TY - JOUR
T1 - Decision of adjuvant chemotherapy in intermediate risk luminal breast cancer patients
T2 - A prospective multicenter trial assessing the clinical and psychological impact of EndoPredict® (EpClin) use (UCBG 2–14)
AU - Penault-Llorca, Frédérique
AU - Kwiatkowski, Fabrice
AU - Arnaud, Antoine
AU - Levy, Christelle
AU - Leheurteur, Marianne
AU - Uwer, Lionel
AU - Derbel, Olfa
AU - Le Rol, Annick
AU - Jacquin, Jean Philippe
AU - Jouannaud, Christelle
AU - Quenel-Tueux, Nathalie
AU - Girre, Véronique
AU - Foa, Cyril
AU - Guardiola, Emmanuel
AU - Lortholary, Alain
AU - Catala, Stéphanie
AU - Guiu, Séverine
AU - Valent, Alexander
AU - Boinon, Diane
AU - Lemonnier, Jérome
AU - Delaloge, Suzette
N1 - Publisher Copyright:
© 2019 The Author(s)
PY - 2020/2/1
Y1 - 2020/2/1
N2 - 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 Chemotherapy was withdrawn in 57 cases (28.4% [22.2–34.8]) and added in 15 (7.5% [3.8–11.2]. 6 changes (8%) were based on patients’ decisions.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.
AB - 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.
KW - Breast cancer
KW - Chemotherapy
KW - EndoPredict®
KW - Genomic test
KW - Patient reported outcomes
UR - http://www.scopus.com/inward/record.url?scp=85075753481&partnerID=8YFLogxK
U2 - 10.1016/j.breast.2019.10.013
DO - 10.1016/j.breast.2019.10.013
M3 - Article
C2 - 31790959
AN - SCOPUS:85075753481
SN - 0960-9776
VL - 49
SP - 132
EP - 140
JO - Breast
JF - Breast
ER -