Diana Luftner (Berlin, Germany)
University Hospital CharitéAuthor Of 5 Presentations
Welcome and introduction (ID 261)
Summary and close (ID 266)
Stay the course _ Working on treatment adherence in HER2+ early breast cancer (ID 264)
74P - Management of early-stage hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer in a real-word setting in Germany: a patient perspective (ID 89)
- Christian Jackisch (Offenbach am Main, Germany)
- Maggie Banys- Paluchowski (Lübeck, Germany)
- Agnieszka Korfel (Bad Homburg, Germany)
- Clemens Stoffregen (Bad Homburg vor der Höhe, Germany)
- Thorsten Otto (Bad Homburg vor der Höhe, Germany)
- Jacqueline Brown (Windlesham, United Kingdom)
- Isaac Sanderson (Bollington, United Kingdom)
- Alex Rider (Bollington, United Kingdom)
- Diana Luftner (Berlin, Germany)
Abstract
Background
Better understanding of patient (pt) perspectives could help in the management of HR+, HER2- early breast cancer (EBC).
Methods
Real-world data were analyzed descriptively from the Adelphi EBC Disease Specific Programme (Jun–Aug 2019). Fifty physicians practicing in Germany completed 400 pt record forms (PRFs) for pts with HR+, HER2- EBC who received/completed adjuvant therapy in the prior 12 months; 281 of these pts completed a pt self-completion form (PSC) including questions on pts’ knowledge/perceptions of, and satisfaction with coping with their illness (Functional Assessment of Cancer Therapy – Breast item GE2).
Results
Among 281 pts (mean [SD] age 56.4 [12.19] years, 59% Eastern Cooperative Onology Group status 0, 100% female) most had tumor size 1–3cm (76%), Grade 1 tumor (54%) and were node negative (73%). Of 48 pts considered by physicians to have high Ki-67, 80% had Ki-67 ≥20%. Most pts were aware of their EBC stage (83%), HER2 status (67%), nodal status (67%) and HR status (64%); 68% felt involved in treatment decisions; 79% thought the goal of current treatment was cure; and 59% were satisfied and 41% less satisfied with how they were coping with their EBC. Among pts satisfied/less satisfied with how they were coping (mean age 56.5/56.3 years), 55%/75% were aware of 3–4 (of a total of 4) aspects of their EBC, 71%/62% felt involved in treatment decisions and 49%/61% had used the internet to find information on EBC. Rates of adverse events (AEs) reported in both PRFs (for 72 of 400 pts with AEs) and 281 PSCs were: nausea 58%/17%, joint/muscle pain 25%/28% (pain), fatigue 24%/43%, vomiting 14%/16%, headache 11%/25%, diarrhea 8%/15% and hair loss/thinning 6%/38%. Differences (≥10%) in AE rates in pts satisfied/less satisfied with how they were coping were found for fatigue 39%/51%, nausea 13%/24%, vomiting 12%/22% and diarrhea 11%/21%.
Conclusions
In pts with HR+, HER2- EBC, behaviors differed in those satisfied with how they were coping with their EBC vs those less satisfied. There was discrepancy in the perception of AEs between physicians and pts. By addressing these points, physicians/caregivers could potentially help optimize pt satisfaction.
Editorial acknowledgement
Medical writing support from Rx Communications (Gill Gummer).
Legal entity responsible for the study
Eli Lilly and Company.
Funding
Eli Lilly and Company.
Disclosure
C. Jackisch: Financial Interests, Other, Travel Grant and Housing Support form Lilly: Eli Lilly and Company. M. Banys- Paluchowski: Financial Interests, Other, Honoraria for lectures and advisory role: Eli Lilly and Company; Financial Interests, Other, Honoraria for lectures and advisory role: Pfizer; Financial Interests, Other, Honoraria for lectures and advisory role: Roche; Financial Interests, Other, Honoraria for lectures and advisory role: Amgen; Financial Interests, Other, Honoraria for lectures and advisory role: Daiichi Sankyo; Financial Interests, Other, Honoraria for lectures and advisory role: Novartis; Financial Interests, Other, Honoraria for lectures and advisory role: GSK. A. Korfel, C. Stoffregen, T. Otto: Financial Interests, Institutional, Affiliate: Eli Lilly and Company. J. Brown: Financial Interests, Institutional, Stocks/Shares: Eli Lilly and Company; Financial Interests, Institutional, Affiliate: Eli Lilly and Company. D.I. Lüftner: Financial Interests, Other, Honoraria and advisory boards: Eli Lilly and Company. All other authors have declared no conflicts of interest.
