Use of the metastatic breast cancer progression (MBC-P) questionnaire to assess the value of progression-free survival for women with metastatic breast cancer.

While overall survival (OS) has historically been the primary endpoint for clinical trials in oncology, progression-free survival (PFS) has gained acceptance as a valuable surrogate endpoint. However, there are no known published reports about the value of PFS from the patient's perspective. We developed a questionnaire that included items regarding quality of life (QoL) and the importance of different treatment outcomes and presented hypothetical scenarios for which respondents were asked to indicate their preferences concerning treatments as they relate to PFS. 282 women with metastatic breast cancer (MBC), ranging in age from 21 to 80 years completed an online version of this questionnaire. The majority of women (66 %) had been diagnosed with MBC within the previous 3 years and 56 % had been told their MBC had progressed. When asked to rank five treatment characteristics from most important to least important, respondents ranked "extending PFS" as the second most important treatment outcome after OS. When presented with a hypothetical scenario of two women receiving different treatments, respondents preferred the treatment that resulted in longer PFS (16 vs. 12 months), even when OS and side effects were assumed to be equal. Specifically, when asked to consider which woman within the hypothetical scenario had better QoL, physical functioning, and emotional well-being, respondents more often chose the woman who experienced longer PFS (QoL: 40 vs. 6 %; physical functioning: 32 vs. 8 %; emotional well-being: 58 vs. 6 %) compared to the woman within the hypothetical scenario who had a shorter time of progression. Respondents rated their own QoL highest after being told their MBC was responding to treatment (mean score 76.6) versus after the initial diagnosis of breast cancer and MBC (68.5 and 60.3). These findings suggest that extending PFS is an important treatment outcome and, from a patient perspective, improves overall QoL, physical functioning, and emotional well-being

Identification and cost of adverse events in metastatic breast cancer in taxane and capecitabine based regimens.

PurposeWe sought to compare the economic impact of treatment-related adverse events (AEs) in patients with metastatic breast cancer (mBC) using taxane- or capecitabine-based treatment regimens as either first- or second-line (FL or SL) therapy in the US.MethodsWe used healthcare claims data from the Truven Health Analytics MarketScan® Commercial Databases to conduct a retrospective cohort study comparing the economic impact of AEs amongst taxane- and capecitabine-treated mBC patients in the US. We selected women diagnosed with mBC between 2008-2010 who received a taxane or capecitabine as first- or second-line (FL or SL) chemotherapy. Costs related to hospitalization, outpatient services, emergency department visits, chemotherapy and other medications were tabulated and combined to determine total healthcare costs. The incremental monthly costs associated with the presence of AEs compared to no AEs were estimated using generalized linear models, controlling for age and Charlson Comorbidity Index.ResultsWe identified 15,443 mBC patients meeting inclusion criteria. Adjusted total monthly costs were significantly higher in those who experienced AEs than in those without AEs in both lines of treatment (FL incremental cost: taxanes $1,142, capecitabine$1,817; SL incremental cost: taxanes $1,448, capecitabine$4,437). Total costs increased with the number of AEs and were primarily driven by increased hospitalization amongst those with AEs.ConclusionsAdverse events in taxane- or capecitabine-treated mBC patients are associated with significant increases in costs. Selecting treatment options associated with fewer AEs may reduce costs and improve outcomes in these patients

Effect of Central Nervous System Metastases on Treatment Discontinuation and Survival in Older Women Receiving Trastuzumab for Metastatic Breast Cancer

Background. Trastuzumab improves survival in HER2-positive women with metastatic breast cancer (MBC). The consequences of longer survival include a higher likelihood of additional metastases, including those in the central nervous system (CNS). The effect of CNS metastases on both trastuzumab discontinuation and survival in older patients has not been described. Patients and Methods. We used the Surveillance Epidemiology and End Results (SEER) Medicare data to identify a cohort of 562 women age 66 or older with MBC who were diagnosed between January 1, 2000 and December 31, 2005, free of CNS metastases, and initiated trastuzumab after MBC diagnosis. Time to discontinuation and time to death were analyzed using proportional hazards models. Results. Newly diagnosed CNS metastases were associated with both higher risk of trastuzumab discontinuation (relative hazard [RH] = 1.78, 95% CI 1.11–2.87) and higher risk of death (RH = 2.49, 95% CI 1.84–3.37). The incidence rate of new CNS metastases was comparable among various sites of metastasis (10.7 to 14.7 per 1,000 patient-months), except for bone which was higher (24.1 per 1,000). Conclusion. The diagnosis of CNS metastases was associated with an increase in both the likelihood of discontinuing trastuzumab therapy as well as the risk of death

Infused Therapy and Survival in Older Patients Diagnosed with Metastatic Breast Cancer who Received Trastuzumab

We used Surveillance, Epidemiology, and End Results-Medicare data (2000-2006) to describe treatment and survival in women diagnosed with metastatic breast cancer (MBC) who received trastuzumab. There were 610 patients with a mean age of 74 years. Overall, 32% received trastuzumab alone and 47% received trastuzumab plus a taxane. In multivariate analysis, trastuzumab plus chemotherapy was associated with a lower adjusted cancer mortality rate (Hazard Ratio [HR] 0.54; 95% Confidence Interval [CI] 0.39-0.74; p < .001) than trastuzumab alone among patients who received trastuzumab as part of first-line therapy. Adding chemotherapy to first-line trastuzumab for metastatic breast cancer is associated with improved cancer survival

