scholarly journals Everolimus-Based Therapy versus Chemotherapy among Patients with HR+/HER2− Metastatic Breast Cancer: Comparative Effectiveness from a Chart Review Study

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Nanxin Li ◽  
Yanni Hao ◽  
Jipan Xie ◽  
Peggy L. Lin ◽  
Valerie Koo ◽  
...  

Objective. To compare the real-world effectiveness of everolimus-based therapy and chemotherapy in postmenopausal women with hormone-receptor-positive/human-epidermal-growth-factor-receptor-2-negative (HR+/HER2−) metastatic breast cancer (mBC).Methods. This retrospective chart review examined a nationwide sample of postmenopausal HR+/HER2− mBC women in community-based oncology practices. Patients received everolimus-based therapy or chemotherapy for mBC between 07/01/2012 and 04/15/2013, after failure of a non-steroidal aromatase inhibitor. Overall survival (OS), progression-free survival (PFS), and time on treatment (TOT) were compared using Kaplan-Meier analysis and Cox proportional hazards models adjusting for line of therapy and baseline characteristics.Results. 234 and 137 patients received everolimus-based therapy and chemotherapy. Patients treated with everolimus-based therapy tended to have less aggressive mBC than patients treated with chemotherapy. Multivariate-adjusted Cox models showed that everolimus-based therapy was associated with significantly longer OS [hazard ratio (HR) = 0.37, 95% confidence interval (CI): 0.22–0.63], PFS (HR = 0.70, 95% CI = 0.50–0.97), and TOT (HR = 0.34, 95% CI: 0.25–0.45) than chemotherapy. Adjusted comparative effectiveness results were generally consistent across lines of therapy.Conclusion. In this retrospective chart review of postmenopausal HR+/HER2− mBC patients, treatment with everolimus-based therapy was associated with longer OS, PFS, and TOT than chemotherapy.

2020 ◽  
pp. 500-513 ◽  
Author(s):  
Gabrielle B. Rocque ◽  
Aidan Gilbert ◽  
Courtney P. Williams ◽  
Kelly M. Kenzik ◽  
Arie Nakhmani ◽  
...  

PURPOSE Sequential drug treatments in metastatic breast cancer (MBC) are disparate. Clinical trial data includes limited reporting of treatment context, primarily including the number of prior therapies. This study evaluates the relationship between prior treatment time, prior lines of treatment, and survival using a novel visualization technique coupled with statistical analyses. PATIENTS AND METHODS This retrospective cohort study used a nationwide, de-identified electronic health record–derived database to identify women with hormone receptor–positive, human epidermal growth factor receptor 2–negative MBC diagnosed in 2014 who subsequently received paclitaxel. Images were created, with individual patients represented on the y-axis and time, on the x-axis. Specific treatments were represented by colored bars, with Kaplan-Meier curves overlaying the image. Separate images assessed progression-free survival and overall survival (OS). Hazard ratios (HRs) and 95% CIs from Cox proportional hazards models evaluated the association between prior treatment time and OS. RESULTS Of 234 patients, median survival from first paclitaxel administration was 20 months (interquartile range, 8-53 months). An inverse relationship was observed between OS after paclitaxel and timing of administration. In adjusted models, each year on treatment prior to paclitaxel was associated with a 16% increased hazard of death after paclitaxel (HR, 1.16; 95% CI, 1.05 to 1.29). CONCLUSION OS after a specific treatment is dependent on when a drug is given in the disease context, highlighting the potential for an overall OS benefit to be observed on the basis of treatment timing. Prior time on treatment should be considered as a stratifying factor in randomized trials and a confounding factor when examining survival in observational data.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11525-e11525 ◽  
Author(s):  
Josefa Ferreiro ◽  
Abigail Ruiz de Lobera ◽  
Aintzane Sancho ◽  
Sergio Carrera ◽  
Ines Marrodan ◽  
...  

