J. Ferrero (Nice, CE, France)

Centre Antoine Lacassagne

Author Of 1 Presentation

 Conference Calendar
Best abstracts Proffered paper

43O - Pertuzumab/Trastuzumab in Early Stage HER2-positive Breast Cancer: 5-year and Final Analysis of the BERENICE Trial (ID 235)

Presentation Number
43O
Lecture Time
17:40 - 17:52
Speakers
Session Name
Best abstracts
Room
Channel 1
Date
Fri, 07.05.2021
Time
17:15 - 18:30

Abstract

Background

BERENICE was designed to establish the cardiac safety of neoadjuvant pertuzumab/trastuzumab (PH) with anthracycline-containing chemotherapies (primary objective). Here we report the 5-year outcomes at end-of-study (clinical cut-off date: 25/08/2020), including additional safety and efficacy data (secondary objectives).

Methods

BERENICE was a multicenter, open-label, non-comparative phase II trial. Patients with stage IIA to III HER2-positive breast cancer and a left ventricular ejection fraction (LVEF) ≥55% were allocated per physician's choice to cohort A (dose-dense doxorubicin/cyclophosphamide every 2 weeks [q2w] x 4 → paclitaxel q1w x 12) or cohort B (5-fluorouracil, epirubicin, cyclophosphamide q3w x 4 → docetaxel q3w x 4). PH q3w was initiated from the start of taxanes and continued after surgery for a total of 17 cycles.

Results

Intention-to-treat population comprised 199 patients in cohort A and 201 in cohort B, with a median follow-up of 64.5 months. No new cardiac safety issues were seen, with few events occurring in the treatment-free period and a low incidence of class III/IV congestive heart failure (Table). Event-free survival (EFS) rates at 5 years were 90.8% (95% CI, 86.5-95.2) and 89.2% (84.8-93.6) in cohorts A and B, respectively. Overall survival rates at 5 years were 96.1% (93.3-98.9) and 93.8% (90.3-97.2) in cohorts A and B, respectively. According to PAM50 classification, available for 339 patients, most patients had HER2-enriched tumors (51.6%), with 5-year EFS rates of 93.1% (87.2-98.9) in cohort A and 88.3% (81.8-94.8) in cohort B

Safety population Cohort A (N=199) Cohort B (N=198)*
No. of patients with at least one LVEF decrease to ≥10% points from baseline to an LVEF <50% (whole study) No. during the treatment-free follow-up period 27 (13.6%) 12 (6.0%) 24 (12.1%)7 (3.5%)
No. of patients with New York Heart Association class III/IV congestive heart failure (whole study)No. during the treatment-free follow-up period 3 (1.5%)0 2 (1.0%)1 (0.5%)

*3 patients without safety data available

 .

Conclusions

The final analysis of BERENICE showed sustained cardiac safety and favorable long-term efficacy outcomes, further supporting neoadjuvant/adjuvant PH with standard anthracycline-containing therapies in patients with early stage HER2-positive breast cancer.

Clinical trial identification

NCT02132949 (WO29217), 25 January 2014.

Editorial acknowledgement

Support for third-party writing assistance for this abstract, furnished by Alison McGonagle, PhD, of Health Interactions, was provided by F. Hoffmann-La Roche Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

