ALEXANDRIA, Va.—Early February saw the American Society of Clinical Oncology (ASCO) issue a new clinical practice guideline for women with early-stage invasive breast cancer and known hormone receptor and human epidermal growth factor 2 (HER2) receptor status. The guideline features recommendations related to biomarker tests to guide therapy decisions, and is one of several guidelines released by the organization in the past few months. A multidisciplinary expert panel—consisting of experts in medical oncology, radiation oncology, community oncology, statistics and health outcome researchers—developed the recommendations, with the help of a cancer survivor, based on a systematic review of literature published between January 2006 through September 2015.
The “Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women with Early-Stage Invasive Breast Cancer: American Society of Clinical Practice Guideline” was published Feb. 8 in the Journal of Clinical Oncology.
Specifically, the recommendations are to consider several biomarker tests to aid in making decisions regarding adjuvant system therapy for certain breast cancer patients: estrogen receptor, progesterone receptor, HER2 receptor, Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1. The guideline cautioned, however, that “No biomarker test, except for estrogen receptor, progesterone receptor and HER2 receptor, should be used to guide choices of specific drugs or treatment regimens” and “Treatment decisions should also consider disease stage, co-morbidities and patient preferences.”
"In the era of precision medicine, the role of biomarkers in guiding clinical care is greater than in the past. An extensive number of new tests have come out in the last 5-10 years, but not all have sufficient evidence of clinical utility," Dr. Lyndsay N. Harris, co-chair of the ASCO expert panel that developed the guideline, said in a statement. "These latest recommendations truly inform physicians about which tests need to be performed. But this is not all that goes into patient care—doctors need to continue discussions with patients to develop individualized treatment plans."
This announcement follows similar news from December, when ASCO, together with the American Cancer Society (ASC), posted a joint clinical practice guideline regarding the care of female adult breast cancer survivors. This series of recommendations focuses on surveillance for breast cancer recurrence, screening for second primary cancers, management of long-term and late effects, health promotion, care coordination and practice implications.
Key suggestions include regular surveillance and screening for cancer recurrence and new primary cancer, with the qualifier that routine laboratory or imaging tests for cancer recurrence are not recommended for asymptomatic patients. In addition, the guideline notes, primary care physicians should stress the importance of a healthy lifestyle, monitoring and adherence to hormone therapy. The “American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline” was published in December in both CA: A Cancer Journal for Clinicians and the Journal of Clinical Oncology.
“The new guideline addresses the issues facing women breast cancer survivors as they transition from treatment to survivorship,” Dr. Carolyn D. Runowicz, FASCO chair of the ASCO/ACS Expert Workgroup that developed the guideline, commented in a press release. “The recommendations should result in high-quality survivorship care, with a focus on improving their quality of life and health outcomes.”