Pooled analysis of prospective European studies assessing the impact of using the 21-gene Recurrence Score assay on clinical decision making in women with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancer.

Albanell Mestres, Joan; Svedman, Christer; Gligorov, Joseph; Holt, Simon D.H.; Bertelli, Gianfilippo; Blohmer, Jens-Uwe; Rouzier, Roman; Lluch, Ana; Eiermann, Wolfgang

Pooled analysis of prospective European studies assessing the impact of using the 21-gene Recurrence Score assay on clinical decision making in women with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancer.

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dc.contributor.author Albanell Mestres, Joanca
dc.contributor.author Svedman, Christerca
dc.contributor.author Gligorov, Josephca
dc.contributor.author Holt, Simon D.H.ca
dc.contributor.author Bertelli, Gianfilippoca
dc.contributor.author Blohmer, Jens-Uweca
dc.contributor.author Rouzier, Romanca
dc.contributor.author Lluch, Anaca
dc.contributor.author Eiermann, Wolfgangca
dc.date.accessioned 2017-01-23T12:33:48Z
dc.date.available 2017-01-23T12:33:48Z
dc.date.issued 2016
dc.description.abstract PURPOSE: The 21-gene Recurrence Score assay (Oncotype DX) provides prognostic/predictive information in oestrogen receptor positive (ER+) early breast cancer, but access/reimbursement has been limited in most European countries in the absence of prospective outcome data. Recently, two large prospective studies and a real-life 5-year outcome study have been reported. We performed a pooled analysis of prospective European impact studies to generate robust data on impact of use in different clinical subgroups. METHODS: The analysis included four studies (French, German, Spanish, and British) in ER+ human epidermal growth factor receptor 2-negative breast cancer patients (n = 527). Node-positive patients were excluded. RESULTS: The analysis demonstrated that treatment recommendations changed in 32% of patients post-testing; chemotherapy recommendation rate decreased from 55% to 34%. Change rates in the individual studies ranged from 30% to 37%. The highest change rates were in patients originally recommended chemotherapy and in grade II tumours; there was no subgroup without a treatment recommendation change. Notably, 31% of patients with an intermediate Recurrence Score result had a treatment recommendation change suggesting that testing provides actionable information in this group. With the exception of the German study (where chemotherapy rates remained high [41%] post-testing), between-study variability in treatment recommendations decreased post-testing (chemotherapy: from 36-52% to 26-29%; hormonal therapy: from 48-64% to 71-74%). Physicians' confidence regarding treatment recommendations improved in all the studies after testing. CONCLUSION: Recurrence Score testing led to changes in adjuvant chemotherapy use in approximately a third of patients, to an overall reduced chemotherapy use, and to more homogeneous decision making.ca
dc.description.sponsorship J.A. acknowledges FIS PI12/00680 RD12/0036/0051, 2014SGR740 intensification grant ISCIII, and A Ll./nPI12/01421 and RD12/0036/0070.
dc.format.mimetype application/pdfca
dc.identifier.citation Albanell J, Svedman C, Gligorov J, Holt SD, Bertelli G, Blohmer JU et al. Pooled analysis of prospective European studies assessing the impact of using the 21-gene Recurrence Score assay on clinical decision making in women with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancer. Eur J Cancer. 2016 Oct;66:104-13. DOI: 10.1016/j.ejca.2016.06.027ca
dc.identifier.doi http://dx.doi.org/10.1016/j.ejca.2016.06.027
dc.identifier.issn 0959-8049
dc.identifier.uri http://hdl.handle.net/10230/27962
dc.language.iso engca
dc.publisher Elsevierca
dc.relation.ispartof European Journal of Cancer. 2016 Oct;66:104-13
dc.rights.accessRights info:eu-repo/semantics/openAccessca
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/ca
dc.subject.other Quimioteràpiaca
dc.subject.other Mama -- Càncer -- Tractamentca
dc.title Pooled analysis of prospective European studies assessing the impact of using the 21-gene Recurrence Score assay on clinical decision making in women with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancer.ca
dc.type info:eu-repo/semantics/articleca
dc.type.version info:eu-repo/semantics/publishedVersionca

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