Αρχική World News Neoadjuvant Pertuzumab/Trastuzumab Demonstrates Long-Term Cardiac Safety in HER2-Positive Breast Cancer

Neoadjuvant Pertuzumab/Trastuzumab Demonstrates Long-Term Cardiac Safety in HER2-Positive Breast Cancer

Patients with stage IIA to III HER2-positive breast cancer demonstrated high rates of event-free survival (EFS) and a low occurrence of cardiac events at 5 years after receiving neoadjuvant/adjuvant pertuzumab plus trastuzumab with standard anthracycline-containing therapies. Chau Dang of the Department of Medicine, Breast Medicine Service, Memorial Sloan Kettering Cancer Centre in New York, USA presented long-term findings from the BERENICE study (NCT02132949) at the ESMO Breast Cancer Virtual Congress 2021, held 5 to 8 May.

Dr. Dang presented data related to the secondary objective, safety and efficacy outcomes at 5-years, which represented the end-of-study analysis with a clinical cut-off date of 25 August 2020.

The multicentre, open-label, non-comparative phase II BERENICE study enrolled patients with stage IIA to III HER2-positive breast cancer and a left ventricular ejection fraction (LVEF) ≥55%. According to physician’s choice patients were assigned to be treated with dose-dense doxorubicin/cyclophosphamide every 2 weeks for 4 cycles plus 4 weekly cycles of paclitaxel for 12 cycles (cohort A: n=199) or to receive 5-fluorouracil, epirubicin, cyclophosphamide every 3 weeks for 4 cycles and 4 cycles of docetaxel every 3 weeks (cohort B; n=201). Pertuzumab/trastuzumab every 3 weeks was initiated from the start of taxanes and continued after surgery for a total of 17 cycles.

The primary objective of BERENICE was to illustrate the cardiac safety of neoadjuvant pertuzumab/trastuzumab with anthracycline-containing chemotherapies.

High rates of event-free survival were observed

The 5-year EFS rates were 90.8% (95% confidence interval [CI] 86.5-95.2) in cohort A and 89.2% (95% CI 84.8-93.6) in cohort B, while the 5-year overall survival rates were 96.1% (95% CI 93.3-98.9) and 93.8% (95% CI 90.3-97.2), respectively.

PAM50 classification was available for 339 patients which showed that the majority (51.6%) of patients had HER2-enriched tumours; the 5-year EFS rates in these patients were 93.1% (95% CI 87.2-98.9) in cohort A and 88.3% (95% CI 81.8-94.8) in cohort B.

No new cardiac safety issues were observed during folllow-up. In addition, few events were observed in the treatment-free period and a low incidence of class III/IV congestive heart failure was reported.

The safety analysis comprised 199 cohort A and 198 cohort B patients. Among these patients, no LVEF episodes occurred during the treatment-free period.

During the treatment interval, 27 (13.6%) patients had at least one LVEF decrease to ≥10% and 12 (6.0%) patients experienced LVEF <50% in cohort A, whereas in cohort B 24 (12.1%) and 7 (3.5%) patients reported these respective LVEF events.

No episodes of New York Heart Association class III/IV congestive heart failure were observed in cohort A and one (0.5%) episode occurred in cohort B during the treatment-free follow-up period. On treatment, in cohorts A and B, 3 (1.5%) and 2 (1.0%) patients, respectively, experienced New York Heart Association class III/IV congestive heart failure. A total of 3 patients in cohort B did not have available safety data.

Dr. Evandro de Azambuja of the Jules Bordet Institute in Brussels, Belgium who discussed the study findings commented about favourable long-term efficacy outcomes with pertuzumab/trastuzumab-based (neo)adjuvant regimens. However, the chemotherapy backbone’s contribution cannot be assessed, due to the non-randomised study design. An anthracycline-free regimen was not evaluated in the present study. He said that the low incidence of cardiac events with the pertuzumab/trastuzumab-based regimen given before and after surgery was maintained during the 5-year follow-up. No new safety concerns arose during long-term follow-up, but additional information on cardiac medications/co-morbidities are needed. He also questioned if LVEF assessment by echocardiography is enough to assess cardiac safety.


