Table 4.
Study | Design | Population | Treatment | Results |
---|---|---|---|---|
Oncotype DX | ||||
| ||||
Asad (2008)27 | Retrospective chart review |
ER+ | CHT for high risk based on NCCN guidelines; and HT for low risk |
GEP testing influenced CHT treatment decision in 37 (44%) of patients; 34% reduction in CHT recommendations |
LN− Mean age: 54 years N = 85 |
||||
| ||||
Rayhanabad (2008)28 |
Retrospective chart review |
ER+ | CHT for high risk based on NCCN guidelines; and HT for low risk |
Results from GEP testing led to change in treatment decisions in 15 (26%) patients |
LN− Tumors ≤ 5 cm Mean age: 54 years (range: 26–78) N = 58 |
||||
| ||||
Geffen (2009)30 | Prospective study |
LN− | Not reported | Nine patients (36%) had their treatment recommendations changed following GEP testing, including six patients from CHT to no CHT |
N = 25 | ||||
| ||||
Henry (2009)29 | Retrospective study |
ER+ | Discretion of medical oncologist; clinical data including Adjuvant! Online (AOL) risk estimates followed by RS |
Results from GEP testing altered CHT decisions in 9/29 (31%) patients—seven from CHT to no CHT and two from no CHT to CHT with low RS |
LN− N = 29 |
||||
| ||||
Lo (2010)31 | Prospective, multicenter study |
ER+ | Clinician treatment recommendation before and after GEP testing |
Oncologist treatment decision changed in 28 (32%) of patients following GEP testing. 20 of these were from CHT to HT. 24 (27%) patients changed their own treatment decision, of whom 9 changed from CHT to HT, 7 from HT to CHT, 2 from undecided to HT, and 2 from undecided to CHT |
LN− Mean age: 55 years (range: 35–77) N = 89 |
||||
| ||||
Ademuyiwa (2011)32 |
Retrospective, consecutive series |
ER+ | CHT recommendations based on clinicopathological characteristics |
RS led to change in treatment in 38% of patients, with 37 (13%) fewer patients receiving CHT |
LN− HER− Mean age: 54.8 years (range: 29–82) N = 276 |
||||
| ||||
Holt (2011)49* | Prospective cohort |
ER+ | Nottingham Prognostic Index | RS led to change in treatment recommendations in 35 (33%) patients, with 25 (23.5%) changing from CHT to no CHT |
LN− or N1 N = 106 |
||||
| ||||
Oratz (2007)34 | Retrospective study |
N = 74 | Clinician treatment recommendation before and after GEP testing |
RS led to change in treatment recommendations in 21% of patients, and in actual treatment received for 25% of patients |
| ||||
Klang (2010)35 | Retrospective study |
N = 313 | Clinician treatment recommendation before and after GEP testing |
RS led to change in treatment recommendations in 40% of patients; 27% reduction in CHT recommendations |
| ||||
Hornberger (2011)36 |
Retrospective study |
N = 952 | Treatment based on guideline recommendations |
RS led to a 27% reduction in CHT |
| ||||
Joh (2011)37 | Retrospective study |
N = 154 | Clinician panel | RS led to a 25% change in treatment recommendations |
| ||||
Partin (2011)38 | Retrospective study |
N = 169 | Treatment recommendations based on AOL and St. Gallen |
RS led to a change in treatment recommendation in 27–74% of patients depending on comparator guideline |
| ||||
MammaPrint | ||||
| ||||
Bueno-de- Mesquita (2007)39 |
Prospective multicenter study |
ER+/− | Initial CHT recommendations based on Dutch Institute for Healthcare Improvement (CBO) guidelines |
Use of guidelines + prognosis signature + patients’ preferences led to an actual change of treatment for 19% of patients, with a 14% overall increase in adjuvant treatment (2% more CHT, 6% more HT, and 6% more CHT + HT) |
LN+/− Mean age: 48 years N = 427 |
||||
| ||||
Gevensleben (2010)40 |
Consecutive cohort |
ER+/− | Not reported | GEP testing showed 40% of patients were either over- or undertreated |
LN+/− N = 136/140 had clinical treatment recorded |
CHT, chemotherapy; ER, estrogen receptor; GEP, gene-expression profiling; HT, hormone therapy; LN, lymph node; NCCN, National Comprehensive Cancer Network; RS, recurrence score.
Results from conference abstract.