Oncotype DX score in hormone receptor-positive/HER2-positive breast cancer: A SEER analysis.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12044-e12044
Author(s):  
Ayman Qasrawi ◽  
Zin Myint ◽  
Yanal Mufeed Alnimer ◽  
Edward H. Romond

e12044 Background: The recurrence score Oncotype DX (RS) predicts the need for adjuvant chemotherapy in hormone receptor positive (HR+) early stage breast cancer (BC). However, it has not been validated for HR+/HER2+ BC cases. We aim to evaluate the results of RS in HR+/HER2+ BC by using the Surveillance, Epidemiology, and End Results Program (SEER) national database. Methods: We identified patients with non-metastatic HR+/HER2+ BC with reported RS scores from the national SEER database between 2010 and 2015. Data obtained included demographics, histologic subtypes, grading, tumor size, nodal status, HR status and overall survival (OS) outcomes. RS scores were divided into low/intermediate (≤30) and high ( > 30). Histologic subtypes were further categorized into favorable (lobular, tubular, mucinous, and cribriform) and unfavorable (infiltrating ductal, mixed ductal, and micropapillary). We used Kaplan-Meier & Cox regression to analyze the survival outcomes. Logistic regression analysis was used to analyze the correlation between variables and different RS scores. Results: A total of 1537 patients were included. Median age was 61 (25-90). Majority of the patients presented with node negative disease (85%), low/intermediate grade (71%), tumor size < 20 mm (73%), unfavorable histology (89%), and only 15% had negative progesterone receptor (PR –). High RS score ( > 30) was seen in 24% of cases. After a median follow-up of 38 m (1-72), the five-year OS was 94.5%. Chemotherapy was given to 71% and 35% of those with RS > 30 and ≤30, respectively. There was a strong correlation between age > 60 ([hazard ratio, HR] = 4.9, p < 0.0001) and RS > 30 (HR = 2.4, p = 0.004) with worse outcomes on multivariate analysis. However, there were no associations between histologic subtype, tumor size, grade, nodal status and chemotherapy with survival. Tumor size > 20 mm (OR = 1.5), unfavorable histology ([odds ratio, OR] = 3.5), PR – (OR = 4.3) and high grade tumors (OR = 4.5) were independent predictors of RS > 30 (p < 0.0001). Conclusions: Our study shows that large tumor size ( > 20 mm), higher grade, PR –, and unfavorable histology were independent risk factors for higher RS in patients with localized early stage HR+/HER2+. High RS was associated with worse outcome.

2020 ◽  
Vol 12 ◽  
pp. 175883591988899
Author(s):  
Sara Bravaccini ◽  
Giuseppe Bronte ◽  
Emanuela Scarpi ◽  
Sara Ravaioli ◽  
Roberta Maltoni ◽  
...  

Background: In the Italian Breast Cancer Intergroup Studies (IBIS) 3 phase III trial, we compared cyclophosphamide, methotrexate, 5-fluorouracil (CMF) alone to sequential epirubicin/CMF regimens in patients with rapidly proliferating early breast cancer (RPEBC). We performed a post hoc analysis in the subgroup of patients with hormone-receptor-positive RPEBC on the prognostic role of progesterone receptor (PgR) status. Methods: RPEBC was defined by thymidine labeling index (TLI) >3% or grade 3 or S-phase >10% or Ki67 >20%. We analyzed 466 patients with hormone-receptor-positive RPEBC receiving sequential epirubicin/CMF regimens followed by tamoxifen, and for whom the status of ER and PgR was available. Results: Considering both cut-off values of 10% and 20%, PgR expression was significantly associated with age, menopausal status, and ER expression; HER2 status was associated with PgR status only at a cutoff value of 20% PgR. Upon univariate analysis, tumor size, nodal status, and PgR were significantly associated with disease-free survival (DFS) and overall survival (OS), while age class and local treatment type were associated only with DFS. Patients with PgR <20% showed lower 5- and 10-year DFS [hazard ratio (HR) = 1.48; 95%CI: 1.01–2.18; p = 0.044] and OS (HR = 1.85; 95%CI: 1.08–3.19, p = 0.025) rates compared with patients with PgR ⩾20%. Upon multivariate analysis, only tumor size, nodal status, and PgR were independent prognostic factors. Conclusions: Our results highlight the independent prognostic relevance of PgR expression in patients with hormone-receptor-positive RPEBC treated with adjuvant chemotherapy and endocrine therapy, where the definition of prognostic subgroups is still a major need.


