Development of a Novel Proteomic Risk-Classifier for Prognostication of Patients With Early-Stage Hormone Receptor–Positive Breast Cancer

Ramkumar, Charusheila; Buturović, Ljubomir; Malpani, Sukriti; Attuluri, Arun Kumar; Basavaraj, Chetana; Prakash, Chandra; Madhav, Lekshmi; Doval, Dinesh Chandra; Mehta, Anurag; Bakre, Manjiri M.

doi:10.1177/1177271918789100

Cited by 21 publications

(66 citation statements)

References 30 publications

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“…Testing was performed on FFPE blocks. The CAB was performed as described previously [14,15]. Briefly, immunohistochemistry was performed for the 5 CAB biomarkers at the CAP-accredited central reference OncoStem lab at Bangalore, India.…”

Section: Canassist Breast Testingmentioning

confidence: 99%

“…The IHC grading information was incorporated along with the 3 clinical parameters (tumor size, tumor grade, and nodal status) as obtained from the treating hospitals to calculate CAB risk scores on a scale of 0-100. A cutoff of 15.5 is used to classify patients into low risk (score ≤ 15.5) or high risk (score > 15.5) for distant recurrence [14].…”

Section: Canassist Breast Testingmentioning

confidence: 99%

“…Some of the commercially available prognostic tests include Oncotype DX (ODX) [9], MammaPrint [10], Prosigna [11], EndoPredict [12], Breast Cancer Index (BCI) [13], and CanAssist Breast (CAB) [14]. All these tests query different gene/protein markers and use different testing methodologies (Table 1) but have been shown to predict risk of recurrence with more than 95% accuracy.…”

Section: Introductionmentioning

confidence: 99%

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CanAssist Breast Impacting Clinical Treatment Decisions in Early-Stage HR+ Breast Cancer Patients: Indian Scenario

Sankaran¹,

Dikshit²,

Sv³

et al. 2019

Indian J Surg Oncol

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CanAssist Breast (CAB) has thus far been validated on a retrospective cohort of 1123 patients who are mostly Indians. Distant metastasis-free survival (DMFS) of more than 95% was observed with significant separation (P < 0.0001) between low-risk and high-risk groups. In this study, we demonstrate the usefulness of CAB in guiding physicians to assess risk of cancer recurrence and to make informed treatment decisions for patients. Of more than 500 patients who have undergone CAB test, detailed analysis of 455 patients who were treated based on CAB-based risk predictions by more than 140 doctors across India is presented here. Majority of patients tested had node negative, T2, and grade 2 disease. Age and luminal subtypes did not affect the performance of CAB. On comparison with Adjuvant! Online (AOL), CAB categorized twice the number of patients into low risk indicating potential of overtreatment by AOL-based risk categorization. We assessed the impact of CAB testing on treatment decisions for 254 patients and observed that 92% low-risk patients were not given chemotherapy. Overall, we observed that 88% patients were either given or not given chemotherapy based on whether they were stratified as high risk or low risk for distant recurrence respectively. Based on these results, we conclude that CAB has been accepted by physicians to make treatment planning and provides a cost-effective alternative to other similar multigene prognostic tests currently available.

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Section: Canassist Breast Testingmentioning

confidence: 99%

Section: Canassist Breast Testingmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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CanAssist Breast Impacting Clinical Treatment Decisions in Early-Stage HR+ Breast Cancer Patients: Indian Scenario

Sankaran¹,

Dikshit²,

Sv³

et al. 2019

Indian J Surg Oncol

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“…A number of available prognostic tests predict risk of recurrence for early stage HR+ breast cancer based on multigene expression (Oncotype DX [ODX], MammaPrint, Breast Cancer Index), or a combination of multigene expression and clinical parameters (Prosigna, EndoPredict‐EPclin, CanAssist Breast [CAB]) 12‐19 …”

Section: Introductionmentioning

confidence: 99%

“…CanAssist Breast combines the immunohistochemistry (IHC) data of five biomarkers with three clinical parameters (tumor size, grade, and node status) with a machine learning‐based statistical algorithm to calculate a risk score. CAB thus stratifies early stage HR+ HER2− breast cancer patients into low‐risk or high‐risk for distant recurrence 17‐19 . CAB has been retrospectively validated in a mixed cohort of Asian and Caucasian patients and is being used by clinicians in India 19,26 …”

