Analysis of factors related to adjuvant chemotherapy decision in early breast cancer patients with intermediate recurrence score.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12032-e12032
Author(s):  
Feilin Qu ◽  
Jiayi Wu ◽  
Xiaosong Chen ◽  
Ou Huang ◽  
Jianrong He ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Early Breast Cancer ◽  
Predictive Factors ◽  
Molecular Subtype ◽  
Recurrence Score ◽  
Tumor Grade ◽  
Clinical Risk ◽  
Gene Assay ◽  
High Clinical Risk

e12032 Background: The 21-gene Recurrence Score (RS) assay has been routinely used to guide systemic chemotherapy in patients (pts) with estrogen receptor positive, node-negative early breast cancer (EBC). However, there has been less clarity in recommendation of adjuvant chemotherapy (ACT) in pts with intermediate RS (IRS). According to the definitions of IRS in retrospective NSABP B14, B20 trials and prospective validation of TAILORx trial, we adopted the broaden cut-offs of 11-30 in our study. We sought to analyze the factors related to ACT decision in this subset of pts. Additionally, the role of Adjuvant!Online (AOL) was evaluated in ACT decision. Methods: A cohort of 564 pts with RS of 11-30 was retrospectively analyzed from January 2014 to October 2016 in Ruijin Hospital Shanghai Jiaotong University School of Medicine. The Oncotype DX RS, a RT-PCR 21-gene assay, was performed on RNA extracted from formalin-fixed paraffin-embedded tissue. The AOL was used to determine pts’ clinical risk. Predictive factors of chemotherapy usage in different clinical risk catogories were also assessed. Results: 267 (47.3%) pts received chemotherapy. Age, tumor grade, pathologic type, pT, pN, molecular subtype and RS were significantly correlated with ACT decision ( p <0.05). These factors were all independent predictors of ACT usage ( p<0.05) in mutivariable model. AOL was successfully measured in 504 (89.4%) pts, of whom 279 (49.5%) were at low clinical risk and 225 (39.9%) had high clinical risk. The distribution of RS correlated significantly with AOL clinical risk catogories. The predictive factors of ACT administration in high and low clinical risk subgroups were highly consistent with the overall population, except pT in high clinical risk pts. Discordances between clinical risk and ACT decision were found in 158 pts (28.0%), probably due to different age, molecular subtype and RS. Conclusions: Age, tumor grade, pathologic type, pT, pN, molecular subtype and RS were independent predictors of ACT administration in EBC pts with IRS. AOL should not be used alone to aid chemotherapy decision in this subset of pts.

scholarly journals Recommendations from the European Commission Initiative on Breast Cancer for multigene testing to guide the use of adjuvant chemotherapy in patients with early breast cancer, hormone receptor positive, HER-2 negative

2021 ◽  
Author(s):  
Paolo Giorgi Rossi ◽  
◽  
Annette Lebeau ◽  
Carlos Canelo-Aybar ◽  
Zuleika Saz-Parkinson ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
European Commission ◽  
Early Breast Cancer ◽  
Hormone Receptor ◽  
Recurrence Score ◽  
Risk Of Recurrence ◽  
Clinical Risk ◽  
Hormone Receptor Positive ◽  
Guidelines Development

