Background: National Comprehensive Cancer Network breast cancer guidelines suggest optimized sequencing of endocrine therapy prior to chemotherapy use for patients who are HR+/HER2-, but it is unclear how those recommendations translate into clinical practice. This study examined sequencing of endocrine and chemotherapy treatment to better understand real-world treatment patterns for HR+/HER2- advanced breast cancer. Methods: This retrospective study examined physician-reported clinical data on patients with breast cancer (BC) linked to medical and pharmacy claims (2008-2012) from a large national US health plan. Patients included in the study had HR+ and HER2- status. Advanced cancer cohorts included patients who were stage IV (SIV) at initial diagnosis, or who developed metastases following initial diagnosis (MET). The first date of diagnosis of advanced cancer or date of metastases following initial diagnosis was designated as index date. Health plan enrollment for 3 months pre- and ≥12-months post- index date was required; patients who died within 12 months after index date and were continuously enrolled were retained. A 3-month baseline period assessed prior treatment; variable post-index follow-up (until disenrollment or Oct 2012) assessed patterns of endocrine and chemotherapy. Results: Of 317 MET patients, 50% initiated chemotherapy after index date without prior endocrine treatment (CH). Remaining patients (OT) used only endocrine therapy (30%), endocrine therapy prior to chemotherapy (17%), or neither endocrine nor chemotherapy (3%). Compared with OT patients, CH patients were younger (50 vs. 55 years, P<0.001) and progressed faster to metastasis after initial BC diagnosis (243 vs. 1633 days, P<0.001). Although CH patients in the MET group had slightly higher comorbidity prior to their metastatic index date, they had lower levels of any non-lymph node metastases (14% vs. 48%, P<0.001) and visceral metastases (5% vs. 16%, P = 0.001) during follow-up. Among MET patients, 92% of CH patients initiated endocrine therapy during follow-up; endocrine therapy started a mean of 235 days after metastatic index date, compared with a mean starting date for chemotherapy of 41 days post-metastatic index date. In the MET group, 55% of CH later initiated treatment with aromatase inhibitors, compared with 64% of OT patients (P = 0.104). Results were similar in newly diagnosed SIV (n = 71) group: 48% had no evidence of endocrine treatment prior to initiating chemotherapy, and remaining patients used only endocrine therapy (27%), had endocrine therapy prior to chemotherapy (21%), or neither therapy (4%). Conclusions: In this population of patients with HR+/HER2- advanced breast cancer, a large proportion initiated chemotherapy without prior endocrine therapy. This group of patients might otherwise benefit from a longer progression free period with tolerable toxicity from endocrine therapy. Further investigation of whether a subgroup of these patients started chemotherapy in the adjuvant setting is warranted. For those starting chemotherapy without prior endocrine therapy, understanding treatment sequencing and patient characteristics will help illuminate the extent to which patterns adhere to NCCN guidelines. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-14-03.
Background: Little is known about real-world outcomes for patients with HR+/HER2- advanced breast cancer. This study examined mortality outcomes, and in particular variations across patients with different stages of cancer and different sequencing of endocrine and chemotherapy treatments. Methods: This retrospective study linked medical and pharmacy claims (2008-2012) from a large national US health plan with a proprietary clinical cancer database containing physician-reported clinical data on patients with breast cancer. Patients included in the study had HR+ and HER2- status, and had stage III (S3) or IV (S4) cancer at initial diagnosis, or had developed metastases following initial diagnosis (MET). The first date of diagnosis of advanced cancer or the first date of metastases following initial diagnosis was designated as the index date. Health plan enrollment for 3 months pre- and ≥12-months post- index date was required; patients who died within 12 months after index date and were continuously enrolled in the health plan were retained. A 3-month baseline period assessed prior treatment; a variable follow-up (until disenrollment or 31 Oct 2012) assessed patterns of endocrine and chemotherapy treatments following the index date. Patient mortality was identified via a combination of Social Security mortality data and patient hospital discharge status from claims data. Chi-square tests compared proportions and t-tests compared means. Results: The study population included 263 S3, 71 S4, and 317 MET patients. Average age at index date was 51.9 years for S3, 54.4 years for SIV, and 52.8 years for MET patients (P = 0.080). Over the entire observable follow-up, 3.4% of S3 (17 per 1000 patient-years), 22.5% of S4 (119 per 1000 patient years), and 10.7% of MET patients (22 per 1000 patient years) died (P≤0.010 for comparisons). Mortality over the 1-year after index date was 1.1%, 12.7%, and 5.1% in the S3, S4, and MET groups respectively (P<0.001). Patients who died in the first year after index date survived on average until 5.8 months (S3), 4.5 months (S4), and 7.3 months (MET) following the metastatic index date. Among MET patients, mean time to death from initial breast cancer diagnosis was 35.7 months for MET patients without endocrine treatment prior to chemotherapy (n = 157), and 76.1 months for other MET patients (n = 160) (P = 0.002). For S4 patients without endocrine treatment prior to chemotherapy (n = 34), patients survived an average of 10.0 months from initial advanced breast cancer diagnosis while the remaining S4 patients (n = 37) survived an average of 14.8 months. Conclusions: Among patients with HR+/HER2- advanced breast cancer, mortality rates varied by stage of disease, and length of survival varied across patients pre-treated with endocrine therapy prior to chemotherapy compared with other patients. Further investigation of drivers behind differences in mortality may reveal the extent to which initial disease severity and sequencing of chemotherapy and endocrine therapy drive these variations. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-06-09.
