Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.

BACKGROUND: In a previous analysis of this phase 3 trial, first-line ribociclib plus letrozole resulted in significantly longer progression-free survival than letrozole alone among postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether overall survival would also be longer with ribociclib was not known. METHODS: Here we report the results of the protocol-specified final analysis of overall survival, a key secondary end point. Patients were randomly assigned in a 1:1 ratio to receive either ribociclib or placebo in combination with letrozole. Overall survival was assessed with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods after 400 deaths had occurred. A hierarchical testing strategy was used for the analysis of progression-free survival and overall survival to ensure the validity of the findings. RESULTS: After a median follow-up of 6.6 years, 181 deaths had occurred among 334 patients (54.2%) in the ribociclib group and 219 among 334 (65.6%) in the placebo group. Ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole. Median overall survival was 63.9 months (95% confidence interval [CI], 52.4 to 71.0) with ribociclib plus letrozole and 51.4 months (95% CI, 47.2 to 59.7) with placebo plus letrozole (hazard ratio for death, 0.76; 95% CI, 0.63 to 0.93; two-sided P = 0.008). No new safety signals were observed. CONCLUSIONS: First-line therapy with ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole in patients with HR-positive, HER2-negative advanced breast cancer. Median overall survival was more than 12 months longer with ribociclib than with placebo. (Funded by Novartis; MONALEESA-2 ClinicalTrials.gov number, NCT01958021.).

Efficacy of Lapatinib in Patients with HER2-Negative Metastatic Breast Cancer and HER2-Positive Circulating Tumor Cells-The DETECT III Clinical Trial.

BACKGROUND: The phenotypes of tumor cells change during disease progression, but invasive rebiopsies of metastatic lesions are not always feasible. Here we aimed to determine whether initially HER2-negative metastatic breast cancer (MBC) patients with HER2-positive circulating tumor cells (CTCs) benefit from a HER2-targeted therapy. METHODS: The open-label, interventional randomized phase III clinical trial (EudraCT Number 2010-024238-46, CliniclTrials.gov Identifier: NCT01619111) recruited from March 2012 until September 2019 with a follow-up duration of 19.5 months. It was a multicenter clinical trial with 94 participating German study centers. A total of 2137 patients with HER2-negative MBC were screened for HER2-positive CTCs with a final modified intention-to-treat population of 101 patients. Eligible patients were randomized to standard therapy with or without lapatinib. Primary study endpoints included CTC clearance (no CTCs at the end of treatment) and secondary endpoints were progression-free survival, overall survival (OS), and safety. RESULTS: In both treatment arms CTC clearance at first follow-up visit-although not being significantly different for both arms at any time point-was significantly associated with improved OS (42.4 vs 14.1 months; P = 0.002). Patients treated additionally with lapatinib had a significantly improved OS over patients receiving standard treatment (20.5 vs 9.1 months, P = 0.009). CONCLUSIONS: DETECT III is the first clinical study indicating that phenotyping of CTCs might have clinical utility for stratification of MBC cancer patients to HER2-targeting therapies. The OS benefit could be related to lapatinib, but further studies are required to prove this clinical observation. ClinicalTrials.gov Registration Number: NCT01619111.

Radiotherapy statements of the 18th St. Gallen International Breast Cancer Consensus Conference-a German expert perspective.

PURPOSE: To summarize the radiotherapy-relevant statements of the 18th St. Gallen Breast Cancer Consensus Conference and interpret the findings in light of German guideline recommendations. METHODS: Statements and voting results from the 18th St. Gallen International Breast Cancer Consensus Conference were collected and analyzed according to their relevance for the radiation oncology community. The voting results were discussed in two hybrid meetings among the authors of this manuscript on March 18 and 19, 2023, in light of the German S3 guideline and the 2023 version of the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) guidelines. RESULTS AND CONCLUSION: There was a high level of agreement between the radiotherapy-related statements of the 18th St. Gallen International Breast Cancer Consensus Conference and the German S3 and AGO guidelines. Discrepancies include the impact of number of lymph node metastases for the indication for postmastectomy radiotherapy.

Dietary supplement intake in women with breast cancer before and after diagnosis: results from the SUCCESS C trial.

