000 02674nam a22003617a 4500
008 220926s20222022 xxu||||| |||| 00| 0 eng d
022 _a2072-6694
024 _a10.3390/cancers14112596 [doi]
024 _acancers14112596 [pii]
024 _aPMC9179451 [pmc]
040 _aOvid MEDLINE(R)
099 _a35681574
245 _aBERENICE Final Analysis: Cardiac Safety Study of Neoadjuvant Pertuzumab, Trastuzumab, and Chemotherapy Followed by Adjuvant Pertuzumab and Trastuzumab in HER2-Positive Early Breast Cancer.
251 _aCancers. 14(11), 2022 May 24.
252 _aCancers (Basel). 14(11), 2022 May 24.
253 _aCancers
260 _c2022
260 _fFY2022
260 _p2022 May 24
265 _sepublish
265 _tPubMed-not-MEDLINE
266 _d2022-07-06
520 _aBERENICE (NCT02132949) assessed the cardiac safety of the neoadjuvant-adjuvant pertuzumab-trastuzumab-based therapy for high-risk, HER2-positive early breast cancer (EBC). We describe key secondary objectives at final analysis. Eligible patients received dose-dense doxorubicin and cyclophosphamide q2w x 4 paclitaxel qw x 12 (Cohort A) or 5-fluorouracil, epirubicin, cyclophosphamide q3w x 4 docetaxel q3w x 4 (B) as per physician's choice. Pertuzumab-trastuzumab (q3w) was initiated from the taxane start and continued post-surgery to complete 1 year. Median follow-up: 64.5 months. There were no new cardiac issues and a low incidence of Class III/IV heart failure (Cohort B only: one patient (0.5%) in the adjuvant and treatment-free follow-up (TFFU) periods). Fourteen patients (7.7%) had LVEF declines of >=10% points from baseline to <50% in Cohort A, as did 20 (10.5%) in B during the adjuvant period (12 (6.2%) in A and 7 (3.6%) in B during TFFU). The five-year event-free survival rates in Cohorts A and B were 90.8% (95% CI: 86.5, 95.2) and 89.2% (84.8, 93.6), respectively. The five-year overall survival rates were 96.1% (95% CI: 93.3, 98.9) and 93.8% (90.3, 97.2), respectively. The final analysis of BERENICE further supports pertuzumab-trastuzumab-based therapies as standard of care for high-risk, HER2-positive EBC.
546 _aEnglish
650 _aIN PROCESS -- NOT YET INDEXED
656 _aAssociate Dean for Research Development
656 _aMedStar Health
657 _aJournal Article
700 _aSwain, Sandra M
790 _aColomer R, Dadswell K, Dang C, de Haas SL, de la Cruz-Merino L, Delaloge S, Eiger D, Ewer MS, Ferrero JM, Restuccia E, Sarkar S, Swain SM, Verrill M, Werner TL
856 _uhttps://dx.doi.org/10.3390/cancers14112596
_zhttps://dx.doi.org/10.3390/cancers14112596
942 _cART
_dArticle
999 _c418
_d418