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The EORTC Quality of Life Utility Core 10 Dimensions (QLU-C10D) and the Patient-Reported Outcome Measurement Information System Preference Score (PROPr) are new health state utility (HSU) scores for quality-adjusted life years in cost-effectiveness analyses. Both are expected to measure HSU more comprehensively than existing measures in cancer patients by including cancer-related health domains such as fatigue. The aim of this study is to compare both scores in a sample of breast cancer patients.We collected QLU-C10D and PROPr from 291 patients 90 days after treatment in the outpatient clinic of the breast cancer center at Charité - University Medicine Berlin between June 2018 and April 2021. We assessed both scores' convergent and known-groups validity, agreement, and ceiling and floor effects.The mean QLU-C10D score [0.71, 95% confidence interval (CI) 0.69-0.74] and the mean PROPr score (0.43, 95% CI 0.41-0.46) differed systematically (0.28, 95% CI 0.27-0.30) and showed fair agreement (intraclass correlation coefficient 0.46, 95% CI 0.32-0.57). The Pearson correlation coefficient was 0.83 (95% CI 0.79-0.86). Both scores showed similar discrimination across known groups of age, treatment, cancer stage, marital status, and education. The QLU-C10D showed relevant ceiling effects.QLU-C10D and PROPr measure HSU differently as a result of different utility models. The choice between QLU-C10D and PROPr should be informed by context, population, disease, and treatment.

Purpose To assess the accuracy of preoperative sonographic staging for prediction of limited axillary disease (LAD, one or two metastatic lymph nodes) and to identify factors associated with high prediction–pathology concordance in patients with early-stage breast cancer meeting the Z0011 criteria. Materials and Methods Patients treated between January 2015 and January 2020 were included in this retrospective, multicentric analysis of prospectively acquired service databases. The accuracy of LAD prediction was assessed separately for patients with one and two suspicious lymph nodes on preoperative sonography. Test validity outcomes for LAD prediction were calculated for both groups, and a multivariate model was used to identify factors associated with high accuracy of LAD prediction. Results Of 2059 enrolled patients, 1513 underwent sentinel node biopsy, 436 primary and 110 secondary axillary dissection. For LAD prediction in patients with one suspicious lymph node on preoperative ultrasound, sensitivity was 92% (95% CI 87–95%), negative predictive value (NPV) was 92% (95% CI 87–95%), and the false-negative rate (FNR) was 8% (95% CI 5–13%). For patients with two preoperatively suspicious nodes, the sensitivity, NPV, and FNR were 89% (95% CI 84–93%), 73% (62–83%), and 11% (95% CI 7–16%), respectively. On multivariate analysis, the number of suspicious lymph nodes was associated inversely with correct LAD prediction ([OR 0.01 (95% CI 0.01–0.93), p ≤ 0.01]. Conclusions Sonographic axillary staging in patients with one metastatic lymph node predicted by preoperative ultrasound showed high accuracy and a false-negative rate comparable to sentinel node biopsy for prediction of limited axillary disease.

Background Altered expression levels and structural variations in the vascular endothelial growth factor (VEGF) have been found to play important roles in cancer development and to be associated with the overall survival and therapy response of cancer patients. Particularly VEGF-A and its splice variants have been found to affect physiological and pathological angiogenic processes, including tumor angiogenesis, correlating with tumor progression, mostly caused by overexpression. This review focuses on the expression and impact of VEGF-A splice variants under physiologic conditions and in tumors and, in particular, the distribution and role of isoform VEGF165b in breast cancer. Conclusions and perspectives Many publications already highlighted the importance of VEGF-A and its splice variants in tumor therapy, especially in breast cancer, which are summarized in this review. Furthermore, we were able to demonstrate that cytoplasmatic VEGFA/165b expression is higher in invasive breast cancer tumor cells than in normal tissues or stroma. These examples show that the detection of VEGF splice variants can be performed also on the protein level in formalin fixed tissues. Although no quantitative conclusions can be drawn, these results may be the starting point for further studies at a quantitative level, which can be a major step towards the design of targeted antibody-based (breast) cancer therapies.

In preparation for the PRO B study which aims to examine the effects of an app-based intensified patient-reported outcome (PRO) monitoring for metastatic breast cancer patients, prior assessment of its feasibility was carried out. Sixteen breast cancer patients visiting the breast cancer unit at Charité were recruited and downloaded an app connected to an ePRO system. They received electronic questionnaires on two occasions (baseline and the following week) and were subsequently contacted for a semi-structured phone interview for evaluation. Eleven participants answered at least one questionnaire. Some participants did not receive any or only a part of the questionnaires due to technical problems with the app. Participants who completed the evaluation questionnaire (n = 6) were overall satisfied with the weekly PRO questionnaire. All interviewed (n = 11) participants thought it was feasible to answer the PRO questionnaires on a weekly basis for one year, as planned in the PRO B study. The pretest revealed a need for major technical adjustments to the app because push notifications about the receipt of new questionnaires were not displayed on some smartphone models. Due to the low number of participants, generalization of the findings is limited to our specific context and study. Nevertheless, we could conclude that if technical aspects of the app were improved, the PRO B study could be implemented as planned. The ePRO questionnaire was considered feasible and adequate from the patients’ perspectives.