Cancer ◽  
2010 ◽  
Vol 116 (13) ◽  
pp. 3112-3118 ◽  
Author(s):  
Masakazu Toi ◽  
Hiroji Iwata ◽  
Takeharu Yamanaka ◽  
Norikazu Masuda ◽  
Shinji Ohno ◽  
...  

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12519-e12519
Author(s):  
Noman Ahmed Jang Khan ◽  
Mahmoud Abdallah ◽  
Todd W. Gress ◽  
Mohamed Farouq Alsharedi

e12519 Background: The 21 gene assay Oncotype Dx Breast Recurrence Score (RS) is currently the standard of care to determine if adjuvant chemotherapy is needed in early stage node negative, hormone receptor positive, HER-2 negative breast cancer. In current American society of clinical oncology (ASCO) guidelines there is little or no benefit of adjuvant chemotherapy in patients older than 50 years whose tumors have Oncotype DX RS <26, and for patients 50 years or less whose tumors have Oncotype DX RS <16. We sought to evaluate the percentage of estrogen receptor (ER) expression as a surrogate measure of determining adjuvant chemotherapy by examining the relationship between ER expression and RS. Methods: We identified 301 patients from years 2015 to 2019 from our cancer registry with early stage hormone receptor positive breast cancer and had oncotype DX testing performed. We divided patients into three groups: Group 1 (ERG1) with ER <10%; Group 2 (ERG2) with ER 10-49%; and Group 3 (ERG3) with ER equal or >50%. We also collected information on tumor size (cm), tumor grade, Nottingham score, and ki-67 percentage. A sub-group analysis was performed for patients < 50 years age (n=30). We compared all continuous variables across ER groups using the Kruskal-Wallis rank test and individual between group comparisons using the Wilcoxon rank sum test. All statistical tests performed utilized a two-tailed p value of <0.05 with the Bonferroni correction for multiple comparisons. Results: Among 301 patients with early stage hormone receptor positive breast cancer, 89.1% were ductal, 7.9% lobular, and 2.9% mixed histology. Median age was 68, 58 and 66 for ERG1, ERG2, and ERG3, respectively (p = 0.41). Median RS was 36 (ERG1), 23 (ERG2), and 16 (ERG3) (p = 0.78 for ERG1 vs. ERG2; p = 0.01 for ERG1 vs. ERG3). As expected, tumor grade, tumor size, and Nottingham score decreased significantly from ERG1 to ERG3. For patients <50 years, median age was 44, 46 and 45 for ERG1, ERG2, and ERG3, respectively (p = 0.75). Median RS was 10 (ERG1), 24 (ERG2) and 18 (ERG3) (p = 0.04 for ERG1 vs. ERG2; p = 0.17 for ERG1 vs. ERG3). Conclusions: We found a significant association between estrogen receptor levels and Oncotype Dx recurrence score (RS) in patients with early stage hormone receptor positive breast cancer patients. Further studies are needed to determine the predictive ability of hormone receptor levels on the outcomes of patients treated for early stage hormone receptor positive breast cancer.


2020 ◽  
Author(s):  
Soo Youn Cho ◽  
Jeong Hoon Lee ◽  
Jai Min Ryu ◽  
Jeong Eon Lee ◽  
Eun Yoon Cho ◽  
...  