BACKGROUND: There is little evidence that dietary supplements are beneficial for patients with breast cancer; therefore, they are usually not recommended by treatment guidelines. The aim of the present analysis was to assess the prevalence of dietary supplement (DS) intake among women before and after a breast cancer diagnosis. METHODS: Participants in the SUCCESS C lifestyle intervention study, a randomized controlled trial in women with newly diagnosed intermediate- to high-risk breast cancer, completed two questionnaires on dietary supplement intake 24 months (QS1) and 48 months (QS2) after beginning the lifestyle intervention. The study was registered on 12.17.2008 under the EU Clinical Trials Register https://www.clinicaltrialsregister.eu/ , trial registration number: 2008-005453-38. The questionnaires collected data on DS intake during the 5-year period prediagnosis (QS1) and in the period postdiagnosis (QS2). Multivariate logistic regression models were fitted to examine differences in DS intake between the two intervention groups. The groups were then pooled to examine differences in DS use between the prediagnostic and postdiagnostic period. RESULTS: A total of 320 questionnaires from 58.5% of intervention group completers and 416 questionnaires from 46.6% of low-level intervention group completers were included in the analysis. Overall, 20.2% of all respondents reported taking DS prior to their diagnosis. After a cancer diagnosis, the percentage of women taking DS significantly increased to 56.4% (p for time effect < 0.0001). No differences in DS intake between the intervention groups were observed. Single or combined preparations of vitamins and minerals/trace elements were the most frequently reported supplements. Notably, a 9-fold increase in vitamin D intake was reported postdiagnosis, where the proportion of women increased from 3.8 to 34.5%. CONCLUSION: A 3-fold increase in the reported intake of dietary supplements was seen in women after a breast cancer diagnosis. These observations underscore the need to incorporate patient education surrounding the use of dietary supplements in a treatment care plan, particularly addressing the negligible benefits as well as the potential risks and treatment interactions.

The impact of physical activity on progression-free and overall survival in metastatic breast cancer based on molecular subtype.

BACKGROUND: Although adequate physical activity has been shown to be beneficial in early breast cancer, evidence in metastatic breast cancer is sparse and contradictory, which could be related to distinct effects of physical activity on the different molecular cancer subtypes. Therefore, we here evaluated the effect of physical activity on progression-free and overall survival (PFS, OS) in metastatic breast cancer, specifically looking at molecular subtypes. METHODS: International Physical Activity Questionnaire (IPAQ) questionnaires, filled out by patients enrolled in the prospective PRAEGNANT registry (NCT02338167; n = 1,270) were used to calculate metabolic equivalent task (MET) minutes, which were subsequently categorized into low (n = 138), moderate (n = 995) or high IPAQ categories (n = 137). Cox regression analyses were used to evaluate the impact of IPAQ categories and its interaction with molecular subtypes on PFS and OS. RESULTS: Patient and tumor characteristics were equally distributed across IPAQ categories. HER2pos, HRpos and TNBC were present in 23.1%, 65.7% and 11.2% of patients, respectively. IPAQ scores did not have an impact on PFS and OS in addition to established prognostic factors, either overall or in particular molecular subtypes (PFS: p = 0.33 and OS: p = 0.08, likelihood ratio test). Exploratory analyses showed higher overall survival rates for high IPAQ categories compared to low/moderate IPAQ categories in luminal B-like breast cancer. CONCLUSIONS: Self-reported physical activity using the IPAQ questionnaire did not significantly affect PFS or OS in patients suffering from metastatic breast cancer. Nevertheless, some hypothesis-generating differences between molecular subtypes could be observed, which may be interesting to evaluate further.

Primary results of the AGO-Zervix-1 Study: A prospective, randomized phase III study to compare the effects of paclitaxel and topotecan with those of cisplatin and topotecan in the treatment of patients with recurrent and persistent cervical cancer.

