Zulkifli Dania, Manan Hanani Abdul, Yahya Noorazrul, Hamid Hamzaini Abdul
Functional Image Processing Laboratory, Department of Radiology, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, Kuala Lumpur 56000, Malaysia.
Department of Radiology and Intervency, Hospital Pakar Kanak-Kanak (Children Specialist Hospital), Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, Kuala Lumpur 56000, Malaysia.
Diagnostics (Basel). 2023 Aug 4;13(15):2595. doi: 10.3390/diagnostics13152595.
This study evaluates the role of high-intensity focused ultrasound (HIFU) ablative therapy in treating primary breast cancer.
PubMed and Scopus databases were searched according to the PRISMA guidelines to identify studies from 2002 to November 2022. Eligible studies were selected based on criteria such as experimental study type, the use of HIFU therapy as a treatment for localised breast cancer with objective clinical evaluation, i.e., clinical, radiological, and pathological outcomes. Nine studies were included in this study.
Two randomised controlled trials and seven non-randomised clinical trials fulfilled the inclusion criteria. The percentage of patients who achieved complete (100%) coagulation necrosis varied from 17% to 100% across all studies. Eight of the nine studies followed the treat-and-resect protocol in which HIFU-ablated tumours were surgically resected for pathological evaluation. Most breast cancers were single, solitary, and palpable breast tumours. Haematoxylin and eosin stains used for histopathological evaluation showed evidence of coagulation necrosis. Radiological evaluation by MRI showed an absence of contrast enhancement in the HIFU-treated tumour and 1.5 to 2 cm of normal breast tissue, with a thin peripheral rim of enhancement indicative of coagulation necrosis. All studies did not report severe complications, i.e., haemorrhage and infection. Common complications related to HIFU ablation were local mammary oedema, pain, tenderness, and mild to moderate burns. Only one third-degree burn was reported. Generally, the cosmetic outcome was good. The five-year disease-free survival rate was 95%, as reported in two RCTs.
HIFU ablation can induce tumour coagulation necrosis in localised breast cancer, with a favourable safety profile and cosmetic outcome. However, there is variable evidence of complete coagulation necrosis in the HIFU-treated tumour. Histopathological evidence of coagulation necrosis has been inconsistent, and there is no reliable radiological modality to assess coagulation necrosis confidently. Further exploration is needed to establish the accurate ablation margin with a reliable radiological modality for treatment and follow-up. HIFU therapy is currently limited to single, palpable breast tumours. More extensive and randomised clinical trials are needed to evaluate HIFU therapy for breast cancer, especially where the tumour is left in situ.
本研究评估高强度聚焦超声（HIFU）消融治疗在原发性乳腺癌治疗中的作用。
根据PRISMA指南检索PubMed和Scopus数据库，以识别2002年至2022年11月期间的研究。符合条件的研究根据实验研究类型、使用HIFU疗法治疗局限性乳腺癌并进行客观临床评估（即临床、放射学和病理学结果）等标准进行选择。本研究纳入了9项研究。
两项随机对照试验和七项非随机临床试验符合纳入标准。在所有研究中，实现完全（100%）凝固性坏死的患者百分比从17%到100%不等。九项研究中的八项遵循治疗后切除方案，即对HIFU消融的肿瘤进行手术切除以进行病理评估。大多数乳腺癌为单发、孤立且可触及的乳腺肿瘤。用于组织病理学评估的苏木精和伊红染色显示有凝固性坏死的证据。MRI的放射学评估显示，HIFU治疗的肿瘤及1.5至2厘米的正常乳腺组织无对比增强，周边有薄的增强边缘，提示凝固性坏死。所有研究均未报告严重并发症，即出血和感染。与HIFU消融相关的常见并发症为局部乳腺水肿、疼痛、压痛以及轻度至中度烧伤。仅报告了一例三度烧伤。总体而言，美容效果良好。两项随机对照试验报告的五年无病生存率为95%。
HIFU消融可在局限性乳腺癌中诱导肿瘤凝固性坏死，具有良好的安全性和美容效果。然而，HIFU治疗的肿瘤中完全凝固性坏死的证据存在差异。凝固性坏死的组织病理学证据不一致，且没有可靠的放射学方法能够自信地评估凝固性坏死。需要进一步探索以建立准确的消融边缘，并采用可靠的放射学方法进行治疗和随访。HIFU治疗目前仅限于单发、可触及的乳腺肿瘤。需要进行更广泛的随机临床试验来评估HIFU治疗乳腺癌的效果，尤其是对于原位保留肿瘤的情况。
