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Zusammenfassung Hintergrund Während einer Krebstherapie leiden viele Patienten an Mangelernährung oder Vitaminmangel. Die Behandlung nährstoffbezogener Mangelzustände sollte daher eine Ernährungstherapie und gegebenenfalls auch eine orale oder intravenöse Substitution von Mikronährstoffen beinhalten. Über Infusionstherapien mit mehreren Nährstoffen liegen nur wenige Informationen vor. Das Ziel dieser Studie bestand in der Entwicklung standardisierter Infusionsprotokolle für die Infusion von Mikronährstoffen im Rahmen der integrativen Medizin (IMed-Infusionen) und der Beschreibung von Nebenwirkungen der Behandlung und der Therapiezufriedenheit der Patientinnen. Methoden Für die IMed-Sprechstunde wurden in Zusammenarbeit mit der Apotheke des Universitätsklinikums Erlangen 4 spezielle Formulierungen für die intravenöse Anwendung entwickelt. Zwischen Oktober 2015 und Januar 2018 wurde eine retrospektive Querschnittsstudie durchgeführt, in der 45 Patientinnen mit gynäkologischen Krebserkrankungen oder Brustkrebs (BK) unter IMed-Infusionstherapie aufgenommen wurden. Von 20 Patientinnen wurden mithilfe eines standardisierten Fragebogens zu IMed-Infusionen Nachbeobachtungsdaten erhoben. Ergebnisse Während des Studienzeitraums wurden insgesamt 280 IMed-Infusionen verabreicht. Die meisten Patientinnen haben IMed-Regenerationsinfusionen erhalten (78 %). Die Patientinnen litten in der Mehrzahl der Fälle an BK und wurden mit Chemotherapie behandelt. Die meisten Patientinnen gaben ein hohes oder sehr hohes Maß an Zufriedenheit mit der Organisation (60 %), der allgemeinen Behandlung (65 %) und der Beratung (85 %) an. Über eine subjektive Besserung von krankheits- oder therapiebedingten Symptomen wie Fatigue, Polyneuropathie und Einschränkung der körperlichen Leistungsfähigkeit berichteten 70 % der Patientinnen, während 75 % eine subjektive Steigerung ihrer Lebensqualität angaben. Nebenwirkungen traten nur selten auf und waren leichter Natur. Schlussfolgerungen Die Therapie mit IMed-Infusionen bei Frauen mit BK oder gynäkologischen Krebserkrankungen muss denselben Standards genügen wie Arzneimitteltherapien. Obwohl es sich bei Vitaminen um Nahrungsergänzungsmittel handelt, sind eine gründliche Erhebung der Anamnese sowie eine angemessene Aufklärung der Patientinnen unerlässlich. Hierfür haben sich standardisierte Vorgehensweisen, wie im Rahmen der IMed-Sprechstunde der Fall, als hilfreich erwiesen.

Background: The usefulness of clinical breast examination (CBE) in general and in breast cancer screening programs has been a matter of debate. This study investigated whether adding vision-impaired medical tactile examiners (MTEs) improves the predictiveness of CBE for suspicious lesions and analyzed the feasibility and acceptability of this approach. Methods: The prospective study included 104 patients. Physicians and MTEs performed CBEs, and mammography and ultrasound results were used as the gold standard. Sensitivity and specificity were calculated and logistic regression models were used to compare the predictive value of CBE by physicians alone, MTEs alone, and physicians and MTEs combined. Results: For CBEs by physicians alone, MTEs alone, and both combined, sensitivity was 71, 82, and 89% and specificity was 55, 45, and 35%, respectively. Using adjusted logistic regression models, the validated areas under the curve were 0.685, 0.692, and 0.710 (median bootstrapped p value (DeLong) = 0.381). Conclusion: The predictive value for a suspicious breast lesion in CBEs performed by MTEs in patients without prior surgery was similar to that of physician-conducted CBEs. Including MTEs in the CBE procedure in breast units thus appears feasible and could be a way of utilizing their skills.

Background: Improved progression-free survival is considered as treatment goal for patients with metastatic breast cancer (MBC) since it is assumed to delay or prevent deterioration of quality of life.Aim of our analysis was to examine the influence of disease progression on health-related quality of life (HRQoL). Methods: The PRAEGNANT study comprises a real-life registry for patients with MBC. HRQoL was assessed with the EORTC-QLQ-C30 Version 3.0 questionnaire at study entry and every 3 months thereafter. The primary endpoint was minimally important deterioration (MID) in global HRQoL score by ≥ five points between baseline and any follow-up assessment. A logistic regression model was built with MID (yes/no) at a follow-up timepoint as outcome variable and several covariates as predictors. Results: In total, 329 patients were included in this analysis, with disease progression in 63 patients. Concerning the primary study aim, progression status predicted MID of global HRQoL status in addition to the other covariates. The adjusted odds ratio for the effect of progression status on MID was 2.22 (95% CI: 1.04 – 4.73). Comparisons of mean differences of QoL domains/scales yielded no differences. Conclusions: We provide evidence that disease progression in patients with metastatic breast cancer in a real-world registry has a significant negative impact on HRQoL as measured by MID of HRQoL. This study emphasizes the relevance of avoiding progression and prolonging PFS to maintain QoL. Citation Format: Wallwiener M, Nabieva N, Haeberle L, Taran FA, Hartkopf AD, Volz B, Overkamp F, Brandl AL, Kolberg H-C, Hadji P, Tesch H, Ettl J, Lux MP, Lueftner D, Belleville E, Fasching PA, Janni W, Beckmann MW, Wimberger P, Hielscher C, Fehm T, Brucker SY, Wallwiener D, Schneeweiss A, Mueller V. Impact of disease progression on health-related quality of life in patients with metastatic breast cancer in the PRAEGNANT breast cancer registry [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-10.

