Real-world practice patterns in treatment of metastatic breast cancer in Washington State.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13038-e13038
Author(s):  
Poorni Manohar ◽  
Hannah M. Linden ◽  
Joshua A. Roth ◽  
Vicky Wu ◽  
Catherine R. Fedorenko ◽  
...  

e13038 Background: Evidence-based, national guidelines for the management of metastatic breast cancer (MBC) recommend numerous treatment options that do not capture the nuances of real-world practice. Disparities may exist across Washington State with financial implications for patients and health systems. The objective of this study was to assess practice patterns around treatment of ER+/HER2- MBC in actual clinical practice. Methods: We collaborated with Hutchinson Institute for Cancer Outcomes Research (HICOR) to link enrollment and insurance claims records with Washington State cancer registries from 2008-2017. Our cohort comprised of women >18 years old with de novo ER+/HER2- MBC who met enrollment criteria in one of four payors (Premera, Regence, Medicare, or Medicaid). We identified receipt of first line treatment, categorized as CDK4/6 inhibitors plus endocrine therapy (CDKi+ET), chemotherapy (CT), or endocrine therapy alone (ET). We examined factors influencing treatment selection using Fisher's and Kruskal-Wallis tests. Total costs (defined as costs from inpatient and outpatient claims one year after diagnosis) was estimated for patients and payors. Results: We identified 140 patients with de novo ER+/HER2- MBC with median age of 64 (range 28-95). The majority of the cohort were Caucasian (90%) with the rest comprising of Asian, Black, American Indian, and Hispanic patients. Based on the Rural Urban Commuting Area (RUCA) classification, patients predominantly lived in metropolitan neighborhoods (96%). Over 20% of patients lived in areas of high deprivation (area of deprivation index, ADI, 8-10). Patients had either Commercial (40.7%), Medicaid/Medicare (43.6%) or multiple (15.7%) insurance. Our data show that 17 patients (12%) received first line therapy with CDKi + ET, 64 patients (46%) with CT, and 59 patients (42%) with ET alone. Factors influencing treatment selection include age, co-morbidity score, and payor type. Older patients (>65 years old) were more likely to receive ET alone compared to younger patients (56% vs 44%, p value <0.001). Patients with high co-morbidity score were more likely to receive ET (30%) compared to CT (5%) or CDKi + ET (23%), p value <0.001. Patients with commercial insurance made up over 50% of patients in our cohort who received CDKi +ET, while Medicare-insured patients were most likely to receive ET alone (p value <0.001). We estimated the mean cost of receiving first line therapy with CDKi +ET ($20,368 and $175,932), CT ($10,624 and $117,847) and ET alone ($13,292 and $60,338) for patients and payors, respectively (costs inflated to December 2019). Conclusions: Our study shows substantial variation across Washington state in treatment selection and costs for patients with metastatic breast cancer in the first-line setting. Our findings demonstrate the need for initiatives to standardize quality of care relative to clinical guidelines in metastatic breast cancer care.

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. LBA671-LBA671 ◽  
Author(s):  
Karen A. Gelmon ◽  
Frances Boyle ◽  
Bella Kaufman ◽  
David Huntsman ◽  
Alexey Manikhas ◽  
...  

LBA671 Background: The relative efficacy of L vs T when combined with Tax chemotherapy in the first-line setting of metastatic breast cancer (BC) is unknown. Methods: MA.31 compares Tax-based therapy, paclitaxel 80mg/m2 wkly or docetaxel 75mg/m2 3 wkly for 24 wks in combination with L or T. The L dose was 1,250 mg po daily with Tax followed by 1,500 mg daily (LTax/L). After a loading dose, the T dose was 2 mg/kg wkly or 6 mg/kg 3 wkly + Tax followed by T 6 mg/kg 3 wkly (TTax/T). Stratification was by prior neo/adjuvant HER2 therapy, prior neo/adjuvant Tax, planned Tax (paclitaxel vs docetaxel), and liver metastases. The primary endpoint is ITT progression-free survival (PFS), defined as time from randomization to objective progressive disease based on RECIST criteria or death from any cause. The protocol-specified IA was performed after observing 333 PFS events; the trial was to stop if the 2-sided p-value from the stratified log-rank test was less than 0.03. The NCIC CTG’s independent DSMC reviewed IA results and recommended disclosure because the superiority boundary was crossed. A secondary analysis utilized central laboratory-confirmed HER2 + status. Results: Between July 17 2008 and Dec 1 2011, 652 pts were accrued. Data from 636 pts (525 HER2 centrally confirmed) were included in the IA with clinical cutoff date of Nov 7 2011 and database lock of Apr 13 2012. Median follow-up was 13.6 mos, 12.9 mos for LTax/L pts and 14.0 mos for TTax/T patients. In the ITT analysis, PFS was inferior with LTax/L compared to TTax/T hazard ratio (HR) =1.33; 95% CI 1.06-1.67; p=0.01. LTax/L had median PFS 8.8 mos (95% CI 8.3-10.6) compared to TTax/T 11.4 mos (95% CI 10.8-13.7). PFS in the centrally confirmed HER2+ had HR 1.48 (95%CI 1.15-1.92; p=0.003) (LTax/L to TTax/T). No difference in overall survival was detected (LTax/L to TTax/T) HR= 1.1 (95% CI 0.75-1.61; p=0.62). More grade 3-4 diarrhea and rash was observed with LTax/L (p<0.001). Conclusions: LTax/L therapy is associated with a shorter PFS compared to TTax/T as first line therapy for HER2+ metastatic BC. ClinicalTrials.gov: NCT00667251. CCSRI grant: 021039. Supported by GlaxoSmithKline.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1003-1003
Author(s):  
Zhongyu Yuan ◽  
Jia-Jia Huang ◽  
Xin Hua ◽  
Jian-Li Zhao ◽  
Ying Lin ◽  
...  

