Autori: Harbeck N, Wrobel D, M. Zaiss M, et al. Background: Neratinib is registered in Europe as extended adjuvant treatment for adult patients with Human Epidermal Growth Factor Receptor 2-positive (HER2+) and Hormone receptor-positive (HR+) eBC within one year after completed adjuvant trastuzumab-based therapy (“EMA-/Swiss-label” population). In the ExteNET trial, extended adjuvant neratinib improved the...
Categoria: Letteratura
Patient-reported outcomes from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine in patients with HER2-positive metastatic breast cancer
Autori: Curigliano G, Dunton K, Rosenlund M, et al. Background: In DESTINY-Breast03 (NCT03529110), T-DXd showed superior progression-free survival by BICR vs T-DM1 (HR, 0.28 [95% CI, 0.22-0.37]; P < 0.001) and manageable safety in pts with HER2+ MBC. PRO measures incorporate pts’ perspective in clinical trials to assess effect of treatment on health-related quality of...
Trastuzumab-deruxtecan in HER2-positive breast cancer patients with active brain metastases: primary outcome analysis from the TUXEDO-1 trial
Autori: Bartsch R, Berghoff AS, Furtner J, et al. Background: Brain metastases (BM) are a frequent and devastating complication of HER2-positive breast cancer (BC). T-DXd is an antibody-drug conjugate with high activity in pretreated pts but information regarding activity in active BM is limited. Therefore, the prospective, single-arm, phase II TUXEDO-1 trial investigated T-DXd in...
Effect of diarrheal prophylaxis or dose escalation on neratinib-associated diarrhea and tolerability in patients with HER2+ early-stage breast cancer: Final findings from the CONTROL trial
Autori: Chan A, Ruiz Borrego M, Marx G, et al. Background: Neratinib (N), an irreversible pan-HER TKI, is approved in the EU for extended adjuvant treatment of early-stage HR+ HER2+ breast cancer (BC) after adjuvant trastuzumab (T)-based therapy. The CONTROL trial (NCT02400476) investigated pre-emptive antidiarrheal prophylaxis or dose escalation (DE) for prevention of diarrhea, the...
Health-related quality of life with pembrolizumab + chemotherapy vs placebo + chemo as 1L treatment for advanced triple-negative breast cancer: results from KEYNOTE-355
Autori: Cescon DW, Schmid P, Rugo HS, et al. Background: KEYNOTE-355 (NCT02819518) evaluated pembro + chemo vs pbo + chemo in previously untreated patients (pts) with locally recurrent inoperable or metastatic TNBC. Pembro + chemo improved the PFS and OS in pts with PD-L1 combined positive score (CPS) ≥10 disease. We present results for...
Optimal 18F-FDG PET/CT cut-off for pathological complete response prediction in HER2-positive early breast cancer patients treated with neoadjuvant trastuzumab and pertuzumab in PHERGain trial
Autori: Gebhart G, Keyaerts M, Guiot T, et al. Background: PHERGain trial investigated the potential of metabolic imaging to identify candidates for chemotherapy (CT) de-escalation in HER2-positive, stage I-IIIA, invasive, operable breast cancer with at least one breast lesion evaluable by FDG-PET. Based on data from NeoALTTO study, FDG-PET “responders” were defined as those pts...
Exploratory biomarker analysis from neoadjuvant atezolizumab, pertuzumab, trastuzumab plus docetaxel (NEO-PATH) in HER2+ early breast cancer
Autori: Ahn HK, Park K, Sim SH, et al. Background: Neoadjuvant atezolizumab plus docetaxel, trastuzumab and pertuzumab therapy showed favorable efficacy and safety profiles in HER2-positive early breast cancer (EBC) in NEO-PATH phase 2 study, which provided evidence of combining immunotherapy and anti-HER2 treatment as a potential new therapeutic option. We evaluated potential genomic biomarkers...
Biobanking in breast cancer: 10 years of practice at the European Institute of Oncology
Autori: Viale G, Bonizzi G, Capra M, et al. Background: Establishing biobanking in cancer research is important for health research infrastructure to collect, store, process, and distribute high-quality human biological samples and associated data. The Biobank for Translational Medicine (B4MED) Unit at the European Institute of Oncology (IEO) is a landmark in this field. The...
Development of a prognostic gene-expression signature for early stage HER2-positive breast cancer patients
Autori: Di Cosimo S, Ciniselli CM, Sotiriou C, et al. Background: With increasing evidence showing the complexity of HER2-positive breast cancer, this study aimed to identify a gene-expression signature with potential prognostic value to assist therapeutic decision in the early disease setting. Methods: Gene-expression profiles of NeoALTTO tumor biopsies before and after 2 weeks of...
Updated overall survival results from the first-line population in the phase III MONALEESA-3 trial of postmenopausal patients with HR+/HER2- advanced breast cancer treated with ribociclib + fulvestrant
Autori: Neven P, Fasching PA, Chia P, et al. Background: The MONALEESA-3 (NCT02422615) final protocol-specified OS analysis and an exploratory OS analysis with extended follow-up demonstrated significant OS benefit with RIB + FUL vs placebo (PBO) + FUL as 1L or second-line (2L) treatment (tx). At the time of these analyses, the median (m) OS...