Martínez-Monge Rafael, Valtueña Peydró Germán, Cambeiro Mauricio, Aramendía José Manuel, Gimeno Marta, Santisteban Marta, Lecanda Fernando, Minguez Jose Angel, Alcázar Juan L, Jurado Matías
Department of Oncology, Clínica Universitaria de Navarra, Pamplona, Navarre, Spain.
Department of Oncology, Clínica Universitaria de Navarra, Pamplona, Navarre, Spain.
Brachytherapy. 2018 Sep-Oct;17(5):734-741. doi: 10.1016/j.brachy.2018.04.007. Epub 2018 May 24.
To determine the long-term results of a Phase II trial of perioperative high-dose-rate brachytherapy (PHDRB) in primary advanced or recurrent gynecological cancer.
Fifty patients with locally advanced and recurrent gynecological cancer suitable for salvage surgery were included. Unirradiated patients (n = 25) received preoperative chemoradiation followed by surgery and PHDRB (16-24 Gy). Previously irradiated patients (n = 25) received surgery and PHDRB alone (32-40 Gy).
Median followup was 11.5 years. Eight unirradiated patients (32%) developed Grade ≥3 toxic events including two fatal events. Local and locoregional control rates at 16 years were 87.3% and 78.9%, respectively. Sixteen-year disease-free and overall survival rates were 42.9% and 46.4%, respectively. Ten previously irradiated patients (40.0%) developed Grade ≥3 adverse events, including four fatal events. Local and locoregional control rates at 14 years were 59.6% and 42.6%, respectively. Fourteen-year disease-free and overall survival rates were 16.0% and 19.2%, respectively.
PHDRB allows effective salvage of a subset of unfavorable gynecological tumors with high-risk surgical margins. Toxicity was unacceptable at the initial dose levels but deescalation resulted in the absence of severe toxicity without a negative impact on locoregional control. A substantial percentage of patients remain alive and controlled at >10 years including a few previously irradiated cases with positive margins.
确定围手术期高剂量率近距离放射治疗（PHDRB）用于原发性晚期或复发性妇科癌症的II期试验的长期结果。
纳入50例适合挽救性手术的局部晚期和复发性妇科癌症患者。未接受过放疗的患者（n = 25）接受术前放化疗，然后进行手术和PHDRB（16 - 24 Gy）。既往接受过放疗的患者（n = 25）仅接受手术和PHDRB（32 - 40 Gy）。
中位随访时间为11.5年。8例未接受过放疗的患者（32%）发生≥3级毒性事件，包括2例致命事件。16年时局部和区域控制率分别为87.3%和78.9%。16年无病生存率和总生存率分别为42.9%和46.4%。10例既往接受过放疗的患者（40.0%）发生≥3级不良事件，包括4例致命事件。14年时局部和区域控制率分别为59.6%和42.6%。14年无病生存率和总生存率分别为16.0%和19.2%。
PHDRB可有效挽救一部分手术切缘具有高风险的不良妇科肿瘤。初始剂量水平时毒性不可接受，但剂量降低后未出现严重毒性，且对区域控制无负面影响。相当比例的患者在10年以上仍存活且病情得到控制，包括一些既往接受过放疗且切缘阳性的病例。
