Fersino Sergio, Tebano Umberto, Mazzola Rosario, Giaj-Levra Niccolò, Ricchetti Francesco, Di Paola Gioacchino, Fiorentino Alba, Sicignano Gianluisa, Naccarato Stefania, Ruggieri Ruggero, Cavalleri Stefano, Alongi Filippo
Radiation Oncology Division, Sacro Cuore Don Calabria Hospital, Cancer Care Center, Negrar-Verona, Italy.
Radiation Oncology Division, Sacro Cuore Don Calabria Hospital, Cancer Care Center, Negrar-Verona, Italy.
Clin Genitourin Cancer. 2017 Aug;15(4):e667-e673. doi: 10.1016/j.clgc.2017.01.025. Epub 2017 Feb 6.
The aim of this study was to evaluate the acute toxicity profiles of a moderate hypofractionated regimen with volumetric modulated arc therapy (VMAT) in patients with prostate cancer (PC) who underwent radical prostatectomy.
From December 2012 to February 2016, 125 patients, previously having undergone radical prostatectomy, received adjuvant (64 patients) or salvage (61 patients) radiotherapy (RT) inside an institutional protocol of moderate hypofractionation schedule using the VMAT technique (Varian RapidArc, Palo Alto, CA). Eligible patients were < 85 years old, with an Eastern Cooperative Oncology Group performance status of 0 to 2, histologically proven adenocarcinoma of the prostate without distant metastases, and pathologic stage pT2-4 N0-1, with at least 1 of the following risk factors: capsular perforation, positive surgical margins, seminal vesicle invasion, and/or postoperative prostate-specific antigen > 0.2 ng/mL. Patients were stratified into low (1%), intermediate (9%), and high-risk (90%) groups. The median age was 68 years. The median doses were 66 Gy (range, 65.5-71.4 Gy) to the prostatic bed and 52.5 Gy (range, 50.4-54 Gy) to the pelvic lymph nodes, in 28 or 30 fractions. The acute genitourinary (GU) and gastrointestinal (GI) toxicities were scored according to the Common Terminology Criteria for Adverse Events, v4.
All 125 patients completed the planned treatment, with good tolerance. After RT, the median follow-up was 18 months. Acute toxicities were recorded for the GU (G0, 45/125 [36%]; G1, 63/125 [50.4%]; G2, 16/125 [12.8%]; G3, 1/125 [0.8%]) and the GI (G0, 42/125 [33.6%]; G1, 72/125 [57.6%]; G2, 11/125 [8.8%]; no G3). Analyzing data according to RT intent, a higher rate of GU toxicity ≥ 2 was found in the adjuvant setting (17.1%) with respect to the salvage group (9.8%); P = .01 with the Fisher exact text. Furthermore, at statistical analysis, no difference was found between the type of surgery (robotic, laparoscopic, or open) and incidence of urinary incontinence (P = .8). The actuarial Kaplan-Meier rates for biochemical disease-free survival were 94% and 77% for adjuvant and salvage RT, at 36 months.
Moderate hypofractionated postoperative RT with VMAT was feasible and safe with acceptable acute GU and GI toxicities. Longer follow-up is needed to assess late toxicity and clinical outcomes.
本研究旨在评估容积调强弧形放疗（VMAT）中度大分割方案对接受根治性前列腺切除术的前列腺癌（PC）患者的急性毒性特征。
2012年12月至2016年2月，125例先前接受过根治性前列腺切除术的患者，按照中度大分割放疗计划，采用VMAT技术（瓦里安公司的快速弧形放疗，加利福尼亚州帕洛阿尔托）接受辅助放疗（64例）或挽救性放疗（61例）。符合条件的患者年龄<85岁，东部肿瘤协作组体能状态为0至2，经组织学证实为前列腺腺癌且无远处转移，病理分期为pT2-4 N0-1，至少具备以下危险因素之一：包膜穿孔、手术切缘阳性、精囊侵犯和/或术后前列腺特异性抗原>0.2 ng/mL。患者被分为低危（1%）、中危（9%）和高危（90%）组。中位年龄为68岁。前列腺床的中位剂量为66 Gy（范围65.5 - 71.4 Gy），盆腔淋巴结的中位剂量为52.5 Gy（范围50.4 - 54 Gy），分28或30次分割。根据不良事件通用术语标准第4版对急性泌尿生殖系统（GU）和胃肠道（GI）毒性进行评分。
所有125例患者均完成了计划治疗，耐受性良好。放疗后，中位随访时间为18个月。记录到的GU急性毒性情况为：G0，45/125（36%）；G1，63/125（50.4%）；G2，16/125（12.8%）；G3，1/125（0.8%）；GI急性毒性情况为：G0，42/125（33.6%）；G1，72/125（57.6%）；G2，11/125（8.8%）；无G3级。根据放疗目的分析数据，发现辅助放疗组中GU毒性≥2级的发生率（17.1%）高于挽救性放疗组（9.8%）；采用Fisher精确检验，P = 0.01。此外，经统计学分析，手术方式（机器人手术、腹腔镜手术或开放手术）与尿失禁发生率之间无差异（P = 0.8）。辅助放疗和挽救性放疗在36个月时的无生化复发生存率的精算Kaplan-Meier率分别为94%和77%。
VMAT中度大分割术后放疗是可行且安全的，急性GU和GI毒性可接受。需要更长时间的随访来评估晚期毒性和临床结局。