BACKGROUND: Before the era of immunotherapies and antibody-drug conjugates, there were limited chemotherapeutic options for patients with recurrent and metastatic cervical cancer. Combination therapies with cisplatin have shown some superiority over monotherapy. This study examined platinum-free treatment regimens, comparing a combination of topotecan and paclitaxel (TP) with topotecan and cisplatin (TC) in patients with recurrent or metastatic cervical cancer, with or without prior platinum-based treatment. METHODS: The AGO-Zervix-1 Study (NCT01405235) is a prospective, randomized phase III study in which patients were randomly assigned at a 1:1 ratio to treatment within the control arm with topotecan (0.75 mg/m2) on days 1-3 and cisplatin (50 mg/m2) on day 1 every 3 weeks and in the study arm topotecan (1.75 mg/m2) and paclitaxel (70 mg/m2) on days 1, 8, and 15 every 4 weeks or treatment. The primary study aim was overall survival; progression-free survival, toxicity, and quality of life were secondary aims. The interim and final analysis is here reported after recruitment of 173 of 312 planned patients. RESULTS: Median overall survival in the TP arm was 9.6 months, compared with 12.0 months in the TC arm (log-rank test, P = 0.33). Median progression-free survival rates were 4.4 months with TP and 4.2 months with TC (log-rank test, P = 0.47). Leukopenia and nausea/vomiting were more frequent in the cisplatin-containing arm. Otherwise, toxicity profiles were comparable. There were no differences in FACT-G-assessed quality of life. CONCLUSION: Platinum-based combination chemotherapy remains the standard of care chemotherapy regimen for patients with recurrent or metastatic cervical cancer.

Out of pocket health-care services in Germany during pregnancy under consideration of migration and acculturation.

PURPOSE: More than a quarter of the German population has a migration background (MB). As various studies in the healthcare sector have already shown, ethnic background and migration status can have an influence on individual patient care. The aim of our study was to evaluate whether there are differences in utilization of out of pocket health-care services and the consultation situation in the context of prenatal care, taking into account migration status, acculturation and socio-demographic aspects. METHODS: In the period from 01.03.21-01.03.22, a total of 511 women in childbed at the University Women's Hospital Ulm were interviewed in a retrospective survey using a standardized questionnaire translated into 9 languages and asked about their prenatal care. Due to the COVID pandemic, the study had to be terminated after one year. RESULTS: Women with MB-particularly 1st generation migrant women-used significantly fewer out of pocket prenatal care services (p < 0.001) and felt less informed and counselled regarding costs and benefits of possible prenatal care examinations (p < 0.001) compared to women without MB. Consistent with these results, there were associations between the assimilation index (AI) of patients with MB and both utilization and perception of individual healthcare services. CONCLUSION: Our study indicates that even today there are still differences in the treatment and perception of various health services in the context of prenatal care between women with and those without MB.

Effect of postpartum pessary use on pelvic floor function: a prospective multicenter study.

PURPOSE: This study evaluates the restitution of pelvic floor function in postpartum women using the Restifem® pessary in a preventive and therapeutic approach. METHODS: In this multicentre study all postpartum women independently of their parity, mode of delivery and existing pelvic floor symptoms were offered to use the Restifem® pessary from 6 weeks postpartum for 3 to 6 months. They completed the validated German pelvic floor questionnaire (GPFQpp) via online survey at 6 weeks, 6 months and 12 months postpartum and were divided, by their own choice, into users and non-users of the pessary. RESULTS: Initially 857 women were enrolled. After 6 weeks 137 pessary users and 133 non-users, after 12 months 53 pessary users and 45 non-users submitted a completed questionnaire. Pessary users had significantly higher (worse) scores in all domains of the GPFQpp at 6 weeks postpartum. At 12 months postpartum pessary users still had a significantly higher bladder score, compared to non-users. There was a greater improvement in the bladder score (p = 0.005) and the pelvic organ prolapse score (p < 0.001) from 6 weeks to 12 months postpartum, among pessary users compared to non-users. CONCLUSION: Pessary users had a significantly greater improvement in pelvic floor function from 6 weeks to 12 months postpartum, compared to non-users. This effect might be in part due to wearing the pessary but also due to greater scope for recovery, given the higher level of pelvic floor dysfunction in the pessary user group. TRIAL REGISTRATION: The trial was registered in the German Clinical Trials Register (DRKS00024733) on 19 of April 2021.

