Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: Update of the ASCO Endorsement of the Cancer Care Ontario Guideline

Abstract

PURPOSE To update the American Society of Clinical Oncology endorsement of the Cancer Care Ontario recommendations on the Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer. METHODS Two phase III trials—the Trial Assigning Individualized Options for Treatment (TAILORx) in women with hormone receptor–positive, node-negative tumors and the Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy (MINDACT) trial—provided the evidence for this update. UPDATED RECOMMENDATIONS Shared decision making between clinicians and patients is appropriate for adjuvant systemic therapy for breast cancer. For patients older than age 50 years and whose tumors have Onco type DX recurrence scores less than 26, and for patients age 50 years or younger whose tumors have Onco type DX recurrence scores less than 16, there is little to no benefit from chemotherapy. Clinicians may offer endocrine therapy alone for these patients. For patients age 50 years or younger with recurrence scores of 16 to 25, clinicians may offer chemoendocrine therapy. Patients with recurrence scores greater than 30 should be considered candidates for chemoendocrine therapy. Based on informal consensus, the Panel recommends that oncologists may offer chemoendocrine therapy to patients with Onco type DX scores of 26 to 30. The MammaPrint assay could be used to guide decisions on withholding adjuvant systemic chemotherapy in patients with hormone receptor–positive lymph node–negative breast cancer and in select patients with lymph node–positive cancers. In both patients with node-positive and node-negative disease, evidence of clinical utility of the MammaPrint assay was only apparent in those determined to be at high clinical risk; the Panel thus did not recommend use of MammaPrint assay in patients determined to be at low clinical risk. Remaining recommendations from the 2016 ASCO guideline endorsement are unchanged. Additional information is available at www.asco.org/breast-cancer-guidelines .

Central Review of Radiation Therapy Planning Among Patients with Breast-Conserving Surgery: Results from a Quality Assurance Process Integrated into the INSEMA Trial

“…Gene expression assays are increasingly used for decision-making regarding adjuvant systemic therapy in early-stage, operable breast cancer. 35 There are some clinical situations in which there is also a need for predictive markers to better estimate the amount of benefit from adjuvant radiation therapy and surgery. To date, the available evidence on the possible predictive value of gene expression assays for radiation therapy or axillary surgery does not support their inclusion in the decision-making process.…”

Restricted Axillary Staging in Clinically and Sonographically Node-Negative Early Invasive Breast Cancer (c/iT1–2) in the Context of Breast Conserving Therapy: First Results Following Commencement of the Intergroup-Sentinel-Mamma (INSEMA) Trial

“…Chemotherapy ± anti-HER2 therapy is always indicated for triple-negative and HER2 positive tumours (stage pT1b and above). There is consensus in all guidelines and treatment recommendations that chemotherapy is not automatically indicated for luminal-like tumours with axillary lymph node involvement [15,[40][41][42][43][44][45]. In particular luminal-A subtype tumours with ≤ 3 involved lymph nodes can be sufficiently treated with endocrine therapy alone [46].…”

Performance of Automated Dissection on Formalin-Fixed Paraffin-Embedded Tissue Sections for the 21-Gene Recurrence Score Assay

“…In this study, we aimed to quantitate the degree of improvement in the precision of the 21-gene RS assay, which provides important information for predicting the benefit of adjuvant chemotherapy for early breast cancer patients. 26 …”