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.

To deliver patient-reported outcome (PRO) reference data for breast cancer and various other breast diseases to facilitate the interpretation of PRO scores during routine breast cancer treatment. To determine reference baseline values for the PRO measures EORTC QLQ-C30 and EORTC QLQ-BR23, PRO data captured in the breast cancer centre at Charité - Universitätsmedizin Berlin from 2016 to 2021 were evaluated. As part of the clinical routine, ambulatory patients were asked to answer a digital survey regarding their medical history, current health status and health-related quality of life using the aforementioned questionnaires prior to their doctor's appointment in the outpatient breast clinic. Adjusted linear and variable dispersion beta regression models were used to compare different diagnosis groups. A total of 3689 patients were included in the digital PRO program, of which 1478 were eligible for this study; 729 had invasive breast cancer or ductal carcinoma in situ, 270 patients were diagnosed with fibroadenoma and 479 patients had other breast diseases such as cysts, mastopathy or abscesses. Overall, patients with breast cancer reported worse scores in almost all domains except for role functioning, sexual functioning and body image. Compared to previously published reference scores for early breast cancer, the current data show a more pronounced impact on perceived emotional and cognitive functioning. The results of this study are of high value for the interpretation of PROs and facilitate their use in clinical practice and clinical trials. The scores indicate an urgent need for psychosocial support prior to treatment.

Background: Despite the progress of research and treatment for breast cancer, still up to 30% of the patients afflicted will develop distant disease. Elongation of survival and maintaining the quality of life (QoL) become pivotal issues guiding the treatment decisions. One possible approach to optimise survival and QoL is the use of patient-reported outcomes (PROs) to timely identify acute disease-related burden. We present the protocol of a trial that investigates the effect of real-time PRO data captured with electronic mobile devices on QoL in female breast cancer patients with metastatic disease. Methods: This study is a randomised, controlled trial with 1:1 randomisation between two arms. A total of 1000 patients will be recruited in 40 selected breast cancer centres. Patients in the intervention arm receive a weekly request via an app to complete the PRO survey. Symptoms will be assessed by study-specific optimised short forms based on the EORTC QLQ-C30 domains using items from the EORTC CAT item banks. In case of deteriorating PRO scores, an alarm is sent to the treating study centre as well as to the PRO B study office. Following the alarm, the treating breast cancer centre is required to contact the patient to inquire about the reported symptoms and to intervene, if necessary. The intervention is not specified and depends on the clinical need determined by the treating physician. Patients in the control arm are prompted by the app every 3 months to participate in the PRO survey, but their response will not trigger an alarm. The primary outcome is the fatigue level 6 months after enrolment. Secondary endpoints include among others hospitalisations, use of rescue services and overall QoL. Discussion: Within the PRO B intervention group, we expect lower fatigue levels 6 months after intervention start, higher levels of QoL, less unplanned hospitalisations and less emergency room visits compared to controls. In case of positive results, our approach would allow a fast and easy transfer into clinical practice due to the use of the already nationwide existing IT infrastructure of the German Cancer Society and the independent certification institute OnkoZert. Trial registration: DRKS (German Clinical Trials Register) DRKS00024015. Registered on 15 February 2021

Background: Since postoperative complications after reconstructive breast surgery are often related to drastic increases of patient suffering and treatment costs, several devices were developed in order to avoid them. In this respect, the intraoperative fluorescence angiography with indocyanine green (ICG) provides promising results by detecting ischemic skin intraoperatively. Methods: Women who underwent reconstructive breast surgery at the breast center at Charité between April and December 2017 were included in the analysis. General patient characteristics, medical history, type of surgery, as well as postoperative parameters, complications and patient reported outcomes were compared between patients operated using ICG fluorescence angiography and conventionally operated patients. Results: Among 68 patients with breast reconstruction 36 (52.9%) were operated with the ICG angiography device and 32 (47.1%) without. No significant differences regarding patient demographics, medical history, and surgical procedure were found. Wound healing disorders occurred in 11.1% of the ICG group and in 9.4% of the control group. About 11% of both groups developed major complications which required revision surgery. Complication rates and patient reported outcome did not differ significantly. Across both groups, only the risk factor resection weight (≥ 500 g) was significantly associated with wound healing disorders (RR = 6.80; 95%CI 1.93–23.81; p = 0.022). Conclusion: The purchase of a device for intraoperative ICG angiography might not be reasonable for every breast center. Further research in a larger cohort and prospective manner should be done to determine if the addition of ICG to breast reconstructive surgery in the German setting really leads to improved patient care.

In the original article published, some of the superscript characters in Table 1 (column p value with superscript references to the footnotes) were incorre