e11525 Background: Antiangiogenic therapies such as bevacizumab (BV), have proven to be effective in improving outcomes in metastatic disease from several tumor types. For metastatic breast cancer (MBC), combinations of BV and established chemotherapy regimens potentially offer new, more efficacious treatments without the significant toxicity associated with combining multiple cytotoxic agents. Methods: This is a retrospective chart review that reflects Hospital of Cruces experience with BV in combination with chemotherapy in patients with MBC. Demographic and treatment data were collected from diagnosis and follow-up period. Results: A total of 66 patients were included. Median age was 53(34-78) years. ECOG PS 0/1/2/3 was 35%/51.5%/10.5%/3%, respectively. Positive hormone receptor (66.7%) and negative hormone receptor (33.3%). Her2 negative and triple negative were 100% and 33.3% of the patients. Adjuvant treatment received was 81.8% chemotherapy and 56.1% hormone therapy. Most frequent metastasis locations: bone (68%), liver 54.5%, lymph nodes (51.5%) and lung (27.3%). Thirty-five patients reported two or 3 metastasis locations. Chemotherapy used with BV was docetaxel (68.2%) and paclitaxel (31.8%). Median of BV courses was 6 (1-20). Response rate was 57.5% (53% partial response) and 28.8% had stable disease. Median Progression Free Survival (PFS) was 11.7 months and median OS was 19.7 months. Statistical differences were observed between patients who received a maintenance therapy with BV vs patients who received no maintenance therapy (PFS: 9.34 vs 15.36 months, p<0.001; OS: 13.81 vs 25.56 months, p<0.001). Most frequent toxicities 3/4 were: neutropenia 31.8%, febrile neutropenia 21.2%, asthenia 21.2%, infection 9.1% and onycholysis 6.1%. Conclusions: BV in combination with chemotherapy improves clinical benefit in terms of increased PFS and OS in first-line treatment of metastatic breast cancer. Maintenance with BV revealed statistical differences. Toxicity profile was manageable and as expected for BV.


2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 158-158 ◽  
Author(s):  
Rex W. Force ◽  
Brooke A. Pugmire ◽  
Gary Binder ◽  
Cindy Duval ◽  
Deya Corzo ◽  
...  

158 Background: Taxanes in metastatic breast cancer (mBC) have demonstrated clinical benefits but have different toxicity profiles. This study evaluated differences in time to discontinuation (D/C) between taxanes overall and by specific events associated with D/C (i.e., death, adverse events (AE), subsequent therapy). Methods: Women receiving >1 dose of either paclitaxel (P), docetaxel (D), or nab-paclitaxel (nab-P) between 2006-2009 were identified by ICD-9 codes indicative of mBC from a commercial payer claims database. Logistic regression and Cox-proportional hazards models were used to compare rates of D/C and time to D/C, respectively. Control variables were age, use of prior or concurrent chemo, and comorbidity score. Drug D/C was defined as no taxane administration for 35 days. AE within 35-days after D/C were considered taxane-associated. Death or disenrollment from the insurance plan within 90 days and initiation of subsequent therapy within 60 days after D/C were considered temporally associated with D/C. Results: 4,503 pts with mBC were included (2,599 received D; 1,643 received P, and 261 received nab-P). The most common reason for D/C in all pts was AEs (37.8%), initiation of subsequent therapy (34.4%), and death or disenrollment (8.4%). A higher proportion of pts on D (29.4%) and P (17.5%) had D/C due to neutropenia vs nab-P (6.9%, p<0.001 for both comparisons). A higher proportion of pts on nab-P (12.3%) continued on therapy until death/disenrollment vs D (8.9%, p 0.046) or P (7.1%, p 0.023). Similarly, a higher proportion of pts on nab-P (51.2%) initiated subsequent therapy at D/C of taxane vs D (31%) or P (37.3%; p<0.01 for both comparisons). Median time to D/C was 85 days for each of D and P, and 127 days for nab-P (p<0.05). Median time to D/C associated with AEs, neutropenia, death/disenrollment or subsequent therapy were significantly longer for nab-P compared with D or P (p<0.05). Conclusions: Women treated for mBC stayed on nab-P therapy 50% longer than with other taxanes. This time on therapy advantage also indicated that pts on nab-P were less likely to D/C due to AEs, more likely to stay on therapy, and more likely to be candidates for subsequent therapies.


