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Abstract：
BACKGROUND: Accelerated partial breast irradiation (APBI) is an alternative breast-conserving therapy approach where radiation is delivered in less time compared to whole breast irradiation (WBI), resulting in improved patient convenience, less toxicity, and cost savings. This prospective randomized study compares the external beam APBI with commonly used moderate hypofractionated WBI in terms of feasibility, safety, tolerance, and cosmetic effects.
METHODS: Early breast cancer patients after partial mastectomy were equally randomized into two arms- external APBI and moderate hypofractionated WBI. External beam technique using available technical innovations commonly used in targeted hypofractionated radiotherapy to minimize irradiated volumes was used (cone beam computed tomography navigation to clips in the tumor bed, deep inspiration breath hold technique, volumetric modulated arc therapy dose application, using flattening filter free beams and the six degrees of freedom robotic treatment couch). Cosmetics results and toxicity were evaluated using questionnaires, CTCAE criteria, and photo documentation.
RESULTS: The analysis of 84 patients with a median age of 64 years showed significantly fewer acute adverse events in the APBI arm regarding skin reactions, local and general symptoms during a median follow-up of 37 months (range 21-45 months). A significant difference in favor of the APBI arm in grade ≥ 2 late skin toxicity was observed (p = 0.026). Late toxicity in the breast area (deformation, edema, fibrosis, and pain), affecting the quality of life and cosmetic effect, occurred in 61% and 17% of patients in WBI and APBI arms, respectively. The cosmetic effect was more favorable in the APBI arm, especially 6 to 12 months after the radiotherapy.
CONCLUSIONS: External APBI demonstrated better feasibility and less toxicity than the standard regimen in the adjuvant setting for treating early breast cancer patients. The presented study confirmed the level of evidence for establishing the external APBI in daily clinical practice.
BACKGROUND: NCT06007118.
METHODS: Early breast cancer patients after partial mastectomy were equally randomized into two arms- external APBI and moderate hypofractionated WBI. External beam technique using available technical innovations commonly used in targeted hypofractionated radiotherapy to minimize irradiated volumes was used (cone beam computed tomography navigation to clips in the tumor bed, deep inspiration breath hold technique, volumetric modulated arc therapy dose application, using flattening filter free beams and the six degrees of freedom robotic treatment couch). Cosmetics results and toxicity were evaluated using questionnaires, CTCAE criteria, and photo documentation.
RESULTS: The analysis of 84 patients with a median age of 64 years showed significantly fewer acute adverse events in the APBI arm regarding skin reactions, local and general symptoms during a median follow-up of 37 months (range 21-45 months). A significant difference in favor of the APBI arm in grade ≥ 2 late skin toxicity was observed (p = 0.026). Late toxicity in the breast area (deformation, edema, fibrosis, and pain), affecting the quality of life and cosmetic effect, occurred in 61% and 17% of patients in WBI and APBI arms, respectively. The cosmetic effect was more favorable in the APBI arm, especially 6 to 12 months after the radiotherapy.
CONCLUSIONS: External APBI demonstrated better feasibility and less toxicity than the standard regimen in the adjuvant setting for treating early breast cancer patients. The presented study confirmed the level of evidence for establishing the external APBI in daily clinical practice.
BACKGROUND: NCT06007118.
摘要：
背景：加速部分乳房照射（APBI）是一种替代的保乳治疗方法，与全胸照射（WBI）相比，放射时间更短，提高了患者的便利性，毒性较小,和成本节约。这项前瞻性随机研究在可行性方面比较了外束APBI和常用的中度低分割WBI。安全,容忍度,和美容效果。
方法：将部分乳房切除术后的早期乳腺癌患者随机分为两例-臂外APBI和中度高分割WBI。使用了在靶向大分割放射治疗中通常使用的可用技术创新的外部束技术，以最大程度地减少被照射的体积（锥形束计算机断层扫描导航到肿瘤床中的夹子，深吸气屏气技术，体积调制电弧治疗剂量应用，使用展平过滤器自由梁和六自由度机器人治疗床)。使用问卷评估化妆品结果和毒性，CTCAE标准,和照片文档。
结果：对84例中位年龄为64岁的患者进行的分析显示，APBI组皮肤反应方面的急性不良事件明显减少，中位随访37个月(范围21-45个月)期间的局部和一般症状.在≥2级晚期皮肤毒性中，APBI组的优势显着差异（p=0.026）。乳房区域的晚期毒性（变形，水肿,纤维化，和痛苦），影响生活质量和美容效果，在WBI和APBI组中分别有61%和17%的患者发生，分别。美容效果在APBI臂中更有利，特别是放疗后6~12个月。
结论：在辅助治疗早期乳腺癌患者中，与标准方案相比，外用APBI显示出更好的可行性和更小的毒性。本研究证实了在日常临床实践中建立外部APBI的证据水平。
背景：NCT06007118。
方法：将部分乳房切除术后的早期乳腺癌患者随机分为两例-臂外APBI和中度高分割WBI。使用了在靶向大分割放射治疗中通常使用的可用技术创新的外部束技术，以最大程度地减少被照射的体积（锥形束计算机断层扫描导航到肿瘤床中的夹子，深吸气屏气技术，体积调制电弧治疗剂量应用，使用展平过滤器自由梁和六自由度机器人治疗床)。使用问卷评估化妆品结果和毒性，CTCAE标准,和照片文档。
结果：对84例中位年龄为64岁的患者进行的分析显示，APBI组皮肤反应方面的急性不良事件明显减少，中位随访37个月(范围21-45个月)期间的局部和一般症状.在≥2级晚期皮肤毒性中，APBI组的优势显着差异（p=0.026）。乳房区域的晚期毒性（变形，水肿,纤维化，和痛苦），影响生活质量和美容效果，在WBI和APBI组中分别有61%和17%的患者发生，分别。美容效果在APBI臂中更有利，特别是放疗后6~12个月。
结论：在辅助治疗早期乳腺癌患者中，与标准方案相比，外用APBI显示出更好的可行性和更小的毒性。本研究证实了在日常临床实践中建立外部APBI的证据水平。
背景：NCT06007118。
