Background

Several Breast Cancer Multigene Signatures (BCMS) are available to profile early breast cancer (eBC) but knowledge regarding their use in clinical practice is scarce. PROCURE Project preliminary results were presented at ESMO Breast Virtual Congress 2021 (Abstract 549). Final results regarding the panelist opinion on the utility of BCMS in treatment decision making for different eBC patient profiles are now available.

Methods

The Delphi questionnaire developed by the Scientific Committee was administered twice to 133 experts across 11 European countries. The questionnaire included 5 sections: 1) Panelists’ profile and experience with BCMS, 2) Current clinical practice in eBC and use of BCMS, 3) Panelists’ opinion on the utility of the BCMS in eBC according to patient profiles, 4) Agreement with a set of recommendations on the use of BCMS in clinical practice and 5) Identification of unmet needs and future applications of BCMS. 70% agreement was used to determine consensus on a topic.

Results

Panelists agreed on the clinical utility of BC molecular intrinsic subtypes for prognosis or residual risk of recurrence with standard of care in eBC HR+ (76%) and to identify a group of patients that can safely avoid chemotherapy (75%). Additionally, panelist agreed on the importance of BCMS prognostic results when deciding chemotherapy in the adjuvant setting in eBC patients with node negative (88%) or with 1 to 3 positive lymph nodes (75%). Regarding BCMS use in different patient profiles, panelists agreed on their utility in post-menopausal eBC patients (90%) and on the absence of utility in the metastatic setting (74%), in eBC patients with an HER2 overexpressed profile (82%) and in eBC triple negative (TN) (74%). Also, just 27% of the panelist considered that BCMS can be useful in the neoadjuvant setting.

Conclusions

The low percentage of panelists performing BCMS in the neoadjuvant setting, the misconception regarding their predictive value on chemotherapy benefits and the fact that some experts consider BCMS useful in TN, HER2+ eBC or in the metastatic setting show that there is a need of education on how to interpret BCMS results.

Legal entity responsible for the study

Veracyte Inc.

Funding

Veracyte Inc.