C. Dang: Honoraria (self): F. Hoffmann-La Roche Ltd., Genentech Inc., Daiichi Sankyo, Lilly, Puma Biotechnology; Advisory/Consultancy: F. Hoffmann-La Roche Ltd., Genentech Inc., Daiichi Sankyo, Lilly, Puma Biotechnology; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. M.S. Ewer: Advisory/Consultancy: AstraZeneca, Bayer, Boehringer Ingelheim; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions.: Roche. S. Delaloge: Advisory/Consultancy: AstraZeneca, Pierre Fabre, BMS, Roche, Lilly, Novartis, Pfizer, Servier, Orion, Puma, Sanofi, Cellectis; Research grant/Funding (institution): AstraZeneca, Roche, GE, Pfizer, Puma, Sanofi, BMS, MSD; Travel/Accommodation/Expenses: Pfizer, Roche, AstraZeneca; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. J-M. Ferrero: Honoraria (self): Pfizer, Lilly, Novartis; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. R. Colomer: Advisory/Consultancy: Roche, Lilly, MSD, AstraZeneca; Research grant/Funding (self): Roche, Lilly, MSD, BMS; Travel/Accommodation/Expenses: Roche, MSD; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. L. de la Cruz Merino: Advisory/Consultancy: MSD, Roche, Celgene; Speaker Bureau/Expert testimony: MSD, Roche, BMS, Amgen; Research grant/Funding (institution): BMS, Roche; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. K. Dadswell: Shareholder/Stockholder/Stock options: Roche; Full/Part-time employment: Roche; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. M. Verrill: Honoraria (self): Roche, Lilly, Pfizer, Novartis, Exact Sciences; Research grant/Funding (institution): Roche, Pfizer, Amgen, Novartis; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. D. Eiger: Research grant/Funding (self): Novartis; Shareholder/Stockholder/Stock options: Roche; Full/Part-time employment: Roche; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. S. Sarkar: Full/Part-time employment, Roche external business partner: PAREXEL; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. S. de Haas: Full/Part-time employment: Roche; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. E. Restuccia: Shareholder/Stockholder/Stock options: Roche; Full/Part-time employment: Roche; Non-remunerated activity/ies, Third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. S.M. Swain: Honoraria (self): AstraZeneca, Daiichi Sankyo, Roche/Genentech, Exact Sciences (Genomic Health), Molecular Templates, Silverback Therapeutics, Tocagen, Lilly, Natera, Athenex, Bejing Medical Foundation; Advisory/Consultancy: AstraZeneca, Daiichi Sankyo, Roche/Genentech, Exact Sciences (Genomic Health), Molecular Templates, Silverback Therapeutics, Tocagen, Lilly, Natera, Athenex, Bejing Medical Foundation; Advisory/Consultancy, Scientific advisory board: Inivata; Research grant/Funding (institution): Roche/Genentech, Kailos Genetics; Travel/Accommodation/Expenses: BMS, Lilly, Roche/Genentech, Daiichi Sankyo, Caris Life Sciences; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche.

Collapse

Author Of 1 Presentation

 On-Demand ePoster Display

102P - Breast cancer patients treated with intrathecal therapy for leptomeningeal metastases: characteristics and validation of prognostic models in a large real-life database

Abstract

Background

Leptomeningeal metastasis (LM) is a rare complication of metastatic breast cancer (MBC), with high rates of morbidity/mortality. Large cohorts are scarce. Our study aimed to describe the largest-to-date real-life population of MBC patients treated with intrathecal (IT) therapy and to evaluate prognostic models.

Methods

ESME MBC database (NCT03275311) includes all consecutive patients having started treatment for MBC since 2008. Overall survival (OS) of patients treated with IT therapy was estimated using the Kaplan-Meier method. Prognostic models were constructed using Cox proportional hazards models. Performance was evaluated using C-index and calibration plots.

Results

Of 22,266 female patients included in the ESME database covering 2008-2016, 312 were IT-treated with methotrexate, cytarabine or thiotepa and included in our analysis (15 patients have been excluded because of lack of data on the treatment line). Compared with non-IT treated ones, these were younger at MBC relapse (median age 52 years vs 61 years) and had more often lobular histology (23.4% vs 12.7%) or triple-negative subtype (24.7% vs 13.3%) (all p<0.001). Median OS was 4.5 months (95% CI 3.8-5.6) and 1-year survival rate was 25.6%. In case of IT therapy, significant prognostic factors associated with worse outcome by multivariable analysis were triple-negative subtype (HR=1.81 [95%CI 1.32-2.47]), treatment line ≥ 3 (HR=1.88 [95% CI 1.30-2.73]), ≥ 3 other metastatic sites (HR=1.33 [95%CI 1.01-1.74]), and IT cytarabine or thiotepa vs methotrexate (HR=1.68 [95%CI 1.28-2.22]), while concomitant systemic therapy was associated with better OS (HR=0.47 [95%CI 0.35-0.62]) (all p<0.001). We validated two previously published prognostic scores, the Curie score and the breast graded prognostic assessment, both with C-index of 0.57.

Conclusions

MBC patients with LM treated with IT therapy have a poor prognosis. However, in this large series, we could identify a subgroup of patients with better prognosis, when concomitant systemic therapy and IT methotrexate were used.

Clinical trial identification

NCT03275311.

Legal entity responsible for the study

UNICANCER.

Funding

UNICANCER. The ESME MBC database receives financial support from an industrial consortium (Roche, Pfizer, AstraZeneca, MSD, Eisai and Daiichi Sankyo). Data collection, analysis and publication are managed entirely by R&D UNICANCER independently of the industrial consortium.

Disclosure

M. Campone: Honoraria (self): Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy: GT1. All other authors have declared no conflicts of interest.

Collapse