Direct and indirect economic evaluation of upfront and sequential adjuvant treatment in postmenopausal women with breast cancer based on the BIG 1–98 trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6594-6594
Author(s):  
C. Skedgel ◽  
D. Rayson ◽  
T. Younis

6594 Background: The monotherapy arms of the BIG 1–98 trial established the clinical superiority of upfront letrozole (LET) relative to tamoxifen alone (TAM) but direct comparison of sequential TAM-LET, LET-TAM and upfront LET did not establish a clinically superior strategy. We undertook an economic evaluation to identify an economically preferred strategy based on the relative cost-effectiveness (CE) of TAM, LET, TAM-LET, and LET-TAM in terms of cost per quality-adjusted life year gained (QALYG). Methods: A state-transition model was developed to calculate cumulative costs and QALYs over a 25yr horizon for hypothetical cohorts of postmenopausal women with HR+ breast cancer undergoing adjuvant hormonal treatment. As the sequential arms were not directly compared to TAM alone, it was not possible to directly compare all strategies. As such, the analysis conducted direct within-arm comparisons and an indirect between-arm comparison. DFS endpoints and relative DFS benefit were derived from the monotherapy and sequential arms of BIG 1–98. Adverse events were not included as these have not yet been reported. Sensitivity analyses were conducted for the key parameters and assumptions, including the baseline recurrence risk and the duration of carry-over benefit. Costs and utility weights were derived from the literature. The analysis took a Canadian direct payer perspective and drug costs were based on 2008 Canadian average wholesale prices. Costs and outcomes were discounted at 3%. Results: In the monotherapy arms LET had a CE of $16,650 relative to TAM. In the sequential arms LET-TAM had superior QALYGs and cost savings relative to LET and TAM-LET. In economic terms, LET-TAM dominated LET and TAM-LET. In the indirect comparison, LET-TAM dominated LET and TAM-LET and had superior QALYGs at increased cost relative to TAM for a CE of $178. Conclusions: Direct comparisons confirm the economic favourability of LET relative to TAM and establish the dominance of LET-TAM over LET and TAM-LET. These indirect comparisons support the strong economic favourability of LET-TAM relative to TAM in the indirect comparison. In the absence of superior clinical outcomes, economic evaluation is a useful in suggesting a preferred strategy. No significant financial relationships to disclose.

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6574-6574
Author(s):  
T. Younis ◽  
D. Rayson ◽  
C. Skedgel

6574 Background: Meta-analyses conducted by the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) demonstrated significant improvements in breast cancer (BC) outcomes associated with tamoxifen (TAM) and/or aromatase inhibitor (AI) therapy. We conducted an economic evaluation, based on these meta-analyses, to examine the cost-effectiveness (CE) of adjuvant TAM, sequential TAM-AI and upfront AI in post menopausal (PM) women with BC. Methods: A generic model was developed to calculate cumulative costs and quality adjusted life year gains (QALYG) over 25-year horizon in hypothetical cohorts of PM women with BC undergoing 5-year treatment with TAM alone, upfront AI, or sequential TAM-AI. We examined different cohorts with varying 10-year baseline recurrence risk (RR) without adjuvant hormonal treatments to reflect the natural spectrum of breast cancer disease encountered (low = 25%; average = 38%; high = 50%; very high = 75%). The efficacy outcomes were derived from the EBCTCG meta-analyses, with 10-year duration of benefit assumed for all strategies. Costs and utilities were derived from the literature, and local resources. The analysis took a direct payer perspective and reports costs in 2008 Cdn$. Costs and benefits were discounted at 3%. CE was based on the $50,000/QALY gained threshold. Adverse events were not included in the primary analysis. Sensitivity analyses were conducted. Results: Adjuvant hormonal treatments with TAM and/or AI are CE strategies in PM women with BC. The costs and QALYG associated with hormonal treatments were dependent on the baseline RR: CE estimates were more favorable in cohorts with higher as opposed to lower RR. The baseline RR also influenced the choice of the optimal economic strategy. Upfront AI was associated with higher costs and more QALY gains compared to TAM-AI. CE however was favorable in patients with average to very high RR and unfavorable in patients with low RR. Conclusions: Adjuvant treatments with TAM and/or AI are associated with favorable CE in PM women with BC. The optimal CE strategies, however, are dependent on the baseline RR without hormonal treatment. A risk-tailored hormonal treatment choice could optimize the overall health system efficiency. [Table: see text]


1995 ◽  
Vol 13 (2) ◽  
pp. 513-529 ◽  
Author(s):  
I A Jaiyesimi ◽  
A U Buzdar ◽  
D A Decker ◽  
G N Hortobagyi