["Who cares about us?" Results of a cross-sectional study on the psychosocial health of obstetricians and midwives after traumatic birth experiences]. / "Wer kümmert sich um uns?" Ergebnisse einer Querschnittsuntersuchung zur psychosozialen Gesundheit von Geburtshelfer*innen und Hebammen nach traumatischen Geburtserlebnissen.

BACKGROUND: Traumatic births not only cause emotional stress for expectant parents but can also affect the psychosocial health of midwives and obstetricians due to their professional demands. AIM: To evaluate the impact of traumatic birth experiences on the psychosocial health of obstetric healthcare professionals. METHODS: A cross-sectional study using validated measurement tools (Impact of Event Scale Revised IES-R, Copenhagen Burnout Inventory CBI) and assessing post-traumatic growth (PGI-SF) through an online survey of midwives and obstetricians in German-speaking areas. RESULTS: The study included 700 participants with peripartum and/or personal traumas. Of the 528 participants who completed the IES-R, 33 (6.3%) with post-traumatic stress disorder (PTSD) received less support from colleagues (p = 0.007) and were more likely to experience workplace consequences (p < 0.001) than participants without PTSD. A moderate to high level of burnout was found in 66.2% of the 542 participants who completed the CBI. Personal growth through experiencing trauma was reported by 75.9% of the 528 participants who completed the PGI-SF. CONCLUSION: The psychosocial health of midwives and obstetricians is at risk due to traumatic birth experiences. Screening tests and the provision of collegial and professional debriefings to strengthen resilience are essential preventive interventions.

Effect of histological breast cancer subtypes invasive lobular versus non-special type on survival in early intermediate-to-high-risk breast carcinoma: results from the SUCCESS trials.

BACKGROUND: Invasive lobular breast carcinomas (ILC) have different histological features compared to non-special type carcinomas (NST), but the effect of histological subtypes on survival is controversial. In this study, we compared clinicopathological characteristics and outcomes between ILC and NST based on a large pooled data set from three adjuvant breast cancer trials (SUCCESS A, B, and C) and investigated a potential differential effect of recurrence risk related to nodal stage on survival. METHODS: From 2005 to 2017, the large randomized controlled SUCCESS A, B, and C trials enrolled 8190 patients with primary, intermediate-to-high-risk breast carcinoma. All patients received adjuvant chemotherapy, and endocrine and/or HER2-targeted treatment was given where appropriate. Survival outcomes in terms of disease-free survival (DFS), overall survival (OS), breast cancer-specific survival (BCSS), and distant disease-free survival (DDFS) were estimated using the Kaplan-Meier method and analyzed using log-rank tests as well as univariable and adjusted multivariable Cox regression models. RESULTS: In the SUCCESS trials, 6284 patients had NST and 952 had ILC. The median follow-up time was 64 months. ILC patients were older, more likely to receive mastectomy, and more likely to have larger tumor sizes, lymph node infiltration, hormone receptor-positive, HER2neu-negative, and luminal A-like tumors than NST patients. In the overall cohort, no significant differences between ILC and NST were detectable regarding the four survival endpoints, with hazard ratios obtained in adjusted multivariable cox regressions of 0.96 (95% CI 0.77-1.21, p = 0.743) for DFS, 1.13 (95% CI 0.85-1.50, p = 0.414) for OS, 1.21 (95% CI 0.89-1.66, p = 0.229) for BCSS, and 0.95 (95% CI 0.73-1.24, p = 0.689) for DDFS. However, a differential effect of nodal stage on survival was observed, with better survival for ILC patients with pN0/pN1 tumors and worse survival for ILC patients with pN2/pN3 tumors compared to NST patients. CONCLUSIONS: Our results revealed that ILC was associated with worse survival compared to NST for patients at high risk of recurrence due to advanced lymph node infiltration. These findings should be taken into account for treatment decisions and monitoring.

Implications for surveillance for breast cancer patients based on the internally and externally validated BRENDA-metastatic recurrence score.

