F. Cardoso (Lisbon, Portugal)
Champalimaud Foundation Cancer CenterAuthor Of 2 Presentations
Progression after CDK 4/6i: How to sequence approved options (ID 304)
93MO - Overall survival (OS) results by age subgroup from the phase III MONALEESA-7 (ML-7) trial of premenopausal patients (pts) with HR+/HER2? advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB) (ID 257)
Abstract
Background
RIB, a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i), significantly prolonged OS in pre- or perimenopausal pts with HR+/HER2− ABC in ML-7 with updated results (median, 58.7 vs 48.0 mo for RIB + ET vs placebo [PBO] + ET; HR, 0.76 [95% CI, 0.61-0.96]; NCT02278120). Younger pts with HR+/HER2− ABC tend to have a poorer prognosis. We conducted an exploratory analysis to characterize outcomes in pts <40 vs ≥40 y of age.
Methods
Pre- or perimenopausal pts with HR+/HER2− ABC with no prior CDK4/6i or ET for ABC were randomized 1:1 to receive RIB or PBO plus goserelin and a nonsteroidal aromatase inhibitor (NSAI) or tamoxifen. OS and other efficacy endpoints were evaluated by Cox proportional hazards model and summarized using Kaplan-Meier methods.
Results
The median follow-up time was 53.5 mo (data cutoff, 29 June 2020). In the RIB vs PBO arm, 98 vs 88 pts were <40 y and 237 vs 249 pts were ≥40 y. Median age (range) in RIB vs PBO was 35 y (25-39 y) vs 36 y (29-39 y) in pts <40 y, and 45 y (40-58 y) vs 46 y (40-58 y) in pts ≥40 y. In pts <40 y, RIB + ET demonstrated an OS benefit vs PBO + ET (median, 51.3 vs 40.5 mo; HR, 0.65; 95% CI, 0.43-0.98). RIB had a longer median OS vs PBO in pts ≥40 y (median, 58.8 vs 51.7 mo; HR, 0.81; 95% CI, 0.62-1.07). Similar trends were observed for OS in NSAI-treated pts and in all pts for PFS2, time to chemotherapy (CT), and CT-free survival (Table). In pts who discontinued, subsequent antineoplastic therapies were received by 77.3% vs 75.0% of pts age <40 y in RIB vs PBO arms, respectively, and 77.2% vs 79.2% of pts ≥40 y. Subsequent CDK4/6i were received in 16.0% vs 27.5% of pts age <40 y and 11.6% vs 25.7% of pts ≥40 y in RIB vs PBO arms. Adverse events were consistent with the known safety profile of ML-7. ITT, intent to treat; NR, not reached. aIn ITT.
Age <40 y Age ≥40 y RIB + ET PBO + ET RIB + ET PBO + ET OS in NSAI cohort n=78 n=66 n=170 n=181 Events, n (%) 36 (46.2) 39 (59.1) 71 (41.8) 81 (44.8) Median, mo 50.2 40.7 58.7 54.1 HR (95% CI) 0.66 (0.42-1.05) 0.85 (0.61-1.16) PFS2a n=98 n=88 n=237 n=249 Events, n (%) 54 (55.1) 60 (68.2) 123 (51.9) 161 (64.7) Median, mo 46.0 25.5 43.6 32.7 HR (95% CI) 0.59 (0.40-0.86) 0.71 (0.56-0.89) Time to first CTa n=98 n=88 n=237 n=249 Events, n (%) 40 (40.8) 43 (48.9) 104 (43.9) 130 (52.2) Median, mo NR 36.6 50.2 36.8 HR (95% CI) 0.65 (0.42-1.01) 0.69 (0.53-0.90) CT-free survivala n=98 n=88 n=237 n=249 Events, n (%) 53 (54.1) 63 (71.6) 137 (57.8) 173 (69.5) Median, mo 46.5 22.7 41.5 27.6 HR (95% CI) 0.58 (0.40-0.85) 0.68 (0.54-0.85)
Conclusions
In ML-7, RIB prolonged OS and improved post-progression outcomes in HR+/HER2− ABC, particularly in younger pts, who have a substantial unmet need.
Clinical trial identification
NCT02278120.
Editorial acknowledgement
This abstract was developed with editorial assistance provided by Chris Carter, PhD of MediTech Media, LLC. Editorial support was funded by Novartis Pharmaceuticals Corporation.
