Departments of Oncology, University of Navarre, Pamplona, Spain.
Breast Surgical Oncology, University of Navarre, Pamplona, Spain.
Brachytherapy. 2022 Jul-Aug;21(4):475-486. doi: 10.1016/j.brachy.2022.01.008. Epub 2022 Apr 5.
To evaluate the feasibility, early toxicity, and clinical outcomes of early-breast cancer patients in a single-arm, phase I/II study of an ultra-accelerated, four-fraction schedule of minimal breast irradiation (4f-AMBI) using a multicatheter, minimally-invasive, intraoperative tumor bed implant (MITBI) during breast-conserving surgery (BCS).
Eligible women aged >40 years with clinically and radiologically confirmed, unifocal invasive or in situ ≤3 cm tumors were considered as potential candidates for MITBI during BCS. After the pathology report, patients who met APBI criteria received ultra-accelerated four-fractions irradiation (6.2 Gy BID x 4fx over 2 days) with perioperative HDR-brachytherapy (PHDRBT). Early complications, toxicity, clinical outcomes, and cosmetic results were analyzed.
Of 89 patients initially implanted, 60(67.4%) were definitively included in the 4f-AMBI-protocol. The median age was 64.4 years; the median CTV was 32.1 cc (6.9-75.4 cc), and the external-V was 43.1 cc (12.87-107 cc), representing 5% of the breast tissue irradiated with a median CTV D of 6.2 Gy (5.6-6.28 Gy). The entire local treatment (BCS&MITBI-4f-AMBI) was completed at a median of 8 days (4-10 days). The rate of early complications was 11%. There were no major complications. Acute skin-subcutaneous G1 toxicity was reported in 11.7%, and late G1 toxicity on 36.7%. After a median follow-up of 27 months (11-51 months), the local, elsewhere, locoregional and distant-control rates were 100%, 98.3%, 100%, and 100% respectively. The early-cosmetic evaluation was excellent-good in 94.5% of patients evaluated.
Ultra-accelerated, four-fraction, minimal breast irradiation (4f-AMBI) using a minimally-invasive tumor bed implant procedure is safe, dosimetrically feasible, and shows small irradiated volumes. This program provides low toxicity rates and excellent short-term clinical and cosmesis outcomes.
在一项单臂、I/II 期研究中，评估超加速、四分割、最小化乳房照射（4f-AMBI）方案治疗早期乳腺癌患者的可行性、早期毒性和临床结果，该方案在保乳手术（BCS）期间使用多导管、微创、术中肿瘤床植入（MITBI）。
年龄>40 岁、临床和影像学确诊、单灶性侵袭性或原位≤3cm 肿瘤的女性患者，经病理报告确诊符合保乳手术适应证且符合加速部分乳腺照射（APBI）标准的患者，在保乳手术后接受超加速四分割照射（6.2Gy，BID×4fx，2 天内完成）联合围手术期高剂量率近距离放疗（PHDRBT）。分析早期并发症、毒性、临床结果和美容效果。
最初植入的 89 例患者中，60 例（67.4%）患者最终纳入 4f-AMBI 方案。中位年龄为 64.4 岁；CTV 中位体积为 32.1cc（6.9-75.4cc），外照射体积为 43.1cc（12.87-107cc），占接受照射的乳房组织的 5%，CTV D 中位值为 6.2Gy（5.6-6.28Gy）。BCS+MITBI+4f-AMBI 局部治疗完成时间的中位数为 8 天（4-10 天）。早期并发症发生率为 11%。无严重并发症。11.7%患者出现急性皮肤-皮下 G1 毒性，36.7%患者出现晚期 G1 毒性。中位随访 27 个月（11-51 个月）后，局部、远处、局部区域和远处控制率分别为 100%、98.3%、100%和 100%。94.5%接受评估的患者早期美容效果评价为优秀-良好。
微创肿瘤床植入术的超加速、四分割、最小化乳房照射（4f-AMBI）方案是安全的，具有可接受的剂量学可行性，照射体积小。该方案具有较低的毒性发生率和极好的短期临床和美容效果。
