Table 2Successful assays, Oncotype DX™

Study, yearProtocolMeasureSuccessTumor < 5%Poor RNAPathological reviewRT-PCRLow reference genesClinically ineligible
Chang, 200755StandardFFPE80/97 (82.4%)16 /97 (16.5%)1/80 (1.2%)
Cobleigh, 200547StandardFFPE78/85 (91.7%)7 (8.2%)1*
Esteva, 200548StandardFFPE149/220 (67.7%)42/220 (19.0%)*4/220 (1.8%)3 /220 (1.3%)22/220 (10%)
Gianni, 200549StandardFFPE89/95 (93.7%)2 patients (2.1%)4 patients (4.2%);
Habel, 200650StandardFFPE865/79019 (7.9%)59§1%
Mina, 200651StandardFFPE45/57 (78.9%)3/57 (5.3%) (< 20%)9/57 (15.8%)
Oratz, in press56StandardFFPE72 /74 (97.3%)2 /74 (2.7%)
Paik, 200428StandardFFPE668/675 (98.9%)675/754 (89.5%)
Paik, 200653StandardFFPE651/670 (97.2%)
*

Clinically Ineligible (Stage IV)

Studies performed according to Oncotype DX protocols, but not performed at Genomic Health

It is not clear what the total number was, since it was not reported

§

59 tumors underwent macro-dissection; it is not clear whether they were used in the subsequent analyses

Out of the 70 eligible patients 57 were analyzed (No consent: 3 patients; No specimen available: 10 patients)

The total of 754 (79+675) patients was computed and not clearly reported in the study

FFPE = formalin fixed paraffin embedded; RNA= ribonucleic acid; RT-PCR= reverse transcriptase polymerase chain reaction.

From: 3, Results

Cover of Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes
Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes.
Evidence Reports/Technology Assessments, No. 160.
Marchionni L, Wilson RF, Marinopoulos SS, et al.

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