Background: Little is known about health care costs and health services utilization of patients with HR+/HER2- advanced breast cancer, particularly in relation to the order in which patient receive endocrine and chemotherapy treatments. Methods: A proprietary database with physician-reported clinical data on patients with breast cancer was linked to medical and pharmacy claims (2008-2012) from a national US health plan. Patients included in the study had HR+ and HER2- status. Advanced cancer included stage III or IV (SIV) at initial diagnosis, or developed metastases following initial diagnosis. The first date of advanced cancer diagnosis or date of metastases following initial diagnosis was designated as the index date. Health plan enrollment for 3 months pre- and ≥12-months post- index date was required; patients who died within 12 months after index date and were continuously enrolled were retained. A 3-month baseline period assessed prior treatment; variable follow-up (until disenrollment or 31 Oct 2012) assessed patterns of endocrine and chemotherapy treatments following index date. All-cause and cancer-specific health care utilization and paid costs were assessed over 12-months following index date. Costs were calculated as per-patient-per-month (PPPM), and utilization measured as rates per patient-month. Cancer-related medication costs included drug costs for endocrine, chemotherapy, targeted therapy, and treatments for pain or chemotherapy-induced nausea/ vomiting. In addition, costs for anti-cancer systemic therapies (chemotherapy, endocrine, and targeted therapy) were calculated PPPM including costs for medication administration. Results: Of 651 study patients, 65% initiated chemotherapy prior to initiating endocrine therapy (CH). Remaining patients (OT) either had no chemotherapy (n = 132 endocrine only, n = 16 neither endocrine nor chemotherapy), or used endocrine therapy prior to chemotherapy (n = 77). Compared with OT, the CH group had more office (4.04 vs. 2.68 visits, P<0.001) and outpatient hospital visits (3.08 vs. 2.10 visits, P<0.001). In addition, 56% of CH vs. 41% of OT had inpatient hospital admissions during the follow-up (P<0.001; rate ratio 0.97, P = NS). Similarly, 60% of CH patients were admitted to emergency rooms vs. 51% of OT (P = 0.033; rate ratio 1.01, P = NS). Mean total all-cause health care costs varied ($11,525 CH vs. $8,196 OT, P<0.001). The largest source of difference in costs were office visits (mean $3,257 CH vs. $1,896 OT, P<0.001), and outpatient hospital ($5,813 CH vs. $3,721 OT, P<0.001). Cancer-related costs comprised the majority of costs (mean $10,249 CH vs. $7,118 OT, P<0.001). The CH group had higher mean cancer-related medication costs than the OT group ($2,051 vs. $1,405 respectively, P = 0.040). Overall mean anti-cancer systemic therapy costs (including administration) were higher in the CH than OT group ($2,934 vs. $1,875, P = 0.012). Conclusions: Among HR+/HER2- advanced breast cancer patients, health care utilization and costs were higher for patients who initiated chemotherapy prior to endocrine therapy compared to other patients. Further investigation of the drivers behind these differences is warranted. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-06-08.
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