Objectives Improved progression-free survival is considered as treatment goal for patients with metastatic breast cancer (MBC) since it is assumed to delay or prevent deterioration of quality of life. Aim of our analysis was to examine the influence of disease progression on health-related quality of life (HRQoL). Materials and methods The PRAEGNANT study comprises a real-life registry for patients with MBC. HRQoL was assessed with the EORTC-QLQ-C30 Version 3.0 questionnaire at study entry and every 3 months thereafter. The primary endpoint was minimally important deterioration (MID) in global HRQoL score by ≥ five points between baseline and any follow-up assessment. A logistic regression model was built with MID (yes/no) at a follow-up timepoint as outcome variable and several covariates as predictors. Results In total, 329 patients were included in this analysis, with disease progression in 63 patients. Concerning the primary study aim, progression status predicted MID of global HRQoL status in addition to the other covariates. The adjusted odds ratio for the effect of progression status on MID was 2.22 (95% CI: 1.04 - 4.73). Comparisons of mean differences of QoL domains/scales yielded no differences. Conclusions We provide evidence that disease progression in patients with metastatic breast cancer in a real-world registry has a significant negative impact on HRQoL as measured by MID of HRQoL. This study emphasizes the relevance of avoiding progression and prolonging PFS to maintain QoL.

Background During cancer therapy, many patients suffer from malnutrition or vitamin deficiency. Treatment for nutrition-related deficiencies should therefore include nutritional therapy and possibly oral or intravenous substitution of micronutrients. Little information exists on multinutrient infusion therapies. The aim of this study was to develop standardized infusion protocols for integrative medicine infusions with micronutrients (IMed infusions) and to report on side effects of the treatment and patientsʼ satisfaction with it. Methods For the IMed consultancy service, four special formulas for intravenous use were developed in cooperation with the pharmacy at Erlangen University Hospital. A retrospective cross-sectional study was conducted between October 2015 and January 2018 in which 45 patients with gynecological or breast cancer (BC) and IMed infusion therapy were included. Follow-up data were obtained from 20 patients using a standardized questionnaire on IMed infusions. Results A total of 280 IMed infusions were administered in the study period. The majority of the patients received an IMed regeneration infusion (78%). The majority of the patients had BC and were receiving chemotherapy. Most patients reported a high or very high level of satisfaction with the organization (60%), general treatment (65%) and counseling (85%). Subjective improvement in their disease-related and therapy-induced symptoms, such as fatigue, polyneuropathy and physical efficiency, was reported by 70% of the patients, while 75% reported a subjective increase in quality of life. Side effects were rare and minor. Conclusions Therapy with IMed infusions in women with BC or gynecological cancer requires the same standards set for drug therapy. Although vitamins represent dietary supplements, appropriate assessment of the patientʼs medical history is needed and patients must receive appropriate information. For this purpose, standardized processes, as in the context of an IMed consultancy service, are helpful.

Background: Despite advancements in the treatment of primary and metastatic breast cancer, many patients lack a durable response to these treatments. Patients with triple-negative breast cancer (TNBC) and human epidermal growth factor receptor 2(HER2)-positive breast cancer who do not have a pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) have a very poor prognosis. Tumor-infiltrating lymphocytes (TILs) have been identified as a predictive marker for pCR after NACT in TNBC and HER2-positive breast cancer. These patient populations could also be suitable for novel treatment strategies including neoepitope-based therapies. This work analyses the effect of TILs on the pCR in neoadjuvantly treated patients in the TILGen study and presents the procedures aimed at establishing neoepitope-based therapies in this study. Methods: Neoadjuvantly treated HER2-positive and TNBC patients were eligible for the presented analysis concerning the association between TILs and pCR. A total of 146 patients could be identified within the TILGen study. TILs were evaluated as percentage of stromal tumor tissue in core biopsies at primary diagnosis. The phenotype ‘lymphocyte-predominant breast cancer' (LPBC) was associated with pCR by logistic regression adjusted for estrogen receptor status, progesterone receptor status, HER2 status, age at diagnosis, and grading. Results: LPBC was seen in 24 (16.4%) patients. In this patient group, 66.7% achieved a pCR, while the pCR rate was 32.8% in patients with a low TIL count. The adjusted odds ratio was 6.60 (95% confidence interval 2.02-21.56; p < 0.01). Conclusion: TILs are a strong predictor of pCR in TNBC and HER2-positive breast cancer patients. Implications for the use of this information including the effect on prognosis might help to identify patients most likely to benefit from a neoepitope-based therapy approach.