75P - Interim analysis (n=150) of the multi-national, prospective, non-interventional ELEANOR study observing real-life extended adjuvant treatment with neratinib in patients with HER2+ / HR+ early breast cancer (eBC) (ID 90)
- Nadia Harbeck (Munich, Germany)
- Denise Wrobel (Bamberg, Germany)
- Matthias Zaiss (Freiburg im Breisgau, Germany)
- Dagmar Guth (Plauen, Germany)
- Andrea Distelrath (Plauen, Germany)
- Jürgen Terhaag (Eggenfelden, Germany)
- Andreas Lorenz (Hildburghausen, Germany)
- Rupert Bartsch (Vienna, Austria)
- Urs Breitenstein (Zurich, Switzerland)
- Michael Schwitter (Chur, Switzerland)
- Marija Balic (Graz, Austria)
- Christian Jackisch (Offenbach am Main, Germany)
- Volkmar Müller (Hamburg, Germany)
- Gabriel Rinnerthaler (Salzburg, Austria)
- Marcus Schmidt (Mainz, Germany)
- Khalil Zaman (Lausanne, Switzerland)
- Timo Schinköthe (Kirchheim, Germany)
- Diana Luftner (Berlin, Germany)
Abstract
Background
Neratinib is registered in Europe as extended adjuvant treatment for adult patients with Human Epidermal Growth Factor Receptor 2-positive (HER2+) and Hormone receptor-positive (HR+) eBC within one year after completed adjuvant trastuzumab-based therapy (“EMA-/Swiss-label” population). In the ExteNET trial, extended adjuvant neratinib improved the absolute 5-year invasive disease-free survival rate by 5.1% vs. placebo in this population (90.8% vs. 85.7%; HR 0.58 [95% CI 0.41-0.82]). More pronounced benefit was observed in patients with non-pCR after neoadjuvant trastuzumab-based therapy and/or in patients who completed one year of neratinib (descriptive post-hoc analyses). In the absence of primary prophylaxis, grade 3 diarrhea occurred in 39% of patients in the ExteNET trial. ELEANOR is the first study to investigate real-world use of neratinib and its management in eBC patients in Germany, Austria and Switzerland.
Methods
300 patients with HER2+/HR+ eBC will be enrolled in accordance with the specifications of the local Summary of Product Characteristics. Primary objective is the proportion of patients adherent to neratinib treatment (i.e., neratinib intake for ≥75% of treatment days). Secondary objectives include analysis of prior trastuzumab-based therapies (including pertuzumab and T-DM1), neratinib dosing and management, relapses, safety / tolerability, and health-related quality of life (using the CANKADO eHealth application).
Results
Between July 2020 and Feb 2022, 206 patients were enrolled at 59 sites; patient enrollment is ongoing. We will present results from the interim analysis on the first 150 enrolled patients who have been observed for at least 3 months (data cut Nov 2021, analyses ongoing). Baseline demographics and tumor characteristics, prior trastuzumab-based treatments, and neratinib safety and tolerability will be reported.
Conclusions
ELEANOR will help to characterize adherence to neratinib and use of extended adjuvant HER2-targeted therapy in the current treatment landscape focusing on neratinib management after different prior therapies.
Editorial acknowledgement
Editorial assistance was provided by Anna Resch, Pierre Fabre Pharma GmbH, Freiburg, Germany.
Legal entity responsible for the study
Pierre Fabre Pharma GmbH (Freiburg, Germany), Pierre Fabre Pharma Austria (Wels, Austria) and Pierre Fabre Pharma AG (Allschwil, Switzerland).