1003 Background: For metastatic breast cancer with hormone receptor-positive and HER2-positive, no evidence showed that which first-line regimens were preferred, either anti-HER2 therapy plus endocrine therapy or anti-HER2 therapy plus chemotherapy. This study aimed to determine whether trastuzumab plus endocrine therapy is as efficacious as trastuzumab plus chemotherapy and with decreased toxic effects. Methods: We conducted an open-label, non-inferiority, phase 3, randomized, controlled trial at nine hospitals in China. Patients with hormone receptor-positive and HER2-positive histologically confirmed advanced breast cancer were randomly assigned (1:1) to receive trastuzumab plus chemotherapy (CT group) or endocrine therapy (ET group). The primary endpoint was progression-free survival with a non-inferiority upper margin of 1.35 for the hazard ratio (HR). This trial is registered with ClinicalTrials.gov, number NCT01950182. Results: Between Sep 16, 2013, and Dec 28, 2019, 392 patients were enrolled and randomly assigned to receive trastuzumab plus endocrine therapy (n = 196) or trastuzumab plus chemotherapy (n = 196). In the intention-to-treat population, the median PFS was 14.8 months (95% CI 12.8-16.8) in the CT group and 19.2 months (95% CI 16.7-21.7) in the ET group (HR 0.88, 95% CI 0.71-1.09; Pnon-inferiority < 0.0001). Significantly higher frequency of toxicities were observed in CT group compared with ET group, including: leucopenia (98 [50%] vs 13 [6.6%]), nausea (93 [47%] vs 24 [12%]), fatigue (47 [24%] vs 31 [16%]), vomiting (45 [23%] vs 12 [6%]), headache (65 [33%] vs 24 [12%]) and alopecia (125 [64%] vs 8 [4%]). No patients died from treatment-related causes. Conclusions: Trastuzumab plus endocrine therapy was non-inferior to and had decreased toxicities to trastuzumab plus chemotherapy in patients with metastatic breast cancer with hormone receptor-positive and HER2-positive. Trastuzumab plus endocrine therapy could provide more convenient treatment and allow better treatment tolerance. Clinical trial information: NCT01950182 .


2021 ◽  
Author(s):  
Jennifer A Ligibel ◽  
Luke Huebner ◽  
Hope S Rugo ◽  
Harold J Burstein ◽  
Debra L Toppmeyer ◽  
...  

Abstract Background Obesity and inactivity are associated with increased risk of cancer related- and overall mortality in breast cancer, but there are few data in metastatic disease. Methods CALGB 40502 was a randomized trial of first-line taxane-based chemotherapy for patients with metastatic breast cancer. Height and weight were collected at enrollment. After 299 patients enrolled, the study was amended to assess recreational physical activity (PA) at enrollment using the Nurses’ Health Study Exercise Questionnaire. Associations with progression-free survival (PFS) and overall survival (OS) were evaluated using stratified Cox modeling (strata included hormone receptor status, prior taxane, bevacizumab use, and treatment arm). Results 799 patients were enrolled and at the time of data lock, median follow-up was 60 months. At enrollment, median age was 56.7 years, 73.1% of participants had hormone receptor-positive cancers, 42.6% had obesity, and 47.6% engaged in less than 3 metabolic equivalents of task (MET)-hours of PA/week (&lt;1 hour of moderate PA). Neither baseline body mass index nor PA was statistically significantly associated with PFS or OS, although there was a marginally statistically significant increase in PFS (hazard ratio = 0.83, 95% confidence interval [CI] = 0.79, 1.02; p = .08) and OS (hazard ratio = 0.81, 95% CI = 0.65, 1.02; p = .07) in patients who reported PA greater than 9 MET-hours/week vs 0–9 MET-hours/week. Conclusions In a trial of first-line chemotherapy for metastatic breast cancer, rates of obesity and inactivity were high. There was no statistically significant relationship between body mass index and outcomes. More information is needed regarding the relationship between PA and outcomes.


2010 ◽  
Vol 10 (4) ◽  
pp. 313-317 ◽  
Author(s):  
Juan de la Haba-Rodriguez ◽  
Rosario González Mancha ◽  
Gumersindo Pérez Manga ◽  
Enrique Aranda Aguilar ◽  
José Manuel Baena Cañada ◽  
...  

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