Disclosure

G. Curigliano: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Ellipsis; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Veracyte; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Exact Sciences; Financial Interests, Institutional, Research Grant, Investigator Initiated Trial: Merck; Financial Interests, Institutional, Funding, Phase I studies: BMS; Financial Interests, Institutional, Funding, Phase I studies: Novartis; Financial Interests, Institutional, Funding, Phase I studies: AstraZeneca; Financial Interests, Institutional, Funding, Phase I studies: Daiichi Sankyo; Financial Interests, Institutional, Funding, Phase I studies: Roche; Financial Interests, Institutional, Funding, Phase I studies: Blueprint Medicine; Financial Interests, Institutional, Funding, Phase I studies: Kymab; Financial Interests, Institutional, Funding, Phase I studies: Astellas; Financial Interests, Institutional, Funding, Phase I studies: Sanofi; Financial Interests, Institutional, Funding, Phase I studies: Philogen; Non-Financial Interests, Officer, Italian National Health Council as Advisor for Ministry of Health: Consiglio Superiore di Sanità; Non-Financial Interests, Advisory Role, Member of the Scientific Council. Patient advocacy association: Europa Donna; Non-Financial Interests, Advisory Role, Cancer Research Foundation: Fondazione Beretta; Non-Financial Interests, Invited Speaker, No compensation for this role. This a public national company for cancer prevention: Lega Italiana Lotta ai Tumori. F. Cardoso: Financial Interests, Personal, Other, Consultancy: Amgen; Financial Interests, Personal, Other, Consultancy: Astellas/Medivation; Financial Interests, Personal, Other, Consultancy: AstraZeneca; Financial Interests, Personal, Other, Consultancy: Celgene; Financial Interests, Personal, Other, Consultancy: Daiichi Sankyo; Financial Interests, Personal, Other, Consultancy: Eisai; Financial Interests, Personal, Other, Consultancy: GE Oncology; Financial Interests, Personal, Other, Consultancy: Genentech; Financial Interests, Personal, Other, Consultancy: GlaxoSmithKline; Financial Interests, Personal, Other, Consultancy: Macrogenics; Financial Interests, Personal, Other, Consultancy: Medscape; Financial Interests, Personal, Other, Consultancy: Merck-Sharp; Financial Interests, Personal, Other, Consultancy: Merus BV; Financial Interests, Personal, Other, Consultancy: Mylan; Financial Interests, Personal, Other, Consultancy: Mundipharma; Financial Interests, Personal, Other, Consultancy: Novartis; Financial Interests, Personal, Other, Consultancy: Pfizer; Financial Interests, Personal, Other, Consultancy: Pierre Fabre; Financial Interests, Personal, Other, Consultancy: prIME Oncology; Financial Interests, Personal, Other, Consultancy: Roche; Financial Interests, Personal, Other, Consultancy: Sanofi; Financial Interests, Personal, Other, Consultancy: Samsung Bioepis; Financial Interests, Personal, Other, Consultancy: Seagen; Financial Interests, Personal, Other, Consultancy: Teva; Financial Interests, Institutional, Invited Speaker: Amgen; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Boehringer-Ingelheim; Financial Interests, Institutional, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker: Bayer; Financial Interests, Institutional, Invited Speaker: Daiichi; Financial Interests, Institutional, Invited Speaker: Eisai; Financial Interests, Institutional, Invited Speaker: Fresenius GmbH; Financial Interests, Institutional, Invited Speaker: Genentech; Financial Interests, Institutional, Invited Speaker: GlaxoSmithKline; Financial Interests, Institutional, Invited Speaker: Ipsen; Financial Interests, Institutional, Invited Speaker: Incyte; Financial Interests, Institutional, Invited Speaker: Nektar Therapeutics; Financial Interests, Institutional, Invited Speaker: Nerviano; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Macrogenics; Financial Interests, Institutional, Invited Speaker: Medigene; Financial Interests, Institutional, Invited Speaker: MedImmune; Financial Interests, Institutional, Invited Speaker: Merck; Financial Interests, Institutional, Invited Speaker: Millenium; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: Pierre Fabre; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: Sanofi-Aventis; Financial Interests, Institutional, Invited Speaker: Sonus; Financial Interests, Institutional, Invited Speaker: Taiho Oncology; Financial Interests, Institutional, Invited Speaker: Tesaro; Financial Interests, Institutional, Invited Speaker: Tigris; Financial Interests, Institutional, Invited Speaker: Wilex; Financial Interests, Institutional, Invited Speaker: Wyeth; Non-Financial Interests, Leadership Role, President: ABC Global Alliance and ABC Consensus Conference and Guidelines; Non-Financial Interests, Member: ESMO; Non-Financial Interests, Member: ESO; Non-Financial Interests, Member: EORTC; Non-Financial Interests, Member: BCG; Non-Financial Interests, Member: IBCSG; Non-Financial Interests, Member: SOLTI; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Member: AACR; Non-Financial Interests, Member: EACR; Non-Financial Interests, Member: SIS; Non-Financial Interests, Member: ASPIC. M.I. Gnant: Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Other, Consulting on scientific matters: LifeBrain; Financial Interests, Personal, Expert Testimony: Veracyte; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Full or part-time Employment: ABCSG GmbH; Financial Interests, Invited Speaker: Pfizer; Other, Spouse is employed by: Sandoz. N. Harbeck: Financial Interests, Invited Speaker: Amgen; Financial Interests, Invited Speaker: AstraZeneca; Financial Interests, Invited Speaker: Daiichi Sankyo; Financial Interests, Invited Speaker: Exact Sciences; Financial Interests, Invited Speaker: Gilead; Financial Interests, Invited Speaker: Lilly; Financial Interests, Invited Speaker: MSD; Financial Interests, Invited Speaker: Novartis; Financial Interests, Invited Speaker Pierre Fabre; Financial Interests, Invited Speaker: Pfizer; Financial Interests, Invited Speaker: Roches; Financial Interests, Invited Speaker: Seagen; Financial Interests, Advisory Board: AstraZeneca; Financial Interests, Advisory Board: Daiichi Sankyo; Financial Interests, Advisory Board: Gilead; Financial Interests, Advisory Board: Lilly; Financial Interests, Advisory Board: MSD; Financial Interests, Advisory Board: Novartis; Financial Interests, Advisory Board: Pfizer; Financial Interests, Advisory Board: Roche; Financial Interests, Advisory Board: Sandoz; Financial Interests, Advisory Board: Seagen. J. King: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Gilead; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Seagen; Financial Interests, Personal, Speaker’s Bureau: Novartis. A. Laenkholm: Financial Interests, Advisory Board: Merck; Financial Interests, Advisory Board: Agilent; Financial Interests, Funding: Novartis; Financial Interests, Funding: Roche. F. Penault-Llorca: Financial Interests, Funding: Veracyte; Financial Interests, Funding: Myriad; Financial Interests, Funding: Illumina; Financial Interests, Advisory Board: Veracyte; Financial Interests, Advisory Board: Exact Science; Financial Interests, Advisory Board: Myriad; Financial Interests, Advisory Board: Agendia; Financial Interests, Advisory Board: Illumina; Financial Interests, Other: Myriad; Financial Interests, Other: Veracyte. A. Prat: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Other, Contracted research:: Roche; Financial Interests, Personal, Invited Speaker, Lecture fees: Pfizer; Financial Interests, Personal, Invited Speaker, Lecture fees: Novartis; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Novartis; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Pfizer; Financial Interests, Personal, Invited Speaker, Lecture fees: Amgen; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Amgen; Financial Interests, Personal, Invited Speaker, Lecture fees: BMS; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: BMS; Financial Interests, Personal, Invited Speaker, Lecture fees: NanoString; Financial Interests, Institutional, Other, Contracted research: NanoString; Financial Interests, Institutional, Invited Speaker, Lecture fees: NanoString; Financial Interests, Institutional, Other, Contracted research: Novartis; Financial Interests, Institutional, Other, Contracted research: Roche; Financial Interests, Institutional, Other, Contracted research: Pfizer; Financial Interests, Personal, Invited Speaker, Lecture fees: Contracted research; Financial Interests, Personal, Invited Speaker, Lecture fees: Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker, Clinical trials: Daiichi Sankyo; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Puma; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Oncolytics; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: MSD; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Guardan Health; Financial Interests, Personal, Expert Testimony, Advisory role/consultancy: Peptomyc; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Lilly; Financial Interests, Institutional, Other, Clinical trials: Lilly; Financial Interests, Institutional, Other, Contracted research: Boehringer; Financial Interests, Institutional, Other, Contracted research: Sysmex Europa GmbH; Financial Interests, Institutional, Other, Contracted research: Medica Scientia inno. Research; Financial Interests, Institutional, Other, Contracted research: Celgene; Financial Interests, Institutional, Other, Contracted research: Astellas; Financial Interests, Institutional, Other, Clinical trials: Roche; Financial Interests, Institutional, Other, Clinical trials: Amgen; Financial Interests, Personal, Invited Speaker, Leadership role: Reveal Genomics, SL.; Financial Interests, Institutional, Other, Clinical trials: Boehringer; Non-Financial Interests, Institutional, Other, Leadership roles: Patronage committee: SOLTI Foundation; Non-Financial Interests, Institutional, Other, Leadership roles: Patronage committee: Actitud Frente al Cáncer Foundation.

Background

The phase 2, noncomparative BYLieve study showed efficacy of ALP (PI3K-α inhibitor and degrader) + ET in pts with PIK3CA-mutated, HR+, HER2– ABC progressing on/after (Cohort A) cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI), (Cohort B) CDKi + fulvestrant (FUL), or (Cohort C) AI followed by chemotherapy or ET as immediate prior treatment (Tx). Here we report efficacy for subgroups of interest.

Methods

Pts received ALP + FUL (Cohorts A and C) or ALP + letrozole (Cohort B). Subgroups were pre- (PreM) or postmenopausal (PM; includes surgically sterile) status, and presence of bone lesion-only (BO) or visceral disease (VD) regardless of PreM/PM status for each cohort, and prior Tx for Cohort C (prior CDKi + FUL or AI; used only once in any line/setting). Efficacy endpoints assessed in pts with centrally confirmed PIK3CA mutation were progression-free survival (PFS) and overall survival (OS) for Cohort A (18-mo follow-up [FU]) and PFS for Cohorts B and C (6-mo FU).

