Table 1.

Oncotype DX^® validation studies

Study	Year	Publication	Country	Sample size	Node negative	Node positive	Population	Adjuvant treatment	End point assessed	Predictive value	Prognostic value	Recurrence score ranges
Paik et al29 Analysis of NSABP-B14 cohort	2004	The New England Journal of Medicine	USA	668	Yes	No	Premenopausal and postmenopausal ER-positive, HER2-negative breast cancer	Tamoxifen for 5 years	Distant recurrence	No	Yes	Low-risk <18 Intermediate 19–30 High-risk ≥31
Paik et al35 Analysis of NSABP-B20 cohort	2006	Journal of Clinical Oncology	USA	651	Yes	No	Premenopausal and postmenopausal ER-positive, HER2-negative breast cancer	Tamoxifen for 5 years or tamoxifen for 5 years + CMF chemotherapy	Locoregional recurrence Distant recurrence	Yes	Yes	Low-risk <18 Intermediate 19–30 High-risk ≥31
Dowsett et al15 Analysis of transATAC cohort	2010	Journal of Clinical Oncology	UK	1,231	Yes	Yes	Postmenopausal ER-positive, HER2-negative breast cancer	Tamoxifen or anastrazole for 5 years	Distant recurrence	No	Yes	Low-risk <18 Intermediate 19–30 High-risk ≥31
Sparano et al5 TAILORx	2015	The New England Journal of Medicine	USA	10,253	Yes	No	Premenopausal and postmenopausal ER-positive, HER2-negative breast cancer Tumor size 1.1–5.0 cm for any grade, 0.6–1 cm for intermediate/high grade	Tamoxifen/aromatase inhibitor, with or without ovarian suppression	Ipsilateral tumor Contralateral second primary locoregional recurrence Second primary nonbreast cancer Death without recurrence	No	Yes	Low-risk <10 Intermediate 11–25 High-risk ≥26
Gluz et al38 Analysis of PlanB cohort	2016	Journal of Clinical Oncology	Germany	2,568	Yes	Yes	Premenopausal and postmenopausal ER-positive, HER2-negative breast cancer Nodal N0 (high-risk – T2, grade 2/3, high uPA/PAI-1, age <35 years) N1 status	4 cycles epirubicin/cyclophosphamide +4 cycles docetaxel vs 6 cycles of docetaxel/cyclophosphamide	3-year disease-free survival (any invasive cancer event/death)	No	Yes	Low-risk ≤11 Intermediate 12–25 High-risk ≥26
Albain et al40 Analysis of SWOG-8814 cohort	2010	The Lancet Oncology	USA	367	No	Yes	Postmenopausal ER-positive breast cancer	Tamoxifen vs sequential CAF chemotherapy + tamoxifen	Local recurrence Distal recurrence Death from any cause New breast primary	Yes	Yes	Low-risk <18 Intermediate 19–30 High-risk ≥31
Goldstein et al14 Analysis of ECOG 2197 cohort	2008	Journal of Clinical Oncology	USA	465	Yes	Yes	Premenopausal and postmenopausal ER-positive breast cancer	Chemotherapy – either 4 cycles of doxorubicin/cyclophosphamide or docetaxel	Local recurrence Distal recurrence	No	Yes	Low-risk <18 Intermediate 19–30 High-risk ≥31

Abbreviations: CAF, cyclophosphamide, doxorubicin, 5-Flurouracil; CMF, cyclophosphamide/methotrexate/5-fluorouracil; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2.