Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy

TPS600 Background: Neoadjuvant chemotherapy (NACT) results in eradication of cancer in the axillary nodes in 40% to 70% of patients. This raises questions about the benefit of further axillary treatment in those patients with no evidence of residual nodal disease (ypN0) after NACT. Methods: Design: ATNEC is a phase 3, randomised (1:1), multi-centre trial, with embedded economic evaluation, comparing standard axillary treatment (axillary lymph node dissection [ALND] or axillary radiotherapy [ART]) with no further axillary treatment in T1-3N1M0 breast cancer patients with needle biopsy proven axillary nodal metastases, who after NACT have no residual nodal disease (ypN0) on dual tracer sentinel node biopsy (SNB) and removal of at least 3 nodes (sentinel nodes and marked involved node). Stratification: Institution, type of surgery (breast conserving surgery vs mastectomy), receptor status (triple negative vs HER2 positive vs ER positive and/or PR positive and HER2 negative). Inclusion criteria are: Age ≥ 18, Male or female, T1-3N1M0 breast cancer at diagnosis (pre-NACT), FNA or core biopsy confirmed axillary nodal metastases at presentation, ER and HER2 status evaluated on primary tumour, received standard NACT as per local guidelines, ultrasound of the axilla at completion of NACT, dual tracer SNB after NACT and at least 3 nodes removed (sentinel nodes and marked node), no evidence of nodal metastases post NACT (ypN0). Exclusion criteria are: bilateral invasive breast cancer, SNB prior to NACT, marked node not removed except where at least one node removed shows evidence of down-staging with complete pathological response e.g. fibrosis/scarring and at least 3 nodes removed, previous ipsilateral axillary surgery, previous cancer within last 5 years or concomitant malignancy except basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, in situ or stage 1 melanoma, contra- or ipsilateral in situ breast cancer. Aims: To assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy - who after NACT have no residual nodal disease on SNB (ypN0) - is non-inferior to axillary treatment in terms of disease free survival, and reduces the risk of lymphoedema at 5 years. Statistical methods: All analyses will be carried out on an intention-to-treat basis to preserve randomisation, avoid bias from exclusions and preserve statistical power. Radiotherapy quality assurance: Study has in-built radiotherapy QA programme that will be co-ordinated by National Radiotherapy Trials QA (RTTQA) group. Target accrual: 1900. Trial status: Recruiting. Number of sites: 100. Clinical trial information: NCT04109079.

Download Full-text

DJ-1 as a predictor of pathologic complete remission of neoadjuvant chemotherapy with breast cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.10544 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 10544-10544

Author(s):

Takahiko Kawate

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Complete Remission ◽

Cancer Patients ◽

Expression Pattern ◽

Therapeutic Effect ◽

Needle Biopsy ◽

Mrna Level ◽

Breast Cancer Patients ◽

Low Expression

10544 Background: DJ-1 is a multifunctional protein which is encoded by the causative gene of familial Parkinson disease (i.e., PARK7), and is associated with carcinogenesis. DJ-1 is also a candidate marker for the presence of breast cancer cells, in which it is secreted in nipple fluid and serum. We previously reported that a DJ-1 expression pattern that is low at the protein level and high at the mRNA level is associated with DJ-1 secretion. This secretory expression pattern correlated with a negative hormone receptor status and with unfavorable clinical outcome in breast cancer patients. However, the association of the DJ-1 secretion pattern with therapeutic effect has yet to be determined. Methods: A total of 299 patients received neoadjuvant chemotherapy and surgery from 2002 to 2010 at our institution. We performed immunohistochemistry and in-situ hybridization of DJ-1 in both the needle biopsy and operative specimens of 147 cases with a follow-up time of 3.1 years. The average degree of staining intensity was evaluated semi-quantitatively using an image analyzer. Univariate and multivariate analyses were used to evaluate the predictive value of the therapeutic effect of neoadjuvant chemotherapy. Results: A low expression of DJ-1 protein was detected in the needle biopsy and operative specimens of 89 of the 147 cases, regardless of a high or maintained mRNA level. The tumor response was evaluated as pathological complete remission (pCR) in 39 cases and as non-pCR in the remaining 108 cases. A low expression of DJ-1 protein, which was detected in 34 (87.2%) pCR cases, was a significant predictor on univariate analysis (P <0.001). On multivariate analysis, a low expression of DJ-1 was shown to be a significant independent predictor similar to established predictors such as estrogen receptor status and human epidermal growth factor receptor 2 score. Conclusions: A low expression of DJ-1 protein can serve as a novel and important predictor of a neoadjuvant chemotherapeutic effect, as well as a promising indicator for serologic diagnosis in breast cancer patients.

Download Full-text

The discordance of the ER, PR, and HER2 status after neoadjuvant chemotherapy in breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e12037 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e12037-e12037

Author(s):

Basak Oven Ustaalioglu ◽

Ahmet Bilici ◽

Fugen Vardar Aker ◽

Burcak Erkol ◽

Mehmet Aliustaoglu ◽

...

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Cancer Patients ◽

Core Needle Biopsy ◽

Needle Biopsy ◽

Locally Advanced Breast Cancer ◽

Locally Advanced ◽

Her2 Status ◽

Breast Cancer Patients ◽

Core Needle

e12037 Background: Neoadjuvant chemotherapy(NAC) is the accepted approach for women with locally advanced breast cancer with technically inoperable disease. Systemic treatment is mainly based on the presence of the Estrogen (ER) receptor, Progesterone (PR) receptor and HER2 status on the core needle biopsy prior to treatment. Previously, discordance of the hormone receptor (HR) status was reported as 8-33% in the breast cancer patients after NAC. In here, we evaluated the HR and HER2 discordance after NAC in locally advanced breast cancer patients. Methods: We reviewed the data of 849 breast cancer patients retrospectively. The pathological specimens of core needle biopsy and operation specimens were re-evaluated for HR and HER2 status in 38 patients who had been treated with NAC. The changing of HR and HER2 status after chemotherapy was defined as discordance. The relationship between clinicopathological parameters and discordance and significance of them for disease-free survival (DFS) was analyzed by chi-square and univariaty test. Results: Over 80% of patients were clinically stage III breast cancer. Out of 24 patients were premenapouse and median age was 44.5(30-94). The patients were received median 4(1-6) cycles of NAC as 2 of them were only hormonotherapy, 8 were only antracycline and others were both antracycline and taxanes. Nearly 80% of patients were performed modified radical mastectomy(MRM).Postoperatively median tumor size was 1.6cm(0-10) and median dissected lymph nodes was 14(0-28). After operation, 4(10.5%), 8(21.1%) and 8(21.1%) discordance were detected for ER, PR and HER2 respectively. While HER2 discordance were related with recurrence(p=0.01) and PR discordance(p=0.04), ER discordance was related with only patological stage(p=0.03). At the median follow-up of 15.7 months, 5 year DFS rate and time were 30% and 30.4 months(18.7-42.2), respectively. Operation type, stage, lymphovascular invasion, perineural invasion were found to be significant for DFS, HR and HER2 discordance was not related with DFS. Conclusions: Until more definitive results will be obtained from future studies, receptor status of the residual tumor after NAC should be retested.

Download Full-text