Results

A total of 16.5%, 5.2%, and 13.9% of pts were PreM in Cohorts A, B, and C, respectively; 18.2% and 67.8%, 9.6% and 76.5%, and 12.2% and 73.9% had BO and VD in Cohorts A, B, and C, respectively. 19.1% and 40.0% of Cohort C pts had prior CDKI + FUL or CDKi + AI Tx, respectively. Median (m) PFS was numerically higher for PM vs PreM pts, pts with vs without BO, and pts without vs with VD (Cohorts A and B). In Cohort C, mPFS was overall similar across subgroups. In Cohort A, mOS was 5.5-mo longer in PM vs PreM pts; Cohorts B and C OS data were immature by cutoff. Efficacy data are summarized in the table. Table: 175P

Conclusions

Overall, these ad hoc exploratory analyses demonstrate clinical benefit of ALP + ET across subgroups of interest (despite low number of pts in some subgroups) in all cohorts, including PreM pts, and pts with VD who typically have worse prognosis.

Clinical trial identification

NCT03056755; EUDRACT2016-004586-67.

Editorial acknowledgement

We thank Marcelene Yumul, MD, and Casandra M. Monzon, PhD, of Healthcare Consultancy Group, LLC, for their medical editorial assistance with this abstract, which was funded by Novartis.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

F. Cardoso: Financial Interests, Personal, Other, Consultancy: Amgen; Financial Interests, Personal, Other, Consultancy: Astellas/Medivation; Financial Interests, Personal, Other, Consultancy: AstraZeneca; Financial Interests, Personal, Other, Consultancy: Celgene; Financial Interests, Personal, Other, Consultancy: Daiichi Sankyo; Financial Interests, Personal, Other, Consultancy: Eisai; Financial Interests, Personal, Other, Consultancy: GE Oncology; Financial Interests, Personal, Other, Consultancy: Genentech; Financial Interests, Personal, Other, Consultancy: GlaxoSmithKline; Financial Interests, Personal, Other, Consultancy: Macrogenics; Financial Interests, Personal, Other, Consultancy: Medscape; Financial Interests, Personal, Other, Consultancy: Merck-Sharp; Financial Interests, Personal, Other, Consultancy: Merus BV; Financial Interests, Personal, Other, Consultancy: Mylan; Financial Interests, Personal, Other, Consultancy: Mundipharma; Financial Interests, Personal, Other, Consultancy: Novartis; Financial Interests, Personal, Other, Consultancy: Pfizer; Financial Interests, Personal, Other, Consultancy: Pierre Fabre; Financial Interests, Personal, Other, Consultancy: prIME Oncology; Financial Interests, Personal, Other, Consultancy: Roche; Financial Interests, Personal, Other, Consultancy: Sanofi; Financial Interests, Personal, Other, Consultancy: Samsung Bioepis; Financial Interests, Personal, Other, Consultancy: Seagen; Financial Interests, Personal, Other, Consultancy: Teva; Financial Interests, Institutional, Invited Speaker: Amgen; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Boehringer-Ingelheim; Financial Interests, Institutional, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker: Bayer; Financial Interests, Institutional, Invited Speaker: Daiichi; Financial Interests, Institutional, Invited Speaker: Eisai; Financial Interests, Institutional, Invited Speaker: Fresenius GmbH; Financial Interests, Institutional, Invited Speaker: Genentech; Financial Interests, Institutional, Invited Speaker: GlaxoSmithKline; Financial Interests, Institutional, Invited Speaker: Ipsen; Financial Interests, Institutional, Invited Speaker: Incyte; Financial Interests, Institutional, Invited Speaker: Nektar Therapeutics; Financial Interests, Institutional, Invited Speaker: Nerviano; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Macrogenics; Financial Interests, Institutional, Invited Speaker: Medigene; Financial Interests, Institutional, Invited Speaker: MedImmune; Financial Interests, Institutional, Invited Speaker: Merck; Financial Interests, Institutional, Invited Speaker: Millenium; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: Pierre Fabre; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: Sanofi-Aventis; Financial Interests, Institutional, Invited Speaker: Sonus; Financial Interests, Institutional, Invited Speaker: Taiho Oncology; Financial Interests, Institutional, Invited Speaker: Tesaro; Financial Interests, Institutional, Invited Speaker: Tigris; Financial Interests, Institutional, Invited Speaker: Wilex; Financial Interests, Institutional, Invited Speaker: Wyeth; Non-Financial Interests, Leadership Role, President: ABC Global Alliance and ABC Consensus Conference and Guidelines; Non-Financial Interests, Member: ESMO; Non-Financial Interests, Member: ESO; Non-Financial Interests, Member: EORTC; Non-Financial Interests, Member: BCG; Non-Financial Interests, Member: IBCSG; Non-Financial Interests, Member: SOLTI; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Member: AACR; Non-Financial Interests, Member: EACR; Non-Financial Interests, Member: SIS; Non-Financial Interests, Member: ASPIC. D. Juric: Financial Interests, Personal, Other, Consulting fees: Novartis, EMD Serono, Eisai, Genentech, Ipsen, Syros Pharmaceuticals, Vibliome Therapeutics, Mapkure, Petra Pharma, Relay Therapeutics; Silverback Therapeutics, PIC Therapeutics; Financial Interests, Institutional, Other, Research funding: Novartis, Genentech, Takeda, Eisai, EMD Serono, Placon, Amgen, Syros Pharmaceuticals, InventisBio, Infinity Pharmaceuticals, Takeda, Pfizer; Financial Interests, Personal, Other, Ownership interest: Relay Therapeutics, PIC Therapeutics, Vibliome Therapeutics. F. Lerebours: Financial Interests, Personal, Other, Support for attending meetings and travel: Eisai, Mundipharma, Novartis, Pfizer, Roche; Financial Interests, Personal, Other, Participation on a Data Safety Monitoring Board or Advisory Board/Honoraria: AstraZeneca/Daiichi Sankyo, Eisai, Lilly, Novartis, Pierre Fabre, Pfizer, Roche, Seagen. I. Krop: Financial Interests, Personal, Other, Support for the present publication: Novartis; Financial Interests, Personal, Other, Payment or honoraria for lectures: Novartis, AstraZeneca, Context Therapeutics, Daiichi Sankyo, Genentech/Roche; Macrogenics, Merck, Seagen; Financial Interests, Institutional, Other, Grants: Genentech/Roche, Macrogenics, Pfizer. M. Ruiz Borrego: Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: AstraZeneca. P. Neven: Financial Interests, Institutional, Other, Consulting or advisory role: Eli Lilly, Gilead, Novartis, Pfizer, Roche, AstraZeneca; Financial Interests, Institutional, Other, Travel, accommodations, expenses: Amgen, AstraZeneca, Eisai, Eli Lilly, Mylan, Novartis, Pierre Fabre, Pfizer, Roche; Financial Interests, Institutional, Research funding non-profit organization: Kom op Tegen Kanker, Think Pink. Y.H. Park: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Other, Research Grant: AstraZeneca; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Institutional, Other, Research Grant: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Other, Research Grant: Roche; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Institutional, Other, Research Grant: MSD; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Non-Financial Interests, Principal Investigator: AstraZeneca; Non-Financial Interests, Principal Investigator: Pfizer; Non-Financial Interests, Principal Investigator: Novartis; Non-Financial Interests, Principal Investigator: MSD; Non-Financial Interests, Principal Investigator: Lilly; Non-Financial Interests, Principal Investigator: Roche; Non-Financial Interests, Principal Investigator: Daiichi Sankyo. D. Yardley: Financial Interests, Institutional, Other, Research funding: AbbVie, Amgen, Biomarin, Biothera Pharmaceuticals, Clovis Pharma, Dana Farber Cancer Institute, Lilly, Roche/Genentech, Inycte, Innocrin Pharmaceuticals, MacroGenics, MedImmune, Medivation, Merck, Merrimack Pharmaceuticals, Nektar Therapeutics, Novartis, NSABP, Pfizer, Tesaro, Polyphor; Financial Interests, Institutional, Other, Consulting/Advisory role: Athenex, bioTheranostics, G1 Therapeutics, Immunomedics, Lilly, Merck, Novartis, Pfizer, Sanofi-Aventis. K. Jhaveri: Financial Interests, Personal, Other, Consulting/Advisory role fees: AbbVie, AstraZeneca, Blueprint Medicines, Biotheranostics, BMS, Genentech, Jounce Therapeutics, Lilly Pharmaceuticals, Novartis, Pfizer, Seattle Genetics, SunPharma Pvt Ltd, Taiho Oncology; Financial Interests, Institutional, Other, Research funding: ADC Therapeutics, AstraZeneca, Clovis Oncology, Debio Pharmaceuticals, Genentech, Immunomedics, Novartis, Lilly Pharmaceuticals, Merck/VelosBio, Novartis, Novita Pharmaceuticals, Pfizer, Puma Biotechnology, Zymeworks. C. Arce, M. Akdere: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares: Novartis. E. Gu: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Other, Travel: Novartis. H.S. Rugo: Financial Interests, Personal, Invited Speaker: Puma; Financial Interests, Personal, Advisory Board: samsung; Financial Interests, Personal, Invited Speaker: mylan; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Lilly; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: OBI Pharma; Financial Interests, Institutional, Invited Speaker: Immunomedics; Financial Interests, Institutional, Invited Speaker: Macrogenics; Financial Interests, Institutional, Invited Speaker: Daiichi; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: Merck; Financial Interests, Institutional, Invited Speaker: Odonate; Financial Interests, Institutional, Invited Speaker: sermonix; Financial Interests, Institutional, Invited Speaker: Seattle Genetics; Financial Interests, Institutional, Invited Speaker: polyphor; Financial Interests, Institutional, Invited Speaker: Boehringer Ingelheim; Non-Financial Interests, Advisory Role, I advise a number of companies without compensation: various.

