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dc.contributor.authorMiles, D.
dc.contributor.authorCiruelos, E.
dc.contributor.authorSchneeweiss, A.
dc.contributor.authorPuglisi, F.
dc.contributor.authorPeretz-Yablonski, T.
dc.contributor.authorCampone, M.
dc.contributor.authorBondarenko, I.
dc.contributor.authorNowecki, Z.
dc.contributor.authorErrihani, H.
dc.contributor.authorPaluch-Shimon, S.
dc.contributor.authorWardley, Andrew M
dc.contributor.authorMerot, J. L.
dc.contributor.authorTrask, P.
dc.contributor.authordu Toit, Y.
dc.contributor.authorPena-Murillo, C.
dc.contributor.authorRevelant, V.
dc.contributor.authorKlingbiel, D
dc.contributor.authorBachelot, T.
dc.date.accessioned2021-08-17T12:22:42Z
dc.date.available2021-08-17T12:22:42Z
dc.date.issued2021en
dc.identifier.citationMiles D, Ciruelos E, Schneeweiss A, Puglisi F, Peretz-Yablonski T, Campone M, et al. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication. Annals of Oncology. 2021 Jul.en
dc.identifier.pmid34224826en
dc.identifier.doi10.1016/j.annonc.2021.06.024en
dc.identifier.urihttp://hdl.handle.net/10541/624435
dc.description.abstractBackground: The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting. Patients and methods: Eligible patients with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Prespecified subgroup analyses included subgroups according to taxane, hormone receptor (HR) status and prior trastuzumab. Exploratory univariable analyses identified potential prognostic factors; those that remained significant in multivariable analysis were used to analyse PFS and OS in subgroups with all, some or none of these factors. Results: Of 1436 treated patients, 588 (41%) initially received paclitaxel and 918 (64%) had HR-positive disease. The most common grade ≥3 adverse events were neutropenia (10%, mainly with docetaxel) and diarrhoea (8%). At the final analysis (median follow-up: 5.7 years), median PFS was 20.7 [95% confidence interval (CI) 18.9-23.1] months overall and was similar irrespective of HR status or taxane. Median OS was 65.3 (95% CI 60.9-70.9) months overall. OS was similar regardless of taxane backbone but was more favourable in patients with HR-positive than HR-negative LR/mBC. In exploratory analyses, trastuzumab-pretreated patients with visceral disease had the shortest median PFS (13.1 months) and OS (46.3 months). Conclusions: Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy. Exploratory analyses suggest risk factors that could guide future trial design.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.annonc.2021.06.024en
dc.titleFinal results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognosticationen
dc.typeArticleen
dc.contributor.departmentMount Vernon Cancer Centre, Northwood, UKen
dc.identifier.journalAnnals of Oncologyen
dc.description.noteen]
refterms.dateFOA2021-08-18T09:28:16Z


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