The ASCO panel endorses the recommendations with minor suggested revisions and highlights three areas that warrant further consideration: tumor histology and adjuvant therapy recommendations, risk stratification tools and proposed Oncotype DX [recurrence score] thresholds to guide decisions about chemotherapy, and patient factors in decision making.— N. Lynn Henry, MD, PhD, and colleagues
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As reported in the Journal of Clinical Oncology (JCO) by N. Lynn Henry, MD, PhD, of University of Michigan Comprehensive Cancer Center, Ann Arbor, and colleagues,1 ASCO has endorsed Cancer Care Ontario guideline recommendations on the role of patient and disease factors in decisions on adjuvant systemic therapy in early-stage operable breast cancer.2 Endorsement was based on review by an ASCO expert panel, co-chaired by Dr. Henry and Ian E. Krop, MD, PhD, of Dana-Farber Cancer Institute, Boston.
The primary Cancer Care Ontario guideline question considered was: Which patient and disease factors should be considered in selecting adjuvant therapy for women with early-stage breast cancer? The target population is women who are being considered for or who are receiving systemic therapy for early-stage invasive breast cancer (stages I–IIA, T1N0–1, T2N0).
The JCO authors concluded: “The ASCO panel endorses the recommendations with minor suggested revisions and highlights three areas that warrant further consideration: tumor histology and adjuvant therapy recommendations, risk stratification tools and proposed Oncotype DX [recurrence score] thresholds to guide decisions about chemotherapy, and patient factors in decision making.”
Cancer Care Ontario recommendations and selected ASCO panel discussion points are summarized below.
Recommendations
For decisions regarding adjuvant therapy, it is recommended that: lymph node status, T stage, estrogen receptor status, progesterone receptor status, HER2 status, tumor grade, and presence of tumor lymphovascular invasion be considered as relevant (either prognostic or predictive); Oncotype DX score (for hormone receptor–positive, N0 or N1mic or isolated tumor cell, and HER2-negative cancers) and Adjuvant! Online may be used as risk-stratification tools; and age, menopausal status, and medical comorbidities should be considered.
- For patients in whom chemotherapy would likely be tolerated and for whom chemotherapy is acceptable, adjuvant chemotherapy should be considered if the following characteristics are present: lymph node–positive tumor (at least one node with macrometastatic deposit > 2 mm), estrogen receptor–negative tumor (> 5 mm), HER2-positive tumor, high-risk node-negative tumors (> 5 mm) and another high-risk feature, and Adjuvant! Online 10-year risk of death from breast cancer > 10%. [The ASCO panel suggested an Adjuvant! Online 10-year risk of > 10% or 15% in this setting.]
- The following features should be considered high risk, and patients who have them should be considered candidates for chemotherapy: Node-negative tumors > 5 mm, grade 3, triple-negative tumors, lymphovascular invasion, Oncotype DX recurrence score associated with an estimated distant relapse risk ≥ 15% at 10 years, and HER2-positive tumors. [The ASCO panel suggested an estimated distant relapse risk > 20% in this setting.]
- Patients with tumor size < 5 mm, node-negative tumors, and no other high-risk features may not benefit from adjuvant chemotherapy.
- Adjuvant chemotherapy may not be required in patients with HER2-negative, strongly estrogen receptor–positive, and progesterone receptor–positive breast cancer and any of the following additional characteristics: positive nodes with micrometastasis only (< 2 mm), or tumor size < 5 mm, or Oncotype DX recurrence score with an estimated distant relapse risk < 15% at 10 years. [The ASCO panel suggested an estimated distant relapse risk < 10% at 10 years in this setting.]
ASCO Panel Discussion Points
In its discussion points, the ASCO panel highlighted three areas thought to warrant further consideration: (1) tumor histology and adjuvant therapy recommendations, (2) risk-stratification tools and proposed Oncotype DX recurrence score thresholds to guide decisions about chemotherapy, and (3) patient factors in decision-making.
The panel noted that some uncommon breast cancer subtypes (eg, tubular, mucinous) may have a favorable prognosis and that such histologic information may be relevant for making decisions regarding adjuvant chemotherapy. The panel also noted that factors such as grade 3 disease and lymphovascular invasion generally should not be used in isolation in decision-making but considered within the overall clinical context.
Ian E. Krop, MD, PhD
It was pointed out that there are now several risk-stratification tools available in addition to Oncotype DX, with practitioners being referred to the current ASCO guideline on biomarker use in this setting (www.asco.org/guidelines/adjuvantbreastmarkers). It was further emphasized that patient preferences should play a role in selection of adjuvant systemic therapy. For older patients, it was recommended that validated geriatric assessment tools be used to evaluate life expectancy and such factors as functional status, comorbidity, cognitive function, and social support in making decisions regarding adjuvant therapy. ■
Disclosure: Dr. Henry has received research funding from BioMarin Pharmaceutical and Celldex. For full disclosures of the study authors, visit jco.ascopubs.org.
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