Comparative Effectiveness Analysis of Monotherapy With Cytotoxic Agents in Triple-negative Metastatic Breast Cancer in a Community Setting

2015 ◽  
Vol 37 (1) ◽  
pp. 134-144 ◽  
Author(s):  
George Dranitsaris ◽  
Stefan Gluck ◽  
Claudio Faria ◽  
David Cox ◽  
Hope Rugo
2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 157-157
Author(s):  
George Dranitsaris ◽  
Stefan Glück ◽  
Claudio Faria ◽  
David Cox ◽  
Hope S. Rugo

157 Background: There has been considerable progress in treatments for MBC. However, the identification of optimal cytotoxic agents in patients with triple negative disease (negative for hormone receptors, ER/PR and HER-2) remains a therapeutic challenge. A comparative effectiveness analysis of four cytotoxic agents was conducted in patients with TN MBC. Methods: We retrospectively identified 225 patients treated with single agent eribulin (E=47), capecitabine (C=69), gemcitabine (G=56) or vinorelbine (V=53) in 19 community oncology clinics across the US. Data collection included baseline patient characteristics, performance status, duration of current therapy, growth factor use and all dose limiting toxicities. Time to treatment failure (TTF) was measured from the first cycle of chemotherapy until disease progression, discontinuation due to toxicity, or death. TTF was then estimated using the Kaplan-Meier method and Cox proportional hazard modeling adjusted for clustering on the practice site. To control for selection bias that is inherent in observational studies, a propensity score weighted TTF analysis was also conducted. Results: Patients were comparable with respect to age, performance status, duration of disease free survival, presence of comorbidities and hemoglobin level prior to the start of chemotherapy. However, the median lines of therapy for use of C, G, V and E were 2nd, 3rd, 3rd, and 4th, respectively. The median duration of treatment was approximately 2 months with C, G, and E compared to 1.6 months with V. Using eribulin as the reference and adjusting for line of therapy and associated prognostic factors, the propensity score weighted Cox regression analysis did not identify statistically significant differences in TTF: C vs. E: HR = 1.15 (0.75 to 1.76), G vs. E: HR = 0.62 (0.34 to 1.13), V vs. E: HR = 1.0 (0.60 to 1.37). Conclusions: In patients with TN-MBC treated in a community oncology setting, eribulin was utilized in later lines than other agents. However, eribulin demonstrated at least comparable drug activity even when used in more heavily pretreated patients. These findings warrant further analyses in a larger population with an evaluation of biologic heterogeneity.


2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 210-210 ◽  
Author(s):  
Monika Parisi ◽  
Corey Pelletier ◽  
Dasha Cherepanov ◽  
Michael S Broder ◽  
Nadia Noormohamed

210 Background: With the accumulation of RWD in healthcare, CER continues to expand. RWD are becoming increasingly relevant in oncology, particularly since the onset of care pathways and CMS’ Oncology Care Model pilot program; yet, CER in oncology presents several challenges as disease biology differs by cancer type and many RWD sources do not capture clinical response, progression or survival. This review examined common endpoints reported in RWD studies on CER and TxP in MBC, focusing on HER2-negative and Triple Negative (TN) MBC. Methods: PubMed (2006-January 2016) and 4 conferences (2011-January 2016)—ASCO and SABC meetings/symposiums—were searched using MeSH/keywords, e.g., metastatic breast cancer, treatment, and comparative effectiveness. RWD CER and TxP studies in U.S. patients with HER2-negative or TNMBC were included; clinical trials were excluded. Results: Of1,782 total records, 17 articles and 9 conference abstracts were included. Studies using RWD increased over time with 2 studies published in 2010, 1 in 2012, 6 in 2013, 6 in 2014, 10 in 2015, and 1 as of January 2016. Of these, 8 were CER and 18 examined TxP. Most studies were retrospective chart reviews (7 CER; 10 TxP studies), others were retrospective secondary database analyses (1 CER; 6 TxP) and physician surveys (2 TxP). RWD sources included commercial insurance claims, SEER-Medicare, and California Cancer Registry data. Nineteen studies reported results in patients with HER2-negative MBC and 7 reported in TNMBC patients. Primary endpoints included overall survival (OS), progression-free survival (PFS), and treatment duration (TD). CER studies most commonly reported TD and survival outcomes (e.g., OS, PFS), each reported in 75% of the studies. TxP studies also most commonly examined survival outcomes (61% of studies), in addition to various treatment patterns and duration outcomes. Conclusions: This literature review indicates that in parallel to the availability of RWD, published CER studies and analysis of treatment patterns have grown in the last 5 years. The most commonly reported outcomes include OS, TD and PFS.


2020 ◽  
Author(s):  
Markus Kuksis ◽  
Yizhuo Gao ◽  
William Tran ◽  
Christianne Hoey ◽  
Alex Kiss ◽  
...  

Abstract Background Patients with metastatic breast cancer (MBC) are living longer, but development of brain metastases often limits their survival. We conducted a systematic review and meta-analysis to determine the incidence of brain metastases in this patient population. Methods Articles published from January 2000 to January 2020 were compiled from four databases using search terms related to: breast cancer, brain metastasis, and incidence. The overall and per patient-year incidence of brain metastases were extracted from studies including patients with HER2+, triple negative, and hormone receptor (HR)+/HER2- MBC; pooled overall estimates for incidence were calculated using random effects models. Results 937 articles were compiled, and 25 were included in the meta-analysis. Incidence of brain metastases in patients with HER2+ MBC, triple negative MBC, and HR+/HER2- MBC was reported in 17, 6, and 4 studies, respectively. The pooled cumulative incidence of brain metastases was 31% for the HER2+ subgroup (median follow-up: 30.7 months, IQR: 24.0 – 34.0), 32% for the triple negative subgroup (median follow-up: 32.8 months, IQR: 18.5 – 40.6), and 15% among patients with HR+/HER2- MBC (median follow-up: 33.0 months, IQR: 31.9 – 36.2). The corresponding incidences per patient-year were 0.13 (95% CI: 0.10 – 0.16) for the HER2+ subgroup, 0.13 (95%CI: 0.09 – 0.20) for the triple negative subgroup, and only 0.05 (95%CI: 0.03 – 0.08) for patients with HR+/HER2- MBC. Conclusion There is high incidence of brain metastases among patients with HER2+ and triple negative MBC. The utility of a brain metastases screening program warrants investigation in these populations.


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