Dual HER2 blockade with pertuzumab (P) and trastuzumab (T) in patients with HER2-positive metastatic breast cancer (mBC) relapsing after adjuvant treatment with T: results from a German non-interventional study (NIS) HELENA (NCT01777958)
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Le résumé fourni par la source
PURPOSE: NIS HELENA documented outcomes in clinical routine practice of first-line therapy with P plus T and docetaxel (D) of patients with advanced HER2-positive BC and prior (neo)adjuvant T. METHODS: Between 06/2013 through 07/2016, 126 patients (in-label use of P at study start = full analysis set, FAS) in 81 German study sites were included. Intense documentation period was limited to 28 treatment cycles. Maximum follow-up (FU) was 24 months (mos). Safety was assessed in the safety set (SAF = eligible patients with at least one dose of P, n = 132). Median progression-free survival (PFS) was the main parameter of interest. RESULTS: Mean age of FAS patients was 55.1 [30.7-80.2] years, 81.7% (95.2%) were < 65 (75) years of age. 51.6% of the FAS patients were hormone receptor-positive (HR+), 91.3% had distant, 73.0% visceral, and 18.3% non-visceral metastases. Median disease-free interval was 40.2 [6.6-95.9] mos. Effectiveness (FAS): Median PFS was 18.8 [15.1; 24.2] mos. Overall response rate was 64.3% (55.6; 72.1). Median overall survival was 55.9 mos [41.2, not reached]. Safety (SAF): 93.9% of patients had an adverse event (AE), 32.6% a serious AE (SAE). AEs related to P occurred in 53.8% of SAF, SAEs related to P in 13.6%. Diarrhea was the most frequently reported related (S)AE. There were 8 (6.1%) patients with a fatal AE. CONCLUSION: Based on the outcomes from NIS HELENA, results of dual blockade with P+T in patients relapsing after (neo)adjuvant T as reported from the CLEOPATRA study (NCT01777958) can be transferred to routine clinical practice. No new safety signals were detected.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Dual HER2 blockade with pertuzumab (P) and trastuzumab (T) in patients with HER2-positive metastatic breast cancer (mBC) relapsing after adjuvant treatment with T: results from a German non-interventional study (NIS) HELENA (NCT01777958)
- Date Crossref
- 12/09/2022
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Agaplesion Markus Hospital Department of Gynecology and Gynecological Oncology pays non établi dans la noticeÉtablissement de santé
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German Cancer Research Center National Center for Tumor Diseases (NCT) pays non établi dans la noticeStructure de recherche
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Heidelberg University pays non établi dans la noticeUniversité ou école supérieure
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Helmholtz-Zentrum Dresden-Rossendorf pays non établi dans la noticeStructure de recherche
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National Center for Tumor Diseases pays non établi dans la noticeOrganisme public
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University Hospital Carl Gustav Carus pays non établi dans la noticeÉtablissement de santé
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Nationales Centrum für Tumorerkrankungen Dresden pays non établi dans la noticeÉtablissement de santé
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Technische Universität Dresden pays non établi dans la noticeUniversité ou école supérieure
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Nordhausen University of Applied Sciences pays non établi dans la noticeUniversité ou école supérieure
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St. Franziskus Hospital pays non établi dans la noticeÉtablissement de santé
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Roche Pharma AG (Germany) pays non établi dans la noticeEntreprise
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University Hospital Heidelberg pays non établi dans la noticeÉtablissement de santé
Department of Gynecology and Gynecological Oncology — Agaplesion Markus Hospital, National Center for Tumor Diseases (NCT) — German Cancer Research Center et Heidelberg University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.