Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, práce podpořená grantem
PubMed
28625777
DOI
10.1016/j.ejca.2017.05.010
PII: S0959-8049(17)30961-9
Knihovny.cz E-zdroje
- Klíčová slova
- Adjuvant, Breast cancer, HER2/neu, Herceptin, Subcutaneous, Trastuzumab,
- MeSH
- adjuvantní chemoterapie MeSH
- analýza přežití MeSH
- dospělí MeSH
- injekce subkutánní škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- nádory prsu farmakoterapie metabolismus MeSH
- protinádorové látky aplikace a dávkování škodlivé účinky MeSH
- receptor erbB-2 metabolismus MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- trastuzumab aplikace a dávkování škodlivé účinky MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- ERBB2 protein, human MeSH Prohlížeč
- protinádorové látky MeSH
- receptor erbB-2 MeSH
- trastuzumab MeSH
AIM: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin® SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). METHODS: Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive. RESULTS: In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. CONCLUSION: SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.
APHP Tenon IUC UPMC Sorbonne University Paris France
Asan Medical Center University of Ulsan College of Medicine Seoul South Korea
Cairo University Clinical Oncology Department Cairo Egypt
F Hoffmann La Roche Ltd Biostatistics Basel Switzerland
F Hoffmann La Roche Ltd Global Pharma Development Basel Switzerland
Genentech Inc Global Pharma Development South San Francisco CA USA
Istituto Nazionale Tumori IRCCS Fondazione G Pascale Division of Breast Oncology Naples Italy
Kliniken Essen Mitte Department of Gynecology and Gynecologic Oncology Essen Germany
Northern Centre for Cancer Care Medical Oncology Department Newcastle UK
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT01566721
