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Mini oral session - Breast cancer, early stage

122MO - Quality of life from the Penelope-B study on high-risk HR+/HER2- early breast cancer patients treated with endocrine therapy with or without palbociclib

Date

20 Sep 2021

Session

Mini oral session - Breast cancer, early stage

Topics

Tumour Site

Breast Cancer

Presenters

José García-Saenz

Citation

Annals of Oncology (2021) 32 (suppl_5): S407-S446. 10.1016/annonc/annonc687

Authors

J.A. García-Saenz1, F. Marmé2, H.S. Rugo3, M. Untch4, H. Bonnefoi5, S. Kim6, H.D. Bear7, N. McCarthy8, K. Gelmon9, M. Martin10, C.M. Kelly11, T. Reimer12, M. Toi13, E.H. Law14, M. Gnant15, A. Makris16, S. Seiler17, N. Burchardi18, V. Nekljudova18, S. Loibl18

Author affiliations

  • 1 Service De Oncología Médica, Instituto de Investigación Sanitaria Hospital Clinico San Carlos (IdISSC) and GEICAM, 28040 - Madrid/ES
  • 2 Gynecologic Oncology Department, UMM - Universitaetsklinikum Mannheim - Medizinische Fakultaet, 68167 - Mannheim/DE
  • 3 Department Of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, 94115 - San Francisco/US
  • 4 Department Of Gynecologic Oncology, Helios Klinikum Berlin-Buch, D-13125 - Berlin/DE
  • 5 Medical Oncology Department, Institute Bergonié and Universite´de Bordeaux INSERM U916, 33076 - Bordeaux/FR
  • 6 Oncology Dept., Asan Medical Center - University of Ulsan College of Medicine, 138-931 - Seoul/KR
  • 7 Division Of Surgical Oncology, Massey Cancer Center, Virginia Commonwealth University, VCU Health, Richmond/US
  • 8 Medical Oncology, Breast Cancer Trials Australia and New Zealand and University of Queensland, Newcastle/AU
  • 9 Medical Oncology, BC Cancer Agency, Vancouver/CA
  • 10 Medical Oncology Service, Instituto de Investigacion Sanitaria Gregorio Marañon, CIBERONC, Universidad Complutense and GEICAM, Madrid/ES
  • 11 Medical Oncology, Breast Group Cancer Trials Ireland and Mater Misericordiae University Hospital, Dublin/IE
  • 12 Department Of Obstetrics And Gynecology, University of Rostock, 18059 - Rostock/DE
  • 13 Department Of Breast Surgery, Kyoto University Graduate School of Medicine, 606-8501 - Kyoto/JP
  • 14 Patient & Health Impact, Pfizer Inc., New York/US
  • 15 Comprehensive Cancer Center, Medical University of Vienna, Vienna/AT
  • 16 Clinical Oncology, Mount Vernon Cancer Centre, Northwood/GB
  • 17 Department Of Medicine And Research, German Breast Group (GBG) Forschungs GmbH, Neu-Isenburg/DE
  • 18 Department Of Medicine And Research, German Breast Group (GBG) Forschungs GmbH, 63263 - Neu-Isenburg/DE

Resources

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Abstract 122MO

Background

The PENELOPE-B trial did not demonstrate improved invasive disease-free survival with the addition of one year of palbociclib to endocrine therapy (ET) compared to placebo plus ET in high risk HR+/HER2- early breast cancer patients with residual invasive breast cancer following neoadjuvant therapy. This analysis compared patient-reported outcomes (PROs) between the two treatment groups.

Methods

Patients were randomized 1:1 to receive palbociclib 125 mg/day (n=631) or placebo (n=619) orally for 3 weeks followed by 1 week off plus ET per standard of care. PROs were assessed during screening, on day 1 of cycles 1, 3, 5, 7, 9, 11, then, every 6 months after end of treatment visit using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) and its breast cancer (BR23) and fatigue (FA13) modules. Higher scores of C30 and FA13 (range 0-100) indicate better functioning and global health status/quality of life (GHS/QoL) or worse symptom severity, respectively. Repeated-measures mixed-effects models were used to evaluate differences in PRO between treatment groups, changes of PRO over time, and treatment-by-time interactions.

