BACKGROUND
Prior studies with the use of a prospective-retrospective design including archival tumor samples have shown that gene-expression assays provide clinically useful prognostic information. However, a prospectively conducted study in a uniformly treated population provides the highest level of evidence supporting the clinical validity and usefulness of a biomarker.


METHODS
We performed a prospective trial involving women with hormone-receptor-positive, human epidermal growth factor receptor type 2 (HER2)-negative, axillary node-negative breast cancer with tumors of 1.1 to 5.0 cm in the greatest dimension (or 0.6 to 1.0 cm in the greatest dimension and intermediate or high tumor grade) who met established guidelines for the consideration of adjuvant chemotherapy on the basis of clinicopathologic features. A reverse-transcriptase-polymerase-chain-reaction assay of 21 genes was performed on the paraffin-embedded tumor tissue, and the results were used to calculate a score indicating the risk of breast-cancer recurrence; patients were assigned to receive endocrine therapy without chemotherapy if they had a recurrence score of 0 to 10, indicating a very low risk of recurrence (on a scale of 0 to 100, with higher scores indicating a greater risk of recurrence).


RESULTS
Of the 10,253 eligible women enrolled, 1626 women (15.9%) who had a recurrence score of 0 to 10 were assigned to receive endocrine therapy alone without chemotherapy. At 5 years, in this patient population, the rate of invasive disease-free survival was 93.8% (95% confidence interval [CI], 92.4 to 94.9), the rate of freedom from recurrence of breast cancer at a distant site was 99.3% (95% CI, 98.7 to 99.6), the rate of freedom from recurrence of breast cancer at a distant or local-regional site was 98.7% (95% CI, 97.9 to 99.2), and the rate of overall survival was 98.0% (95% CI, 97.1 to 98.6).


CONCLUSIONS
Among patients with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who met established guidelines for the recommendation of adjuvant chemotherapy on the basis of clinicopathologic features, those with tumors that had a favorable gene-expression profile had very low rates of recurrence at 5 years with endocrine therapy alone. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00310180.).

Prospective Validation of a 21-Gene Expression Assay in Breast Cancer

This consensus statement revises and updates the recommendations for biomarkers use in the diagnosis and treatment of breast cancer, and is a joint initiative of the Spanish Society of Medical Oncology and the Spanish Society of Pathology. This expert group recommends determining in all cases of breast cancer the histologic grade and the alpha-estrogen receptor (ER), progesterone receptor, Ki-67 and HER2 status, in order to assist prognosis and establish therapeutic options, including hormone therapy, chemotherapy and anti-HER2 therapy. One of the four available genetic prognostic platforms (MammaPrint®, Oncotype DX®, Prosigna® or EndoPredict®) may be used in node-negative ER-positive patients to establish a prognostic category and decide with the patient whether adjuvant treatment may be limited to hormonal therapy. Newer technologies including next-generation sequencing, liquid biopsy, tumour-infiltrating lymphocytes or PD-1 determination are at this point investigational.

/pdf/biomarkers-in-breast-cancer-a-consensus-statement-by-the-1sh6qcp88e.pdf

Biomarkers in breast cancer: A consensus statement by the Spanish Society of Medical Oncology and the Spanish Society of Pathology.

Breast cancer stem cell antigens as targets for immunotherapy.

BACKGROUND It is not clear whether clinical practice guidelines (CPGs) and consensus statements (CSs) are adequately promoting shared decision making (SDM). OBJECTIVE To evaluate the recommendations about SDM in CPGs and CSs concerning breast cancer (BC) treatment. SEARCH STRATEGY Following protocol registration (Prospero no.: CRD42018106643), CPGs and CSs on BC treatment were identified, without language restrictions, through systematic search of bibliographic databases (MEDLINE, EMBASE, Web of Science, Scopus, CDSR) and online sources (12 guideline databases and 51 professional society websites) from January 2010 to December 2019. INCLUSION CRITERIA CPGs and CSs on BC treatment were selected whether published in a journal or in an online document. DATA EXTRACTION AND SYNTHESIS A 31-item SDM quality assessment tool was developed and used to extract data in duplicate. MAIN RESULTS There were 167 relevant CPGs (139) and CSs (28); SDM was reported in only 40% of the studies. SDM was reported more often in recent publications after 2015 (42/101 (41.6 %) vs 46/66 (69.7 %), P = .0003) but less often in medical journal publications (44/101 (43.5 %) vs 17/66 (25.7 %), P = .009). In CPGs and CSs with SDM, only 8/66 (12%) met one-fifth (6 of 31) of the quality items; only 14/66 (8%) provided clear and precise SDM recommendations. DISCUSSION AND CONCLUSIONS SDM descriptions and recommendations in CPGs and CSs concerning BC treatment need improvement. SDM was more frequently reported in CPGs and CSs in recent years, but surprisingly it was less often covered in medical journals, a feature that needs attention.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/hex.13112

Shared decision making in breast cancer treatment guidelines: Development of a quality assessment tool and a systematic review.

Distinguishing early-stage tumors from normal tissues is of great importance in cancer diagnosis. We report fiber-based confocal visible/near-infrared (NIR) optical-resolution photoacoustic microscopy that can image tumor microvasculature, oxygen saturation, and nanoprobes in a single scanning. We develop a cost-efficient single laser source that provides 532, 558, and 1064 nm pulsed light with sub-microseconds wavelength switching time. Via dual-fiber illumination, we can focus the three beams to the same point. The optical and acoustic foci are confocally aligned to optimize the sensitivity. The visible and NIR wavelengths enable simultaneous tumor imaging with three different contrast modes. Results show obvious angiogenesis, significantly elevated oxygen saturation, and accumulated nanoparticles in the tumor regions, which offer comprehensive information to detect the tumor. This approach also allows us to identify feeding and draining vessels of the tumor and thus to determine local oxygen extraction fraction. In the tumor region, the oxygen extraction fraction significantly decreases along with tumor growth, which can also assist in tumor detection and staging. Fiber-based confocal visible/NIR photoacoustic microscopy offers a new tool for early detection of cancer.

Confocal visible/NIR photoacoustic microscopy of tumors with structural, functional, and nanoprobe contrasts

Breast cancer is the most common cancer in women in our country and it is usually diagnosed in the early and potentially curable stages. Nevertheless, around 20–30% of patients will relapse despite appropriate locoregional and systemic therapies. A better knowledge of this disease is improving our ability to select the most appropriate therapy for each patient with a recent diagnosis of an early stage breast cancer, minimizing unnecessary toxicities and improving long-term efficacy.

/pdf/seom-clinical-guidelines-in-early-stage-breast-cancer-2018-1vugf9zn6v.pdf

E. Dalmau

Papers

SEOM clinical guidelines in early stage breast cancer (2018).