NRG Oncology/NSABP B-47 menstrual history study: impact of adjuvant chemotherapy with and without trastuzumab

Ganz, Patricia A.; Cecchini, Reena S.; Fehrenbacher, Louis; Geyer, Charles E.; Crown, John; Thirlwell, Michael P.; Ellison, David M.; Boileau, Jean François; Flynn, Patrick J.; Jeong, Jong Hyeon; Mamounas, Eleftherios P.; Wolmark, Norman

doi:10.1038/s41523-021-00264-2

Cited by 6 publications

(3 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…It is possible that therapy-induced amenorrhea contributes to the benefit but it should be noted that many women with chemotherapy-induced amenorrhea continue to have premenopausal estradiol levels. 32 Therefore, direct antitumor effects of chemotherapy also likely contribute to the observed benefit. Qualifying statement: The genomic assay is prognostic and may be used for shared patient-physician treatment decision making.…”

Section: Characteristics Of Studies Identified In the Literature Searchmentioning

confidence: 99%

Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update

Varga

Ismaila

Allison

et al. 2022

JCO

206

197

View full text Add to dashboard Cite

PURPOSE To update recommendations on appropriate use of breast cancer biomarker assay results to guide adjuvant endocrine and chemotherapy decisions in early-stage breast cancer. METHODS An updated literature search identified randomized clinical trials and prospective-retrospective studies published from January 2016 to October 2021. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert Panel members used informal consensus to develop evidence-based recommendations. RESULTS The search identified 24 studies informing the evidence base. RECOMMENDATIONS Clinicians may use Onco type DX, MammaPrint, Breast Cancer Index (BCI), and EndoPredict to guide adjuvant endocrine and chemotherapy in patients who are postmenopausal or age > 50 years with early-stage estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative (ER+ and HER2–) breast cancer that is node-negative or with 1-3 positive nodes. Prosigna and BCI may be used in postmenopausal patients with node-negative ER+ and HER2– breast cancer. In premenopausal patients, clinicians may use Onco type in patients with node-negative ER+ and HER2– breast cancer. Current data suggest that premenopausal patients with 1-3 positive nodes benefit from chemotherapy regardless of genomic assay result. There are no data on use of genomic tests to guide adjuvant chemotherapy in patients with ≥ 4 positive nodes. Ki67 combined with other parameters or immunohistochemistry 4 score may be used in postmenopausal patients without access to genomic tests to guide adjuvant therapy decisions. BCI may be offered to patients with 0-3 positive nodes who received 5 years of endocrine therapy without evidence of recurrence to guide decisions about extended endocrine therapy. None of the assays are recommended for treatment guidance in individuals with HER2-positive or triple-negative breast cancer. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. Additional information is available at www.asco.org/breast-cancer-guidelines .

show abstract

Section: Characteristics Of Studies Identified In the Literature Searchmentioning

confidence: 99%

Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update

Varga

Ismaila

Allison

et al. 2022

JCO

206

197

View full text Add to dashboard Cite

show abstract

“…The NSABP B-47 clinical trial showed that chemotherapy induced amenorrhea in pre-menopausal women is common but it is often discordant with hormone level measurements. In this study, 85% of patients were amenorrhoeic at 12 months after starting adjuvant chemotherapy but only 28 and 22% had postmenopausal estradiol levels at 12 and 24 months 11 . The SOFT and TEXT trials demonstrated that in premenopausal HR+ patients ovarian suppression plus an aromatase inhibitor is more effective than tamoxifen alone to improve recurrence-free survival 12 , 13 .…”

Section: Introductionmentioning

confidence: 52%

Molecular differences between younger versus older ER-positive and HER2-negative breast cancers

et al. 2022

View full text Add to dashboard Cite

The RxPONDER and TAILORx trials demonstrated benefit from adjuvant chemotherapy in patients age ≤ 50 with node-positive breast cancer and Recurrence Score (RS) 0–26, and in node-negative disease with RS 16–25, respectively, but no benefit in older women with the same clinical features. We analyzed transcriptomic and genomic data of ER+/HER2− breast cancers with in silico RS < 26 from TCGA (n = 530), two microarray cohorts (A: n = 865; B: n = 609), the METABRIC (n = 867), and the SCAN-B (n = 1636) datasets. There was no difference in proliferation-related gene expression between age groups. Older patients had higher mutation burden and more frequent ESR1 copy number gain, but lower frequency of GATA3 mutations. Younger patients had higher rate of ESR1 copy number loss. In all datasets, younger patients had significantly lower mRNA expression of ESR1 and ER-associated genes, and higher expression of immune-related genes. The ER- and immune-related gene signatures showed negative correlation and defined three subpopulations in younger women: immune-high/ER-low, immune-intermediate/ER-intermediate, and immune-low/ER-intermediate. We hypothesize that in immune-high cancers, the cytotoxic effect of chemotherapy may drive the benefit, whereas in immune-low/ER-intermediate cancers chemotherapy induced ovarian suppression may play important role.

show abstract

“…It is possible that therapy-induced amenorrhea contributes to the benefit but it should be noted that many women with CT-induced amenorrhea continue to have premenopausal estradiol levels. 10,11 Is the number of positive LN a determinant of which GES to use?…”

Section: Genomic Definition Of High Riskmentioning

confidence: 99%

Hormone Receptor-Positive / HER2-Negative Early Breast Cancer High-Risk Population: An Algorithm for Optimization Systemic Adjuvant Treatment Based on 2022 Updates

González-Hurtado,

Rivero,

Samamé Pérez-Vargas

et al. 2023

Breast Cancer�(Auckl)

View full text Add to dashboard Cite

Prognostic and predictive factors for early and late distant distance recurrence risk in estrogen-receptor positive and HER2-receptor negative early breast cancer are well known, but not all these variables work equally for the prediction. The following are the most widely accepted variables for categorizing risk levels: clinic-pathologic features (tumor size, lymph node involvement, histological grade, age, menopausal status, Ki-67 expression, estrogen, and progesterone expression), primary systemic treatment response (pathologic response and/or Ki-67 downstaging), and gene expression signatures stratification. Treatment guidelines from cancer societies and collaborative groups, online predict-tools, real-world data and experts’ opinion recommends different adjuvant strategies (chemotherapy, endocrine therapy, ovarian suppression, olaparib, or abemaciclib) depending on the low (< 10%), intermediate (10%-20%) or high-risk of distance recurrence at least in the first 5 years. Multiple randomized prospective trials were updated in 2022, that evidence allow us to perform a stratification of risk in pre- and postmenopausal women with estrogen-receptor positive and HER2-receptor negative early breast cancer based on a combination of clinic-pathologic features and genomic assays and guide the adjuvant systemic treatment recommendation for those with high risk.

show abstract

NRG Oncology/NSABP B-47 menstrual history study: impact of adjuvant chemotherapy with and without trastuzumab

Cited by 6 publications

References 9 publications

Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update

Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update

Molecular differences between younger versus older ER-positive and HER2-negative breast cancers

Hormone Receptor-Positive / HER2-Negative Early Breast Cancer High-Risk Population: An Algorithm for Optimization Systemic Adjuvant Treatment Based on 2022 Updates

Contact Info

Product

Resources

About