The investigators noted that the BERENICE study demonstrated favourable long-term efficacy outcomes, and sustained cardiac safety in patients with early HER2-positive breast cancer. They stated that these findings support the use of neoadjuvant/adjuvant pertuzumab plus trastuzumab with standard anthracycline-containing therapies in this patient population.

The study was funded by F. Hoffmann-La Roche.


43O – Dang C, Ewer MS, Delaloge S, et al. Pertuzumab/Trastuzumab in Early Stage HER2-positive Breast Cancer: 5-year and Final Analysis of the BERENICE Trial. ESMO Breast Cancer Virtual Congress 2021 (5-8 May).



Συμπληρώστε το email σας για να λαμβάνετε τις σημαντικότερες ειδήσεις από το ogkologos.com

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like

Διαβαστε Επίσης

Καρκίνος και Κορωνοϊός (COVID-19) ΜΕΡΟΣ Α

Εάν είστε καρκινοπαθής, το ανοσοποιητικό σας σύστημα μπορεί να μην είναι τόσο ισχυρό όσο κανονικά, έτσι μπορεί να ανησυχείτε για τους κινδύνους που σχετίζονται...


Η Παγκόσμια Ημέρα Κατά του Καρκίνου καθιερώθηκε με πρωτοβουλία της Διεθνούς Ένωσης κατά του Καρκίνου (UICC), που εκπροσωπεί 800 οργανώσεις σε 155 χώρες του...


ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ) Γράφει ο Δρ Παπαδούρης Σάββας, Παθόλογος-Ογκολόγος   Ο ΜΜΚΠ βρίσκεται αναλογικά στο 80% και πλέον του συνολικού...

Διατρέχουν όντως οι καρκινοπαθείς μεγαλύτερο κίνδυνο λόγω κοροναϊού;

Σε πρακτικό επίπεδο, τα δεδομένα των σχετικών μελετών υποδηλώνουν ότι η χημειοθεραπεία ή οι άλλες αντι-νεοπλασματικές θεραπείες δεν αυξάνουν σημαντικά τον κίνδυνο θνησιμότητας από...

FDA: Η ακτινοβολία των smartphones δεν προκαλεί καρκίνο

Σε μια νέα έκθεσή της, η Υπηρεσία Τροφίμων και Φαρμάκων (FDA) των ΗΠΑ αναφέρει ότι επανεξέτασε τις σχετικές επιστημονικές έρευνες που δημοσιεύθηκαν τα τελευταία...

Νέα ανακάλυψη, νέα ελπίδα για τον καρκίνο

Ένα νεοανακαλυφθέν τμήμα του ανοσοποιητικού μας συστήματος θα μπορούσε να αξιοποιηθεί για την αντιμετώπιση όλων των ειδών καρκίνου, σύμφωνα με επιστήμονες του πανεπιστημίου Cardiff...
- Advertisment -

Ροή Ειδήσεων

Combining existing drugs improves prostate cancer survival

Adding abiraterone to standard hormone therapy improves survival for men with high-risk prostate cancer that’s not spread elsewhere in the body. “Today’s results are the...

New Combination of Old Drugs Improves Survival in Patients with Prostate Cancer [ESMO Congress 2021 Press Release]

LBA4_PR - Abiraterone acetate plus prednisolone (AAP) with or without enzalutamide (ENZ) added to androgen deprivation therapy (ADT) compared to ADT alone for men...

Immunotherapy Prolongs Survival in Recurrent, Persistent or Metastatic Cervical Cancer [ESMO Congress 2021 Press Release]

LBA2_PR - Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for persistent, recurrent, or metastatic cervical cancer: Randomized, double-blind, phase 3 KEYNOTE-826 study N. Colombo1, C....

Woman Diagnosed with Breast Cancer at 33 Launches Self-Examination App

Jessica Baladad has had a long history with self-examinations after a breast cancer scare in her early 20s. This habit helped save her life,...

Extended Adjuvant Treatment with Letrozole Results in Longer Survival in Postmenopausal Patients with Breast Cancer

According to results from a prospective, open-label, phase III study conducted in 69 Italian hospitals within the Gruppo Italiano Mammella among the postmenopausal patients...

Foodie Fridays: Apple Bok Choy Salad

While the temps may still be in the 80’s, apple season is upon us! Give this Apple Bok Choy salad a try!  It is...