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使用诊断超声和微泡增强HER2阴性乳腺癌新辅助化疗的人体临床试验。

Human clinical trial using diagnostic ultrasound and microbubbles to enhance neoadjuvant chemotherapy in HER2- negative breast cancer.

作者信息

Zhou Biqiang, Lian Qingshu, Jin Chunchun, Lu Jianghao, Xu Lifeng, Gong Xuehao, Zhou Peng

机构信息

Department of Geriatric & Spinal Pain Multi-Department Treatment, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, China.

Department of Ultrasound, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, China.

出版信息

Front Oncol. 2022 Oct 20;12:992774. doi: 10.3389/fonc.2022.992774. eCollection 2022.

DOI:10.3389/fonc.2022.992774
PMID:36338760
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9630359/
Abstract

BACKGROUND

and experiments have demonstrated that diagnostic ultrasound combined with microbubbles (USMB) can enhance tumor chemotherapy, but few clinical studies have explored the effect of USMB in human HER2-negative breast cancer. We aimed to compare USMB combined with neoadjuvant chemotherapy (NAC) with NAC alone in the treatment of human HER2-negative breast cancer.

METHODS

Patients (n=10) enrolled in the study were treated with TAC (taxane - (docetaxel), anthracycline - (epirubicin or doxorubicin liposomes), and cyclophosphamide) and ultrasound using a commercial clinical ultrasound scanner for 20 min after each chemotherapy session, followed by intermittent injections of SonoVue to induce sonoporation and enhance therapeutic efficacy. Contrast-enhanced ultrasound (CEUS) was used to record tumor perfusion before and after ultrasound treatment.

RESULTS

After completion of chemotherapy, the maximum tumor diameter of patients in the combined treatment group (n=10) was significantly smaller than that in the control group (n=16) (=0.017). Although the combined treatment group had higher overall response and clinical benefit rates than those in the control group, there was no statistically significant difference in RECIST between the combined treatment group and the control groups (=0.590). More patients in the combination therapy group achieved pathologic complete response than in the control group (=0.014). For combined treatment, CEUS revealed that the peak intensity, mean transit time, and area under the curve were higher after treatment than before treatment (<0.001, <0.001, =0.003, respectively). Combined therapy did not cause additional toxicity or increase side effects.

CONCLUSION

USMB and chemotherapy can be combined in a clinical setting using commercially available equipment, without additional toxicity, and may improve the efficacy of NAC in HER2-negative breast cancer.

摘要

背景

实验已证明,诊断性超声联合微泡(USMB)可增强肿瘤化疗效果,但很少有临床研究探讨USMB对人HER2阴性乳腺癌的作用。我们旨在比较USMB联合新辅助化疗(NAC)与单纯NAC治疗人HER2阴性乳腺癌的效果。

方法

纳入研究的患者(n = 10)接受TAC(紫杉烷 - (多西他赛)、蒽环类药物 - (表柔比星或阿霉素脂质体)和环磷酰胺)治疗,每次化疗后使用商用临床超声扫描仪进行20分钟超声治疗,随后间歇性注射声诺维以诱导声孔效应并提高治疗效果。使用超声造影(CEUS)记录超声治疗前后的肿瘤灌注情况。

结果

化疗完成后,联合治疗组(n = 10)患者的最大肿瘤直径显著小于对照组(n = 16)(P = 0.017)。虽然联合治疗组的总体缓解率和临床获益率高于对照组,但联合治疗组与对照组之间的实体瘤疗效评价标准(RECIST)差异无统计学意义(P = 0.590)。联合治疗组达到病理完全缓解的患者比对照组更多(P = 0.014)。对于联合治疗,CEUS显示治疗后峰值强度、平均通过时间和曲线下面积均高于治疗前(分别为P < 0.001、P < 0.001、P = 0.003)。联合治疗未引起额外毒性或增加副作用。

结论

使用商用设备可在临床环境中将USMB与化疗联合,且无额外毒性,可能提高NAC对HER2阴性乳腺癌的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/f5aa1874de6c/fonc-12-992774-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/38eb1e969c19/fonc-12-992774-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/ce5aeacb9551/fonc-12-992774-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/cdecab65fcb2/fonc-12-992774-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/aca33a47e4a8/fonc-12-992774-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/766b155849be/fonc-12-992774-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/f5aa1874de6c/fonc-12-992774-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/38eb1e969c19/fonc-12-992774-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/ce5aeacb9551/fonc-12-992774-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/cdecab65fcb2/fonc-12-992774-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/aca33a47e4a8/fonc-12-992774-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/766b155849be/fonc-12-992774-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a52a/9630359/f5aa1874de6c/fonc-12-992774-g006.jpg

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