P196 Results from a prospective clinical study on the impact of Oncotype DX on adjuvant treatment decision and risk classification by Nottingham prognostic index (NPI) and recurrence score (RS)

Holt, S.D.H.; Bertelli, G.; Pudney, Delia; Rolles, Martin; Moe, Maung; Brinkworth, Elaine; Wheelan, Sarah J.; Khawaja, Saira; Pitcher, Sage; Sharaiha, Yousef

doi:10.1016/s0960-9776(11)70137-0

Cited by 7 publications

(22 citation statements)

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“…Only three studies stated that the design was prospective. [76][77][78] The majority of participants analysed in the studies were ER+, LN-, and the mean age was around 50-60 years. Most studies included a small number of participants (range 25-367), although three analysed relatively large cohorts [Dowsett et al 79 (n = 1231), Mamounas et al 80 and Tang et al 81 (both n = 1674 -analyses of the B14 and B20 trials)].…”

Section: Description Of Included Studiesmentioning

confidence: 99%

“…The methodological quality of the 12 included studies [76][77][78][79][80][81][82][83][84][85][86][87][88] is summarised in Figure 3 (further details are provided in Appendix 7). Generally, only three studies (four citations) performed well, receiving a positive assessment for at least 17 out of 21 methodological quality items.…”

Section: Quality Of Included Studies: Oncotypedxmentioning

confidence: 99%

“…In a conference poster Holt et al 78 reported a study investigating the impact of RS on clinical decision-making in Wales. The 106 patients included in the study were ER+ and either LN-or N1.…”

Section: Clinical Utilitymentioning

confidence: 99%

“…Four new studies [76][77][78]82 presented further evidence on the impact of OncotypeDX on clinical decision-making. These indicate that the use of OncotypeDX leads to changes in decision-making for between 31.5% and 38% of patients.…”

Section: Clinical Validity (Prognostic Ability) Of Oncotypedxmentioning

confidence: 99%

“…However, only one of these studies was UK based, and limitations in relation to study design were identified for this study. Specifically, these data were based on a small sample size (n = 106) and were derived from a conference poster, 78 which was lacking the detail necessary to make judgements about the quality of the evidence. Two new studies (with three related citations 81,83,86 ) provided evidence supporting the case that OncotypeDX predicts chemotherapy benefit.…”

Section: Clinical Validity (Prognostic Ability) Of Oncotypedxmentioning

confidence: 99%

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Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis

Ward

Scope²,

Rafia³

et al. 2013

Health Technol Assess

126

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Section: Description Of Included Studiesmentioning

confidence: 99%

Section: Quality Of Included Studies: Oncotypedxmentioning

confidence: 99%

Section: Clinical Utilitymentioning

confidence: 99%

Section: Clinical Validity (Prognostic Ability) Of Oncotypedxmentioning

confidence: 99%

Section: Clinical Validity (Prognostic Ability) Of Oncotypedxmentioning

confidence: 99%

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Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis

Ward

Scope²,

Rafia³

et al. 2013

Health Technol Assess

126

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A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the UK

et al. 2013

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Background:Tumour gene expression analysis is useful in predicting adjuvant chemotherapy benefit in early breast cancer patients. This study aims to examine the implications of routine Oncotype DX testing in the UK.Methods:Women with oestrogen receptor positive (ER+), pNO or pN1mi breast cancer were assessed for adjuvant chemotherapy and subsequently offered Oncotype DX testing, with changes in chemotherapy decisions recorded. A subset of patients completed questionnaires about their uncertainties regarding chemotherapy decisions pre- and post-testing. All patients were asked to complete a diary of medical interactions over the next 6 months, from which economic data were extracted to model the cost-effectiveness of testing.Results:Oncotype DX testing resulted in changes in chemotherapy decisions in 38 of 142 (26.8%) women, with 26 of 57 (45.6%) spared chemotherapy and 12 of 85 (14.1%) requiring chemotherapy when not initially recommended (9.9% reduction overall). Decision conflict analysis showed that Oncotype DX testing increased patients' confidence in treatment decision making. Economic analysis showed that routine Oncotype DX testing costs £6232 per quality-adjusted life year gained.Conclusion:Oncotype DX decreased chemotherapy use and increased confidence in treatment decision making in patients with ER+ early-stage breast cancer. Based on these findings, Oncotype DX is cost-effective in the UK setting.

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Clinical utility of gene-expression profiling in women with early breast cancer: an overview of systematic reviews

Marrone

Stewart

Dotson

2015

Genetics in Medicine

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Purpose This overview systematically evaluates the clinical utility of using Oncotype DX and MammaPrint gene-expression profiling tests to direct treatment decisions in women with breast cancer. The findings are intended to inform an updated recommendation from the Evaluation of Genomic Applications in Practice and Prevention Working Group. Methods Evidence reported in systematic reviews evaluating the clinical utility of Oncotype DX and MammaPrint, as well as the ability to predict treatment outcomes, change in treatment decisions, and cost-effectiveness, was qualitatively synthesized. Results Five systematic reviews found no direct evidence of clinical utility for either test. Indirect evidence showed Oncotype DX was able to predict treatment effects of adjuvant chemotherapy, whereas no evidence of predictive value was found for MammaPrint. Both tests influenced a change in treatment recommendations in 21 to 74% of participants. The cost-effectiveness of Oncotype DX varied with the alternative compared. For MammaPrint, lack of evidence of the predictive value led to uncertainty in the cost-effectiveness. Conclusion No studies were identified that provided direct evidence that using gene-expression profiling tests to direct treatment decisions improved outcomes in women with breast cancer. Three ongoing studies may provide direct evidence for determining the clinical utility of gene-expression profiling testing.

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P196 Results from a prospective clinical study on the impact of Oncotype DX on adjuvant treatment decision and risk classification by Nottingham prognostic index (NPI) and recurrence score (RS)

Cited by 7 publications

References 0 publications

Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis

Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis

A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the UK

Clinical utility of gene-expression profiling in women with early breast cancer: an overview of systematic reviews

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