Abstract PS9-54: Healthcare costs for metastatic breast cancer patients treated with human epidermal growth factor receptor 2 targeted agents

Abstract Background: Human Epidermal Growth Factor Receptor 2 positive (HER2+) breast cancer (BC) represents approximately 15% of early stage BC cases and is associated with a more aggressive clinical phenotype and poor prognosis with respect to most BC. Over the last decade new HER2-targeted therapies have become available that have prolonged survival for both early stage and metastatic breast cancer (mBC). However, the cost impact of these therapies has not been fully assessed in recent years. Given the evidence for major clinical benefit, it is imperative that health systems evaluate new treatments to maximize the value of health care expenditures. This study evaluated healthcare costs among mBC patients treated with HER2-targeted therapy. Methods: A retrospective cohort study using the IQVIA Real-World Data Adjudicated Claims Database (1/1/2015-7/31/2019) was conducted. Adult (≥18-years) female patients who initiated HER2-targeted therapy with evidence of mBC diagnosis in the prior year were identified. The study index date was the initiation date of the HER2-targeted agent after which, patients were required to have ≥12 months of follow-up. Annual all-cause and BC-related healthcare costs per patient (2019 USD) were computed using payer-paid amounts in the first and second year following the index date. BC-related costs were defined as costs for claims with a primary diagnosis for BC (ICD-9-CM: 174.% or ICD-10-CM: C50.%) or BC-related treatment (surgery – mastectomy or lumpectomy, HER2-targeted therapy, chemotherapy, hormone therapy, immunotherapy, and radiation). Results: 708 mBC patients treated with HER2-targeted therapy were included with a mean age (SD) of 53.2 (10.2) years and mean follow-up of about 2 years. During the follow-up period, trastuzumab (96.5%) and pertuzumab (81.2%) were the most common HER2-targeted therapies used followed by ado-trastuzumab (15.4%), neratinib (6.3%), and lapatinib (5.3%). Additionally, patients received other treatments including chemotherapy (88.0%), hormone therapy (56.6%), and radiation therapy (57.6%). Of note, 40.3% of patients underwent surgery (mastectomy or lumpectomy) following evidence of metastasis. Following initiation of HER2-targeted therapy, mean annual costs per patient in Year 1 and Year 2 were $330,784 and$196,139, respectively. Correspondingly, BC-related costs in Year 1 and Year 2 were $255,273 and$144,978, respectively. HER2-targeted therapies accounted for 72% of BC-related costs in both Year 1 and 2. Surgery patients incurred $37,822 higher BC-related costs in Year 1 compared to non-surgery patients. However, in Year 2, the opposite was noted with non-surgery patients having$70,885 higher BC-related costs, mainly due to a differences in BC treatment rates in Year 2 for HER2 targeted drugs, other BC drugs and radiation. Conclusion: Total BC-related costs of mBC patients treated with HER2-targeted therapy is highest in the first year following treatment initiation, with the main cost driver being the cost of HER2-targeted therapy. While total costs decreased in the subsequent year, the cost of HER2 targeted therapy remained the dominant component. Results of this study highlight the significant economic burden of treating HER2+ mBC and also the need for therapies that limit disease progression. Page 1 of 1 Citation Format: Reshma Mahtani, Deepa Lalla, Nina Oestreicher, Augustina Ogbonnaya, Vishal Saundankar, Joanne Willey, Anna Coutinho, Kelly McCann. Healthcare costs for metastatic breast cancer patients treated with human epidermal growth factor receptor 2 targeted agents [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-54

Investigation of Adverse‐Event‐Related Costs for Patients With Metastatic Breast Cancer in a Real‐World Setting

BACKGROUND. Existing treatments for metastatic breast cancer (mBC) are often effective but can cause adverse events (AEs). This study aimed to identify AEs associated with chemotherapies commonly used in mBC treatment (phase 1) and to quantify the economic impact of these AEs (phase 2). MATERIALS AND METHODS. Patients in phase 1 had at least one claim for therapy for mBC, with at least one episode with single or multiple agents. The most common chemotherapy-related complications were identified using medical and pharmacy claims data. In phase 2, patients meeting study criteria were divided into four treatment cohorts by the line of treatment and chemotherapy received: first-line taxane-treated patients, second-line taxane-treated patients, first-line capecitabine-treated patients, and second-line capecitabine-treated patients. Average monthly AE-related health care costs per cohort were stratified by cost component. Total monthly costs per number of AEs were also calculated. RESULTS. On average, patients in phase 1 (n = 1,551) had 2 episodes of treatment, with a mean duration of 131 days. The most frequently noted complications were anemia (50.7% of mBC treatment episodes), bilirubin elevation (26.4%), and leukopenia (24.8%). In phase 2, costs related to AEs were primarily driven by incremental inpatient, outpatient, and pharmacy costs. Increases in average monthly costs ranged from $854 (9.0$5,320 (69.5%), according to cohort. Overall costs increased with increasing numbers of AEs. CONCLUSION. Chemotherapy-related AEs in patients with mBC are associated with a substantial economic burden that increases with the number of AEs reported