Result card

  • TEC18: Are the reference values or cut-off points clearly established?
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Are the reference values or cut-off points clearly established?

Authors: Pseudo169 Pseudo169, Pseudo90 Pseudo90, Pseudo154 Pseudo154, Pseudo98 Pseudo98

Internal reviewers: Patricia Harrington, Michelle O'Neill, Leonor Varela

The manufacturers’ websites as well as the results from the basic search were used to develop this assessment element.

The results of the FEMTELLE uPA/PAI-1 assay are reported as absolute protein concentrations of uPA and PAI-1 in the patient’s tumour tissue. The uPA and PAI-1 values refer to the respective total protein concentrations {16}. The results help to identify those node-negative patients who have a low risk of disease recurrence and those patients who have a high risk of disease recurrence after surgery.

Cut off values are:

  • uPA = 3 ng/mg total protein
  • PAI-1 = 14 ng/mg total protein

Patients with low uPA and low PAI-1 values (below the cut off) are predicted to have a low risk of disease recurrence. The risk value, intended as percentage of recurrence within a timeframe without further adjuvant therapy, is not stated. Patients with high uPA and/or high PAI-1 values (above the cut off) are predicted to have an increased risk of disease recurrence {20}. The risk value, intended as percentage of recurrence within a timeframe without further adjuvant therapy, is not stated.

The results of the MammaPrint test are used for risk-group assignment on the basis of a dichotomised value only (i.e., high or low risk). A tumour is defined as having a low-risk gene signature if the cosine correlation coefficient for the expression of the 70-gene profile in that tumour with the previously established classifier is above 0.4, which is the cut-off point used in the original study by van’t Veer {9} {21}. A “low risk” result means that a patient has a 10% chance that her cancer will recur within 10 years without additional adjuvant treatment, either hormonal therapy or chemotherapy. A “high risk” result means that a patient has a 29% chance that her cancer will recur within 10 years without any additional adjuvant treatment, either hormonal therapy or chemotherapy {9}.

The results of the Oncotype DX are used to calculate the 10-year risk of distant recurrence as a continuous function of the RS. Three risk groups have been defined: low risk (RS ≤17), intermediate risk (18 ≤RS ≤30), and high risk (RS ≥ 31) {9}.

Critical
Completely
Pseudo169 P et al. Result Card TEC18 In: Pseudo169 P et al. Description and technical characteristics of technology In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 7 February 2023]. Available from: http://corehta.info/ViewCover.aspx?id=113

References