Simple Summary Metastatic breast cancer (MBC) remains incurable despite treatment improvements. The health-related quality of life is a multidimensional entity which covers physical, psychological and social dimensions. It is an important outcome particularly in patients with metastatic disease, as the primary goal of therapy is no longer curation, but to provide the best possible quality of life weighted against treatment risks and adverse symptoms. Patient-reported outcomes reflecting the quality of life are usually measured with validated questionnaires to evaluate treatment strategies based on symptom burden and to improve care delivery. This review shares insights into the role of patient-reported outcome measurements in MBC patients and describes the heterogeneity of current questionnaires. We conclude that an up-to-date and standardized outcome set is needed, containing relevant domains referring to individual needs to improve the quality of life assessment among MBC patients. This is a prerequisite to learn about how they could impact the clinical care pathway. Abstract Metastatic breast cancer (MBC) patients are almost always treated to minimize the symptom burden, and to prolong life without a curative intent. Although the prognosis of MBC patients has improved in recent years, the median survival after diagnosis is still only 3 years. Therefore, the health-related quality of life (HRQoL) should play a leading role in making treatment decisions. Heterogeneity in questionnaires used to evaluate the HRQoL in MBC patients complicates the interpretability and comparability of patient-reported outcomes (PROs) globally. In this review, we aimed to provide an overview of PRO instruments used in real-world MBC patients and to discuss important issues in measuring HRQoL. Routinely collecting symptom information using PROs could enhance treatment evaluation and shared decision-making. Standardizing these measures might help to improve the implementation of PROs, and facilitates collecting and sharing data to establish valid comparisons in research. This is a prerequisite to learn about how they could impact the clinical care pathway. In addition, the prognostic value of intensified PRO collection throughout therapy on survival and disease progression is promising. Future perspectives in the field of PROs and MBC are described.

Background Exact localization of non-palpable breast lesions is necessary to ensure that the correct lesion is removed. Conventional methods come with several disadvantages. Patients and methods We compared 28 patients who underwent breast-conserving surgery for a non-palpable lesion. By surgeon choice, 14 patients were assigned to undergo magnetic seed localization and 14 underwent standard wire localization. The primary outcome was the operative time, and secondary outcome was the patient pain level. Results The mean age was 52±10 (SD) years in the seed arm, and 55±13 years in the wire arm. The median time from skin incision to tumor extraction was not significantly different between the two groups. Patients in the wire localized group significantly more often reported pain during coughing/breathing, movement, and sleep. Conclusion Using seed localization at Charite Breast Center did not lead to a significant decrease in operative time but might allow time savings once established, while increasing patient comfort and reducing organizational burden.

Background Sentinel lymph node biopsy after technetium-99 (Tc99) localization is a mainstay of oncologic breast surgery. The timing of Tc99 injection can complicate operating room schedules, which can cause increasing overall costs of care and patient discomfort. Methods This study compared 59 patients who underwent breast cancer surgery including sentinel lymph node biopsy. Based on the surgeon’s choice, 29 patients were treated with Tc99, and 30 patients received the iron-based tracer, Magtrace. The primary outcomes were time spent on the care pathway and operating time from commissioning of the probe to removal of the sentinel node. The secondary outcomes were patient pain levels and reimbursement. Results The mean time spent on the preoperative breast cancer care pathway was significantly shorter for the Magtrace group (5.4 ± 1.3 min) than for the Tc99 group (82 ± 20 min) (p p = 0.151). Reimbursement and pain levels remained unchanged, and the hospital length of stay was similar in the two groups (Magtrace: 5.1 ± 2.3 days vs Tc99: 4.5 ± 3.2 days). Conclusions Magtrace localization shortened the preoperative care pathway and did not affect surgical time or reimbursement. Once established, it could allow for cost reduction and improve patient comfort.

Background: Neoadjuvant chemotherapy (NACT) is a standard approach of the multidisciplinary treatment of breast cancer. Depending on the biological subtype a pathological complete response in the breast (bpCR) can be achieved in up to 60% of the patients. However, only limited accuracy can be reached when using imaging for prediction of bpCR prior to surgery. Due to this diagnostic uncertainty, surgery after NACT is considered to be obligatory for all patients in order to either completely remove residual disease or to diagnose a bpCR histologically. The purpose of this trial is to evaluate the accuracy of a vacuum-assisted biopsy (VAB) to diagnose a bpCR after NACT prior to surgery. Methods: This study is a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial. The study will take place at 21 trial sites in Germany. Six hundred female patients with breast cancer after completed NACT showing at least a partial response to NACT treatment will be enrolled. A vacuum-assisted biopsy (VAB) guided either by ultrasound or mammography will be performed followed by histopathological evaluation of the VAB specimen before standard, guideline-adherent breast surgery. The study is designed to prove that the false negative rate of the VAB is below 10%. Discussion: As a bpCR is becoming a more frequent result after NACT, the question arises whether breast surgery is therapeutically necessary in such cases. To study this subject further, it will be crucial to develop a reliable test to diagnose a bpCR without surgery. During the study we anticipate possible problems in patient recruitment as the VAB intervention does not provide participating patients with any personal benefit. Hence, a proficient informed consent discussion with the patient and a detailed explanation of the study aim will be crucial for patient recruitment. Another critical issue is the histopathological VAB evaluation of a non-tumorous specimen as this may have been taken either from the former tumor region (bpCR) or outside of the (former) tumor region (non-representative VAB, sampling error). Trial registration: The trial has been registered at clinicaltrials.gov with the identifier NCT02948764 on October 28, 2016 and at the German Clinical Trials Register ( DRKS00011761 ) on February 20, 2017. The date of enrolment of the first participant to the trial was on March 8, 2017.