2015 ◽  
Vol 9 ◽  
pp. BCBCR.S30771
Author(s):  
Yan Song ◽  
Yanni Hao ◽  
Alexander R. Macalalad ◽  
Peggy L. Lin ◽  
James E. Signorovitch ◽  
...  

Objective To describe patient profiles and clinical outcomes associated with first-line endocrine monotherapy (ET) and chemotherapy (CT) for postmenopausal HR+/HER2– metastatic breast cancer (mBC) patients. Methods This is a retrospective chart review of 139 postmenopausal HR+/HER2– mBC patients initiating first-line ET monotherapy or CT. Overall survival (OS) was described using Kaplan–Meier curves. Exploratory comparative proportional hazards regression was conducted. Results Patients on first-line CT had significantly more frequent liver metastases than patients on first-line ET monotherapy at baseline. The median OS was 35.5 months [95% confidence interval (CI), 22.7–41.2 months] for patients on first-line ET monotherapy and 22.2 months (95% CI, 13.6–25.9 months) for those on first-line CT ( P = 0.021). Adjusting for baseline characteristics, the OS between first-line ET monotherapy and CT was not significantly different. Conclusions Patients who were prescribed CT as first-line treatment had evidence of more advanced disease at baseline and shorter OS than those who received ET monotherapy as first-line treatment, suggesting a need for additional safe and effective treatment options for these patients.


2019 ◽  
Vol 17 (2) ◽  
pp. 141-147 ◽  
Author(s):  
Jing Xi ◽  
Aabha Oza ◽  
Shana Thomas ◽  
Foluso Ademuyiwa ◽  
Katherine Weilbaecher ◽  
...  

Background: Cyclin-dependent kinase (CDK) 4/6 inhibitors are now the standard of care for hormone receptor–positive (HR+), HER2-negative (HER–) metastatic breast cancer (MBC). However, guidelines are lacking regarding their optimal sequencing with other available agents. This study examines physician practice patterns and treatment outcomes of palbociclib and subsequent therapies in a real-world setting. Methods: A retrospective chart review was conducted for consecutive patients with MBC who received palbociclib between February 2015 and August 2017 at the Alvin J. Siteman Cancer Center. Kaplan-Meier method was used to generate time-to-event curves and estimate median progression-free survival (mPFS). Log-rank test was used to compare differences. Results: A total of 200 patients, with a median age of 59.4 years and a follow-up of 19.5 months, were included. Palbociclib was most frequently combined with letrozole (73.5%), followed by fulvestrant (25%), anastrozole (1%), and tamoxifen (0.5%). Most patients received palbociclib in the endocrine-resistant setting (n=42, n=50, and n=108 in the first-, second-, and subsequent-line settings, respectively), and the fraction of patients receiving palbociclib as first- or second-line therapy increased in recent months (P=.0428). mPFS was 20.7, 12.8, and 4.0 months with palbociclib administered in the first-, second-, and subsequent-line settings, respectively (P<.0001). Incidences of grade 3/4 neutropenia (41.5%) and dose reductions (29%) were comparable to reports in the literature. Among patients whose disease progressed on palbociclib (n=104), the most frequent next-line treatment was capecitabine (n=21), followed by eribulin (n=16), nab-paclitaxel (n=15), and exemestane + everolimus (n=12). mPFS with hormone therapy alone or in combination with targeted agents (n=32) after first-, second-, and subsequent-line palbociclib was 17.0, 9.3, and 4.2 months, respectively (P=.04). mPFS with chemotherapy (n=70) was not reached, 4.7, and 4.1 months after first-, second-, and subsequent-line palbociclib, respectively (P=.56). Conclusions: Palbociclib is effective for HR+/HER2– MBC in real-world practice. Hormone therapy alone or in combination with targeted agents remains an effective option after palbociclib progression.


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