超声引导下真空辅助切除乳腺病灶的多中心队列真实世界研究

Ultrasound guided vacuum assisted excision in treating breast diseases in a multicenter cohort prospective real world research

目的在真实世界研究(RWR)模式下,探讨乳腺病灶真空辅助切除术(VAE)手术效果、适应证、偶发乳腺癌的临床及影像特征。方法本研究为多中心前瞻性研究。收集2020年5月—2021年4月符合纳入标准的3278例乳腺病灶患者,均行超声引导下VAE。符合正态分布的计量资料采用t检验,非正态分布的连续变量采用Wilcoxon秩和检验;计数资料采用χ^(2)检验,理论频数<1,采用Fisher确切概率法;分析乳腺良恶性病灶患者的基线资料、术前临床资料与影像特征、VAE适应证的差异,以及恶性病灶患者行二次手术后保乳、前哨淋巴结活检、病灶残留情况。结果3278例中,病理恶性75例、病理良性3203例。恶性病灶患者年龄(41.5~55.0岁、中位年龄48.0岁)比良性病灶患者(31.5~48.0岁、39.0岁)大,差异有统计学意义(χ^(2)=6.630,P<0.001)。恶性病灶患者体质量指数(BMI)比良性患者大,BMI分别是(21.5~25.1)kg/m2、(20.0~23.7)kg/m2,中位BMI分别是23.1kg/m2、21.8 kg/m2,差异有统计学意义(χ^(2)=3.630,P<0.001)。良性病灶患者有生育史的2337例,明显高于恶性病灶患者66例;良恶性罩杯A~E比较,差异均具有统计学意义(P均<0.05)。术前检查与影像特征中:可触及肿块、超声声波衰减、乳腺影像报告和数据系统(BI-RADS)Ⅳa级、钼靶检查发现钙化和肿块,在良性病灶患者中分别为471例、12例、918例、92例、39例,在恶性病灶患者中分别为19例、4例、41例、6例、4例,且恶性病灶患者较良性病灶患者占比高,差异具有统计学意义(P均<0.05)。良性病灶与恶性病灶患者在手术适应证各指征占比中的比较,差异均有统计学意义(P均<0.001),其中恶性BI-RADS分级增高占比最高。75例恶性病灶患者中,42例行二次根治性手术,保乳成功16例,前哨淋巴结活检成功39例,病灶残留18例。结论对超声检查BI-RADS分级增高,并伴有高龄、肥胖因素的乳腺良性病灶患者,应警惕恶性可能;VAE对乳腺癌的保乳率、前哨淋巴结活检成功率影响较小。

Objective In the real-world research(RWR) mode,to explore the effects of the surgery,indications,and clinical and imaging characteristics of breast cancer in patients undergoing vacuum-assisted excision(VAE) of breast lesions. Methods This study was a multicentric prospective study. 3 278 patients with breast lesions who met the criteria were enrolled from May 2020 to April 2021. Ultrasound-guided vacuum-assisted excision was performed. The data were measured by t-test(continuous variable of normal distribution) and Wilcoxon rank sum test(continuous variable of non-normal distribution). The counting data were measured by χ~2 test or Fisher exact probability method(when any theoretical frequency is less than 1). The difference in baseline information,preoperative clinical data,imaging characteristics,and the indications of VAE for breast tumors were compared between patients with benign and malignant lesions and the breast conservation therapy,biopsy of anterior lymph nodes,and residual lesions after secondary surgery in patients with malignant lesions. Results In 3 278cases,75 were pathologically malignant,and 3 203 were pathologically benign. Compared with patients with benign lesions(31.5-48.0 years old,median age 39.0 years old),patients with malignant lesions are older(41.5-55.0 years old,median age 48.0 years old),and the difference was statistically significant(χ^(2)=6.630,P<0.001). Patients with malignant lesions have a higher BMI. The BMI of patients with benign and malignant lesions(21.5-25.1 kg/m~2,median BMI 23.1 kg/m~2;20.0-23.7 kg/m~2,median BMI 21.8 kg/m~2) and the difference was statistically significant(χ^(2)=3.630,P<0.001). The patients with benign lesions had a childbearing history of 2 337,which was higher than 66 patients with malignant lesions without a childbearing history.Between the two groups(benign and malignant),there were differences in the distribution of breast size,and the differences were statistically significant(P<0.05). Among the preoperative examinations and imaging features: the cases of palpable lesions in benign patients,cases of sound attenuation on ultrasonography,cases of Breast Imaging Reporting and Data System(BI-RADS)grade Ⅳa,cases of calcifications,and cases of breast lump found on mammography are 471,12,918,92 and 39 which were significantly higher than those of patients with malignant lesions,19 cases,4 cases,41 cases,6 cases,and 4 cases. A higher proportion of patients with malignant lesions than with benign lesions,with statistically significant differences(all P<0.05). The differences in the percentage of patients with benign versus malignant lesions for each indication of surgical indication were statistically significant(all P<0.001),with the highest proportion of the increase in malignant BI-RADS classification. Among the 75 patients with malignant lesions,42 malignant patients underwent secondary radical surgery,breast-conserving success in 16 cases,successful biopsies of anterior lymph nodes in 39 cases,and residual lesions in 18 cases. Conclusion Patients with breast lesions with increased BI-RADS grade on ultrasound and "benign lesions" with advanced age and obesity should be alerted to the possibility of the malignant lesion;there is little effect between VAE and breast conservation rate and success rate of sentinel lymph node biopsy in incidental breast cancer.