Abstract Background Predicting the risk of recurrence and response to chemotherapy in women with early breast cancer is crucial to optimise adjuvant treatment. Despite the common practice of using multigene tests to predict recurrence, existing recommendations are inconsistent. Our aim was to formulate healthcare recommendations for the question “Should multigene tests be used in women who have early invasive breast cancer, hormone receptor-positive, HER2-negative, to guide the use of adjuvant chemotherapy?” Methods The European Commission Initiative on Breast Cancer (ECIBC) Guidelines Development Group (GDG), a multidisciplinary guideline panel including experts and three patients, developed recommendations informed by systematic reviews of the evidence. Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision frameworks were used. Four multigene tests were evaluated: the 21-gene recurrence score (21-RS), the 70-gene signature (70-GS), the PAM50 risk of recurrence score (PAM50-RORS), and the 12-gene molecular score (12-MS). Results Five studies (2 marker-based design RCTs, two treatment interaction design RCTs and 1 pooled individual data analysis from observational studies) were included; no eligible studies on PAM50-RORS or 12-MS were identified and the GDG did not formulate recommendations for these tests. Conclusions The ECIBC GDG suggests the use of the 21-RS for lymph node-negative women (conditional recommendation, very low certainty of evidence), recognising that benefits are probably larger in women at high risk of recurrence based on clinical characteristics. The ECIBC GDG suggests the use of the 70-GS for women at high clinical risk (conditional recommendation, low certainty of evidence), and recommends not using 70-GS in women at low clinical risk (strong recommendation, low certainty of evidence).

Prospective WSG phase III PlanB trial: Final analysis of adjuvant 4xEC→4x doc vs. 6x docetaxel/cyclophosphamide in patients with high clinical risk and intermediate-to-high genomic risk HER2-negative, early breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 504-504 ◽  
Author(s):  
Nadia Harbeck ◽  
Oleg Gluz ◽  
Michael R. Clemens ◽  
Wolfram Malter ◽  
Toralf Reimer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Breast Cancer ◽  
Triple Negative ◽  
Recurrence Score ◽  
Final Analysis ◽  
Clinical Risk ◽  
Central Pathology ◽  
High Clinical Risk

504 Background: Optimal chemotherapy in HER2-negative, particularly HR-positive, early breast cancer (EBC), especially the survival impact of anthracyclines, is still a matter of debate. Retrospective analyses saw most benefit of 6xCEF vs. 6xCMF in HER2+ EBC. Prospective trials have shown conflicting results; no predictive molecular factors have been validated so far, particularly for HR+ EBC. The WSG PlanB trial is the first trial that randomized only patients with high clinical risk or with Recurrence Score >11 in the HR+/HER2- subgroup (pN0-1). Patients with RS<11 (pN0-1) had an excellent prognosis (five-year DFS of 94%) with endocrine therapy alone (Gluz et al. ASCO 2016). Methods: The WSG PlanB trial was originally planned as a non-inferiority study for comparison of 6 cycles of anthracycline-free TC (Arm A) vs. standard anthracycline-taxane based chemotherapy (4xEC→4xDoc) (Arm B) in patients with high-risk pN0 (T2-4, G2-3, <35 years, or high uPA/PAI-1) or pN+ HER2- EBC. Following an early amendment, Oncotype DX was performed in all HR+ tumors, and omission of chemotherapy (CT) was recommended in RS≤11 HR+ pN0-1 disease. Primary endpoint was DFS, defined as time to any recurrence, secondary cancer or death. Final analysis for the CT randomization was planned after completed 5-year follow-up in all patients. Results: From 2009 to 2011, PlanB enrolled 3198 patients (n=3073 with central pathology review). In 348 patients (15.3%), CT was omitted based on RS≤11. 2449 patients were randomized to 6xTC (n=1222) and 4xEC→4xDoc (n=1227). Within this cohort, 41% were pN+, 42% had G3 tumors and 18% HR-negative tumors by central pathology. After median follow-up of 61 months, very similar five-year DFS of 89.9% [88.1%-91.7%] vs. 90.2% [88.4%-92.0%] and five-year OS of 94.7% [93.4%-96.1%] vs. 94.6% [93.2%-96.0%] were observed in Arms A vs. B. Five treatment-related deaths were observed in Arm A (TC) vs. one in Arm B (EC-Doc) (0.4% vs. 0.1%), despite a trend to more SAE’s in Arm B vs. Arm A (n=397 vs. 358). Although recurrence score is a strong prognostic factor, it was not predictive for anthracycline efficacy; no efficacy differences between the study arms were observed in (locally) triple-negative patients or in those with >4 involved lymph nodes, despite the prognostic impact of these factors. Conclusion: In the WSG PlanB trial, patients with early HER2-negative BC seem to be sufficiently treated by six cycles of docetaxel/cyclophosphamide compared to four cycles of EC followed by four cycles of docetaxel -- no efficacy differences are evident in high-risk subgroups defined by triple-negative status, nodal status, or high Recurrence Score. Further prospective studies are urgently needed before final conclusions for impact of anthracyclines in HER2-negative BC can be drawn. Clinical trial information: NCT01049425.

