Purpose of the Report: Accurate clinical axillary evaluation plays an important role in the diagnosis and treatment planning for early-stage breast cancer (BC). This study aimed to develop a scalable, non-invasive and robust machine learning model for predicting of the pathological node status using dedicated-PET integrating the clinical characteristics in early-stage BC. Materials and Methods: A total of 420 BC patients confirmed by postoperative pathology were retrospectively analyzed. 18F-fluorodeoxyglucose (¹⁸F-FDG) Mammi-PET, ultrasound, physical examination, Lymph-PET, and clinical characteristics were analyzed. The least absolute shrinkage and selection operator (LASSO) regression analysis were used in developing prediction models. The characteristic curve (ROC) of the area under receiver-operator (AUC) and DeLong test were used to evaluate and compare the performance of the models. The clinical utility of the models was determined via decision curve analysis (DCA). Then, a nomogram was developed based on the model with the best predictive efficiency and clinical utility and was validated using the calibration plots. Results: A total of 290 patients were enrolled in this study. The AUC of the integrated model diagnosed performance was 0.94 (95% confidence interval (CI), 0.91–0.97) in the training set (n = 203) and 0.93 (95% CI, 0.88–0.99) in the validation set (n = 87) (both p < 0.05). In clinical N0 subgroup, the negative predictive value reached 96.88%, and in clinical N1 subgroup, the positive predictive value reached 92.73%. Conclusions: The use of a machine learning integrated model can greatly improve the true positive and true negative rate of identifying clinical axillary lymph node status in early-stage BC.

Less developed countries (LDCs) are struggling with an increasing burden of breast cancer. It is important to identify what interventions might be most effective and feasible in reducing overall breast cancer mortality in a resource constrained settings. Mammography screening (MS) utilized in developed countries cannot be equally applied to LDCs. We provide a summary of the status of existing and past MS program attempts in LDCs, and try to determine the prerequisites under which any developing country is ready to benefit from a MS program. We make the case for a “mixed” portfolio of tools to reduce breast cancer mortality with MS reserved only for those sub-populations that meet the criteria. We hope our review will provide a background for policy makers to apply rigorous criteria before attempting to implement costly MS program and before judiciously evaluating additional competed programs in their countries.

Standard neoadjuvant regimens for HER2-positive breast cancer include trastuzumab and pertuzumab combined with chemotherapy, and the efficacy and safety of third-generation HER2-direted antibody-drug conjugate (ADC) remain to be elucidated. This open-label, randomized, phase 2 study enrolled patients aged 18 years or older with stage II-III Her2-positive breast cancer. Patients were randomly assigned (1:1:1) to receive neoadjuvant treatment either with SHR-A1811 monotherapy, SHR-A1811 with pyrotinib, or nab-paclitaxel combined with carboplatin, trastuzumab, and pertuzumab (PCbHP) for 24 weeks. The primary endpoint was pathological complete response (pCR). Safety was analysed in patients who received at least one dose of study medication. Between December 27, 2022, and February 11, 2024, 265 patients were randomly allocated to neoadjuvant, mono-SHR-A1811 (n=87), SHR-A1811 plus pyrotinib (n=88), or PCbHP (n=90). The baseline characteristics were well balanced; approximately 45% of the patients were hormone receptor (HR)-positive, and 70% of the patients were stage III. The pCR rate was 63.2% for mono-SHR-A1811 (50% for HR+ and 74.5% for HR-), 62.5% for SHR-A1811 plus pyrotinib (44.7% for HR+ and 76% for HR-) and 64.4% for PCbHP (54.1% for HR+ and 71.7% for HR-), with no significant difference between the groups. Grade 3 or higher treatment-related adverse events occurred in 44.8% of patients with mono-SHR-A1811, 71.6% with SHR-A1811 plus pyrotinib and 38.8% with PCbHP. One patient experienced grade 2 interstitial lung disease in SHR-A1811, 9.1% of patients experienced grade 3 diarrhea in SHR-A1811 plus pyrotinib, and no treatment-related deaths occurred. This is the first study to report the efficacy and safety of third-generation HER2-directed ADC in the neoadjuvant setting for HER2-positive breast cancer. SHR-A1811 showed robust activity, with a tolerable safety profile. (ClinicalTrials.gov, NCT05582499).

Background: Targeted axillary dissection (TAD) includes biopsy of clipped lymph node and sentinel lymph nodes. However, clinical evidence regarding clinical feasibility and oncological safety of non-radioactive TAD in a real-world cohort remains limited. Methods: In this prospective registry study, patients routinely underwent clip insertion into biopsy-confirmed lymph node. Eligible patients received neoadjuvant chemotherapy (NACT) followed by axillary surgery. Main endpoints included the false-negative rate (FNR) of TAD and nodal recurrence rate. Results: Data from 353 eligible patients were analyzed. After completion of NACT, 85 patients directly proceeded to axillary lymph node dissection (ALND), furthermore, TAD with or without ALND was performed in 152 and 85 patients, respectively. Overall detection rate of clipped node was 94.9% (95%CI, 91.3%-97.4%) and FNR of TAD was 12.2% (95%CI, 6.0%-21.3%) in our study, with FNR decreasing to 6.0% (95%CI, 1.7%-14.6%) in initially cN1 patients. During a median follow-up of 36.6 months, 3 nodal recurrences occurred (3/237 with ALND; 0/85 with TAD alone), with a three-year freedom-from-nodal-recurrence rate of 100.0% among the TAD-only patients and 98.7% among the ALND patients with axillary pathologic complete response (P=0.29). Conclusions: TAD is feasible in initially cN1 breast cancer patients with biopsy-confirmed nodal metastases. ALND can safely be foregone in patients with negativity or a low volume of nodal positivity on TAD, with a low nodal failure rate and no compromise of three-year recurrence-free survival.

Background: Vacuum-assisted biopsy (VAB) and core needle biopsy (CNB) are both widely used methods in diagnosing breast lesions. We aimed to determine whether the Elite 10-gauge VAB achieves higher accuracy than the BARD spring-actuated 14-gauge CNB. Materials and methods: This was a phase 3, open-label, parallel, randomized controlled trial (NCT04612439). In total, 1470 patients with ultrasound (US)-visible breast lesions requiring breast biopsy were enrolled from April to July 2021 and randomized at a 1 : 1 ratio to undergo VAB or CNB. All patients underwent surgical excision after needle biopsy. The primary outcome was accuracy, defined as the proportion of patients who had a consistent qualitative diagnosis between the biopsy and surgical pathology results. The underestimation rate, false-negative rate and safety evaluations were the secondary endpoints. Results: A total of 730 and 732 patients were evaluable for endpoints in the VAB and CNB groups, respectively. The accuracy of VAB surpassed that of CNB in the whole population (94.8 vs. 91.1%, P=0.009). The overall malignant underestimation rate was significantly lower in the VAB group than in the CNB group (21.4 vs. 30.9%, P=0.035). Additionally, significantly more false-negative events were noted in the CNB group (4.9 vs. 7.8%, P=0.037). In patients who presented with accompanying calcification, the accuracy of VAB surpassed that of CNB (93.2 vs. 88.3%, P=0.022). The potential superiority of VAB was indicated in patients with heterogeneous echo on US. Conclusions: In general, the 10-G VAB procedure is a reasonable alternative to the 14-G CNB procedure with higher accuracy. We recommend the use of VAB for lesions with accompanying calcification or heterogeneous echo on US.