Radiation Oncology Unit, Gemelli Molise Hospital - Università Cattolica del Sacro Cuore, Campobasso, Italy.
Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Radiol Med. 2022 Nov;127(11):1292-1302. doi: 10.1007/s11547-022-01538-w. Epub 2022 Sep 10.
Adjuvant radiotherapy (aRT) has been shown to reduce the risk of local relapse in vulvar cancer (VC). In this multicentre study (OLDLADY-1.2), several Institutions have combined their retrospective data on VC patients to produce a real-world dataset aimed at collecting data on efficacy and safety of aRT.
The primary study end-point was the 2-year-local control, secondary end-points were the 2-year-metastasis free-survival, the 2-year-overall survival and the rate and severity of acute and late toxicities. Participating centres were required to fill data sets including age, stage, tumor diameter, type of surgery, margin status, depth of invasion, histology, grading as well technical/dosimetric details of radiotherapy. Data about response, local and regional recurrence, acute and late toxicities, follow-up and outcome measures were also collected.
One hundred eighty-one patients with invasive VC from 9 Institutions were retrospectively identified. The majority of patients were stage III (63%), grade 2 (62.4%) squamous carcinoma (97.2%). Positive nodes were observed in 117 patients (64.6%), moreover tumor diameter > 4 cm, positive/close margins and depth of invasion deeper than 5 mm were found in 59.1%, 38.6%, 58% of patients, respectively. Sixty-one patients (33.7%) received adjuvant chemoradiation, and 120 (66.3%) received radiotherapy alone. aRT was started 3 months after surgery in 50.8% of patients. Prescribed volumes and doses heterogeneity was recorded according to margin status and nodal disease. Overall, 42.5% locoregional recurrences were recorded. With a median follow-up of 27 months (range 1-179), the 2-year actuarial local control rate, metastasis free and overall survival were 68.7%, 84.5%, and 67.5%, respectively. In term of safety, aRT leads to a prevalence of acute skin toxicity with a low incidence of severe toxicities.
In the context of aRT for VC the present study reports a broad spectrum of approaches which would deserve greater standardization in terms of doses, volumes and drugs used.
辅助放疗（aRT）已被证明可降低外阴癌（VC）局部复发的风险。在这项多中心研究（OLDLADY-1.2）中，多个机构联合了他们的 VC 患者回顾性数据，以产生一个旨在收集 aRT 疗效和安全性数据的真实世界数据集。
主要研究终点为 2 年局部控制率，次要终点为 2 年无转移生存率、2 年总生存率和急性和迟发性毒性的发生率和严重程度。参与中心需填写包括年龄、分期、肿瘤直径、手术类型、切缘状态、浸润深度、组织学、分级以及放疗技术/剂量学细节等数据。还收集了关于反应、局部和区域复发、急性和迟发性毒性、随访和结果测量的数据。
从 9 个机构中回顾性确定了 181 例侵袭性 VC 患者。大多数患者为 III 期（63%）、II 级（62.4%）鳞状细胞癌（97.2%）。117 例患者有淋巴结转移（64.6%），此外，肿瘤直径＞4cm、阳性/接近切缘和浸润深度超过 5mm 的患者分别占 59.1%、38.6%和 58%。61 例（33.7%）患者接受了辅助放化疗，120 例（66.3%）患者单独接受了放疗。50.8%的患者在手术后 3 个月开始接受 aRT。根据切缘状态和淋巴结疾病记录了靶区体积和剂量的异质性。总体而言，42.5%的患者发生了局部区域复发。中位随访时间为 27 个月（范围 1-179），2 年局部无进展生存率、无转移生存率和总生存率分别为 68.7%、84.5%和 67.5%。就安全性而言，aRT 导致急性皮肤毒性的发生率较高，但严重毒性的发生率较低。
在 VC 的 aRT 背景下，本研究报告了广泛的治疗方法，这些方法在剂量、靶区和使用的药物方面需要更大程度的标准化。
