CDK 4/6 inhibitors play an important role in hormone receptor (HR)-positive, HER2-negative advanced and metastatic breast cancer. Oral medications such as palbociclib offer advantages but pose a challenge for therapy adherence. An eHealth-based platform such as CANKADO can help to support therapy management by probing the quality of life (QoL) status of the patient continuously throughout the course of treatment and, ideally, providing a basis for intensified care when indicated.
PreCyle (NCT03220178) is a multicenter, randomized phase IV Intergroup trial to evaluate the impact of eHealth-based Patient-Reported Outcome (ePRO) assessment on QoL in patients with HR+ HER2-, locally advanced or metastatic breast cancer treated with palbociclib and endocrine therapy. Patients were randomized (2:1; stratified by line of treatment) to the active arm A (supported by CANKADO PRO-React) or the inform arm B (drug intake documentation only). This exploratory analysis reports the impact of CANKADO PRO-React on safety. Time to first serious adverse event (SAE) was estimated taking competing risks into account.
The safety population comprised 318 patients in Arm A (23.3% SAEs) and 161 in arm B (31.1% SAEs). While distributions of adverse events (AEs) were similar by arm on the whole, patients in the CANKADO active arm had a favorable hazard ratio of 0.67 (95%-CI: 0.46-0.97; p=.04) for time to first SAE and were significantly less likely overall to suffer an SAE than patients in the inform arm.
Safety analysis of the PreCycle trial demonstrates for the first time in a randomized prospective trial that interactive eHealth-based support has a substantial favorable impact on the risk of SAEs for patients with advanced and metastatic HR+/HER2- breast cancer on oral tumor therapy. While eHealth-based support may not prevent adverse events, CANKADO PRO-React could mitigate their progression to a serious adverse event, thus resulting in a substantial QoL benefit for patients.
EudraCT 2016-004191-22, NCT03220178.
palleos healthcare GmbH.
Pfizer.
N. Harbeck: Financial Interests, Personal, Invited Speaker: AstraZeneca, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Seagen, Medscape, Art Tempi, Onkowissen, Gilead, Sanofi, Exact Sciences; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo, Novartis, Pfizer, Roche, Sandoz-Hexal, Seagen, Aptitude Health, Gilead, Sanofi; Financial Interests, Personal, Other, Husband: WSG (Husband); Financial Interests, Personal, Ownership Interest: West German Study Group; Financial Interests, Institutional, Funding: AstraZeneca, BMS, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Palleos, Seagen, TRIO, WSG; Non-Financial Interests, Member, Member German AGO Breast Guideline Committee: AGO Breast Committee; Non-Financial Interests, Member, Breast Cancer Educational Programs: ESO/ESCO; Other, Founding Editor: BreastCare Journal. R. Würstlein: Financial Interests, Personal, Advisory Role: Agendia, Amgen, Aristo, AstraZeneca, Celgene, Clovis Oncology, Daiichi Sankyo, Eisai, Exact Sciences, Gilead, Glaxo Smith Kline, Hexal, Lilly, Medstrom Medical, MSD, Mundipharma, Mylan, NanoString , Novartis, Odonate, Paxman, palleos , Pfizer, Pierre Fabre, PINK, PumaBiotechnology, Riemser, Roche, Sandoz/Hexal, Sanofi Genzyme, Seattle Genetics/Seagen, Stemline, Tesaro Bio, Teva, Veracyte, Viatris; Non-Financial Interests, Personal, Full or part-time Employment: Breast Center, LMU University Hospital, Munich. D.I. Lüftner: Financial Interests, Personal, Other, Honoraria: Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Loreal, Novartis, Pfizer, Seagen; Financial Interests, Personal, Speaker’s Bureau: Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Loreal , Novartis, Pfizer, Seagen; Financial Interests, Institutional, Funding: Novartis; Financial Interests, Personal, Expert Testimony: Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Loreal , Novartis, Pfizer, Seagen; Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Loreal, Novartis, Pfizer, Seagen. O. Hoffmann: Financial Interests, Personal, Advisory Role: Roche, Novartis, MSD, Pfizer, AstraZeneca, Daiichi Sankyo, Hexal, Riemser, Celgene, Gilead, Lilly, Seagen; Financial Interests, Personal, Expert Testimony: Deutsche Krebsgesellschaft; Non-Financial Interests, Personal, Principal Investigator: Department of Gynecology and Obstetics, University Hospital of Essen Germany. T. Decker: Financial Interests, Personal, Advisory Board: Novartis, iOMEDICO. M. Reinisch: Financial Interests, Personal, Other, Honoraria: MSD, Lilly, AstraZeneca, Roche, Novartis, Pfizer, Seagen, Somatex. P. Staib: Financial Interests, Personal, Other, Honoraria: AbbVie, Amgen, AstraZeneca, Celgene, BMS, MSD, Pfizer, Merck Serono, Roche, Novartis; Financial Interests, Personal, Advisory Role: AbbVie, Amgen, AstraZeneca, BMS; Financial Interests, Personal, Speaker’s Bureau: AbbVie, Amgen, AstraZeneca, BMS, Roche, Pfizer; Financial Interests, Personal, Funding: AbbVie, Novartis, Celgene, Roche. O. Gluz: Financial Interests, Personal, Advisory Board: Roche, Lilly, Amgen, Novartis, Pierre Fabre, MSD, Celgene, Pfizer, Gilead, Molecular Health, Seagen; Financial Interests, Personal, Invited Speaker: AstraZeneca, Exact Science; Financial Interests, Institutional, Invited Speaker: Roche; Non-Financial Interests, Leadership Role: West German Study Group; Non-Financial Interests, Personal, Proprietary Information: West German Study Group. P.A. 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, Invited Speaker: BionTech, Cepheid; Non-Financial Interests, Member: ASCO, Arbeitsgemeinschaft für Gynäkologische Onkologie e.V., Translational Research in Oncology, Deutsche Gesellschaft für Senologie e.v. M. Schmidt: Financial Interests, Institutional, Research Grant: AstraZeneca, BioNTech, Eisai, German Breast Group, Genentech, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche; Financial Interests, Personal, Advisory Role: AstraZeneca, BioNTech, Eisai, Daiichi Sankyo, Lilly, MSD, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche, Seagen; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Novartis, Pfizer, Roche, Seagen; Financial Interests, Personal, Licensing Fees: EP 2951317B1, EP 2390370B1; Financial Interests, Personal, Advisory Board: AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, Lilly, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche, Seagen. All other authors have declared no conflicts of interest.