Tumor grade, Ki 67%, and relantionship with the 21-gene recurrence score assay in early breast cancer tumors.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e11540-e11540 ◽  
Author(s):  
Ioana Bonta ◽  
Dacian Bonta ◽  
Rita A. Blanchard
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Recurrence Score ◽  
Tumor Grade ◽  
Ki 67

SEER study of breast cancer specific mortality (BCSM) in patients with lobular tumors treated based on recurrence score results.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 11568-11568
Author(s):  
Frederick L. Baehner ◽  
Steven Shak ◽  
Dave P. Miller ◽  
Valentina I. Petkov
Keyword(s):  
Breast Cancer ◽  
Tumor Size ◽  
Multivariable Analysis ◽  
Recurrence Score ◽  
Tumor Grade ◽  
Nodal Status ◽  
Large Sample Size ◽  
Lobular Breast Cancer ◽  
Gene Assay ◽  
Actuarial Methods

11568 Background: Linking the 21-gene assay RS result to the SEER Registries demonstrated very low 5-y BCSM with low RS and high 5-y BCSM with high RS across subgroups, such as nodal status, age, tumor size and grade (npj Breast Cancer 2016). Given the large sample size and interest in outcomes as a function of tumor characteristics, we characterized the relationship between RS results and BCSM in patients reported by SEER with lobular morphology. Methods: Patients with RS and lobular morphology based on the registry ICD-O-3 code 8520 were eligible if node negative (N0) or node positive up to 3 positive nodes (N+mic,1-3), HR+, HER2- negative, no prior malignancy, and diagnosed between Jan 2004 and Dec 2012. No information in SEER is available regarding lobulars, ie., trabecular, alveolar, solid and pleomorphic. 5-y BCSM was estimated using actuarial methods. Results: There were 6,075 eligible patients reported with lobular morphology (11% of cases). Median age was 59 years; 88%/12% were N0/N+; 31%/62%/7% grade 1/2/3; 61%/39% ≤2 cm/>2 cm. Median follow-up was 44 months. A minority (8%) had RS >25. Chemotherapy (CT) use and BCSM increased with increasing RS. In multivariable analysis in N0 disease, continuous RS result and tumor size predicted BCSM (p=0.003 and p=0.04, respectively), whereas age and tumor grade were non-significant. In multivariable analysis in N+ disease, continuous RS result alone predicted BCSM (p=0.002). Conclusions: In these analyses the prognosis of patients with lobular breast cancer treated based on RS results depends on both nodal status and the RS result. The 5-y BCSM for lobular breast cancer is excellent with RS of 25 or less, and increases for RS >25. [Table: see text]

Relationship of pathological features and a 21 gene expression assay in young women with early breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12050-e12050
Author(s):  
Martin Boniface Gitobu Mutonga ◽  
Sedona Speedy ◽  
Regina Uthe ◽  
Kelly Kindy ◽  
Aisha Brownlee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Gene Expression ◽  
Adjuvant Chemotherapy ◽  
Older Women ◽  
Older Patients ◽  
Recurrence Score ◽  
Pathological Feature ◽  
Pathological Features ◽  
Gene Expression Assay ◽  
Gene Assay