Section: Introductionmentioning

confidence: 99%

Comparison of breast cancer prognostic tests CanAssist Breast and Oncotype DX

Sengupta¹,

Gunda²,

Malpani³

et al. 2020

Cancer Medicine

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Background CanAssist Breast (CAB) is a prognostic test for early stage hormone receptor‐positive (HR+), human epidermal growth factor receptor 2 negative (HER2−) breast cancer patients, validated on Indian and Caucasian patients. The 21‐gene signature Oncotype DX (ODX) is the most widely used commercially available breast cancer prognostic test. In the current study, risk stratification of CAB is compared with that done with ODX along with the respective outcomes of these patients. Methods A cohort of 109 early stage breast cancer patients who had previously taken the ODX test were retested with CAB, and the results respectively compared with old cut‐offs of ODX as well as cut‐offs suggested by TAILORx, a prospective randomized trial of ODX. Distant metastasis‐free survival after 5 years was taken as the end point. Results CanAssist Breast stratified 83.5% of the cohort into low‐risk and 16.5% into high‐risk. With the TAILORx cut‐offs, ODX stratified the cohort into 89.9% low‐risk and 10.1% into high‐risk. The low, intermediate, and high‐risk groups with ODX old cut‐offs were 62.4%, 31.2%, and 6.4%, respectively. The overall concordance of CAB with ODX using both cut‐offs is 75%‐76%, with ~82%‐83% concordance in the low‐risk category of these tests. The NPV of the low‐risk category of CAB was 93.4%, and of ODX with TAILORx cut‐offs was 91.8% and 89.7% with old cut‐offs. Conclusions Compared to the concordance reported for other tests, CAB shows high concordance with ODX, and in addition shows comparable performance in the patient outcomes in this cohort. CAB is thus an excellent and cost‐effective alternative to ODX.

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Clinical validation of an immunohistochemistry‐based CanAssist‐Breast test for distant recurrence prediction in hormone receptor‐positive breast cancer patients

Bakre¹,

Ramkumar²,

Attuluri³

et al. 2019

Cancer Medicine

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CanAssist‐Breast (CAB) is an immunohistochemistry (IHC)‐based prognostic test for early‐stage Hormone Receptor (HR+)‐positive breast cancer patients. CAB uses a Support Vector Machine (SVM) trained algorithm which utilizes expression levels of five biomarkers (CD44, ABCC4, ABCC11, N‐Cadherin, and Pan‐Cadherin) and three clinical parameters such as tumor size, grade, and node status as inputs to generate a risk score and categorizes patients as low‐ or high‐risk for distant recurrence within 5 years of diagnosis. In this study, we present clinical validation of CAB. CAB was validated using a retrospective cohort of 857 patients. All patients were treated either with endocrine therapy or chemoendocrine therapy. Risk categorization by CAB was analyzed by calculating Distant Metastasis‐Free Survival (DMFS) and recurrence rates using Kaplan‐Meier survival curves. Multivariate analysis was performed to calculate Hazard ratios (HR) for CAB high‐risk vs low‐risk patients. The results showed that Distant Metastasis‐Free Survival (DMFS) was significantly different (P‐0.002) between low‐ (DMFS: 95%) and high‐risk (DMFS: 80%) categories in the endocrine therapy treated alone subgroup (n = 195) as well as in the total cohort (n = 857, low‐risk DMFS: 95%, high‐risk DMFS: 84%, P < 0.0001). In addition, the segregation of the risk categories was significant (P = 0.0005) in node‐positive patients, with a difference in DMFS of 12%. In multivariate analysis, CAB risk score was the most significant predictor of distant recurrence with hazard ratio of 3.2048 (P < 0.0001). CAB stratified patients into discrete risk categories with high statistical significance compared to Ki‐67 and IHC4 score‐based stratification. CAB stratified a higher percentage of the cohort (82%) as low‐risk than IHC4 score (41.6%) and could re‐stratify >74% of high Ki‐67 and IHC4 score intermediate‐risk zone patients into low‐risk category. Overall the data suggest that CAB can effectively predict risk of distant recurrence with clear dichotomous high‐ or low‐risk categorization.

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Development of a Novel Proteomic Risk-Classifier for Prognostication of Patients With Early-Stage Hormone Receptor–Positive Breast Cancer

Cited by 21 publications

References 30 publications

CanAssist Breast Impacting Clinical Treatment Decisions in Early-Stage HR+ Breast Cancer Patients: Indian Scenario

CanAssist Breast Impacting Clinical Treatment Decisions in Early-Stage HR+ Breast Cancer Patients: Indian Scenario

Comparison of breast cancer prognostic tests CanAssist Breast and Oncotype DX

Clinical validation of an immunohistochemistry‐based CanAssist‐Breast test for distant recurrence prediction in hormone receptor‐positive breast cancer patients

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