Decision of adjuvant chemotherapy in intermediate risk luminal breast cancer patients: A prospective multicenter trial assessing the clinical and psychological impact of EndoPredict® (EpClin) use (UCBG 2-14)

被引：20

作者：

Penault-Llorca, Frederique ^{[1
]}

Kwiatkowski, Fabrice ^{[2
]}

Arnaud, Antoine ^{[3
]}

Levy, Christelle ^{[4
]}

Leheurteur, Marianne ^{[5
]}

Uwer, Lionel ^{[6
]}

Derbel, Olfa ^{[7
]}

Le Rol, Annick ^{[8
]}

Jacquin, Jean-Philippe ^{[9
]}

Jouannaud, Christelle ^{[10
]}

Quenel-Tueux, Nathalie ^{[11
]}

Girre, Veronique ^{[12
]}

Foa, Cyril ^{[13
]}

Guardiola, Emmanuel ^{[14
]}

Lortholary, Alain ^{[15
]}

Catala, Stephanie ^{[16
]}

Guiu, Severine ^{[17
]}

Valent, Alexander ^{[18
]}

Boinon, Diane ^{[19
]}

Lemonnier, Jerome ^{[20
]}

Delaloge, Suzette ^{[21
]}

机构：

[1] Univ Clermont Auvergne, Ctr Jean Perrin, Dept Biol & Pathol, INSERM,U1240 Imagerie Mol & Strategies Theranost, Clermont Ferrand, France

[2] Univ Clermont Auvergne, Ctr Jean Perrin, Dept Biostat, INSERM,U1240 Imagerie Mol & Strategies Theranost, Clermont Ferrand, France

[3] Inst St Catherine, Dept Med Oncol, Avignon, France

[4] Ctr Francois Baclesse, Dept Med Oncol, Caen, France

[5] Ctr Henri Becquerel, Dept Med Oncol, Rouen, France

[6] Inst Cancerol Lorraine, Dept Med Oncol, Vandoeuvre Les Nancy, France

[7] Hop Prive Jean Mermoz, Dept Med Oncol, Lyon, France

[8] Ctr Hosp Intercommunal, Dept Med Oncol, Quimper, France

[9] Inst Cancerol Lucien Newirth, Dept Med Oncol, Saint Priest En Jarez, France

[10] Inst Jean Godinot, Dept Med Oncol, Reims, France

[11] Inst Bergonie, Dept Med Oncol, Bordeaux, France

[12] Ctr Hosp Dept Vendee, Dept Med Oncol, La Roche Sur Yon, France

[13] Hop St Joseph, Dept Med Oncol, Marseille, France

[14] Ctr Hosp La Dracenie, Dept Med Oncol, Draguignan, France

[15] Ctr Catherine Sienne, Dept Med Oncol, Nantes, France

[16] Ctr Catalan Oncol, Dept Med Oncol, Perpignan, France

[17] Inst Reg Canc Montpellier ICM, Dept Med Oncol, Montpellier, France

[18] Gustave Roussy, Dept Biopathol, Villejuif, France

[19] Gustave Roussy, Psychooncol Unit, Dept Support Care, Villejuif, France

[20] R&D UNICANC, Paris, France

[21] Gustave Roussy, Dept Med Oncol, Villejuif, France

来源：

BREAST | 2020年 / 49卷

关键词：

Breast cancer; Genomic test; Chemotherapy; Patient reported outcomes; EndoPredict (R); WOMEN; GUIDELINES; SIGNATURES; THERAPY; SCORE; ASSAY;

D O I：

10.1016/j.breast.2019.10.013

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: Genomic tests can identify ER-positive HER2-negative localized breast cancer patients who may not benefit from adjuvant chemotherapy. Such tests seem especially interesting in "intermediate" clinico-pathological risk categories. The psychological impact of the decision uncertainty in these women remains largely unexplored. We assessed the clinical and psychological impact of EndoPredict (R) (EpClin), a clinico-genomic test, in these patients. Methods: This multicenter, single arm prospective study (NCT02773004) enrolled patients for which adjuvant chemotherapy was uncertain, based on predefined criteria. The primary endpoint was the proportion of change between initial adjuvant decision and final administration of chemotherapy. Secondary endpoints included post-test (Day 17) and 1-year patient reported outcomes. Results: One third of 200 evaluable patients had a high EpClin score (>= 3.32867; 10 years cumulative risk of distance failure >= 10%). The overall change rate of chemotherapy decision was 72/200 (35.8%, 95% CI 42.4). Chemotherapy was withdrawn in 57 cases (28.4% [22.2-34.8]) and added in 15 (7.5% [3.8 -11.2]. 6 changes (8%) were based on patients' decisions. Anxiety and distress levels increased at Day 17 when adding chemotherapy after the test result (p < 10(-7) and 0.00022 respectively), while stable in other situations. At 1-year, all patients had returned to the baseline anxiety and distress levels (mean anxiety 51.5, +/- SD = 2.5 [max. 80], mean distress 3 +/- 1 [max. 10]). Conclusions: EndoPredict (R) (EpClin) is clinically useful in deciding whether or not to administer adjuvant chemotherapy in patients with intermediate risk. A single-step decision is preferable since adding chemotherapy at a later stage increases anxiety and distress. (C) 2019 The Author(s). Published by Elsevier Ltd.