e12050 Background: There is emerging evidence that a 21 gene expression assay recurrence score (RS) is prognostic independent of age. In practice, pathological markers may influence decision to recommend adjuvant chemotherapy. Methods: The primary objective of this study is to investigate the relationship between the RS and pathological markers between younger (29-49) and older (50-79) women with early stage ER+ breast cancer. Pathological markers investigated included the progesterone receptor (PR), grade, Ki-67, and P53. Patients who underwent 21 gene assay testing between 2002 through 2012 were sequantially identified. Data was extracted via the institutional tumor registry or chart reviewing. For each pathological feature, mean RS was compared between younger and older patients by t-tests. Trends in chemotherapy recommendation were assessed between younger and older patients within each RS risk category (≤10, 11-25, ≥26). Results: Between 2002 and 2012, 344 eligible patients were identified. 133 were ≤49 years of age, and 211 ≥50. There was no difference in distribution of RS across age (R2=3x10-4). Between younger and older patients, there was no difference in mean RS for any pathological marker (table 1). Within each age group, mean RS was always higher in tumors that were PR negative, grade 2/3, Ki67 >10%, and P53 ≥10% (p<0.05, respectively). In patients with a RS ≤10, 0% were recommended adjuvant chemotherapy irrespective of age. In patients with a RS 11-25, 39% of younger and 40% of older women were recommended chemotherapy. In patients with a RS ≥26, 100% of younger and 98% of older women were recommended chemotherapy. Conclusions: The relationships between pathological features and RS are consistent across age, supporting observations that the RS can predict benefit irrespective of age. See table. [Table: see text]

Omitting chemotherapy in more patients with early breast cancer in the post-TAILORx era.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12534-e12534
Author(s):  
Christos Markopoulos ◽  
Zoi Andromahi Sariyanni ◽  
Dimitrios C. Ziogas ◽  
Zoh Antonopoulou ◽  
Nikolaos Tsoulos
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Regression Models ◽  
Recurrence Score ◽  
Treatment Decisions ◽  
Oncotype Dx ◽  
Logistic Regression Models ◽  
Previously Treated ◽  
High Clinical Risk

e12534 Background: The purpose of this analysis is to evaluate how many patients previously treated according to OncotypeDX Recurrence Score (RS) could have been spared of Chemotherapy if the TAILORx RS data had been taken into account in the clinical treatment decisions. Methods: A series of 182 patients, 34-74 years of age with early breast cancer, treated in our Breast Unit during the last 10 years, for whom treatment decisions were based on OncotypeDX RS. The Recurrence Scores of all these patients were obtained and the actual treatment decisions that were made based on the pre-TAILORx cut-offs of RS 18 and 31 were recorded. These decisions were then re-evaluated based on the after TAILORx cut-off scores, by taking also into consideration the patients’ age. Descriptive statistics were used as well as logistic regression models to estimate the potential change in treatment decisions based on the new Oncotype Dx cut-offs. Results: In the cohort of patients we analyzed that underwent Oncotype Dx testing, 34.1% (62/182) received Chemotherapy, based on the initial pre-TAILORX cut-offs of the RS. When utilizing the new cut-offs (after TAILORx results) in combination with age, we have estimated that, for the patients > 50 years of age, a 12.7% was potentially over-treated and for those ≤50 years old, 9.1% was potentially over-treated since they have received chemotherapy with a RS below 16; additionally, 30.8% of the patients of that age that have RS between 16 and 20 have received chemotherapy even though the average chemotherapy benefit for this group is 1.6% and can go up to 6.7% if they have a high clinical risk as it was defined by the investigators of the TAILORx trial. Finally, 84,6% of patients ≤50 years old with RS between 21-25 received chemotherapy with a 6.5% potential benefit demonstrated in the TAILORx trial. Conclusions: Our analysis suggests that, by using the cut-offs of TAILORx trial, adjuvant chemotherapy could had been omitted in at least a further 11.5% of patients with early breast cancer, reassuring their quality of life without declining their prognosis.

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