Table 1: GRADE Assessment of Quality of Evidence Regarding Prognostic Value of Oncotype-DX.
| Studies | Quality Assessment | Summary of Findings | |||||
|---|---|---|---|---|---|---|---|
| Design | Quality | Consistency | Directness | Other Modifying Factors | Effect Size | Overall Quality | |
| Lymph-Node Negative | |||||||
| Toi 2010 (31) Dowsett 2009 (29) Paik 2004 (5) Paik 2006 (15) (n=1,967) (# events=216) |
Retrospective observational cohort study following women through the arms of a multisite hospital cohort / Retrospective analysis of a single arm of an RCT (-2) LOW |
No major limitations LOW |
No important inconsistency LOW |
Generalizability issues: - HER-2/neu LOW |
No important imprecision or sparse data LOW |
HRs for the association of distant recurrence and 50-point increment in RS: 6.03 (2.17–16.7) 3.92 (2.08–7.39) 2.81 (1.70–4.64) LOW |
LOW |
| Lymph-Node Positive | |||||||
| Albain 2010 (26) (n=148) (# events=66) Dowset 2009 (29) (n=306) (# events=74) |
Retrospective analysis of a single arm of an RCT (-2) LOW |
No major limitations LOW |
No important inconsistency LOW |
Generalizability issues: - HER-2/neu - Postmenopausal women only LOW |
No important imprecision or sparse data LOW |
HR for theassociation of distant recurrence and 50-point increment in RS: 2.64 (1.33–5.27) 3.47 (1.64–7.38) LOW |
LOW |
Abbreviations: HER-2, Human Epidermal growth factor Receptor 2; HR, hazard ratio; RCT, randomized controlled trial; RS, recurrence score