Abstract P3-09-17: One year of adjuvant hormone therapy does not increase patient fatigue: Results of a prospective early stage breast cancer trial

Author(s):  
EE Lower ◽  
D Kennedy ◽  
P Adams
2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12065-e12065
Author(s):  
Christian A. Thomas

e12065 Background: Adjuvant hormone therapy is a crucial part of the treatment for patients with early stage breast cancer and an important quality measure for programs such as QOPI and the oncology care model (OCM). However, it is not known which factors influence some patients with early stage breast cancer to decline adjuvant hormone therapy. We hypothesized that specific self-reported symptoms might impact a patient’s decision to accept or decline adjuvant hormone therapy. Methods: Patients with stage 0 or I breast cancer were identified by chart review from 2011-2016 and de-identified. On the day patients received a recommendation for adjuvant treatment the following patient reported outcome measures (PROs) were analyzed: difficulty sleeping (DS), fatigue (F), mood (M such as anxiety and depression), and pain (P) on a 0-4 symptom scale based on CTCAE v. 4. PROs were then linked with a patient’s decision to accept or decline adjuvant therapy. Results: A total of 287 patients with stage 0 (n = 80) or stage I (n = 207) breast cancer were identified. 38 stage O and 103 stage I patients had evaluable PROs on the same day a recommendation for adjuvant hormone therapy was made. Overall 18/38 (47.4%) of stage 0 patients and 90 of 103 (87.4%) of stage I patients accepted adjuvant treatment. Stage 0 patients declining adjuvant therapy reported any grade of PROs: DS (40%, n = 8), F (35%, n = 7), M (35%, n = 7), P (20%, n = 4). Stage 0 patients accepting treatment reported: DS (22%, n = 4), F (44%, n = 8), M (6%, n = 1), P (20%, n = 4). Stage I patients who declined treatment reported: DS (54%, n = 7), F (46%, n = 6), M (38%, n = 5), P (62%, n = 8). Stage I patients accepting treatment reported: DS (41%, n = 37), F (49%, n = 44), M (31%, n = 28), P (36%, n = 32). Conclusions: Early stage breast cancer patients declining adjuvant hormone therapy are more likely to self report symptoms such as difficulty sleeping, mood disturbances (anxiety, depression), and pain than those accepting treatment.


2006 ◽  
Vol 21 (2) ◽  
pp. 111-122
Author(s):  
R. Longo ◽  
M.R. D'Andrea ◽  
G. Gasparini

For the past 15 years tamoxifen has been the standard adjuvant hormone therapy for women with early-stage breast cancer and estrogen receptor (ER)-positive tumors, irrespective of nodal status and other clinicopathological parameters. Recent studies provided evidence that the optimal duration of tamoxifen treatment is 5 years. Based on the positive clinical results obtained with the administration of aromatase inhibitors (AIs) in the metastatic setting, several controlled clinical trials have evaluated the efficacy and side effects of AIs versus standard tamoxifen also as adjuvant therapy in postmenopausal breast cancer patients. The results of the above studies, suggest a therapeutic advantage of AIs over tamoxifen with regard to relapse-free survival and the risk of metachronous contralateral breast cancer. We review the rationale and the available clinical data on initial or sequential hormone treatment with AIs and we propose a novel scenario for possible therapeutic strategies based on the clinicopathological characteristics of the patients and on the biology of each single tumor.


2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 11-11
Author(s):  
Danielle Lindsay LaMorte ◽  
Katherine E. Hartmann ◽  
Vandana Gupta Abramson ◽  
Ingrid A. Mayer ◽  
Nancy Walker Peacock ◽  
...  

11 Background: Aromatase inhibitors (AIs) are standard of care for adjuvant endocrine therapy (AET) to prevent recurrence of early stage breast cancer in postmenopausal women. Previous AET adherence research has focused on the 25-96% adherence observed with, but more information is needed about AI adherence, especially regarding the role of arthralgia (joint pain or stiffness) in AET changes. Our objective was to understand AET changes within a year of AI initiation. Methods: We examined AET switching (either to another AI or to tamoxifen), overall changes in AET (including switching and temporary or permanent discontinuation), and physician- and patient-reported arthralgia, using data abstracted from medical records and self-administered surveys among 93 patients initiating AI. We conducted Chi-square and Wilcoxon univariate analyses. Results: Anastrazole was initially prescribed to 64 patients (69%), letrozole to 28 patients (30%), and exemestane to 1 patient. A year after AI initiation, 64 patients (69%) had no change in AET. Among the 29 patients (31%) who had an AET change, 14 switched to at least one other AI, 11 switched to tamoxifen, 9 temporarily discontinued AET, and 7 entirely discontinued AET (categories not mutually exclusive). Average time to first AET switch was 182.7 days. Average number of AET switches was 1.4. Arthralgia was the most common reason for AET changes, noted in the records of 19 patients (66% of those who changed AET). Patients who changed AET reported more severe arthralgia (median pain from 0-10 among 8 joint groups =1.4, interquartile range [IQR]=0.3-2.6) at week 12 than those who did not (median=0.3, IQR=0-1.1), p=0.03. A higher proportion (46%) of the 28 patients who initiated with letrozole changed AET due to arthralgia, compared with 20% of the 64 patients who initiated with anastrazole (p=0.01). Conclusions: A substantial proportion of women initiating AI change AET over one year. Arthralgia appears to play a key role in AET changes, particularly for letrozole as compared with anastrazole. More longitudinal patient-reported arthralgia data are needed to guide clinical decision making about AI initiation and AET changes.


Circulation ◽  
2017 ◽  
Vol 135 (suppl_1) ◽  
Author(s):  
Hsin-Hui Huang ◽  
Emma Barinas-Mitchell ◽  
Brenda Diergaarde ◽  
Chung-Chou Chang ◽  
Marnie Bertolet

Introduction: Adjuvant hormone therapy prolongs survival of patients with early-stage hormone receptor-positive breast cancer (BC). For postmenopausal patients, aromatase inhibitors (AIs) have been shown to improve disease free survival compared to tamoxifen, but the impact on overall survival has been inconsistent. A meta-analysis showed higher risk of cardiovascular diseases (CVDs) for patients taking AIs. Deteriorating lipids induced by AIs may contribute to this result. This analysis aims to compare the effects of hormone therapeutic options on changes in lipids from published randomized clinical trials (RCTs). Methods: RCTs evaluating effects of adjuvant hormone therapy on lipids (total cholesterol, high-density lipoprotein cholesterol (HDLc), low density lipoprotein cholesterol (LDLc), and/or triglycerides) in postmenopausal early-stage BC patients published in PubMed and Embase, prior to Jan. 31, 2016 were reviewed. Bayesian network meta-analysis was used to compare effects of placebo, selective estrogen receptor modulators (SERMs- tamoxifen and toremifene) and AIs (letrozole, anastrozole, and exemstane) on lipids across longitudinal time points. Heterogeneity was examined by meta-regressions adjusting for mean age, baseline lipid value, and prior tamoxifen use. An arm-based random effect model tested the consistency of the direct and indirect evidence of the drug effects. Results: We identified 17 articles from 13 RCTs for a total of 1,913 subjects. The Table summarizes the results, with statistically significant results bolded. Toremifene significantly improved all lipids and was the best choice regardless of covariate adjustment, while tamoxifen had weaker but significant LDLc lowering but opposite HDLc/triglyceride effects to toremifene. AIs generally had little effect on lipids. Conclusions: In general, AIs tend to have worse effects on lipids than SERMs, while only toremifene had beneficial effects on all lipid values. Patients on AIs with high risk of CVD should monitor their lipids.


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