PURPOSE The mechanisms of antitumor activity, clinical pharmacology, toxicity, and efficacy of tamoxifen in women with early and advanced breast cancer and the drug's potential role in prevention of breast cancer were reviewed. DESIGN A comprehensive review of the literature from 1966 to 1994 was conducted; reports were identified using the Cancerline and Medline data bases. RESULTS The cellular actions of tamoxifen are not completely understood, but it appears that the drug's antiproliferative effects are mediated primarily by inhibition of the activities of estrogen through binding to estrogen receptors (ERs). Disease-free and overall survival rates have been increased in postmenopausal women with ER-positive tumors when tamoxifen has been used as adjuvant therapy (irrespective of nodal status). In premenopausal women, adjuvant therapy with tamoxifen has been associated with prolongation of disease-free survival, but its impact on survival remains to be defined. Tamoxifen is the initial hormonal treatment of choice in both premenopausal and postmenopausal women with ER-positive metastatic disease. Retrospective review of adjuvant therapy studies showed an approximately 39% reduction in the incidence of contralateral primary breast carcinoma in tamoxifen-treated women, which indicates that tamoxifen could have a role in breast cancer prevention. CONCLUSION The use of tamoxifen has resulted in a substantial modification of breast cancer's natural history, particularly in postmenopausal women. Ongoing clinical trials will examine the effects of tamoxifen therapy on lipids, coagulation proteins, bone, and endometrium, and its effectiveness as an agent in the prevention of breast cancer.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e11504-e11504
Author(s):  
Gary Gustavsen ◽  
Brock Schroeder ◽  
Patrick Kennedy ◽  
Kristin Ciriello Pothier ◽  
Catherine A. Schnabel ◽  
...  

e11504 Background: Numerous studies have demonstrated the cost utility of gene expression-based assessment of recurrence risk in breast cancer. Cost savings rely primarily on decreased use of adjuvant chemotherapy in patients predicted to be low-risk. Breast Cancer Index (BCI) is a gene expression-based test that significantly predicts overall risk of recurrence, late (≥5y) recurrence and likelihood of benefit from extended (≥5y) endocrine therapy in patients with ER+, LN- breast cancer. This study evaluated the potential cost utility of BCI from a US third-party payer perspective. Methods: A fact-based economic model was developed which projected the cost and effectiveness of BCI in a hypothetical population of patients with ER+, LN- breast cancer compared to standard clinicopathologic diagnostic modalities. Patients flowed through the model based on patterns of care and BCI data. Costs associated with adjuvant chemotherapy, toxicity, follow-up, endocrine therapy, and recurrence were modeled over 10 yrs. Model inputs were based primarily on published literature, and supplemented by interviews with disease experts and payers. Sensitivity analyses were performed around key inputs to estimate effects on the model. Results: Use of BCI is projected to be cost saving in this patient population, with a net cost savings of $4,005 per patient tested after accounting for BCI cost. Gross cost savings were projected to be achieved through targeted use of adjuvant chemotherapy ($5,785), reduced recurrence in patients receiving extended endocrine therapy based on BCI ($2,350), and reduced recurrence in previously non-compliant patients ($370). Sensitivity analyses demonstrated that results were most sensitive to chemotherapy utilization in low- and intermediate-risk patients, cost of adjuvant chemotherapy, cost of recurrence, and percentage of patients classified as low risk. Conclusions: BCI is projected to be cost saving in an ER+, LN-, breast cancer patient population. Cost savings are achieved through projected impact on adjuvant chemotherapy use, extended endocrine therapy use, and endocrine therapy compliance. These findings require validation in additional cohorts, including studies of real-world clinical practice.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12003-e12003
Author(s):  
Cynthia Mayte Villarreal-Garza ◽  
Bertha Alejandra Martinez-Cannon ◽  
Andrea Castro-Sanchez ◽  
Alejandra Platas ◽  
Alan Fonseca ◽  
...  

e12003 Background: Young age has been associated with significantly increased risk of breast cancer (BC) death among women with luminal BC. One contributing factor might be the low rate of tamoxifen (TMX) adherence previously reported in this young group. Given that in Mexico a disproportionate rate of BC is diagnosed among YW, information regarding TMX adherence is particularly relevant. Our study's aim was to report TMX adherence in Mexican YW and its associated determinants. Methods: Consecutive patients ≤40y at diagnosis at the National Cancer Institute in Mexico City, under TMX treatment, completed a multiple-choice survey regarding the use and attitudes about hormonal therapy and adherence. Data of TMX disposal was collected from the pharmacy’s records, and the medication possession ratio (MPR) was calculated; an MPR ≥80% was considered adherent. Results: 135 YW with a median age at diagnosis of 35.7y (24-40) were included. 77% were undergraduate, 28% unpaired and 33% childless. Median follow-up was 26 months. 95% of patients reported a regular TMX intake: 70% did not miss any doses, while 25% missed 1-6 doses a month. Only 45% considered that the information received regarding TMX therapy was sufficient and for 37% was incomprehensive. 43% thought TMX significantly reduced their recurrence-risk and 60% strongly believed that they needed to be on TMX treatment. 73% of women reported adverse effects, being menopausal symptoms the most frequent, but only 27% were worried about the treatment long-term effects. From the 99 patients with a pharmacy record, 73% had an MPR > 80%. No significant factor was statistically associated with TMX adherence. Conclusions: Although Mexican YW and pharmacy data surprisingly sustained higher rates of TMX adherence compared to previous data, still a significant proportion of patients were non-adherent. Two-thirds of our patients reported having adverse effects, which might contribute to late TMX discontinuation. Since the newer recommendations of double hormonal blockade could lead to higher withdrawal rates of endocrine therapy in YW, adherence should be emphasized and closely monitored. Accordingly, hormonal treatment adherence should be a key component in the medical assessment of young luminal BC patients.


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