PURPOSE: Although the incidence of distant relapse is decreasing, 20-30% of patients with early breast cancer die of metastasis. The aim of this study is to characterize patients with metastasis-free survival(MFS) less than 5 years, to analyze the most probable site of metastases according to the internally and externally validated BRENDA-score. The BRENDA-score is a combination of the biological subtype and clinical staging. METHOD: 3832 patients with primary diagnosis of breast cancer and either distant metastatic recurrence within 5 years or MFS ≥ 5 years were assigned to this study. Patients were classified for metastatic recurrence according to the BRENDA-score. 1765 patients were in a validation set. Statistical methods were Kaplan-Meier curves, Cox regression analysis, Exhausted CHAID, likelihood-ratio tests and the Nearest Neighbor Estimation method. RESULTS: There was a significant(p < 0.001) difference between the Kaplan-Meier MFS-functions of M0-patients stratified by BRENDA-score. The BRENDA score outperforms intrinsic subtypes and the Nottingham prognostic score. It fits the original data and the validation set equally well (p = 0.179).There was a significant(p < 0.001) difference between mean BRENDA-Index for patients with MFS < 5y(21.0 ± 9.0) and patients with MFS ≥ 5y(mean BRENDA-Index 11.7 ± 8.2). 55.6% of the very high risk patients(BRENDA-Index ≥ 27) had metastases within 5 years. The most likely primary metastatic site was bone(30%) followed by liver(19%) and lung(18%). The discriminatory ability(areas under the time dependent ROC curve) of the BRENDA score is good to acceptable for the first 5 years. In the very low/low risk (intermediate, high/very high) risk group 50% of all metastases were diagnosed within 26 months. Guideline adherence had a highly significant influence on outcome independent of the risk group. CONCLUSION: The evaluation showed that the BRENDA-Score is a robust predictive tool for breast cancer recurrence and site of metastases in the first five years after diagnosis. It outperforms intrinsic subtypes and the Nottingham prognostic score. The BRENDA-score could be a tool for a risk orientated and targeted follow up.

Return of individual genomic research results within the PRAEGNANT multicenter registry study.

PURPOSE: The PRAEGNANT study is a registry study for metastatic breast cancer patients, focusing on biomarker detection. Recently, within this study, genetic alterations in 37 breast cancer predisposition genes were analyzed and genetic findings were detected for 396 participants. The aim of this project was to return genetic results to the physicians and to analyze actions taken (e.g., disclosure of results to patients, validation of results, clinical impact, and impact on the patient's quality of life) using a questionnaire. METHODS: 235 questionnaires were sent out to the study centers, with each questionnaire representing one patient with a genetic finding. The questionnaire consisted of twelve questions in the German language, referring to the disclosure of results, validation of test results, and their impact on treatment decisions and on the patient's quality of life. RESULTS: 135 (57.5%) questionnaires were completed. Of these, 46 (34.1%) stated that results were returned to the patients. In 80.0% (N = 36) of cases where results were returned, the patient had not been aware of the finding previously. For 27 patients (64.3%), genetic findings had not been validated beforehand. All validation procedures (N = 15) were covered by the patients' health insurance. For 11 (25.0%) patients, physicians reported that the research results influenced current or future decision-making on treatment, and for 37.8% (N = 17) the results influenced whether family members will be genetically tested. CONCLUSION: This study provides novel insights into the return of research results and into clinical and personal benefits of disclosure of genetic findings within a German registry.

Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment.

ESR1 mutation (ESR1m) is a frequent cause of acquired resistance to aromatase inhibitor (AI) plus cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i), which is a first-line therapy for hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD) that in a phase II study significantly improved progression-free survival (PFS) over fulvestrant (also a SERD) in ER+/HER2- ABC. SERENA-6 (NCT04964934) is a randomized, double-blind, phase III study evaluating the efficacy and safety of switching from an AI to camizestrant, while maintaining the same CDK4/6i, upon detection of ESR1m in circulating tumor DNA before clinical disease progression on first-line therapy for HR+/HER2- ABC. The aim is to treat ESR1m clones and extend the duration of control of ER-driven tumor growth, delaying the need for chemotherapy. The primary end point is PFS; secondary end points include chemotherapy-free survival, time to second progression event (PFS2), overall survival, patient-reported outcomes and safety.

