21-Gene Recurrence Score and Adjuvant Chemotherapy Decision for Breast Cancer Patients with Positive Lymph Nodes

Tong, Yiwei; Wu, Jiayi; Huang, Ou; He, Jianxing; Zhu, Li; Chen, Weiguo; Li, Yafen; Chen, Xiaosong; Shen, Kunwei

doi:10.1038/s41598-019-49644-6

Cited by 10 publications

(12 citation statements)

References 30 publications

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“…Regarding the optimized aCTC cut-off, >50% reduction (n = <50% reduction (n = 49) showed a median PFS of 6 (5-10) vs. 3 (3-5) months (p = 0.0085) and a OS of 24 (17-34) vs. 10 (7-16) months (p < 0.0001). Regarding the optimized iCTC+aCTC >66.7% reduction (n = 57) vs. <66.7% reduction (n = 51) showed a median PFS of 6 (5-10) vs. months (p = 0.0063) and a median OS of 24 [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] vs. 10 (7-15) months (p = 0.0025). The impact of the optimized cut-offs on OS and PFS is shown in Figure 3.…”

Section: Resultsmentioning

confidence: 99%

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Cut-Off Analysis of CTC Change under Systemic Therapy for Defining Early Therapy Response in Metastatic Breast Cancer

Deutsch

Feißt

et al. 2020

Cancers

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Detection of circulating tumor cells (CTC) can distinguish between aggressive and indolent metastatic disease in breast cancer patients and is thus considered an independent, negative prognostic factor. A clear decline in CTCs is observed in patients who respond to systemic therapy. Nevertheless, CTCs can decrease in patients experiencing disease progression during systemic therapy, too. This study aims to determine the differences between CTC decline in patients responding to therapy and those in whom disease is progressing. Therefore, CTC values were compared at the start and after one cycle of a new line of systemic therapy. In all, 108 initially CTC-positive patients (with ≥5 intact CTCs in 7.5 mL blood) were enrolled in this study and intact and apoptotic CTCs were measured via the CellSearch® system. A cut-off analysis was performed using Youden’s J statistics to differentiate between CTC change in the two groups. Here, 64 (59.3%) patients showed stable disease or partial response vs. 44 (40.7%) presenting disease progression. Median overall survival was 23 (range: 4–92) vs. 7 (2–43) months (p < 0.001). Median intact CTC count at enrollment was 15.0 (5–2760) vs. 30.5 (5–200000) cells (p = 0.39) and 2.5 (0–420) vs. 8.5 (0–15000) cells after one cycle of systemic therapy (p = 0.001). Median apoptotic CTC count at enrollment was 10.5 (0–1500) vs. 9 (0–800) cells (p = 0.475) and 1 (0–200) vs. 3 (0–250) cells after one cycle of systemic therapy (p = 0.01). A 50% reduction in baseline apoptotic CTC count represents the optimal cut-off to differentiate between therapy response and disease progression. An apoptotic CTC reduction of ≤10% is 74% specific for early disease progression.

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Section: Resultsmentioning

confidence: 99%

“…Many prognostic factors for MBC have been identified thus far [14,[28][29][30][31][32][33]. In a previous study we could show that a 25% therapy-induced reduction in both the number of aCTCs and iCTCs in the peripheral blood were associated with increased survival and progression-free survival (PFS) in the MBC setting [24].…”

Section: Discussionmentioning

confidence: 99%

Cut-Off Analysis of CTC Change under Systemic Therapy for Defining Early Therapy Response in Metastatic Breast Cancer

Deutsch

Feißt

et al. 2020

Cancers

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“…Over the past two decades, several gene expression signatures by microarray analysis have been developed in effort to predict prognosis and chemotherapy (CT) benefit ( 17 ). Among them, the 21-gene Recurrence Score (RS) assay was most widely applied and evaluated in clinical trials, which can predict both the benefit of adjuvant CT ( 18 ) and prognosis in HR-positive, human epidermal growth factor receptor-2 (HER2)-negative, node-negative patients ( 19 , 20 ). The 2019 National Comprehensive Cancer Network Clinical Practice Guideline ( 21 ) also suggested to spare selective low-risk patients from adjuvant CT, while to apply adjuvant CT in high-risk patients based on RS results according to TAILORx and NSABP B-20 trials ( 22 , 23 ).…”

Section: Introductionmentioning

confidence: 99%

Primary 21-Gene Recurrence Score and Disease Outcome in Loco-Regional and Distant Recurrent Breast Cancer Patients

Tong

Huang

et al. 2020

Front. Oncol.

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Background: The 21-gene recurrence score (RS) assay has been proven prognostic and predictive for hormone receptor-positive/HER2-negative, node-negative early breast cancer patients. However, whether primary 21-gene RS can predict prognosis in recurrent breast cancer patients remained unknown. Patients and Methods: Consecutive breast cancer patients operated in Comprehensive Breast Health Center, Shanghai Ruijin Hospital between January 2009 and December 2018 were retrospectively analyzed. Patients with available 21-gene RS result for the primary tumor and reporting disease recurrence during follow-up were included. Association of 21-gene RS and overall survival (OS), post-recurrence overall survival (PR-OS), post-recurrence progression-free survival (PR-PFS), and first-line systemic treatment after recurrence were compared among different groups. Results: A total of 74 recurrent patients were included, with 10, 27, 37 patients in the RS < 18, 18-30, and ≥ 31 groups, respectively. Recurrent patients with RS ≥ 31 were more likely to receive chemotherapy as their first-line treatment compared to those with RS < 31 (P = 0.025). Compared to those with RS < 31, patients with RS ≥ 31 had significantly worse OS (P = 0.025), worse PROS (P = 0.026), and a trend of inferior PR-PFS (P = 0.106). Multivariate analysis demonstrated that primary ER expression level

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“…Numerous studies have observed the utility of ODX on node positive patients, and this aspect continues to be discussed in literature 37‐43 . Additionally, the West German Study Group Plan B trial and RxPONDER investigate the relevance of ODX scores in clinically intermediate to high‐risk early stage breast cancer patients, including in node positive patients 38,41‐43,45,46 . We have hence included 16 node positive patients in the current study, but have also analyzed the node negative sub‐cohort separately.…”

Section: Discussionmentioning

confidence: 99%

“…[37][38][39][40][41][42][43] Additionally, the West German Study Group Plan B trial and RxPONDER investigate the relevance of ODX scores in clinically intermediate to high-risk early stage breast cancer patients, including in node positive patients. 38,[41][42][43]45,46 We have hence included 16 node positive patients in the current study, but have also analyzed the node negative sub-cohort separately. Also, all the node positive patients in the current cohort were prescribed ODX at least 5 years ago, and thus, we believe the inclusion of node positive patients in the current cohort is clinically relevant and of interest to practicing clinicians.…”

Section: Discussionmentioning

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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21-Gene Recurrence Score and Adjuvant Chemotherapy Decision for Breast Cancer Patients with Positive Lymph Nodes

Cited by 10 publications

References 30 publications

Cut-Off Analysis of CTC Change under Systemic Therapy for Defining Early Therapy Response in Metastatic Breast Cancer

Cut-Off Analysis of CTC Change under Systemic Therapy for Defining Early Therapy Response in Metastatic Breast Cancer

Primary 21-Gene Recurrence Score and Disease Outcome in Loco-Regional and Distant Recurrent Breast Cancer Patients

Comparison of breast cancer prognostic tests CanAssist Breast and Oncotype DX

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