Results

Overall, 924 of 1250 patients (73.9%) completed the baseline and at least one post baseline questionnaire of all PRO instruments. GHS/QoL by the EORTC QLQ-C30 was generally high in both treatment arms (mean [SD]: palbociclib 70.1 [19.3], placebo 71.4 [18.8]) and was slightly higher in the placebo arm (LeastSquare mean difference: 0.82, p<0.001), especially during the active treatment phase of the study. Higher fatigue was reported in the palbociclib compared to placebo arm (mean [SD]: 30.3 [23.8] vs. 28.3 [22.7]; p<0.001). In contrast, no statistically significant differences were observed among the FA13 physical, cognitive, and emotional fatigue subscales.

Conclusions

In general, patient-reported QoL and fatigue was maintained during the study in both treatment arms. Statistically significant differences were observed between treatments in favor of the placebo arm; however, none were clinically relevant.

Clinical trial identification

NCT01864746

Editorial acknowledgement

Legal entity responsible for the study

German Breast Group.

Funding

Pfizer Inc.

Disclosure

J.A. García-Saenz: Financial Interests, Personal, Funding: Lilly; Financial Interests, Personal, Funding: Pfizer; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Funding: Seagen; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Funding: Daiichi Sankyo; Financial Interests, Personal, Funding: MSD; Financial Interests, Other: Roche. F. Marmé: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: Clovis; Financial Interests, Personal, Other: GSK/Tesaro; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Celgene; Financial Interests, Personal, Other: Seagen; Financial Interests, Personal, Other: Myriad; Financial Interests, Personal, Other: PharmaMar; Financial Interests, Personal, Other: Eisai; Financial Interests, Personal, Other: Janssen-Cilag. H.S. Rugo: Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Odonate; Financial Interests, Institutional, Research Grant: Daiichi; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Macrogenics; Financial Interests, Institutional, Research Grant: Sermonix; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Polyphor; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Immunomedics; Financial Interests, Personal, Advisory Role: Puma; Financial Interests, Personal, Advisory Role: Mylan; Financial Interests, Personal, Advisory Role: Samsung. M. Untch: Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: AbbVie; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Amgen GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: AstraZeneca; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: BMS; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Celgene GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Daiji Sankyo; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Eisai GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Lilly Deutschland; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Lilly Int.; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: MSD Merck; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Mundipharma; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Myriad Genetics; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Pfizer GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Roche Pharma AG; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Sanofi Aventis Deutschland GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: TEVA Pharmaceuticals Ind Ltd; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Novartis; Financial Interests, Institutional, Funding, All fees to the institution/employer: Pierre Fabre; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Clovis Oncology; Financial Interests, Institutional, Funding, All fees to the institution/employer: Seattle Genetics; Financial Interests, Institutional, Funding, All fees to the institution/employer: Seagen. S. Kim: Financial Interests, Institutional, Research Grant, institutional: Novartis; Financial Interests, Institutional, Research Grant, institutional: Sanofi-Aventis; Financial Interests, Institutional, Research Grant, institutional: DongKook Pharm Co; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Dae Hwa Pharmaceutical Co. Ltd; Financial Interests, Personal, Advisory Board: ISU Abxis; Financial Interests, Personal, Advisory Board: Daiichi-Sankyo; Financial Interests, Personal, Stocks/Shares: Genopeaks; Financial Interests, Personal, Stocks/Shares: NeogeneTC. H.D. Bear: Financial Interests, Personal, Research Grant: NSABP Foundation; Other, Personal, Stocks/Shares, Own stock in Pfizer: Pfizer. N. McCarthy: Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Specialised Therapeutics; Financial Interests, Personal, Advisory Role: Easai; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Novartis. K. Gelmon: Financial Interests, Personal, Funding: Pfizer; Financial Interests, Personal, Funding: Eli Lilly; Financial Interests, Personal, Funding: AstraZeneca; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Funding: Seagen; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Eli Lilly; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Seagen; Financial Interests, Personal, Advisory Role: Mylan; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Nanostring; Financial Interests, Personal, Advisory Role: Genomic Health; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Seagen; Financial Interests, Personal, Expert Testimony: Genentech. M. Martin: Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Funding: Lilly; Financial Interests, Personal, Research Grant: Puma; Financial Interests, Personal, Funding: AstraZeneca; Financial Interests, Personal, Funding: Pierre Fabre; Financial Interests, Personal, Funding: Pfizer. T. Reimer: Financial Interests, Personal, Funding: