Department of Radiation Oncology and Medical Physics, I,C,M, - Institut regional du Cancer Montpellier, INSERM U896, Montpellier cedex 5, F-34298, France.
Radiat Oncol. 2013 Aug 1;8:191. doi: 10.1186/1748-717X-8-191.
The Montpellier cancer institute phase II trial started in 2004 and evaluated the feasibility of intraoperative radiotherapy (IORT) technique given as a sole radiation treatment for patients with an excellent prognostic and very low recurrence risk.
Forty-two patients were included between 2004 and 2007. Inclusion criteria were patients ≥ 65 years old, T0-T1, N0, ductal invasive unifocal carcinoma, free-margin > 2 mm. IORT was delivered using dedicated linear accelerator. One fraction of 21 Gy was prescribed and specified at the 90% isodose using electrons. In vivo dosimetry was performed for all patients. Primary end-point was the quality index. Secondary endpoints were quality of life, local recurrences, cosmetic results, specific and overall survival.
At inclusion, median age was 72 years (range, 66-80). Median tumor diameter was 10 mm. All patients received the total prescribed dose. No acute grade 3 toxicities were observed. Late cosmetic results were good at 5 years despite the poor agreement of accuracy assessment between patients and physicians. Four patients (9.5%) experienced a local failure and underwent salvage mastectomy. The 5 year-disease free survival is 92.7% (range 79.1-97.6). All patients are still alive with a median follow-up of 72 months (range 66-74).
Our results confirm with a long-term follow-up that exclusive partial breast IORT is feasible for early-breast cancer in selected patients. IORT provides good late cosmetics results and should be considered as a safe and very comfortable "one-step" treatment procedure. Nevertheless, patient assessments are essential for long-term quality results.
蒙彼利埃癌症研究所的 II 期临床试验始于 2004 年，评估了术中放疗（IORT）技术作为一种单一放射治疗方法的可行性，适用于预后良好且复发风险极低的患者。
2004 年至 2007 年期间共纳入 42 例患者。纳入标准为年龄≥65 岁，T0-T1，N0，导管浸润性单发癌，切缘游离>2mm。IORT 使用专用线性加速器提供。处方剂量为 21Gy，使用电子束在 90%等剂量线处规定。对所有患者进行体内剂量测定。主要终点是质量指数。次要终点为生活质量、局部复发、美容效果、特异性和总体生存率。
纳入时，中位年龄为 72 岁（范围 66-80 岁）。中位肿瘤直径为 10mm。所有患者均接受了全剂量照射。未观察到急性 3 级毒性反应。尽管患者和医生对准确性评估的一致性较差，但 5 年时的晚期美容效果良好。4 例患者（9.5%）发生局部复发，行挽救性乳房切除术。5 年无病生存率为 92.7%（范围 79.1-97.6）。所有患者均存活，中位随访时间为 72 个月（范围 66-74 个月）。
我们的长期随访结果证实，对于选定的早期乳腺癌患者，单独使用部分乳房 IORT 是可行的。IORT 提供良好的晚期美容效果，应被视为一种安全且非常舒适的“一步式”治疗方法。然而，患者评估对于长期质量结果至关重要。
