乳腺癌新辅助治疗二次活检诊断病理学应答研究进展及临床意义

doi:10.19401/j.cnki.1007-3639.2022.04.006

摘要/Abstract

摘要：

随着乳腺癌新辅助治疗的发展,病理学完全缓解率明显提高。对于已经达到病理学完全缓解的患者,使用局域放疗替代手术治疗在理论上可行,因此术前准确判断病理学完全缓解至关重要。新辅助化疗后二次活检因其对病理学完全缓解预测准确率较高而被认为是有希望替代手术诊断病理学完全缓解的方法。最近发表的几项国外的前瞻性临床试验结果表明,新辅助化疗后二次活检具有相对较高的假阴性率,对新辅助化疗反应极好的患者豁免手术仍需要进一步研究。本文首先阐述二次活检的临床应用及其意义,并将国外已发表的临床研究分为小型可行性研究和大型前瞻性研究,对其主要结果及特点进行分析。

关键词: 乳腺癌, 新辅助治疗, 病理学完全缓解, 二次活检

Abstract:

With the development of neoadjuvant therapy, the pathological complete response rate has significantly increased for breast cancer patients.Theoretically, the use of locoregional radiotherapy instead of surgery is available for patients with pathological complete response, thus it is essential to predict pathological complete response precisely before surgery. Due to its higher accuracy for assessing the pathological complete response, the second biopsy after neoadjuvant chemotherapy is believed to have potential for diagnosing pathological complete response instead of surgery. Recently several published prospective trials showed the relatively high false negative rates of the second biopsy and omitting surgery for the exceptional responders to neoadjuvant chemotherapy required further investigation. This review elaborated on the clinical utility and significance of the second biopsy firstly and divided these studies into small feasible research and large prospective research in which the results and features were discussed.

Key words: Breast cancer, Neoadjuvant therapy, Pathological complete response, Second biopsy

中图分类号:

R737.9

许炳琦, 张国强. 乳腺癌新辅助治疗二次活检诊断病理学应答研究进展及临床意义[J]. 中国癌症杂志, 2022, 32(4): 335-342.

XU Bingqi, ZHANG Guoqiang. Advances in the diagnosis of pathological response by a second biopsy in breast cancer neoadjuvant therapy and their clinical significance[J]. China Oncology, 2022, 32(4): 335-342.

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参考文献 36

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Approach	Clinical examination	Mammography	Ultrasound	MRI	Second biopsy
Advantages	Simple and convenient	High sensitivity	Easy to operate and free of radiation; High accuracy; Assessable for axillary response;	High resolution for soft tissue; Non-invasive and free of radiation; Highest accuracy in traditional radiology	Higher accuracy than MRI; Lower false-negative rate
Disadvantages	Effect by subjective judgement; Lower accuracy than other approaches	Effect by breast density, benign calcification and artifacts etc.; Exposure to radiation; Axillary status cannot be assessed; Difficult to distinguish the residual disease and post-chemotherapy fibrosis	Highly effect by the operator; High false positive rate	Expensive; Risk of contrast agent sensitization	Invasive; Required marker clips; Accuracy depends on the size of needle and number of specimens; Guided by imaging

Study	Eligibility criteria	Number of patients	Type of biopsy	Type of guidance	Results
Heil, et al.^[12]	Early breast cancer; cCR after NACT	164	111 by CC and 46 by VAB	143 by ultrasound; 20 by mammograph; 1 by unknow	NPV=71.3% FNR=49.3%
Heil, et al.^[25]	Operable breast cancer; cCR/cPR after NACT; target lesion visible on ultrasound	50	VAB	Ultrasound	Entire cohort: NPV=76.7%; FNR=49.3%; Pathologic representative specimens: NPV=94.4%; FNR=4.8%
MD Anderson Cancer Center^[26]	TNBC and HER2⁺ breast caner; Lesion size < 5 cm on imaging after NACT	40	VAB and FNA; median sampling number of 12	63% by stereotactic techniques; 37% by ultrasound	Accuracy=98%; FNR=5%; NPV=95%
NOSTRA PRELIM^[27]	Invasive breast cancer regardless of subtypes; Received NACT	20	CNB; median sampling number of 4	Ultrasound	Cases of false negative of 4/18
Lee, et al.^[28]	Near pCR after NACT (Size of lesion≤0.5 cm or L-to-B SER ≤1.6 on MRI)	40	CNB or VAB	MRI assisted ultrasound	NPV=87.1%; FNR=30.8%; Accuracy=90%

Study group	Eligibility criteria	Type of biopsy	Number of patients	Unique features	Results
MICRA^[29]	Invasive breast cancer; No metastasis; rPR/rCR by CE-MRI after NACT	Ultrasound-guided 14G biopsies targeted around pre-NACT-placed marker (4 central and 4 peripheral)	167 (still recruiting)	Included all subtypes; Assessing response by CE-MRI	FNR=37%
RESPONDER^[30]	Invasive breast cancer; cCR/PR; Visible targeted lesion on ultrasound/mammography	Ultrasound/mammography guided VAB	398	pCR identified by VAB	FNR=17.8% (95% CI: 12.8%-23.7%)
NRG-BR005^[31]	Unifocal or multifocal; cCR after NACT; rCR/nearCR by triple- modality radiology; Patients must have a biopsy marker placed within the tumor bed with imaging confirmation of marker placement prior to NST	6, 8, 11G VAB, stereotactic-guided	98 (still recruiting)	Multicenter, triple-modality radiology was required	FNR=50% NPV=77.5% (95% CI: 66.8%-86.1%)
Multicenter pooled analysis^[32]	Invasive breast cancer; Any subtypes; At least achieved rCR; Marker/residual tumor/microcalcification can be clearly identified within the primary lesion location	VAB/CNB; Ultrasound or stereotactic	166	Multicenter pooled data analysis	FNR=18.7% NPV=84.3%