Filipa Lynce and Claudine Isaacs
Suzanne C. O'Neill, Claudine Isaacs, Calvin Chao, Huei-Ting Tsai, Chunfu Liu, Bola F. Ekezue, Nandini Selvam, Larry G. Kessler, Marc D. Schwartz, Tania Lobo and Arnold L. Potosky
Background: A number of practice guidelines incorporate the use of gene expression profiling (GEP) tests for early-stage, hormone receptor–positive, HER2-negative breast tumors. Few studies describe factors associated with GEP testing in US oncology practice. We assessed the relationship between clinical, demographic, and group-level socioeconomic variables and test use in women younger than 65 years. Patients and Methods: Data from 5 state cancer registries were linked with insurance claims data and GEP test results. We assessed rates of testing and variables associated with test use in an incident cohort of 9,444 commercially insured women younger than 65 years, newly diagnosed with stage I or II hormone receptor–positive breast cancer from 2006 through 2012. Results: Rates of testing for women with N0 disease increased from 20.4% in 2006 to 35.2% in 2011. Variables associated with higher rates of testing, beyond clinical factors such as nodal status (P<.001), included being diagnosed from 2008 through 2012 versus 2006 through 2007 (adjusted odds ratio [OR], 1.67; 95% CI, 1.47–1.90), having preexisting comorbidities (adjusted OR, 1.35; 95% CI, 1.14–1.59), and higher out-of-pocket pharmacy costs (adjusted OR, 1.66; 95% CI, 1.40–1.97). Women younger than 50 years were more likely to be tested if they had stage I versus stage II disease (P<.0001). Conclusions: In an insured population of women younger than 65 years, GEP testing increased after its inclusion in clinical practice guidelines and mounting evidence. Additional research is needed to better understand oncologists' decision not to order GEP testing for their patients who are otherwise eligible.
Huei-Ting Tsai, Claudine Isaacs, Filipa C. Lynce, Suzanne C. O'Neill, Chunfu Liu, Marc D. Schwartz, Nandini Selvam, Yingjun Zhou and Arnold L. Potosky
Purpose: Studies have reported disparities by age and race in the initiation of adjuvant trastuzumab for the initial treatment of older women with early-stage breast cancer, but less is known about its initiation in younger patients. Therefore, we assessed temporal trends and clinical and demographic factors associated with trastuzumab initiation in a large, population-based cohort of patients aged <64 years in 5 states. Methods: Using a cancer registry and claims-linked data set of 13,398 women with incident invasive breast cancer from 2006 to 2011, we identified 934 patients aged <64 years with HER2-positive stage I–III breast cancer. We assessed trastuzumab initiation within the first 9 months after diagnosis and conducted logistic regression analyses to assess sociodemographic and clinical factors associated with trastuzumab initiation. Results: From 2006 to 2011, trastuzumab initiation steadily increased in patients with node-positive (from 65% to 91%) and node-negative (from 39% to 75%) breast cancers. Several tumor-related factors were associated with trastuzumab initiation, including high histologic grades (adjusted odds ratio [aOR], 6.43; 95% CI, 3.27–12.65; and aOR, 3.25; 95% CI, 1.66–6.36, for grades 3 and 2, respectively), node-positive status (aOR, 1.88; 95% CI, 1.28–2.78; P=.001), tumor size >2 cm (aOR, 1.50; 95% CI, 1.04–2.16; P=.03), and hormone receptor–negative status (aOR, 1.51; 95% CI, 1.01–2.26; P=.04). We found a null effect of race. Conclusions: Adjuvant trastuzumab therapy for early-stage breast cancer has been widely disseminated among women aged <64 years. The initiation of this targeted therapy was associated with higher-risk features, consistent with practice guidelines.
Colby J. Hyland, Flora Varghese, Christina Yau, Heather Beckwith, Katia Khoury, William Varnado, Gillian L. Hirst, Robert R. Flavell, A. Jo Chien, Douglas Yee, Claudine J. Isaacs, Andres Forero-Torres, Laura J. Esserman and Michelle E. Melisko
Background: Metastatic staging imaging is not recommended for asymptomatic patients with stage I–II breast cancer. Greater distant metastatic disease risk may warrant baseline imaging in patients with stage II–III with high-risk biologic subtypes. NCCN Guidelines recommend considering CT of the chest, abdomen, and pelvis (CT CAP) and bone scan in appropriate patients. CT CAP and bone scan are considered standard of care (SoC), although PET/CT is a patient-centered alternative. Methods: Data were available for 799 high-risk patients with clinical stage II–III disease who initiated screening for the I-SPY2 trial at 4 institutions. A total of 564 complete records were reviewed to compare PET/CT versus SoC. Costs were determined from the payer perspective using the national 2018 Medicare Physician Fee Schedule and representative reimbursements to the University of California, San Francisco (UCSF). Incremental cost-effectiveness ratio (ICER) measured cost of using PET/CT per percent of patients who avoided a false-positive (FP). Results: The de novo metastatic disease rate was 4.6%. Imaging varied across the 4 institutions (P<.0001). The FP rate was higher using SoC versus PET/CT (22.1% vs 11.1%; P=.0009). Mean time between incidental finding on baseline imaging to FP determination was 10.8 days. Mean time from diagnosis to chemotherapy initiation was 44.3 days with SoC versus 37.5 days with PET/CT (P=.0001). Mean cost per patient was $1,132 (SoC) versus $1,477 (PET/CT) using the Medicare Physician Fee Schedule, with an ICER of $31. Using representative reimbursements to UCSF, mean cost per patient was $1,236 (SoC) versus $1,073 (PET/CT) for Medicare, and $3,083 (SoC) versus $1,656 (PET/CT) for a private payer, with ICERs of −$15 and −$130, respectively. Conclusions: Considerable variation exists in metastatic staging practices. PET/CT reduced FP risk by half and decreased workup of incidental findings, allowing for earlier treatment start. PET/CT may be cost-effective, and at one institution was shown to be cost-saving. Better alignment is needed between hospital pricing strategies and payer coverage policies to deliver high-value care.