Along with the diagnosis of breast cancer comes many decisions regarding treatment options. Oncotype DX, a genomic/gene expression assay, provides quantitative assessment of chemotherapy benefit and risk of distant recurrence in early-stage estrogen receptor–positive (ER+), HER2/neu-negative breast cancer to assist in developing individualized treatment plans. Validated by the National Surgical Adjuvant Breast and Bowel Project NSABP B-14 and recognized by the National Comprehensive Cancer Network (NCCN), the Oncotype DX assay gene panel demonstrates that the recurrence score can be used as an accurate estimate of the risk of distant recurrence and overall survival in individual patients.
It has been documented in oncology literature that timely treatment increases survival and reduces the risk of metastases. As reported by Gagliato et al (J Clin Oncol. 2014;32:735-744), women who started chemotherapy within 30 days of surgery had better outcomes in regard to survival and remaining disease free. Timely treatment has also been reported to have a positive impact on the quality of care and the patient’s experience.
Case Scenario
After a suspicious finding on her yearly screening mammogram, CP, a 42-year-old married mother of 2 and a pianist in the local orchestra, undergoes a stereotactic breast biopsy that is positive for malignancy. The patient is notified by the radiologist of the pathology result and is referred for surgical consultation as well as navigation services. The surgical consultation is scheduled within 7 days, and CP undergoes lumpectomy with sentinel node biopsy within 2 weeks. The final surgical pathology is available within 5 to 7 days, indicating a 1.2-cm ER+, HER2/neu-negative, node-negative invasive adenocarcinoma of the breast.
As a member of the multidisciplinary team of surgeons, radiologists, oncologists, and nurses of the breast cancer center, the navigator accesses eligibility criteria for Oncotype DX testing, expedites the ordering of the Oncotype DX testing, schedules the initial medical oncology consultation to occur after the Oncotype DX test results are available, and meets with CP to educate her on the Oncotype DX testing and the implications of the test results. With knowledge of the role of genomics in the planning of treatment for breast cancer, the navigator is also able to discuss the recommendation for BRCA testing based on CP’s history of breast cancer before age 50 years. CP is seen by medical oncology within 1 to 2 weeks of referral, and the Oncotype DX score is available for treatment planning. With the role of the navigator, the turnaround time for reporting Oncotype DX results is 20 days. CP’s Oncotype DX recurrence score indicates high risk of recurrence, for which the treatment option of chemotherapy is recommended. At the time of her medical oncology consultation, CP and her oncology team are able to discuss and develop her individualized treatment plan.
It is worth noting that Medicare will not pay for Oncotype DX unless initiated 10 days after surgery.
Metrics
Patient Experience Metrics
- Patient experience survey—percentage of patients extremely satisfied with the patient experience related to navigation services
- Physician experience survey—number of physicians who received a physician experience survey related to navigation services and outcomes
- Patient discharge experience—number of patients who received a discharge assessment and educational packet upon discharge from the navigator
- Surgical oncology patient experience—number of patients who received a surgical oncology educational packet regarding discharge instructions from the navigator
Clinical Outcome Metrics
- Timeliness of care—measuring Oncotype DX ordering and reporting turnaround times in conjunction with first consultation and treatment plan
- Compliance with NCCN recommendations for genomic testing—percentage of treatment plans that followed the NCCN guidelines and recommendations. Measuring the number of eligible patients and number of Oncotype DX tests ordered
- Patient pathway and guideline compliance—percentage of patients who were compliant with their treatment plan
- Barriers to care and interventions provided and outcomes—number and type of interventions provided to patient and resolution/outcome of barriers
- Psychosocial distress screening—number of patients who received psychosocial distress screening (compliance with Commission on Cancer Standard 3.2) and interventions
- Clinical trial education/referral to clinical trial—number of patients educated in regard to clinical trials with documented barriers and interventions
- Quality of life—number of patients who received a quality-of-life survey at pivotal points throughout the continuum of care and measurement of interventions provided
Business Performance/Return-on-Investment Metrics
- Decrease outmigration/increase retention rates—percentage of patients who are diagnosed and treated
- Referrals to revenue-generating services/downstream revenue and outcome—number of patients referred to revenue-generating services (ie, radiology, prehabilitation/rehabilitation)
- Reduction in length of stay and discharge delays for inpatient medical and surgical oncology units—measuring average length of stay and documentation of navigation services in coordination of care
- Medication coverage/reconciliation—number of patients eligible and assisted with pharmaceutical assistance programs
- Immediate referrals of self-pay patients for financial assistance—number of self-pay patients referred by navigator for financial assessment/assistance for Medicaid, Medicare, Social Security
Tools/Resources
- Genomic Health. Oncotype DX. http://breast-cancer.oncotypedx.com.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Breast Cancer. Version 2.2015. www.nccn.org/professionals/physician_gls/f_guidelines.asp.
- Myriad Genetic Laboratories. BRCA Analysis. www.myriadtests.com.
- NCCCP Navigation Assessment Tool.
Conclusion
The navigator can have an impact in expediting testing to ensure timely initiation of treatment, which is an important role within the multidisciplinary team. The integration of genomics into the care of patients with cancer is rapidly changing the way healthcare providers identify, screen, diagnose, and treat cancer. Navigators need to advance their knowledge of genomics and maintain competence with the continuing advancements in order to provide education to patients and their families on the impact of genomics in their cancer care so they can make the best informed decisions.