Why will we perform this study? Patients with advanced breast cancer in which the cancer cells have the receptor for the hormone estrogen and/or progesterone are typically treated with an aromatase inhibitor, a hormone therapy that decreases estrogen being made in the body, together with an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), a drug that blocks the growth of cancer cells. Although cancers usually respond to treatment initially, the cancer cells eventually change, so the drug combination no longer works. For example, mutation of the estrogen receptor (referred to as ESR1m) can stop aromatase inhibitors from working. Camizestrant is an investigational drug that blocks estrogen receptors, including mutated receptors, reducing the growth and spread of cancer. Here we describe the SERENA-6 clinical trial, which is testing camizestrant as a treatment for patients with breast cancer with ESR1m. How will we perform this research? The phase III SERENA-6 trial will use blood tests to monitor if patients with breast cancer develop ESR1m while being treated with an aromatase inhibitor and a CDK4/6 inhibitor. If ESR1m is detected, yet the disease is stable, participants will be randomly assigned to either continue with the same aromatase inhibitor or switch to camizestrant while continuing with the same CDK4/6 inhibitor. The study will assess whether switching to camizestrant prolongs the time before the cancer grows, spreads or worsens. It will also assess the length of time that participants live for versus those who continue with an aromatase inhibitor. Clinical Trial Registration: NCT04964934 (ClinicalTrials.gov).

Reducing preventable adverse events in obstetrics by improving interprofessional communication skills - Results of an intervention study.

BACKGROUND: Progress in medicine involves the structured analysis and communication of errors. Comparability between the individual disciplines is only possible to a limited extent and obstetrics plays a special role: the expectation of a self-determined and joyful event meets with possibly serious complications in highly complex care situations. This must be managed by an interdisciplinary team with an increasingly condensed workload. Adverse events cannot be completely controlled. However, taking controllable risk factors into account and with a focused communication a reduction of preventable adverse events is possible. In the present study, the effect of interprofessional team training on preventable adverse events in an obstetric department was investigated. METHODS: The training consisted of a 4-h interdisciplinary training session based on psychological theories. Preventable adverse events were defined in six categories according to potential patterns of causation. 2,865 case records of a refence year (2018) and 2,846 case records of the year after the intervention (2020) were retrospectively evaluated. To determine the communication training effect, the identified preventable adverse events of 2018 and 2020 were compared according to categories and analyzed for obstetrically relevant controllable and uncontrollable risk factors. Questionnaires were used to identify improvements in self-reported perceptions and behaviors. RESULTS: The results show that preventable adverse events in obstetrics were significantly reduced after the intervention compared to the reference year before the intervention (13.35% in the year 2018 vs. 8.83% in 2020, p < 0.005). Moreover, obstetrically controllable risk factors show a significant reduction in the year after the communication training. The questionnaires revealed an increase in perceived patient safety (t(28) = 4.09, p < .001), perceived communication behavior (t(30) = -2.95, p = .006), and self-efficacy to cope with difficult situations (t(28) = -2.64, p = .013). CONCLUSIONS: This study shows that the communication training was able to reduce preventable adverse events and thus increase patient safety. In the future, regular trainings should be implemented alongside medical emergency trainings in obstetrics to improve patient safety. Additionally, this leads to the strengthening of human factors and ultimately also to the prevention of second victims. Further research should follow up implementing active control groups and a randomized-controlled trail study design. TRIAL REGISTRATION: The study was approved by the Ethics Committee of University Hospital (protocol code 114/19-FSt/Sta, date of approval 29 May 2019), study registration: NCT03855735 .

Post-traumatic stress syndromes following childbirth influenced by birth mode-is an emergency cesarean section worst?

