title: Comparison of efficacy of 95-gene and 21-gene classifier (Oncotype DX) for prediction of recurrence in ER-positive and node-negative breast cancer patients.
abstract: We recently developed a 95-gene classifier (95(GC)) for the prognostic prediction for ER-positive and node-negative breast cancer patients treated with only adjuvant hormonal therapy. The aim of this study was to validate the efficacy of 95(GC) and compare it with that of 21(GC) (Oncotype DX) as well as to evaluate the combination of 95(GC) and 21(GC). DNA microarray data (gene expression) of ER-positive and node-negative breast cancer patients (n = 459) treated with adjuvant hormone therapy alone as well as those of ER-positive breast cancer patients treated with neoadjuvant chemotherapy (n = 359) were classified with 95(GC) and 21(GC) (Recurrence Online at http://www.recurrenceonline.com/ ). 95(GC) classified the 459 patients into low-risk (n = 285; 10 year relapse-free survival: 88.8 %) and high-risk groups (n = 174; 70.6 %) (P = 5.5e-10), and 21(GC) into low-risk group (n = 286; 89.3 %), intermediate-risk (n = 81; 75.7 %), and high-risk (n = 92; 64.7 %) groups (P = 2.9e-10). The combination of 95(GC) and 21(GC) classified them into low-risk (n = 324; 88.9 %) and high-risk (n = 135; 65.0 %) groups (P = 5.9e-14), and also showed that pathological complete response rates were significantly (P = 2.5e-6) higher for the high-risk (17.9 %) than the low-risk group (3.6 %). In addition, we demonstrated that 95(GC) was calculated on a single-sample basis if the reference robust multi-array average workflow was used for normalization. The prognostic prediction capability of 95(GC) appears to be comparable to that of 21(GC). Moreover, their combination seems to result in the identification of more low-risk patients who do not need chemotherapy than either classification alone. The patients in the high-risk group were found to be more chemo-sensitive so that they can benefit more from adjuvant chemotherapy.
authors.affiliation: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2-E10 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan.
authors.forename: Yasuto
authors.initials: Y
authors.lastname: Naoi
authors.forename: Kazuki
authors.initials: K
authors.lastname: Kishi
authors.forename: Ryo
authors.initials: R
authors.lastname: Tsunashima
authors.forename: Kenzo
authors.initials: K
authors.lastname: Shimazu
authors.forename: Atsushi
authors.initials: A
authors.lastname: Shimomura
authors.forename: Naomi
authors.initials: N
authors.lastname: Maruyama
authors.forename: Masafumi
authors.initials: M
authors.lastname: Shimoda
authors.forename: Naofumi
authors.initials: N
authors.lastname: Kagara
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Baba
authors.forename: Seung Jin
authors.initials: SJ
authors.lastname: Kim
authors.forename: Shinzaburo
authors.initials: S
authors.lastname: Noguchi
mesh_terms: D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D009364:Neoplasm Recurrence, Local / Q000235:genetics / Q000473:pathology*; D009367:Neoplasm Staging; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods*; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D011960:Receptors, Estrogen / Q000235:genetics
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; C508053:ERBB2 protein, human