ABSTR ACTIntroduction This prospective study reports on the impact of psychological factors on women with primary breast cancer undergoing neoadjuvant chemotherapy. These women are in a special situation, where they not only have to deal with the shock of the cancer diagnosis but also with the fact that the malignant tumor will not be removed immediately but only after completing chemotherapy. A situation like this is stressful and requires a personal strength which not every woman may have.Methods In a prospective study 53 patients were assessed using various psychological and psycho-oncological questionnaires which aimed to evaluate their psychological stress and their coping resources. The women were evaluated before starting systemic treatment (t-1) and again immediately after completing chemotherapy but prior to surgery (t-2). The patients were also asked about their coping strategies at t-1 and t-2. Using the Ulm Coping Manual (UCM) the interviews were rated by independent assessors blinded to the respective patientʼs medical data. Patients were followed up for 3.7-5.5 years after completing chemotherapy.

Background: NEPA, an oral fixed dose combination of netupitant at 300 mg and palonosetron at 500 mg has been approved for the prevention of acute and delayed chemotherapy (Ctx)-induced nausea and vomiting (CINV) in cancer patients (pts) receiving highly (HEC) or moderately emetogenic chemotherapy (MEC). The primary objective of the prospective, non-interventional study (NIS) AkyPRO was the evaluation of quality of life (QoL) in adults receiving NEPA as primary prophylaxis for CINV associated with MEC or HEC. Secondary endpoints were efficacy and safety of NEPA. Here, we present an interim analysis in the subgroup of breast cancer (BC) pts, who represent the largest subpopulation (66%) enrolled in the AkyPRO. Since September 2015, 2427 pts have been recruited, of whom 986 suffered from BC. Methods: This NIS has been designed to evaluate NEPA in 2,500 cancer pts receiving single day or two day MEC or HEC. QoL was recorded by FLIE questionnaires. Efficacy of NEPA as indicated by complete response (CR: no vomiting, no rescue medication), additional medication, and adverse events were recorded in patient diaries over three consecutive Ctx cycles. Patients and physicians documented overall antiemetic efficacy on a 4-point scale (very good, good, satisfactory, poor). Results: At the cut-off date November 11, 2017, 2427 pts had been enrolled in the study. For the interim analysis, 986 BC pts were evaluated who had been completely documented in the eCRF at the cut-off date. 80% of pts received HEC, mostly (79%) anthracycline/cyclophosphamide (AC) combinations. Of the women receiving MEC, the majority were treated with carboplatin-based regimens (9%). 7% of patients received other MEC regimens. More than 84% of pts reported no impact on daily life due to vomiting in all analysed cycles. The percentage of pts with no impact on daily life due to nausea ranged from 51-56%. More than 93% of pts reported no emesis and more than 81% reported CR during the 5 days post-chemotherapy during all 3 cycles. Nausea was more difficult to control, 37% of pts documented to have suffered from nausea one or more times during the 5 days following chemotherapy. Effectiveness, evaluated by physicians’ assessment, was rated very good/good for 89 -91% of the pts in cycle 1, 2, and 3. Comparison of patients’ and physicians’ perception of antiemetic treatment effectiveness showed that patients judged the effectiveness equally well. NEPA was well tolerated. Low-grade constipation (2.2%) and insomnia (1.4%) were the most frequent treatment-related adverse events. Conclusion: In this real-life study, NEPA was effective in the prevention of CINV in the subgroup of breast cancer pts receiving HEC or MEC. Together with its convenient administration attributes of one single dose per ctx cycle, NEPA might facilitate adherence to antiemetic guidelines and ultimately may improve CINV control. Citation Format: Jörg Schilling, Steffi Busch, Andrea Stefek, Eberhard Müller, Jürgen Schwickerath, Falk Altmann, Martin Holländer, Meinolf Karthaus. Quality of life data of breast cancer patients receiving a fixed combination of netupitant/palonosetron (NEPA) for prevention of chemotherapy-induced nausea and vomiting - A real life study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-12-02.

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Zusammenfassung Einleitung Diese prospektive Studie berichtet über die Auswirkungen psychologischer Faktoren bei Patientinnen mit primärer Mammakarzinomerkrankung, die sich einer neoadjuvanten Chemotherapie unterzogen haben. Die spezielle Situation dieser Frauen ist nicht nur gekennzeichnet durch den Schock der Krebsdiagnose, sondern auch durch die Tatsache, dass der bösartige Tumor nicht sofort, sondern erst nach Abschluss der Chemotherapie entfernt wird. Eine solche Situation belastet und benötigt persönliche Stärken, über die nicht jede Frau verfügt. Methoden In einer prospektiven Studie wurden 53 Patientinnen vor dem Staging und der systemischen Therapie mithilfe verschiedener psychologischer und psychoonkologischer Fragebögen und Interviews auf ihre psychische Belastung und ihre Bewältigungsressourcen hin untersucht (t 1). Unmittelbar nach Abschluss der Chemotherapie und noch vor dem operativen Eingriff erfolgte eine weitere Testung mit denselben Messinstrumenten (t 2). Zusätzlich wurden die Patientinnen zu t 1 und t 2 bezüglich ihrer Bewältigungsstrategien interviewt. Die Interviews wurden mit dem Ulmer Coping-Manual (UCM) von bezüglich der medizinischen Informationen blinden Ratern objektiv geratet. Ergebnisse Patientinnen mit einer schlechten psychosozialen Anpassung an die Situation konnten zum Zeitpunkt t 1 identifiziert werden. Sie wiesen Defizite im sozialen Bewältigungsverhalten auf. Weiterhin wiesen sie höhere Werte in resignativem Bewältigungsverhalten und niedrigere Werte in der Suche nach sozialer Unterstützung auf, was insgesamt das Risiko für das Auftreten eines Rezidivs bzw. einer anderen Krebserkrankung im Betrachtungszeitraum von 3,7 bis 5,5 Jahren nach der chemotherapeutischen Behandlung erhöhte. Im Gegensatz dazu konnten wir über unsere Studie Patientinnen identifizieren, die über eine Stärkung ihrer Copingfaktoren die primär systemische Therapie signifikant besser bewältigten. Schlussfolgerung Ein sorgfältiges psychologisches Screening unmittelbar nach der Diagnose und noch vor der onkologischen Behandlung ist dringend empfohlen. Über diese Maßnahmen könnten jene Patientinnen identifiziert werden, die aufgrund ihrer psychisch hohen Vulnerabilität eine zusätzliche psychoonkologische Unterstützung erhalten sollten.