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A population-based validation study of the DCIS Score predicting recurrence risk in individuals treated by breast-conserving surgery alone.

Rakovitch E, Nofech-Mozes S, Hanna W, Baehner FL, Saskin R, Butler SM, Tuck A, Sengupta S, Elavathil L, Jani PA, Bonin M, Chang MC, Robertson SJ, Slodkowska E, Fong C, Anderson JM, Jamshidian F, Miller DP, Cherbavaz DB, Shak S, Paszat L - Breast Cancer Res. Treat. (2015)

Bottom Line: Our objective was to confirm these results in a larger population-based cohort of individuals.Cox model was used to determine the relationship between independent covariates, the DS (hazard ratio (HR)/50 Cp units (U)) and LR.Final evaluable population includes 718 cases, of whom 571 had negative margins.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada, eileen.rakovitch@sunnybrook.ca.

ABSTRACT
Validated biomarkers are needed to improve risk assessment and treatment decision-making for women with ductal carcinoma in situ (DCIS) of the breast. The Oncotype DX DCIS Score (DS) was shown to predict the risk of local recurrence (LR) in individuals with low-risk DCIS treated by breast-conserving surgery (BCS) alone. Our objective was to confirm these results in a larger population-based cohort of individuals. We used an established population-based cohort of individuals diagnosed with DCIS treated with BCS alone from 1994 to 2003 with validation of treatment and outcomes. Central pathology assessment excluded cases with invasive cancer, DCIS < 2 mm or positive margins. Cox model was used to determine the relationship between independent covariates, the DS (hazard ratio (HR)/50 Cp units (U)) and LR. Tumor blocks were collected for 828 patients. Final evaluable population includes 718 cases, of whom 571 had negative margins. Median follow-up was 9.6 years. 100 cases developed LR following BCS alone (DCIS, N = 44; invasive, N = 57). In the primary pre-specified analysis, the DS was associated with any LR (DCIS or invasive) in ER+ patients (HR 2.26; P < 0.001) and in all patients regardless of ER status (HR 2.15; P < 0.001). DCIS Score provided independent information on LR risk beyond clinical and pathologic variables including size, age, grade, necrosis, multifocality, and subtype (adjusted HR 1.68; P = 0.02). DCIS was associated with invasive LR (HR 1.78; P = 0.04) and DCIS LR (HR 2.43; P = 0.005). The DCIS Score independently predicts and quantifies individualized recurrence risk in a population of patients with pure DCIS treated by BCS alone.

No MeSH data available.


Related in: MedlinePlus

Consolidated standards of reporting trials flow diagram for study numbers. DCIS ductal carcinoma in situ, GHI Genomic Health, Inc., BCS breast-conserving surgery
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Fig1: Consolidated standards of reporting trials flow diagram for study numbers. DCIS ductal carcinoma in situ, GHI Genomic Health, Inc., BCS breast-conserving surgery

Mentions: The population cohort includes 3320 individuals with pure DCIS (Fig. 1). There were 1658 cases treated by BCS alone (N = 1061 with negative margins). Median follow-up was 9.6 years. We obtained tissue blocks for 828 patients treated with BCS alone (50 % of provincial cohort) and for each case an optimal representative tissue block was sent for gene analysis. 110 cases were excluded: 10 with no evidence of DCIS, four with evidence of invasive carcinoma on further analysis, 68 cases with insufficient RNA and 28 cases with poor qPCR sample quality.Fig. 1


A population-based validation study of the DCIS Score predicting recurrence risk in individuals treated by breast-conserving surgery alone.

Rakovitch E, Nofech-Mozes S, Hanna W, Baehner FL, Saskin R, Butler SM, Tuck A, Sengupta S, Elavathil L, Jani PA, Bonin M, Chang MC, Robertson SJ, Slodkowska E, Fong C, Anderson JM, Jamshidian F, Miller DP, Cherbavaz DB, Shak S, Paszat L - Breast Cancer Res. Treat. (2015)

Consolidated standards of reporting trials flow diagram for study numbers. DCIS ductal carcinoma in situ, GHI Genomic Health, Inc., BCS breast-conserving surgery
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4491104&req=5

Fig1: Consolidated standards of reporting trials flow diagram for study numbers. DCIS ductal carcinoma in situ, GHI Genomic Health, Inc., BCS breast-conserving surgery
Mentions: The population cohort includes 3320 individuals with pure DCIS (Fig. 1). There were 1658 cases treated by BCS alone (N = 1061 with negative margins). Median follow-up was 9.6 years. We obtained tissue blocks for 828 patients treated with BCS alone (50 % of provincial cohort) and for each case an optimal representative tissue block was sent for gene analysis. 110 cases were excluded: 10 with no evidence of DCIS, four with evidence of invasive carcinoma on further analysis, 68 cases with insufficient RNA and 28 cases with poor qPCR sample quality.Fig. 1

Bottom Line: Our objective was to confirm these results in a larger population-based cohort of individuals.Cox model was used to determine the relationship between independent covariates, the DS (hazard ratio (HR)/50 Cp units (U)) and LR.Final evaluable population includes 718 cases, of whom 571 had negative margins.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada, eileen.rakovitch@sunnybrook.ca.

ABSTRACT
Validated biomarkers are needed to improve risk assessment and treatment decision-making for women with ductal carcinoma in situ (DCIS) of the breast. The Oncotype DX DCIS Score (DS) was shown to predict the risk of local recurrence (LR) in individuals with low-risk DCIS treated by breast-conserving surgery (BCS) alone. Our objective was to confirm these results in a larger population-based cohort of individuals. We used an established population-based cohort of individuals diagnosed with DCIS treated with BCS alone from 1994 to 2003 with validation of treatment and outcomes. Central pathology assessment excluded cases with invasive cancer, DCIS < 2 mm or positive margins. Cox model was used to determine the relationship between independent covariates, the DS (hazard ratio (HR)/50 Cp units (U)) and LR. Tumor blocks were collected for 828 patients. Final evaluable population includes 718 cases, of whom 571 had negative margins. Median follow-up was 9.6 years. 100 cases developed LR following BCS alone (DCIS, N = 44; invasive, N = 57). In the primary pre-specified analysis, the DS was associated with any LR (DCIS or invasive) in ER+ patients (HR 2.26; P < 0.001) and in all patients regardless of ER status (HR 2.15; P < 0.001). DCIS Score provided independent information on LR risk beyond clinical and pathologic variables including size, age, grade, necrosis, multifocality, and subtype (adjusted HR 1.68; P = 0.02). DCIS was associated with invasive LR (HR 1.78; P = 0.04) and DCIS LR (HR 2.43; P = 0.005). The DCIS Score independently predicts and quantifies individualized recurrence risk in a population of patients with pure DCIS treated by BCS alone.

No MeSH data available.


Related in: MedlinePlus