Background

Gaps in RW evidence exist regarding pts’ and health-care professionals’ (HCPs) perspectives on SEs impacting QOL. Previously, RW survey results showed disconnects between pts with ABC and HCPs on the importance of QOL discussions (Cardoso, SABCS 2021). Here, we examine how SEs impacting QOL in pts with ABC are perceived.

Methods

The survey was designed by a committee of oncologists, nurses, advocates, and pts. After ethical approval, data were collected from July 2020 to May 2021 via a cross-sectional online survey of oncologists, nurses, and pts with HR+/HER2− ABC in 7 countries. HCPs and pts were surveyed on the impact of SEs on QOL and HCP interactions. Observations were assessed using a 4-point Likert scale.

Results

The survey was completed by 467 pts and 502 HCPs. Most pts and HCPs believed fear of progression (76% & 92%, respectively) and pain (73% & 96%) had a moderate/severe impact on QOL. The most common SEs experienced by pts since starting ABC tx or their current tx were fatigue (73% & 64%) and pain (64% & 42% [back pain]). Fatigue relieved by rest was believed to have a moderate/severe impact on QOL more so by pts (78%) than HCPs (40%). Most pts did not discuss SEs with HCPs (79% for fatigue, 74% for pain) until these were moderate/severe. Pts reported that insomnia (83%), anxiety (82%), back pain (78%), fatigue (77%), and diarrhea (71%) had a moderate/severe impact on their QOL. Pts were least willing to live with back pain (52%), fatigue (42%), diarrhea (41%), and loss of appetite (41%) even if tx was working. In pts on a CDK4/6i, 83% experienced ≥ 1 moderate/severe SE, with insomnia (85%), diarrhea (75%), back pain (75%), and fatigue (74%) having a moderate/severe impact on QOL.

Conclusions

Pts with ABC and HCPs were generally aligned on SEs that severely impacted QOL, but HCPs may undervalue the impact of mild SEs on pts. Fatigue and pain were the most common SEs experienced by pts. In pts on a CDK4/6i, insomnia, diarrhea, back pain, and fatigue had a moderate/severe impact on QOL. These data support close monitoring, early intervention, and when indicated, prophylaxis of SEs that may greatly impact QOL in pts with ABC.

