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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

Kaplan–Meier estimates of the 10-year risk of local recurrence by DCIS Score Group (a) and Cox model estimates of 10-year local recurrence risk according to the continuous DCIS Score (b), in patients treated with BCS alone and negative margins. The number of patients at risk is included for each pre-specified risk group based on the DCIS Score of low (<39), intermediate (39–54) and high (>55). The risk based on continuous DCIS Score assumes a monotone incremental risk as DCIS Score increases. Although formal statistical tests for non-linearity were negative, the Kaplan–Meier estimates suggest that a non-linear effect is plausible
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Fig2: Kaplan–Meier estimates of the 10-year risk of local recurrence by DCIS Score Group (a) and Cox model estimates of 10-year local recurrence risk according to the continuous DCIS Score (b), in patients treated with BCS alone and negative margins. The number of patients at risk is included for each pre-specified risk group based on the DCIS Score of low (<39), intermediate (39–54) and high (>55). The risk based on continuous DCIS Score assumes a monotone incremental risk as DCIS Score increases. Although formal statistical tests for non-linearity were negative, the Kaplan–Meier estimates suggest that a non-linear effect is plausible

Mentions: In the pre-specified primary analysis, the DCIS Score was significantly associated with the risk of LR in patients with ER-positive DCIS treated with BCS alone with negative margins (hazard ratio [HR] 2.26; 95 % CI 1.41, 3.59; P < 0.001; Table 2). The DCIS Score was also associated with LR in all patients treated by BCS alone with negative margins irrespective of ER status (HR 2.15; 95 % CI 1.43, 3.22; P < 0.001; Table 2). Since 94.7 % of patients treated with BCS alone had ER-positive DCIS (by RT-PCR), data for all cases regardless of ER status is presented (Fig. 2, panels a, b). The DCIS Score was also significantly associated with invasive LR (HR 1.78; 95 % CI 1.03, 3.05; P = 0.04) and DCIS LR (HR 2.43, 95 % CI 1.31, 4.42; P = 0.005) (Table 2). On univariable analysis, other factors associated with the development of LR include the presence of multifocality, tumor size, subtype, nuclear grade, and comedo necrosis (Supplemental Table 2).Table 2


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)

Kaplan–Meier estimates of the 10-year risk of local recurrence by DCIS Score Group (a) and Cox model estimates of 10-year local recurrence risk according to the continuous DCIS Score (b), in patients treated with BCS alone and negative margins. The number of patients at risk is included for each pre-specified risk group based on the DCIS Score of low (<39), intermediate (39–54) and high (>55). The risk based on continuous DCIS Score assumes a monotone incremental risk as DCIS Score increases. Although formal statistical tests for non-linearity were negative, the Kaplan–Meier estimates suggest that a non-linear effect is plausible
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig2: Kaplan–Meier estimates of the 10-year risk of local recurrence by DCIS Score Group (a) and Cox model estimates of 10-year local recurrence risk according to the continuous DCIS Score (b), in patients treated with BCS alone and negative margins. The number of patients at risk is included for each pre-specified risk group based on the DCIS Score of low (<39), intermediate (39–54) and high (>55). The risk based on continuous DCIS Score assumes a monotone incremental risk as DCIS Score increases. Although formal statistical tests for non-linearity were negative, the Kaplan–Meier estimates suggest that a non-linear effect is plausible
Mentions: In the pre-specified primary analysis, the DCIS Score was significantly associated with the risk of LR in patients with ER-positive DCIS treated with BCS alone with negative margins (hazard ratio [HR] 2.26; 95 % CI 1.41, 3.59; P < 0.001; Table 2). The DCIS Score was also associated with LR in all patients treated by BCS alone with negative margins irrespective of ER status (HR 2.15; 95 % CI 1.43, 3.22; P < 0.001; Table 2). Since 94.7 % of patients treated with BCS alone had ER-positive DCIS (by RT-PCR), data for all cases regardless of ER status is presented (Fig. 2, panels a, b). The DCIS Score was also significantly associated with invasive LR (HR 1.78; 95 % CI 1.03, 3.05; P = 0.04) and DCIS LR (HR 2.43, 95 % CI 1.31, 4.42; P = 0.005) (Table 2). On univariable analysis, other factors associated with the development of LR include the presence of multifocality, tumor size, subtype, nuclear grade, and comedo necrosis (Supplemental Table 2).Table 2

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