378O - Persistence under abemaciclib and endocrine treatment (ABA+ET) in patients with advanced breast cancer (aBC): First results of the randomized IMPACT trial comparing patient coaching with the MASCC oral agent teaching tool (MOATT) versus local routine patient coaching (LC)

Background

Recent studies showed the positive impact of supportive care programs on patients. Possible benefits include the prevention of incorrect medication intake, a decrease of treatment-related symptoms and the reduction of hospitalization due to adverse events. MOATT is a standardized patient coaching program which might be suitable to improve the therapy management of BC patients with oral treatments. Aim of this study was to investigate the impact of MOATT on persistence and therapy management under ABA+ET.

Methods

IMPACT (NCT04030728) was a prospective randomized, controlled trial in patients with hormone receptor positive, HER2-negative aBC treated with ABA+ET. Patients were randomized to LC vs. MOATT. Primary endpoint was the persistence rate after 24 weeks of treatment. Further endpoints included compliance rate, the number of dose reduction and dose interruptions.

Results

A total of 211 patients were randomized between 06/20 and 02/22. Persistence probability after 24 weeks was 0.71 (95%CI 0.63-0.81) with LC and 0.82 (95%CI: 0.74-0.90) with MOATT (hazard ratio: 0.59 (95%CI: 0.32-1.07; p_log-rank = 0.078). Disease progression or death were the main reasons for therapy discontinuation in 14 cases in the LC arm and in 10 cases in the MOATT arm. A decision for a permanent discontinuation of ABA in the first 24 weeks was seen in 14 patients (14.1%) in the LC arm and 8 Patients (7.8%) in the MOATT arm. Dose reductions were planned in 24.5% of patients with LC and in 17.2% of patients in the MOATT arm. Therapy interruptions were planned in 14.9% of LC-patients and 10.1% in the MOATT arm.

Conclusions

The risk of therapy discontinuation within the first 24 weeks of treatment is clinically relevant. Coaching with MOATT reduced the probability for permanent therapy discontinuations by about 40% during the first 6 months of therapy. Standardized patient coaching improved therapy management of oral cancer therapies like abemaciclib. Patient coaching might be very useful to improve therapy management also in the adjuvant breast cancer setting.

Clinical trial identification

NCT04030728 and July 24, 2019.

Editorial acknowledgement

Legal entity responsible for the study

Onco Medical Consult GmbH, Tennelbachstr. 59, D-65193 Wiesbaden.

Funding

Lilly.

Disclosure

P. Fasching: Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Hexal, Lilly, Pierre Fabre, Seagen, Agendia, Sanofi Aventis; Financial Interests, Personal, Invited Speaker: Novartis, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Lilly, Seagen, Gilead; Financial Interests, Personal, Other, Medical Writing Support: Roche; Financial Interests, Institutional, Local PI: BionTech, Cepheid; Non-Financial Interests, Member: ASCO, Arbeitsgemeinschaft für Gynäkologische Onkologie e.V., Translational Research in Oncology, Deutsche Gesellschaft für Senologie e.v.. L. Mueller: Financial Interests, Institutional, Invited Speaker: Iomedico. E. Belleville: Financial Interests, Institutional, Other, Research Support/Medical Education Support: Novartis, Lilly, MSD; Financial Interests, Personal, Other, Clinical Research Management/Medical Education: ClinSol; Financial Interests, Institutional, Other, Medical Education Support: Gilead, Daiichi Sankyo, Pfizer, Astra Zenca, Hexal, Sandoz, Roche, Amgen, Ipsen, Eisai, SUN Pharma, Sanofi, Immunocore, Takeda, BMC, SERVIER, Janssen, Stemline; Financial Interests, Institutional, Other, Clinical Research Support / Medical Education Support: Seagen; Financial Interests, Personal, Officer: Onkowissen, Clinsol, High5md; Financial Interests, Institutional, Funding, Research Support: Lilly, Novartis, Seagen, Bayer, Pfizer, Daiichi. L. Rieger: Financial Interests, Personal, Stocks/Shares: Pfizer. H. Tesch: Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi, Exact Science, Gilead, GSK, Lilly, MSD, Myan, Novartis, Pfizer, Piere Fabre, Roche Pharma GmbH, Seagan; Financial Interests, Personal, Other, Reporting SABSC, ESMO 2022 : ClinSol; Financial Interests, Personal, Other, Travel Expenses: GSK, Pfizer; Financial Interests, Personal, Writing Engagement: Novartis; Financial Interests, Personal, Other, Clinical trial manager: Novartis; Financial Interests, Personal, Invited Speaker, SABCS 2020 : Onkowissen; Financial Interests, Personal, Other, ownership of shares: CHOP GmbH, Onco Medical Consul, VISION MED GmbH, Care and Coach GmbH; Financial Interests, Personal, Other, Medical Co-Lead Impact: Lilly; Non-Financial Interests, Member: ASCO. All other authors have declared no conflicts of interest.