Editorial acknowledgement

Medical writing support was provided by Shashank Tandon at MediTech Media, funded by Novartis Pharmaceuticals Corporation.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

F. Cardoso: Financial Interests, Personal, Other: Amgen; Financial Interests, Personal, Other: Astellas/Medivation; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Celgene; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Other: EISAI; Financial Interests, Personal, Other: GE Oncology; Financial Interests, Personal, Other: Genentech; Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Other: Macrogenics; Financial Interests, Personal, Other: Medscape; Financial Interests, Personal, Other: Merck-Sharp; Financial Interests, Personal, Other: Merus; Financial Interests, Personal, Other: Mylan; Financial Interests, Personal, Other: Mundipharma; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Pierre Fabre; Financial Interests, Personal, Other: prIME Oncology; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Sanofi; Financial Interests, Personal, Other: Samsung Bioepis; Financial Interests, Personal, Other: Teva; Financial Interests, Personal, Other: Seagen; Financial Interests, Personal, Other: Debiopharm; Financial Interests, Personal, Other: Gilead; Financial Interests, Personal, Other: Iqvia; Financial Interests, Personal, Other: Touchime; Other, Personal, Writing Engagements, Medical Writer Support: Novartis. J. Rihani: Financial Interests, Personal, Invited Speaker, For participating in various Novartis (sponsored) events, i.e. giving talks, a member in committees and on patient engagement panels: Novartis. D. Aubel: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares: Novartis. J. de Courcy: Financial Interests, Institutional, Other, Adelphi Real World received payment from Novartis to conduct the study: Novartis; Financial Interests, Institutional, Other, Adelphi Real World received payment from Novartis to conduct the study: Adelphi Real World. N. Harbeck: Financial Interests, Personal, Other, Consulting: Novartis; Financial Interests, Personal, Invited Speaker, Lectures: Novartis; Financial Interests, Personal, Invited Speaker, Lectures: Lilly; Financial Interests, Personal, Other, Consulting: Lilly; Financial Interests, Personal, Invited Speaker, Lectures: AstraZeneca; Financial Interests, Personal, Other, Consulting: AstraZeneca; Financial Interests, Personal, Invited Speaker, Lectures: Daiichi Sankyo; Financial Interests, Personal, Other, Consulting: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker, Lectures: MSD; Financial Interests, Personal, Other, Consulting: MSD; Financial Interests, Personal, Invited Speaker, Lectures: Pierre Fabre; Financial Interests, Personal, Other, Consulting: Pierre Fabre; Financial Interests, Personal, Invited Speaker, Lectures: Roche; Financial Interests, Personal, Other, Consulting: Roche; Financial Interests, Personal, Invited Speaker, Lectures: Sandoz/Hexal; Financial Interests, Personal, Other, Consulting: Sandoz/Hexal; Financial Interests, Personal, Invited Speaker, Lectures: Seattle Genetics; Financial Interests, Personal, Other, Consulting: Seattle Genetics; Non-Financial Interests, Personal, Member of the Board of Directors, Co-Director WSG: West German Study Group. H.S. Rugo: Financial Interests, Institutional, Research Grant, Grant - Institution: Plexxikon; Financial Interests, Institutional, Research Grant, Grant - Institution: Macrogenics; Financial Interests, Institutional, Research Grant, Grant - Institution: OBI Pharma; Financial Interests, Institutional, Research Grant, Grant - Institution: Eisai; Financial Interests, Institutional, Research Grant, Grant - Institution: Pfizer; Financial Interests, Institutional, Research Grant, Grant - Institution: Novartis; Financial Interests, Institutional, Research Grant, Grant - Institution: Eli Lilly; Financial Interests, Institutional, Research Grant, Grant - Institution: GlaxoSmithKline; Financial Interests, Institutional, Research Grant, Grant - Institution: Genentech; Financial Interests, Institutional, Research Grant, Grant - Institution: Celsion; Financial Interests, Institutional, Research Grant, Grant - Institution: Merck; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: Novartis; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: Roche/Genentech; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: OBI Pharma; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: Bayer; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Genomic Health. P.A. Fasching: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Institutional, Funding, Institutional Funding: BioNTech; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Invited Speaker: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Institutional, Funding, Institutional Funding: Cepheid; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Personal, Advisory Board: Seagen; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Hexal; Financial Interests, Personal, Advisory Board: Agendia; Financial Interests, Personal, Advisory Board: Sanofi Aventis; Financial Interests, Personal, Invited Speaker: Gilead; Financial Interests, Personal, Advisory Board: Gilead.

S. Haftchenary: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares, Stock ownership: Novartis. P. Pathak: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares, Stock ownership: Novartis. All other authors have declared no conflicts of interest.

Background

Outcomes for breast cancer are monitored through the International Consortium for Health Outcomes Measurement core outcomes set (COS). This COS is deemed less relevant for women with metastatic breast cancer (MBC). We aimed to develop a COS applicable for a heterogeneous group of patients with metachronous or synchronous MBC. The study was part of the Innovative Medicines Initiative - Health Outcomes Observatory (H2O) project, creating a governance model for health data that captures the patient perspective on the impact of cancer.

Methods

The COS applies to patients with MBC in active treatment (excluding end-of-life phase). H2O consortia members gathered an international working group (n=17, patient representatives, medical oncologists, surgeons, radiation oncologists, and nurse specialists) to review potential outcomes generated through literature review. A broader group of patients/patient representatives (n=42), healthcare professionals/academic researchers (n=56), pharma employees (n=20), and health authority employees (n=4) participated in a modified Delphi procedure. In two survey rounds, participants scored the relevance of outcomes from the preliminary list; additional outcomes could be added in the first round. Consensus was defined as >70% of participants scoring an outcome as ‘highly relevant’. The working group finalised the COS in a consensus meeting.

Results

The Delphi procedure was feasible and interest to participate was high (n=144). The final COS includes 102 variables relating to: 1) health-related quality of life (HRQoL, n=26)) and adverse effects of treatment (n=24); 2) case-mix factors (n=9); 3) clinical outcomes (n=42). Many patient-reported outcomes that influence HRQoL, e.g. daily functioning, psychosocial, emotional, and sexual functioning, were included.