Pfizer. M. Toi: Financial Interests, Personal, Member of the Board of Directors: JBCRG association, Organisation for Oncology and Translational Research, Kyoto Breast Cancer Research Network; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Chugai; Financial Interests, Personal, Research Grant: Takeda; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Pfizer; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria, Advisory role for a drug development: Kyowa-Kirin; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Taiho; Financial Interests, Personal, Research Grant, Research grant: JBCRG association; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Eisai; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria, Advisory role for a drug development: Daiichi-Sankyo; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: AstraZeneca; Financial Interests, Personal, Advisory Role, Lecture Honoraria, An advisory role: Eli Lilly; Financial Interests, Personal, Invited Speaker, Lecture Honoraria: MSD; Financial Interests, Personal, Invited Speaker, Lecture Honoraria: Exact Science; Financial Interests, Personal, Invited Speaker, Lecture Honoraria: Novartis; Financial Interests, Personal, Advisory Board, Honoraria for an advisory meeting: Konica Minolta; Financial Interests, Institutional, Research Grant, Research grant: Astellas; Financial Interests, Personal, Advisory Board, Honoraria for an advisory meeting: BMS; Financial Interests, Personal, Research Grant, Research grant, Lecture Honoraria: Shimadzu; Financial Interests, Personal, Research Grant, Research grant, Lecture Honoraria: Yakult; Financial Interests, Personal, Research Grant, Research Fund and Honoraria for lecture: Nippon Kayaku; Financial Interests, Institutional, Research Grant, Research grant: AFI technologies; Financial Interests, Personal, Advisory Role, An advisory role: Athenex Oncology; Financial Interests, Personal, Advisory Board, An advisory role: Bertis; Financial Interests, Personal, Advisory Board, An advisory role: Terumo; Financial Interests, Institutional, Research Grant, Research grant, an advisory role: Luxonus; Financial Interests, Institutional, Research Grant, Research grant: Shionogi; Financial Interests, Institutional, Research Grant, Research grant: GL Science; Financial Interests, Personal, Advisory Board, An advisory role: Kansai Medical Net. E.H. Law: Financial Interests, Personal, Full or part-time Employment: Pfizer Inc. M. Gnant: Financial Interests, Personal, Funding: Amgen; Financial Interests, Personal, Funding: Daiichi Sankyo; Financial Interests, Personal, Funding: AstraZeneca; Financial Interests, Personal, Funding: Eli Lilly; Financial Interests, Personal, Funding: LifeBrain; Financial Interests, Personal, Funding: Nanostring; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Funding: TLC Biopharmaceuticals; Other, Personal, Funding, an immediate family member is employed by Sandoz.: Sandoz. A. Makris: Financial Interests, Personal, Invited Speaker, Lectures for Pfizer: Pfizer; Financial Interests, Personal, Advisory Board, Advisory Boards with Pfizer: Pfizer. S. Loibl: Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards & Lecture, paid to institute / Medical Writing: Pfizer; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, paid to institute: AbbVie; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, paid to institute: Amgen; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards & Lectures, paid to institute / Medical Writing: AstraZeneca; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: Bayer; Non-Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute / Medical Writing: BMS; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute / Medical Writing: Celgene; Financial Interests, Personal, Invited Speaker, lecture: Chugai; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board & Lecture, paid to institute / Medical Writing: Daiichi-Sankyo; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: Eirgenix; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: GSK; Financial Interests, Institutional, Research Grant, paid to institute: Immunomedics/Gilead; Financial Interests, Institutional, Other, paid to institute: Ipsen; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, paid to institute: Lilly; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: Merck; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board & Lectures, paid to institute / Medical Writing: Novartis; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board & Lecture, paid to institute: Pierre Fabre; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board & Lecture, paid to institute: Prime/Medscape; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: Puma; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards & Lectures, paid to institute / Medical Writing: Roche; Financial Interests, Institutional, Invited Speaker, honorarium for Lecture, paid to institute: Samsung; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, paid to institute: Seagen; Financial Interests, Institutional, Writing Engagements, paid to institute / Medical Writing: Vifor; Financial Interests, Personal, Licensing Fees, Method for predicting the response to cancer immunotherapy in cancer patients: EP18209672.7; Financial Interests, Personal, Licensing Fees, Method for predicting the response to CDK4/6 inhibitor therapy in cancer patients: EP21152186.9; Financial Interests, Personal, Licensing Fees, Method for predicting the response to an anti-HER2 containing therapy and/or chemotherapy in patients with breast cancer: EP15702464.7; Financial Interests, Institutional, Licensing Fees, paid to institute: VM Scope GmbH,. All other authors have declared no conflicts of interest.

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