PREDICT Plus: development and validation of a prognostic model for early breast cancer that includes HER2

Wishart, Gordon; Bajdik, Chris; Dicks, Ed; Provenzano, Elena; Schmidt, Marjanka K.; Sherman, Mark E.; Greenberg, David; Green, A. R; Gelmon, Karen A.; Kosma, Veli‐Matti; Olson, Janet E.; Beckmann, Matthias W.; Winqvist, Robert; Cross, Simon S.; Severi, Gianluca; Huntsman, David G.; Pylkäs, Katri; Ellis, Ian O.; Nielsen, Torsten O.; Giles, Graham G.; Blomqvist, Carl; Fasching, Peter A.; Couch, Fergus J.; Rakha, Emad A.; Foulkes, William D.; Blows, Fiona M.; Bégin, Louis R.; Veer, Laura J. van’t; Southey, Melissa C.; Nevanlinna, Heli; Mannermaa, Arto; Cox, Angela; Cheang, Maggie C.U.; Baglietto, Laura; Caldas, Carlos; García-Closas, Montserrat; Pharoah, Paul D.P.

doi:10.1038/bjc.2012.338

Cited by 172 publications

(169 citation statements)

References 41 publications

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“…1 Tools that incorporate these features, such as Adjuvant! Online 2,3 and PREDICT Plus, 4 were created to assist in such decision making. However, these algorithms do not take into account the individual biologic characteristics of the patient's tumor.…”

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confidence: 99%

70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer

Cardoso

Veer

Bogaerts³

et al. 2016

N Engl J Med

1,566

1,386

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BACKGROUNDThe 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy. METHODSIn this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online). Women at low clinical and genomic risk did not receive chemotherapy, whereas those at high clinical and genomic risk did receive such therapy. In patients with discordant risk results, either the genomic risk or the clinical risk was used to determine the use of chemotherapy. The primary goal was to assess whether, among patients with high-risk clinical features and a low-risk gene-expression profile who did not receive chemotherapy, the lower boundary of the 95% confidence interval for the rate of 5-year survival without distant metastasis would be 92% (i.e., the noninferiority boundary) or higher. RESULTSA total of 1550 patients (23.2%) were deemed to be at high clinical risk and low genomic risk. At 5 years, the rate of survival without distant metastasis in this group was 94.7% (95% confidence interval, 92.5 to 96.2) among those not receiving chemotherapy. The absolute difference in this survival rate between these patients and those who received chemother apy was 1.5 percentage points, with the rate being lower without chemotherapy. Similar rates of survival without distant metastasis were reported in the subgroup of patients who had estrogen-receptor-positive, human epidermal growth factor receptor 2-negative, and either node-negative or node-positive disease. CONCLUSIONSAmong women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on the basis of the 70-gene signature led to a 5-year rate of survival without distant metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these findings, approximately 46% of women with breast cancer who are at high clinical risk might not require chemo-

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mentioning

confidence: 99%

70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer

Cardoso

Veer

Bogaerts³

et al. 2016

N Engl J Med

1,566

1,386

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“…The study population was 5694 breast cancer patients and was validated with another set of 5468 patients recorded in West Midlands Cancer Intelligence Unit (WMCIU) [117]. Wishart et al incorporated the prognostic effect of HER2 status to produce the new version; PREDICT+, using the cohort cases from British Columbia which was used to validate the original PREDICT [111,118]. It estimates the benefit of treatment from hormone treatment, chemotherapy and trastuzumab at 10-year time points.…”

Section: Predictmentioning

confidence: 99%

Molecular-Based Diagnostic, Prognostic and Predictive Tests in Breast Cancer

Muftah

Aleskandarany

Ellis

et al. 2015

Molecular Pathology Library

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“…Prognostic model which was available on the internet [8][9][10][11][12]. They used survival results from the Surveillance, Epidemiology and End Results (SEER) programme which had data on local treatment & prognostic factors.…”

Section: Prognostic Modelsmentioning

confidence: 99%

Medico-legal Aspects of Delay in Diagnosis of Breast Cancer

Fentiman¹

2017

Cancer Surg

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Delayed diagnosis of breast cancer forms a substantial part of medical litigation and may sometimes result from communication failure in the multidisciplinary team. Review of such cases may result in improved patient pathways as a result of lessons learned. There is evidence that delay may significantly worsen prognosis. For a claimant to successfully pursue a case it is necessary for the medical experts to confirm that both negligence and causation have occurred. Methods are available whereby likely tumour size at the time of negligence and likelihood of axillary nodal involvement can be estimated. There are now various prognostic models that can be used to estimate the impact of delay on prognosis but as a result of improvements in treatment many cases will not meet the criteria for causation.

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PREDICT Plus: development and validation of a prognostic model for early breast cancer that includes HER2

Cited by 172 publications

References 41 publications

70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer

70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer

Molecular-Based Diagnostic, Prognostic and Predictive Tests in Breast Cancer

Medico-legal Aspects of Delay in Diagnosis of Breast Cancer

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