Conclusions

The COS will be available in English, Spanish, Portuguese, Dutch, Swedish, and German, suitable for implementation across geographies. The outcomes can be collected through combined administrative data, clinical records, clinician-reported measures, and patient-reported outcome measures. We coordinated our efforts with the development of the MBC PROM by the European Organisation for Research and Treatment of Cancer Quality of Life Group.

Editorial acknowledgement

On behalf of the Innovative Medicines Initiative - Health Outcomes Observatory (H2O) project.

Legal entity responsible for the study

On behalf of the Innovative Medicines Initiative - Health Outcomes Observatory (H2O) project.

Funding

Innovative Medicines Initiative 2 Joint Undertaking, under grant agreement No 945345-2.

Disclosure

All authors have declared no conflicts of interest.

Background

The phase 2, noncomparative BYLieve study showed efficacy of ALP (PI3K-α inhibitor and degrader) + ET in pts with PIK3CA-mutated, HR+, HER2– ABC progressing on/after (Cohort A) cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI), (Cohort B) CDKi + fulvestrant (FUL), or (Cohort C) AI followed by chemotherapy or ET as immediate prior treatment (Tx). Here we report efficacy for subgroups of interest.

Methods

Pts received ALP + FUL (Cohorts A and C) or ALP + letrozole (Cohort B). Subgroups were pre- (PreM) or postmenopausal (PM; includes surgically sterile) status, and presence of bone lesion-only (BO) or visceral disease (VD) regardless of PreM/PM status for each cohort, and prior Tx for Cohort C (prior CDKi + FUL or AI; used only once in any line/setting). Efficacy endpoints assessed in pts with centrally confirmed PIK3CA mutation were progression-free survival (PFS) and overall survival (OS) for Cohort A (18-mo follow-up [FU]) and PFS for Cohorts B and C (6-mo FU).

Results

A total of 16.5%, 5.2%, and 13.9% of pts were PreM in Cohorts A, B, and C, respectively; 18.2% and 67.8%, 9.6% and 76.5%, and 12.2% and 73.9% had BO and VD in Cohorts A, B, and C, respectively. 19.1% and 40.0% of Cohort C pts had prior CDKI + FUL or CDKi + AI Tx, respectively. Median (m) PFS was numerically higher for PM vs PreM pts, pts with vs without BO, and pts without vs with VD (Cohorts A and B). In Cohort C, mPFS was overall similar across subgroups. In Cohort A, mOS was 5.5-mo longer in PM vs PreM pts; Cohorts B and C OS data were immature by cutoff. Efficacy data are summarized in the table. Table: 175P

Conclusions

Overall, these ad hoc exploratory analyses demonstrate clinical benefit of ALP + ET across subgroups of interest (despite low number of pts in some subgroups) in all cohorts, including PreM pts, and pts with VD who typically have worse prognosis.

Clinical trial identification

NCT03056755; EUDRACT2016-004586-67.

Editorial acknowledgement

We thank Marcelene Yumul, MD, and Casandra M. Monzon, PhD, of Healthcare Consultancy Group, LLC, for their medical editorial assistance with this abstract, which was funded by Novartis.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