PURPOSE: The experience of birth is an emotional challenge for women. Traumatic birth experiences can cause psychological stress symptoms up to post-traumatic stress disorders (PTSD), with impact on women's wellbeing. Primarily unplanned interventions can trigger birth-mode-related traumatization. The aim of the study was to evaluate whether an emergency cesarean section (ECS) is the most traumatizing. METHODS: A retrospective case-control study was undertaken. Therefore, data were collected by standardized questionnaires (Impact of Event Scale-Revised and City Birth Trauma Scale) that were sent to women with singleton pregnancies > 34 weeks of gestation who either give birth by ECS (case group, n = 139), unplanned cesarean section (UCS), operative vaginal birth (OVB), or natural birth (NB) (three control groups, n = 139 each). The investigation period was 5 years. RESULTS: Overall, 126 of 556 (22%) sent questionnaires were returned and could be analyzed (32 ECS, 38 UCS, 36 OVB, and 20 NB). In comparison to other birth modes, women with ECS were associated with a higher degree of traumatization as revealed by statistically significant differences regarding the DSM-5 criteria intrusion and stressor. In addition, women who underwent ECS declared more frequently a demand for professional debriefing compared to other birth modes. DISCUSSION: ECS is associated with more post-traumatic stress symptoms compared to other birth modes. Therefore, early interventions are recommended to reduce long-term psychological stress reactions. In addition, outpatient follow-ups by midwives or emotional support programs should be implemented as an integral component of postpartum debriefings.

Evaluating ChatGPT as an adjunct for the multidisciplinary tumor board decision-making in primary breast cancer cases.

BACKGROUND: As the available information about breast cancer is growing every day, the decision-making process for the therapy is getting more complex. ChatGPT as a transformer-based language model possesses the ability to write scientific articles and pass medical exams. But is it able to support the multidisciplinary tumor board (MDT) in the planning of the therapy of patients with breast cancer? MATERIAL AND METHODS: We performed a pilot study on 10 consecutive cases of breast cancer patients discussed in MDT at our department in January 2023. Included were patients with a primary diagnosis of early breast cancer. The recommendation of MDT was compared with the recommendation of the ChatGPT for particular patients and the clinical score of the agreement was calculated. RESULTS: Results showed that ChatGPT provided mostly general answers regarding chemotherapy, breast surgery, radiation therapy, chemotherapy, and antibody therapy. It was able to identify risk factors for hereditary breast cancer and point out the elderly patient indicated for chemotherapy to evaluate the cost/benefit effect. ChatGPT wrongly identified the patient with Her2 1 + and 2 + (FISH negative) as in need of therapy with an antibody and called endocrine therapy "hormonal treatment". CONCLUSIONS: Support of artificial intelligence by finding individualized and personalized therapy for our patients in the time of rapidly expanding amount of information is looking for the ways in the clinical routine. ChatGPT has the potential to find its spot in clinical medicine, but the current version is not able to provide specific recommendations for the therapy of patients with primary breast cancer.

Awareness, offer, and use of psychosocial services by breast cancer survivors in Germany: a prospective multi-centre study.

PURPOSE: This study examined the pattern of psychosocial care in breast cancer survivors. METHODS: In a prospective study with measurements before surgery, 1 month, 8 months, and 5 years thereafter, we examined the proportion of breast cancer survivors who were aware about, had been offered and received various types of psychosocial services from psychologists, social workers, doctors, self-help groups etc. The degree of helpfulness per service among users was ascertained with Likert scales. Determinants of awareness, offer and use were investigated using binary logistic regression analyses. How the services are inter-related was tested with principal component analyses. RESULTS: Among 456 breast cancer survivors who participated until 5 years, psychological services were known by 91%, offered to 68%, and used by 55% of patients. Social services were known by 86%, offered to 65%, and used by 51%. Women ≥ 65 years were less likely to be informed about (odds ratio (OR) 0.2) and get offers for psychosocial services (OR 0.4 for social and 0.5 for psychological services) than women < 65 years. The services rated most helpful were social services in the hospital, psychological counselling by a consultant and psychotherapy in private practices. CONCLUSION: These findings underline the importance of psychosocial support by physicians in addition to the "professional" mental health and social care providers. They also show that elderly women in need for support might be in danger of not being well-informed about the services available.

Evaluating compliance and applicability of postpartum pessary use for preventing and treating pelvic floor dysfunction: a prospective multicenter study.