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
Y-S. Lu: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Honoraria (self), Speaker Bureau/Expert testimony: Roche; Honoraria (self), Speaker Bureau/Expert testimony, Research grant/Funding (institution): Merck Sharp & Dohme; Honoraria (self), Speaker Bureau/Expert testimony: Eisai. N.S. El Saghir: Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Eli Lilly; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: AstraZeneca. S.A. Hurvitz: Research grant/Funding (institution): Ambryx; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Bayer; Research grant/Funding (institution), Travel/Accommodation/Expenses: OBI Pharma; Research grant/Funding (institution): Bimarin; Research grant/Funding (institution): Cascadian; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Dignitana; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): GSK; Research grant/Funding (institution), Travel/Accommodation/Expenses: Lilly; Research grant/Funding (institution): Macrogenics; Research grant/Funding (institution): Medivation; Research grant/Funding (institution): Merrimack; Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Pieris; Research grant/Funding (institution): Puma; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Seattle Genetics. D. Tripathy: Honoraria (self), Advisory/Consultancy: Genomic Health; Honoraria (self), Advisory/Consultancy: GlaxoSmithKline; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Polyphor; Advisory/Consultancy: Puma Biotechnology; Honoraria (self), Speaker Bureau/Expert testimony: AstraZeneca; Leadership role: OncoPep; Advisory/Consultancy: Sellas Life Sciences Group. F. Cardoso: Honoraria (self): Novartis; Honoraria (self): Amgen; Honoraria (self): Astellas/Medivation; Honoraria (self): AstraZeneca; Honoraria (self): Celgene; Honoraria (self): Daiichi Sankyo; Honoraria (self): Eisai; Honoraria (self): GE Oncology; Honoraria (self): Genentech; Honoraria (self): GSK; Honoraria (self): Macrogenics; Honoraria (self): Medscape; Honoraria (self): Merck-Sharp; Honoraria (self): Merus; Honoraria (self): Mylan; Honoraria (self): Mundipharma; Honoraria (self): Pfizer; Honoraria (self): Pierre Fabre; Honoraria (self): Prime; Honoraria (institution): Roche. M.A. Colleoni: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self): Novartis; Honoraria (self), Advisory/Consultancy: OBI Pharma; Honoraria (self), Advisory/Consultancy: Puma Biotechnology; Honoraria (self), Advisory/Consultancy: Celldex. S. Campos-Gomez: Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb. C. Wang, Y. Wang, J.P. Zarate, A. Chakravartty: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. S-A. Im: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy: Hanmi; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Eisai; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): MediPacto; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): GSK; Research grant/Funding (institution): Daewoong. All other authors have declared no conflicts of interest.
Presenter Of 1 Presentation
Progression after CDK 4/6i: How to sequence approved options (ID 304)
Moderator Of 1 Session
Author Of 2 Presentations
24P - Consensus on the utility of breast cancer multigene signatures in routine clinical practice among European Breast Cancer clinicians - The PROCURE project.
Abstract
Background
Several genomic assays are available to profile early breast cancer (BC) that, according to current evidence, can provide reliable information including the risk of recurrence. However, little is known regarding their current use and the perception of utility across Europe. The PROCURE project aims to develop a consensus on the utility of breast cancer multigene signatures (BCMS) in treatment decision making for different eBC patient profiles based on the opinion of a panel of experts.
Methods
A Scientific Committee of 8 experts in BC from 8 European countries developed a Delphi questionnaire to be administered in two-waves to experienced clinicians across Europe, selected based on their experience in BC. The questionnaire includes 5 sections in order to characterize the participants and their expertise in BCMS, to understand the current clinical practice in eBC and the use of BCMS, to recall the participant’s opinion on the utility of the BCMS in eBC according to the patient profiles, to define recommendations on the use of BCMS in clinical practice and finally, to identify unmet needs and future applications of BCMS. 180 participants, including medical oncologists, surgeons, pathologists and gynaecologists, are expected to answer anonymously the online Delphi questionnaire. 70% agreement will be used to determine consensus on a topic.
Results
At the end of January 2021, 146 participants from 11 European countries (Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, Switzerland and the UK) registered to participate. 61 of them had already fully completed the 1st wave Delphi questionnaire. Results from the 1st wave will be presented to engage larger discussion with congress participants.
Conclusions
The PROCURE Project will provide useful information regarding how BCMS are currently used in clinical practice across Europe and will help to measure the utility attributed to the different BCMS by BC experts for their daily clinical practice, to establish recommendations on the use of BCMS to make treatment decision in different eBC patient profiles and to define current unmet needs and future applications of BCMS according to experts point of view.
Editorial acknowledgement
Adelphi Targis SL.
Legal entity responsible for the study
Veracyte Inc.
Funding
Veracyte Inc.