F. Cardoso: Financial Interests, Personal, Other, Consultancy: Amgen; Financial Interests, Personal, Other, Consultancy: Astellas/Medivation; Financial Interests, Personal, Other, Consultancy: AstraZeneca; Financial Interests, Personal, Other, Consultancy: Celgene; Financial Interests, Personal, Other, Consultancy: Daiichi Sankyo; Financial Interests, Personal, Other, Consultancy: Eisai; Financial Interests, Personal, Other, Consultancy: GE Oncology; Financial Interests, Personal, Other, Consultancy: Genentech; Financial Interests, Personal, Other, Consultancy: GlaxoSmithKline; Financial Interests, Personal, Other, Consultancy: Macrogenics; Financial Interests, Personal, Other, Consultancy: Medscape; Financial Interests, Personal, Other, Consultancy: Merck-Sharp; Financial Interests, Personal, Other, Consultancy: Merus BV; Financial Interests, Personal, Other, Consultancy: Mylan; Financial Interests, Personal, Other, Consultancy: Mundipharma; Financial Interests, Personal, Other, Consultancy: Novartis; Financial Interests, Personal, Other, Consultancy: Pfizer; Financial Interests, Personal, Other, Consultancy: Pierre Fabre; Financial Interests, Personal, Other, Consultancy: prIME Oncology; Financial Interests, Personal, Other, Consultancy: Roche; Financial Interests, Personal, Other, Consultancy: Sanofi; Financial Interests, Personal, Other, Consultancy: Samsung Bioepis; Financial Interests, Personal, Other, Consultancy: Seagen; Financial Interests, Personal, Other, Consultancy: Teva; Financial Interests, Institutional, Invited Speaker: Amgen; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Boehringer-Ingelheim; Financial Interests, Institutional, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker: Bayer; Financial Interests, Institutional, Invited Speaker: Daiichi; Financial Interests, Institutional, Invited Speaker: Eisai; Financial Interests, Institutional, Invited Speaker: Fresenius GmbH; Financial Interests, Institutional, Invited Speaker: Genentech; Financial Interests, Institutional, Invited Speaker: GlaxoSmithKline; Financial Interests, Institutional, Invited Speaker: Ipsen; Financial Interests, Institutional, Invited Speaker: Incyte; Financial Interests, Institutional, Invited Speaker: Nektar Therapeutics; Financial Interests, Institutional, Invited Speaker: Nerviano; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Macrogenics; Financial Interests, Institutional, Invited Speaker: Medigene; Financial Interests, Institutional, Invited Speaker: MedImmune; Financial Interests, Institutional, Invited Speaker: Merck; Financial Interests, Institutional, Invited Speaker: Millenium; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: Pierre Fabre; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: Sanofi-Aventis; Financial Interests, Institutional, Invited Speaker: Sonus; Financial Interests, Institutional, Invited Speaker: Taiho Oncology; Financial Interests, Institutional, Invited Speaker: Tesaro; Financial Interests, Institutional, Invited Speaker: Tigris; Financial Interests, Institutional, Invited Speaker: Wilex; Financial Interests, Institutional, Invited Speaker: Wyeth; Non-Financial Interests, Leadership Role, President: ABC Global Alliance and ABC Consensus Conference and Guidelines; Non-Financial Interests, Member: ESMO; Non-Financial Interests, Member: ESO; Non-Financial Interests, Member: EORTC; Non-Financial Interests, Member: BCG; Non-Financial Interests, Member: IBCSG; Non-Financial Interests, Member: SOLTI; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Member: AACR; Non-Financial Interests, Member: EACR; Non-Financial Interests, Member: SIS; Non-Financial Interests, Member: ASPIC. D. Juric: Financial Interests, Personal, Other, Consulting fees: Novartis, EMD Serono, Eisai, Genentech, Ipsen, Syros Pharmaceuticals, Vibliome Therapeutics, Mapkure, Petra Pharma, Relay Therapeutics; Silverback Therapeutics, PIC Therapeutics; Financial Interests, Institutional, Other, Research funding: Novartis, Genentech, Takeda, Eisai, EMD Serono, Placon, Amgen, Syros Pharmaceuticals, InventisBio, Infinity Pharmaceuticals, Takeda, Pfizer; Financial Interests, Personal, Other, Ownership interest: Relay Therapeutics, PIC Therapeutics, Vibliome Therapeutics. F. Lerebours: Financial Interests, Personal, Other, Support for attending meetings and travel: Eisai, Mundipharma, Novartis, Pfizer, Roche; Financial Interests, Personal, Other, Participation on a Data Safety Monitoring Board or Advisory Board/Honoraria: AstraZeneca/Daiichi Sankyo, Eisai, Lilly, Novartis, Pierre Fabre, Pfizer, Roche, Seagen. I. Krop: Financial Interests, Personal, Other, Support for the present publication: Novartis; Financial Interests, Personal, Other, Payment or honoraria for lectures: Novartis, AstraZeneca, Context Therapeutics, Daiichi Sankyo, Genentech/Roche; Macrogenics, Merck, Seagen; Financial Interests, Institutional, Other, Grants: Genentech/Roche, Macrogenics, Pfizer. M. Ruiz Borrego: Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: AstraZeneca. P. Neven: Financial Interests, Institutional, Other, Consulting or advisory role: Eli Lilly, Gilead, Novartis, Pfizer, Roche, AstraZeneca; Financial Interests, Institutional, Other, Travel, accommodations, expenses: Amgen, AstraZeneca, Eisai, Eli Lilly, Mylan, Novartis, Pierre Fabre, Pfizer, Roche; Financial Interests, Institutional, Research funding non-profit organization: Kom op Tegen Kanker, Think Pink. Y.H. Park: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Other, Research Grant: AstraZeneca; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Institutional, Other, Research Grant: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Other, Research Grant: Roche; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Institutional, Other, Research Grant: MSD; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Non-Financial Interests, Principal Investigator: AstraZeneca; Non-Financial Interests, Principal Investigator: Pfizer; Non-Financial Interests, Principal Investigator: Novartis; Non-Financial Interests, Principal Investigator: MSD; Non-Financial Interests, Principal Investigator: Lilly; Non-Financial Interests, Principal Investigator: Roche; Non-Financial Interests, Principal Investigator: Daiichi Sankyo. D. Yardley: Financial Interests, Institutional, Other, Research funding: AbbVie, Amgen, Biomarin, Biothera Pharmaceuticals, Clovis Pharma, Dana Farber Cancer Institute, Lilly, Roche/Genentech, Inycte, Innocrin Pharmaceuticals, MacroGenics, MedImmune, Medivation, Merck, Merrimack Pharmaceuticals, Nektar Therapeutics, Novartis, NSABP, Pfizer, Tesaro, Polyphor; Financial Interests, Institutional, Other, Consulting/Advisory role: Athenex, bioTheranostics, G1 Therapeutics, Immunomedics, Lilly, Merck, Novartis, Pfizer, Sanofi-Aventis. K. Jhaveri: Financial Interests, Personal, Other, Consulting/Advisory role fees: AbbVie, AstraZeneca, Blueprint Medicines, Biotheranostics, BMS, Genentech, Jounce Therapeutics, Lilly Pharmaceuticals, Novartis, Pfizer, Seattle Genetics, SunPharma Pvt Ltd, Taiho Oncology; Financial Interests, Institutional, Other, Research funding: ADC Therapeutics, AstraZeneca, Clovis Oncology, Debio Pharmaceuticals, Genentech, Immunomedics, Novartis, Lilly Pharmaceuticals, Merck/VelosBio, Novartis, Novita Pharmaceuticals, Pfizer, Puma Biotechnology, Zymeworks. C. Arce, M. Akdere: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares: Novartis. E. Gu: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Other, Travel: Novartis. H.S. Rugo: Financial Interests, Personal, Invited Speaker: Puma; Financial Interests, Personal, Advisory Board: samsung; Financial Interests, Personal, Invited Speaker: mylan; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Lilly; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: OBI Pharma; Financial Interests, Institutional, Invited Speaker: Immunomedics; Financial Interests, Institutional, Invited Speaker: Macrogenics; Financial Interests, Institutional, Invited Speaker: Daiichi; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: Merck; Financial Interests, Institutional, Invited Speaker: Odonate; Financial Interests, Institutional, Invited Speaker: sermonix; Financial Interests, Institutional, Invited Speaker: Seattle Genetics; Financial Interests, Institutional, Invited Speaker: polyphor; Financial Interests, Institutional, Invited Speaker: Boehringer Ingelheim; Non-Financial Interests, Advisory Role, I advise a number of companies without compensation: various.

Background

Gaps in RW evidence exist regarding pts’ and health-care professionals’ (HCPs) perspectives on SEs impacting QOL. Previously, RW survey results showed disconnects between pts with ABC and HCPs on the importance of QOL discussions (Cardoso, SABCS 2021). Here, we examine how SEs impacting QOL in pts with ABC are perceived.

Methods

The survey was designed by a committee of oncologists, nurses, advocates, and pts. After ethical approval, data were collected from July 2020 to May 2021 via a cross-sectional online survey of oncologists, nurses, and pts with HR+/HER2− ABC in 7 countries. HCPs and pts were surveyed on the impact of SEs on QOL and HCP interactions. Observations were assessed using a 4-point Likert scale.