Funding
Pierre Fabre Pharma GmbH (Freiburg, Germany), Pierre Fabre Pharma Austria (Wels, Austria) and Pierre Fabre Pharma AG (Allschwil, Switzerland).
Disclosure
N. Harbeck: Financial Interests, Personal, Other: Amgen, AstraZeneca, Daiichi Sankyo, Exact Sciences, Eli Lilly, Gilead, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Sandoz, Seagen, WSG; Financial Interests, Institutional, Other: clinical trials. D. Wrobel: Financial Interests, Personal, Other: Roche, Novartis. M. Zaiss: Financial Interests, Personal, Other: Celgene, AstraZeneca, RG, AKS, Vifor, Pfizer, Janssen, Novartis, AbbVie; Financial Interests, Personal and Institutional, Other: Roche, Eli Lilly; Financial Interests, Institutional, Other: GBG. R. Bartsch: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Daiichi; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Institutional, Funding, Investigator Initiated Trial: Daiichi; Financial Interests, Institutional, Invited Speaker, Drug support for investigator initiated trial: MSD. U. Breitenstein: Financial Interests, Institutional, Other: Novartis, Roche, AstraZeneca, Eli Lilly, Pierre Fabre, Pfizer, SAKK; Non-Financial Interests, Personal, Other: SGMO, SGS, SAKK. M. Schwitter: Financial Interests, Personal and Institutional, Other: Pierre Fabre. M. Balic: Financial Interests, Personal, Other: Amgen, Pierre Fabre, Daiichi Sankyo, Bayer, Samsung, Seagen; Financial Interests, Personal and Institutional, Other: Novartis, Eli Lilly, Pfizer, Celgene, AstraZeneca, MSD, Roche; Financial Interests, Institutional, Other: ABCSG, IBCSG, BIG. C. Jackisch: Financial Interests, Personal, Other: Roche, AstraZeneca, Eisai, Pfizer, Eli Lilly, Novartis, Exact Sciences; Non-Financial Interests, Personal, Other: Roche. V. Müller: Financial Interests, Personal, Other: Amgen, AstraZeneca, Daiichi Sankyo, Eisai, GSK, Pfizer, MSD, Medac, Novartis, Roche, Teva, Seagen, Onkowissen, high5 Oncology, Medscape, Gilead; Financial Interests, Institutional, Other: Novartis, Roche, Seattle Genetics, Genentech. G. Rinnerthaler: Financial Interests, Personal and Institutional, Other: Roche, Pierre Fabre; Financial Interests, Personal, Other: AstraZeneca, Novartis, BMS, Roche, Pfizer, Eli Lilly, MSD, Daiichi Sankyo. M. Schmidt: Financial Interests, Personal, Other: Amgen, Seagen; Financial Interests, Personal and Institutional, Other: Pierre Fabre, Roche, Pfizer, Novartis, AstraZeneca, Eisai, Pantarhei, BioNTech; Financial Interests, Institutional, Other: Genentech; Non-Financial Interests, Personal, Other: Roche, Pfizer, Pantarhei, BioNTech; Non-Financial Interests, Personal, Other, Issued patent EP: 2951317, Issued patent EP: 2390370: Other. K. Zaman: Financial Interests, Personal and Institutional, Other: Roche; Financial Interests, Institutional, Other: Eli Lilly, Novartis, MSD Oncology, Mylan, Daiichi Sankyo, Pierre Fabre, Genentech. T. Schinköthe: Financial Interests, Personal, Full or part-time Employment: CANKADO Service GmbH; Financial Interests, Personal, Ownership Interest: CANKADO Service GmbH. D. Lüftner: Financial Interests, Institutional, Other: Novartis; Financial Interests, Personal, Other: Amgen, Pfizer, GSK, Loreal, Teva, Gilead, Sanofi Aventis, Daiichi Sankyo, Samsung, AstraZeneca, Novartis. All other authors have declared no conflicts of interest.