PURPOSE: Pelvic floor disorders are common and associated with pregnancy and childbirth. For restitution of pelvic floor connective tissue and thereby therapy of postpartum pelvic organ prolapse and stress urinary incontinence, the Restifem® pessary is approved. It supports the anterior vaginal wall behind the symphysis, the lateral sulci and the sacro-uterine ligaments and stabilises the connective tissue. We evaluated the compliance and applicability of Restifem® use in women postpartum in a preventive and therapeutic approach. METHODS: Restifem® pessary was handed out to 857 women. Six weeks after birth, they started the pessary use. After 8 weeks, 3 and 6 months postpartum, women received a questionnaire via online survey for evaluation of pessary applicability and efficacy. RESULTS: After 8 weeks, 209 women answered the questionnaire. 119 women used the pessary. Common problems were discomfort, pain and the pessary use was to circuitous. Vaginal infections were rare. After 3 months, 85 women and after 6 months, 38 women still used the pessary. 3 months postpartum, 94% of women with POP, 72% of women with UI and 66% of women with OAB stated to have an improvement of their symptoms using the pessary. 88% women without any disorder felt an improvement of stability. CONCLUSIONS: Use of the Restifem® pessary in the postpartum period is feasible and accompanied with less complications. It reduces POP and UI and leads to an increased sense of stability. So, Restifem® pessary can be offered to women postpartum to improve pelvic floor dysfunction.

Association of social service counseling in breast cancer patients with financial problems, role functioning and employment-results from the prospective multicenter BRENDA II study.

BACKGROUND: This study examined the relationship between social service counseling (SSC) and financial and role functioning problems in primary breast cancer (BC) patients over a 5-year observation period. METHODS: In the multicenter prospective study, patients were approached before surgery (t1), before initiation of adjuvant treatment (t2), after therapy completion (t3), and 5 years after surgery (t4). We examined the proportion of BC survivors who had financial and role functioning problems and the proportion who were employed at t4. We examined how frequently patients were informed about, offered, or used SSC, and we used multivariate logistic regression analyses to examine the relationship between this and financial and role functioning problem prevalence. RESULTS: Of the 456 BC survivors, 33% had financial problems and 22% reported role functioning problems at t4. There was no evidence that women with increased financial problems were informed about SSC more often than those without (OR 1.1, p = 0.84) or that they used SSC more often (OR 1.3, p = 0.25). However, women with role functioning problems were informed about SSC significantly more often (OR 1.7, p = 0.02) and attended counseling significantly more often (OR 1.6, p = 0.03). Among participants aged < 65 years at t4 (n = 255), 70% were employed. Patients who had received SSC were more likely to be employed at t4 than patients who did not (OR 1.9, p = 0.04). CONCLUSION: These findings underline the importance of SSC for BC patients with role functioning issues. They indicate that individuals who use SSC are more likely to be employed later on than individuals who do not.

The Clinical Relevance of the NATALEE Study: Application of the NATALEE Criteria to a Real-World Cohort from Two Large German Breast Cancer Centers.

The NATALEE study showed a significant benefit in invasive disease-free survival (iDFS) for patients with HR+/HER2- early breast cancer (eBC) at intermediate and high risk of recurrence who were treated with the CDK4/6 inhibitor Ribociclib in combination with endocrine therapy (ET). This retrospective study aims to apply the NATALEE inclusion criteria to a representative real-world cohort to estimate the proportion of HR+/HER2- breast cancer patients eligible for adjuvant Ribociclib therapy. Patients who underwent full surgical treatment for eBC between January 2018 and December 2020 at two large German university breast cancer centers (University of Ulm, University of Tuebingen) were included. Descriptive statistics were used to characterize the patient population eligible for Ribociclib treatment based on the NATALEE study's inclusion criteria. Out of 2384 enrolled patients, 1738 had HR+/HER2- eBC, of whom 43% (747/1738) met the NATALEE inclusion criteria. Of note, these patients were older, received less chemotherapy and presented with less advanced tumor stages compared to the NATALEE study cohort. Additionally, compared to the NATALEE study cohort, fewer patients had lymph node involvement (72.4% vs. 88.7%). Our analysis suggests that approximately 43% of all HR+/HER2- breast cancer patients will qualify for Ribociclib treatment. Given the numerous treatment options for patients with HR+/HER2- eBC, as well as the differences between the NATALEE cohort and patients in the real-world clinical setting, future analyses will be needed to determine which patients would benefit most from adjuvant CDK4/6 inhibitor treatment.