Subjective cognitive complaints one year after ceasing adjuvant endocrine therapy for early-stage breast cancer: Findings from the Breast International Group (BIG) 1-98 trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9022-9022
Author(s):  
Kelly-Anne Phillips ◽  
Karin Ribi ◽  
Julie Aldridge ◽  
Alastair Mark Thompson ◽  
Vernon J. Harvey ◽  
...  

9022 Background: We have previously reported that, in the BIG 1-98 trial, objective cognitive function improved in postmenopausal women one year after cessation of adjuvant endocrine therapy for breast cancer. Here we evaluate changes in subjective cognitive function (SCF). Methods: One hundred postmenopausal women, randomized to receive five years of adjuvant tamoxifen, letrozole, or sequences of both, completed self-reported measures on SCF, psychological distress, fatigue and quality of life during the fifth year of trial treatment (year 5) and one year after treatment completion (year 6). Changes between years 5 and 6 were evaluated using the Wilcoxon signed-rank test. SCF and its correlates were explored. Results: Mean age of participants was 63.9 years [SD=7.1 years]. SCF and the other patient-reported outcomes did not change significantly after cessation of endocrine therapy with the exception of improvement in hot flushes (p=0.0005). No difference in changes was found between women who were taking tamoxifen or letrozole at year 5. SCF was the only psychosocial outcome with a substantial correlation between year 5 and 6 (Spearman’s R=0.80). Correlations between SCF and the other patient-reported outcomes were generally low. Conclusions: Although objective cognitive function improved after cessation of adjuvant endocrine therapy in the BIG 1-98 trial, improvement in SCF was not evident. The underlying reason for the clear disconnect between objective and subjective cognitive function seen in this and most other studies, is a crucial issue. It should be a research priority in order to effectively tackle the concerns of women about their cognition during and after breast cancer treatment.

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.


2009 ◽  
Vol 20 (3) ◽  
pp. 431-436 ◽  
Author(s):  
V. Ziller ◽  
M. Kalder ◽  
U.-S. Albert ◽  
W. Holzhauer ◽  
M. Ziller ◽  
...  

2020 ◽  
Vol 182 (2) ◽  
pp. 259-266
Author(s):  
Daniel Reinhorn ◽  
Rinat Yerushalmi ◽  
Assaf Moore ◽  
Alexandra Desnoyers ◽  
Ramy R. Saleh ◽  
...  

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. LBA528-LBA528
Author(s):  
H. T. Mouridsen ◽  
A. Keshaviah ◽  
L. Mauriac ◽  
J. Forbes ◽  
R. Paridaens ◽  
...  

LBA528 Background: The Primary Core Analysis (PCA) of BIG 1–98 comparing letrozole (L) to tamoxifen (T) as initial adjuvant endocrine therapy showed that L significantly prolonged disease-free survival (DFS), particularly reducing the risk of relapse in distant sites, compared with T for postmenopausal women with endocrine-responsive breast cancer (BC). The aim of the Second Primary Analysis (SPA) is to compare L and T given in sequence vs. alone. On Mar 15, ‘06, the Data Safety Monitoring Committee (DSMC) will review the results of the 2nd interim analysis of the SPA. We will present safety and efficacy data from this analysis if the DSMC recommends release of the results. Methods: 8028 women were randomized upfront to Tx5 years (yrs) (A), Lx5 (B), Tx2→Lx3 (C), or Lx2→Tx3 (D); 1835 to the 2-arm option of the study (arm A vs. B; Mar ’98 - Mar ‘00) and 6193 to the 4-arm option (arm A vs. B vs. C vs. D; Apr ’99 - May ‘03). The primary endpoint was DFS (time from randomization to first occurrence of invasive BC recurrence, invasive contralateral BC, second non-breast malignancy, or death from any cause). The SPA is comprised of two pair-wise comparisons: arm A vs. C and B vs. D. Only 4-arm patients (pts) alive and disease-free at 2 yrs after study entry (corresponding to the treatment switch for arms C and D) are included. These analyses will determine if the risk of an event beyond 2 yrs is reduced by switching agents. Additional exploratory analyses based on all events and follow-up (FU) for 4-arm pts will be conducted, including the comparison of arm B vs. C. The final SPA is planned for Feb ‘08, after 662 events. In Jan ‘05, the 1st interim efficacy analysis was presented to the DSMC, after 162 events among 3641 pts (excluding those who had an event within 2 yrs or did not yet have at least 2 yrs of FU). The median SPA FU (from 2 yrs after study entry) was 11.1 months. The 2nd interim efficacy analysis will be presented to the DSMC on Mar 15, ‘06 based on data received as of a Dec 21, ‘05. Results: Conclusions: No significant financial relationships to disclose.


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