Disclosure
G. Curigliano: Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche; Advisory/Consultancy: Lilly; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Veracyte; Advisory/Consultancy: Genomic health; Advisory/Consultancy: Ellipsis. F. Cardoso: Honoraria (self): Amgen; Honoraria (self): Astellas/Medivation; Honoraria (self): AstraZeneca; Honoraria (self): Celgene; Honoraria (self): Daiichi Sankyo; Honoraria (self): GE Oncology; Honoraria (self): Genentech; Honoraria (self): GlaxoSmithKline; Honoraria (self): Macrogenics; Honoraria (self): Medscape; Honoraria (self): Merck-Sharp; Honoraria (self): Merus BV; Honoraria (self): Mylan; Honoraria (self): Mundipharma; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Pierre Fabre; Honoraria (self): priME Oncology; Honoraria (self): Roche; Honoraria (self): Samsung Bioepis; Honoraria (self): Eisai. M.I. Gnant: Honoraria (self): Veracyte; Honoraria (self): Amgen; Honoraria (self): Novartis; Honoraria (self): AstraZeneca; Honoraria (self): Eli Lilly; Honoraria (self): Daiichi Sankyo; Honoraria (self): Tolmar; Honoraria (self): LifeBrain. A-V. Lænkholm: Honoraria (self): Veracyte. F. Penault-Llorca: Honoraria (self), Research grant/Funding (self): Veracyte; Honoraria (self), Research grant/Funding (self): Exact science former Genomic Health; Honoraria (self): Agendia; Honoraria (self), Research grant/Funding (self): Myriad. A. Prat: Honoraria (self): Veracyte; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo; Advisory/Consultancy: Amgen; Advisory/Consultancy: BMS; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy, Research grant/Funding (institution): Puma Biotechnology; Advisory/Consultancy: Oncolytics Biotech; Advisory/Consultancy: AbbVie; Honoraria (institution): NanoString technologies; Research grant/Funding (institution): Incyte; Honoraria (self): Oncolytics; Honoraria (self), Research grant/Funding (self): Novartis; Advisory/Consultancy: Peptomyc; Honoraria (self), Advisory/Consultancy: Guardian health; Honoraria (self), Shareholder/Stockholder/Stock options: Reveal genomics; Advisory/Consultancy: AstraZeneca; Research grant/Funding (self): Incyte. All other authors have declared no conflicts of interest.
- S. Almeida (Lisbon, Portugal)
- D. Frasquilho (Lisbon, Portugal)
- G. Cotovio (Lisbon, Portugal)
- F. Viana (Lisbon, Portugal)
- B. Sousa (Lisbon, Portugal)
- J. Oliveira (Lisbon, Portugal)
- J. Mattson (Helsinki, Finland)
- C. Marzorati (Milan, Italy)
- I. Roziner (Tel Aviv, Israel)
- E. Karademas (Heraklion, Greece)
- E. Kolokotroni (Athens, Greece)
- G. Stamatakos (Athens, Greece)
- K. Mazzocco (Milan, Italy)
- R. Pat-Horenczyk (Tel Aviv, Israel)
- P. Poikonen-Saksela (Helsinki, Finland)
- F. Cardoso (Lisbon, Portugal)
- A. Oliveira-Maia (Lisbon, Portugal)
132P - The psychological impact of the COVID-19 pandemic on patients with early breast cancer
Abstract
Background
Direct impact of the COVID-19 pandemic, in addition to the measures adopted to control its spread, may cause a significant emotional burden, especially in patients with cancer. This study aims to understand the psychological impact of COVID-19 pandemic on patients with early breast cancer.
Methods
The BOUNCE study, assessing, among others, depression and anxiety symptoms, has a longitudinal design and includes early breast cancer patients across 3 European countries and Israel. The study was ongoing when the COVID-19 pandemic started in Europe and data collection has continued, allowing for measurements of associations between symptom severity in three time points and COVID-related parameters (CRP) retrieved from a publicly available database (Our World in Data). Descriptive statistics and series of multilevel mixed-effects linear regression models were performed to assess variation in individual level symptom severity as a function of country-level COVID-19 pandemic parameters across time.
Results
Among 724 participants included in the analyses, 307 were exposed to the pandemic. For depressive symptoms, anxiety symptoms and general psychological distress, we did not find statistically significant associations with weekly COVID-19 incidence, weekly COVID-19 death rate or weekly stringency level of government-imposed COVID-19 containment measures. For depressive symptoms only, we found statistically significant negative interactions with time for COVID-19 incidence (β= −0.002, SE=0.001, p=0.04) and containment measures (β= −0.001, SE=0.001, p=0.02), that we are currently exploring in further analyses.
Conclusions
In women with early breast cancer across 3 European countries and Israel, country-wide CRPs did not seem to have a significant psychological impact, namely regarding to symptoms of depression and anxiety. Given the continuing nature of the pandemic, we will continue the data collection, including more time points of assessment to evaluate possible lagged effects.
Legal entity responsible for the study
Albino Oliveira-Maia.
Funding
This project has received funding from the European Union’s Horizon 2020 research and innovationprogramme under grant agreement No 777167.
Disclosure
F. Cardoso: Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Amgen; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Astellas/Medivation; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: AstraZeneca; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Celgene; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Daiichi Sankyo; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Eisai; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: GE oncology; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Genentech; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results.: GlaxoSmithKline; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results.: Macrogenics; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Medscape; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Merck-Sharp; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Merus BV; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Mylan; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Mundipharma; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Novartis; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Pfizer; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Pierre Fabre; Advisory/Consultancy, The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: prIME Oncology; Advisory/Consultancy, The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing, or in the decision to publish the results: Roche, Samsung Bioepis, Sanofi, Seagen, Teva. A. Oliveira-Maia: Research grant/Funding (self), A grant for norming and validation of cognitive tests: Schuhfried GmBH; Leadership role, National coordinator for Portugal of a Non-interventional Study (EDMS-ERI-143085581, 4.0) to characterize a Treatment-Resistant Depression Cohort in Europe: Janssen-Cilag Ltd.; Research grant/Funding (self), A trial of psilocybin therapy for treatment-resistant depression: Compass Pathways, Ltd. All other authors have declared no conflicts of interest.