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)

Breast

Alexander Valent¹  Stéphanie Catala²  Alain Lortholary³  Christelle Levy⁴  Marianne Leheurteur⁵  Véronique Girre⁶  Annick Le Rol⁷  Emmanuel Guardiola⁸  Suzette Delaloge⁹  Olfa Derbel^1,10  Cyril Foa^1,11  Nathalie Quenel-Tueux^1,12  Christelle Jouannaud^1,13  Séverine Guiu^1,14  Antoine Arnaud^1,15  Jean-Philippe Jacquin^1,16  Lionel Uwer^1,17  Diane Boinon^1,18  Jérome Lemonnier^1,19  Frédérique Penault-Llorca^2,20  Fabrice Kwiatkowski^2,21 

[1] Department of Biopathology, Gustave Roussy, Villejuif, France;Department of Medical Oncology, Centre Catalan D’oncologie, Perpignan, France;Department of Medical Oncology, Centre Catherine de Sienne, Nantes, France;Department of Medical Oncology, Centre François Baclesse, Caen, France;Department of Medical Oncology, Centre Henri Becquerel, Rouen, France;Department of Medical Oncology, Centre Hospitalier Départemental de Vendée, La Roche sur Yon, France;Department of Medical Oncology, Centre Hospitalier Intercommunal, Quimper, France;Department of Medical Oncology, Centre Hospitalier de La Dracénie, Draguignan, France;Department of Medical Oncology, Gustave Roussy, Villejuif, France;Department of Medical Oncology, Hôpital Privé Jean Mermoz, Lyon, France;Department of Medical Oncology, Hôpital Saint Joseph, Marseille, France;Department of Medical Oncology, Institut Bergonié, Bordeaux, France;Department of Medical Oncology, Institut Jean Godinot, Reims, France;Department of Medical Oncology, Institut Régional Du Cancer Montpellier (ICM), Val D’Aurelle, Montpellier, France;Department of Medical Oncology, Institut Sainte Catherine, Avignon, France;Department of Medical Oncology, Institut de Cancérologie Lucien Newirth, Saint Priest en Jarez, France;Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre Les Nancy, France;Department of Supportive Care, Psycho-oncology Unit, Gustave Roussy, Villejuif, France;R&D UNICANCER, Paris, France;Université Clermont Auvergne, Centre Jean Perrin, Department of Biology and Pathology, INSERM, U1240 Imagerie Moléculaire et Stratégies Théranostiques, Clermont Ferrand, France;Université Clermont Auvergne, Centre Jean Perrin, Department of Biostatistics, INSERM, U1240 Imagerie Moléculaire et Stratégies Théranostiques, Clermont Ferrand, France;

关键词: Breast cancer;    Genomic test;    Chemotherapy;    Patient reported outcomes;    EndoPredict®;   

DOI  :  

来源: DOAJ

【 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® (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 29.2–42.4). 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 ® (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.

【 授权许可】

Unknown