Abstract Background: The predictive value of adjuvant chemotherapy for early-stage hormone receptor-positive breast cancer has been only validated by a 21-gene expression assay. We hypothesized that deep-learning prediction from HE images, called Lunit-SCOPE, is a potential prognostic and predictive biomarker of adjuvant chemotherapy.Methods: We retrospectively collected HE slides from 1153 de-identified breast cancer patients at the Samsung Medical Center (SMC) in order to develop a deep-learning algorithm called Lunit-SCOPE. The histological parameters from 255 patients, deciphered by Lunit-SCOPE, were trained to predict the recurrence score (RS) using the 21-gene assay from Oncotype DX. We validated the model’s performance using the recurrence survival of 898 patients and The Cancer Genome Atlas (TCGA) cohort, and examined related biological functions through RNA sequence data.Results: The histologic parameter-based RS prediction model predicted the oncotype DX score (R2=0.96) and the recurrence survival analysis on the validation (p<0.01) and TCGA cohort (p<0.01), where the most important variables were the nuclear grade and the mitotic cells in the cancer epithelium. Of the 85 patients classified as the high-risk group, 72 patients who received adjuvant therapy had a significantly better survival (p<0.01). The functions of the top 300 highly correlated genes with a predicted RS were enriched for cell cycle, nuclear division and cell division. Of the 21-genes from the Oncotype DX, the predicted RS had positive correlations with the proliferation category genes and was negatively correlated with the prognostic genes in the estrogen category.Conclusion: An integrative analysis using Lunit-SCOPE predicts a high risk of recurrence and those who would benefit from adjuvant chemotherapy for early-stage hormone-positive breast cancer.


Author(s):  
Natalie Hills ◽  
Macall Leslie ◽  
Rachel Davis ◽  
Marielle Crowell ◽  
Hiroyasu Kameyama ◽  
...  

Abstract Background Time to surgery (TTS) has been suggested to have an association with mortality in early-stage breast cancer. Objective This study aims to determine the association between TTS and preoperative disease progression in tumor size or nodal status among women diagnosed with clinical T1N0M0 ductal breast cancer. Methods Women diagnosed with clinical T1N0M0 ductal breast cancer who had breast-conserving surgery as their first definitive treatment between 2010 and 2016 (n = 90,405) were analyzed using the National Cancer Database. Separate multivariable logistic regression models for hormone receptor (HR)-positive and HR-negative patients, adjusted for clinical and demographic variables, were used to assess the relationship between TTS and upstaging of tumor size (T-upstaging) or nodal status (N-upstaging). Results T-upstaging occurred in 6.76% of HR-positive patients and 11.00% of HR-negative patients, while N-upstaging occurred in 12.69% and 10.75% of HR-positive and HR-negative patients, respectively. Among HR-positive patients, odds of T-upstaging were higher for 61–90 days TTS (odds ratio [OR] 1.18, 95% confidence interval [CI] 1.05–1.34) and ≥91 days TTS (OR 1.47, 95% CI 1.17–1.84) compared with ≤30 days TTS, and odds of N- upstaging were higher for ≥91 days TTS (OR 1.35, 95% CI 1.13–1.62). No association between TTS and either T- or N-upstaging was found among HR-negative patients. Other clinical and demographic variables, including grade, tumor location, and race/ethnicity, were associated with both T- and N-upstaging. Conclusion TTS ≥61 and ≥91 days was a significant predictor of T- and N-upstaging, respectively, in HR-positive patients; however, TTS was not associated with upstaging in HR-negative breast cancer. Delays in surgery may contribute to measurable disease progression in T1N0M0 ductal breast cancer.


Author(s):  
Simon Peter Gampenrieder ◽  
Gabriel Rinnerthaler ◽  
Richard Greil

SummaryThe three top abstracts at the 2020 virtual San Antonio Breast Cancer Symposium regarding hormone-receptor-positive early breast cancer, from our point of view, were the long-awaited results from PenelopeB and RxPONDER as well as the data from the ADAPT trial of the West German Study Group. PenelopeB failed to show any benefit by adjuvant palbociclib when added to standard endocrine therapy in patients without pathologic complete response after neoadjuvant chemotherapy. RxPONDER demonstrated that postmenopausal patients with early hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2−) breast cancer, 1–3 positive lymph nodes and an Oncotype DX Recurrence Score of less than 26 can safely be treated with endocrine therapy alone. In contrast, in premenopausal women with positive nodes, adjuvant chemotherapy plays still a role even in case of low genomic risk. Whether the benefit by chemotherapy is mainly an indirect endocrine effect and if ovarian function suppression would be similarly effective, is still a matter of debate. The HR+/HER2− part of the ADAPT umbrella trial investigated the role of a Ki-67 response to a short endocrine therapy before surgery in addition to Oncotype DX—performed on the pretreatment biopsy—to identify low-risk patients who can safely forgo adjuvant chemotherapy irrespective of menopausal status.


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