Results

The survey was completed by 467 pts and 502 HCPs. Most pts and HCPs believed fear of progression (76% & 92%, respectively) and pain (73% & 96%) had a moderate/severe impact on QOL. The most common SEs experienced by pts since starting ABC tx or their current tx were fatigue (73% & 64%) and pain (64% & 42% [back pain]). Fatigue relieved by rest was believed to have a moderate/severe impact on QOL more so by pts (78%) than HCPs (40%). Most pts did not discuss SEs with HCPs (79% for fatigue, 74% for pain) until these were moderate/severe. Pts reported that insomnia (83%), anxiety (82%), back pain (78%), fatigue (77%), and diarrhea (71%) had a moderate/severe impact on their QOL. Pts were least willing to live with back pain (52%), fatigue (42%), diarrhea (41%), and loss of appetite (41%) even if tx was working. In pts on a CDK4/6i, 83% experienced ≥ 1 moderate/severe SE, with insomnia (85%), diarrhea (75%), back pain (75%), and fatigue (74%) having a moderate/severe impact on QOL.

Conclusions

Pts with ABC and HCPs were generally aligned on SEs that severely impacted QOL, but HCPs may undervalue the impact of mild SEs on pts. Fatigue and pain were the most common SEs experienced by pts. In pts on a CDK4/6i, insomnia, diarrhea, back pain, and fatigue had a moderate/severe impact on QOL. These data support close monitoring, early intervention, and when indicated, prophylaxis of SEs that may greatly impact QOL in pts with ABC.

Editorial acknowledgement

Medical writing support was provided by Shashank Tandon at MediTech Media, funded by Novartis Pharmaceuticals Corporation.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

F. Cardoso: Financial Interests, Personal, Other: Amgen; Financial Interests, Personal, Other: Astellas/Medivation; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Celgene; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Other: EISAI; Financial Interests, Personal, Other: GE Oncology; Financial Interests, Personal, Other: Genentech; Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Other: Macrogenics; Financial Interests, Personal, Other: Medscape; Financial Interests, Personal, Other: Merck-Sharp; Financial Interests, Personal, Other: Merus; Financial Interests, Personal, Other: Mylan; Financial Interests, Personal, Other: Mundipharma; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Pierre Fabre; Financial Interests, Personal, Other: prIME Oncology; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Sanofi; Financial Interests, Personal, Other: Samsung Bioepis; Financial Interests, Personal, Other: Teva; Financial Interests, Personal, Other: Seagen; Financial Interests, Personal, Other: Debiopharm; Financial Interests, Personal, Other: Gilead; Financial Interests, Personal, Other: Iqvia; Financial Interests, Personal, Other: Touchime; Other, Personal, Writing Engagements, Medical Writer Support: Novartis. J. Rihani: Financial Interests, Personal, Invited Speaker, For participating in various Novartis (sponsored) events, i.e. giving talks, a member in committees and on patient engagement panels: Novartis. D. Aubel: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares: Novartis. J. de Courcy: Financial Interests, Institutional, Other, Adelphi Real World received payment from Novartis to conduct the study: Novartis; Financial Interests, Institutional, Other, Adelphi Real World received payment from Novartis to conduct the study: Adelphi Real World. N. Harbeck: Financial Interests, Personal, Other, Consulting: Novartis; Financial Interests, Personal, Invited Speaker, Lectures: Novartis; Financial Interests, Personal, Invited Speaker, Lectures: Lilly; Financial Interests, Personal, Other, Consulting: Lilly; Financial Interests, Personal, Invited Speaker, Lectures: AstraZeneca; Financial Interests, Personal, Other, Consulting: AstraZeneca; Financial Interests, Personal, Invited Speaker, Lectures: Daiichi Sankyo; Financial Interests, Personal, Other, Consulting: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker, Lectures: MSD; Financial Interests, Personal, Other, Consulting: MSD; Financial Interests, Personal, Invited Speaker, Lectures: Pierre Fabre; Financial Interests, Personal, Other, Consulting: Pierre Fabre; Financial Interests, Personal, Invited Speaker, Lectures: Roche; Financial Interests, Personal, Other, Consulting: Roche; Financial Interests, Personal, Invited Speaker, Lectures: Sandoz/Hexal; Financial Interests, Personal, Other, Consulting: Sandoz/Hexal; Financial Interests, Personal, Invited Speaker, Lectures: Seattle Genetics; Financial Interests, Personal, Other, Consulting: Seattle Genetics; Non-Financial Interests, Personal, Member of the Board of Directors, Co-Director WSG: West German Study Group. H.S. Rugo: Financial Interests, Institutional, Research Grant, Grant - Institution: Plexxikon; Financial Interests, Institutional, Research Grant, Grant - Institution: Macrogenics; Financial Interests, Institutional, Research Grant, Grant - Institution: OBI Pharma; Financial Interests, Institutional, Research Grant, Grant - Institution: Eisai; Financial Interests, Institutional, Research Grant, Grant - Institution: Pfizer; Financial Interests, Institutional, Research Grant, Grant - Institution: Novartis; Financial Interests, Institutional, Research Grant, Grant - Institution: Eli Lilly; Financial Interests, Institutional, Research Grant, Grant - Institution: GlaxoSmithKline; Financial Interests, Institutional, Research Grant, Grant - Institution: Genentech; Financial Interests, Institutional, Research Grant, Grant - Institution: Celsion; Financial Interests, Institutional, Research Grant, Grant - Institution: Merck; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: Novartis; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: Roche/Genentech; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: OBI Pharma; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: Bayer; Financial Interests, Personal, Other, Travel, Accomodations, and Expenses: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Genomic Health. P.A. Fasching: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Institutional, Funding, Institutional Funding: BioNTech; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Invited Speaker: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Institutional, Funding, Institutional Funding: Cepheid; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Personal, Advisory Board: Seagen; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Hexal; Financial Interests, Personal, Advisory Board: Agendia; Financial Interests, Personal, Advisory Board: Sanofi Aventis; Financial Interests, Personal, Invited Speaker: Gilead; Financial Interests, Personal, Advisory Board: Gilead.

S. Haftchenary: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares, Stock ownership: Novartis. P. Pathak: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares, Stock ownership: Novartis. All other authors have declared no conflicts of interest.