引用

页码：132 / 140

页数：9

共 26 条

[1] 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 2enegative early-stage breast cancer [J].

Albanell, Joan ;

Svedman, Christer ;

Gligorov, Joseph ;

Holt, Simon D. H. ;

Bertelli, Gianfilippo ;

Blohmer, Jens-Uwe ;

Rouzier, Roman ;

Lluch, Ana ;

Eiermann, Wolfgang .

EUROPEAN JOURNAL OF CANCER, 2016, 66 :104-113

[2]

Buus R, 2016, JNCI-J NATL CANCER I, V10, P108

[3] 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer [J].

Cardoso, F. ;

van't Veer, L. J. ;

Bogaerts, J. ;

Slaets, L. ;

Viale, G. ;

Delaloge, S. ;

Pierga, J. -Y. ;

Brain, E. ;

Causeret, S. ;

DeLorenzi, M. ;

Glas, A. M. ;

Golfinopoulos, V. ;

Goulioti, T. ;

Knox, S. ;

Matos, E. ;

Meulemans, B. ;

Neijenhuis, P. A. ;

Nitz, U. ;

Passalacqua, R. ;

Ravdin, P. ;

Rubio, I. T. ;

Saghatchian, M. ;

Smilde, T. J. ;

Sotiriou, C. ;

Stork, L. ;

Straehle, C. ;

Thomas, G. ;

Thompson, A. M. ;

van der Hoeven, J. M. ;

Vuylsteke, P. ;

Bernards, R. ;

Tryfonidis, K. ;

Rutgers, E. ;

Piccart, M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (08) :717-729

[4] Tailoring therapies-improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015 [J].

Coates, A. S. ;

Winer, E. P. ;

Goldhirsch, A. ;

Gelber, R. D. ;

Gnant, M. ;

Piccart-Gebhart, M. ;

Thuerlimann, B. ;

Senn, H. -J. .

ANNALS OF ONCOLOGY, 2015, 26 (08) :1533-1546

[5]

Dolbeault Sylvie, 2008, Palliat Support Care, V6, P107, DOI 10.1017/S1478951508000187

[6] EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer [J].

Dubsky, P. ;

Filipits, M. ;

Jakesz, R. ;

Rudas, M. ;

Singer, C. F. ;

Greil, R. ;

Dietze, O. ;

Luisser, I. ;

Klug, E. ;

Sedivy, R. ;

Bachner, M. ;

Mayr, D. ;

Schmidt, M. ;

Gehrmann, M. C. ;

Petry, C. ;

Weber, K. E. ;

Kronenwett, R. ;

Brase, J. C. ;

Gnant, M. .

ANNALS OF ONCOLOGY, 2013, 24 (03) :640-647

[7] Patients' preferences for adjuvant chemotherapy in early breast cancer: what makes AC and CMF worthwhile now? [J].

Duric, VM ;

Stockler, MR ;

Heritier, S ;

Boyle, F ;

Beith, J ;

Sullivan, A ;

Wilcken, N ;

Coates, AS ;

Simes, RJ .

ANNALS OF ONCOLOGY, 2005, 16 (11) :1786-1794

[8] Decision impact and feasibility of different ASCO-recommended biomarkers in early breast cancer: Prospective comparison of molecular marker EndoPredict and protein marker uPA/PAI-1 [J].

Ettl, Johannes ;

Klein, Evelyn ;

Hapfelmeier, Alexander ;

Lackmann, Kirsten Grosse ;

Paepke, Stefan ;

Petry, Christoph ;

Specht, Katja ;

Wolff, Laura ;

Hoefler, Heinz ;

Kiechle, Marion .

PLOS ONE, 2017, 12 (09)

[9] Enhancing decision-making about adjuvant chemotherapy in early breast cancer following EndoPredict testing [J].

Fallowfield, Lesley ;

Matthews, Lucy ;

May, Shirley ;

Jenkins, Valerie ;

Bloomfield, David .

PSYCHO-ONCOLOGY, 2018, 27 (04) :1264-1269

[10]

Filipits M, 2011, CLIN CANCER RES, V15, P17

← 1 2 3 →