Severe acute toxicity (Grade 3-4) was rare, occurring in only 1 patient. Median follow-up was 38 months. According to the Phoenix definition for biochemical failure, the rate of biochemical control at 14 months was 97%. According to the previous American Society for Therapeutic Radiology and Oncology definition, biochemical control at 3 years was 76%. The incidence of late toxicity was low, with no severe (Grade > or =3) toxicity at the most recent assessment.
Hypofractionated RT using 60 Gy in 20 fractions over 4 weeks with image guidance is feasible and is associated with low rates of late bladder and rectal toxicity. At early follow-up, biochemical outcome is comparable to that reported for conventionally fractionated controls. The findings are being tested in an ongoing, multicenter, Phase III trial.
在一项前瞻性试验中评估前列腺癌大分割放疗（RT）的可行性和晚期毒性。
符合条件的患者患有临床分期为T1c - 2cNXM0的疾病。他们在4周内接受20次分割的60 Gy调强放疗，包括每日使用前列腺内基准标记进行在线图像引导。
2001年6月至2004年3月期间，92例患者接受了大分割放疗。该队列的前列腺特异性抗原中位值为7.06 ng/mL。大多数患者为Gleason分级5 - 6（38%）或7（59%）疾病，82例患者为T1c - T2a临床分期。总体而言，29例患者为低风险，56例为中风险，7例为高风险疾病。严重急性毒性（3 - 4级）罕见，仅1例患者出现。中位随访时间为38个月。根据生化失败的Phoenix定义，14个月时的生化控制率为97%。根据先前美国放射治疗及肿瘤学会的定义，3年时的生化控制率为76%。晚期毒性发生率低，在最近一次评估中无严重（≥3级）毒性。
采用4周内20次分割60 Gy并结合图像引导的大分割放疗是可行的，且晚期膀胱和直肠毒性发生率低。在早期随访中，生化结果与传统分割放疗对照组报告的结果相当。这些发现正在一项正在进行的多中心III期试验中进行验证。
