Impact of delays in initiation of adjuvant endocrine therapy and survival among patients with breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 537-537
Author(s):  
Kimberley Lee ◽  
Lisa K. Jacobs ◽  
Jodi Segal
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Endocrine Therapy ◽  
Invasive Breast Cancer ◽  
Population Level ◽  
Initial Diagnosis ◽  
Adjuvant Endocrine Therapy ◽  
Delayed Surgery ◽  
Delayed Initiation

537 Background: Time to adjuvant endocrine therapy concerns patients and clinicians, but its impact on overall survival is not clear. There are no population level studies that address this question. Our primary objective is to describe the relationship between time from diagnosis of breast cancer to start of adjuvant endocrine therapy and overall survival. Methods: This is a population-based cohort study using prospectively collected population level data from the National Cancer Database (NCDB). The NCDB prospectively collects data on incident cancer cases from over 1500 Commission on Cancer-accredited facilities nationally. NCDB captures approximately 70% of incident cases of cancer in the United States. The participants are women with Stage II and III estrogen or progesterone receptor positive, human epidermal receptor 2 negative, invasive breast cancer who underwent definitive surgical treatment. Results: Of the 391,594 women in this study, 12,162 (3.1%) began treatment with adjuvant endocrine therapy more than 12 months after initial diagnosis of hormone receptor positive, invasive breast cancer. Mean age at diagnosis was 59.7 years (SD 13.4). Predictors of delayed initiation of adjuvant endocrine therapy include Black race or Hispanic ethnicity (adjusted odds ratio [aOR] of Black vs White, 1.57; 95% CI, 1.48-1.66; P < .001, Hispanic vs White, aOR 1.22, 95% CI 1.13-1.32; P < .001), Insurance other than private insurance (Medicare vs Private, aOR 1.09, 95% CI 1.01-1.17; P = .007, Medicaid vs Private, aOR 1.36, 95% CI 1.28-1.45; P < .001), higher stage of disease at diagnosis (Stage III vs II, aOR 1.24, 95% CI 1.19-1.30; P < .001), and delayed surgery or chemotherapy (Delayed surgery vs On-time lumpectomy, aOR 2.76, 95% CI 2.60-2.93; P < .001 and Delayed chemotherapy vs no chemotherapy, aOR 11.5, 95%CI 10.6-12.5). With median follow-up of 63.2 months, 67,335 (17.2%) patients died by the end of follow-up. Delayed initiation of AET resulted in no change in the hazard of death (HR, 1.00; 95% CI, 0.95-1.05; P = .97) compared to initiation within 12 months of diagnosis after adjusting for age, race and ethnicity, insurance type, urban vs rural residence, neighborhood income and education, comorbidity, cancer grade, stage, and receipt of timely or delayed surgery, chemotherapy, and/or radiation therapy. Conclusions: These results suggest that there may be no detriment to survival if initiation of adjuvant endocrine therapy occurs 12 to 24 months after initial diagnosis compared to within 12 months of diagnosis, as currently recommended.

Disease-Related Outcomes With Long-Term Follow-Up: An Updated Analysis of the Intergroup Exemestane Study

2012 ◽  
Vol 30 (7) ◽  
pp. 709-717 ◽  
Author(s):  
Judith M. Bliss ◽  
Lucy S. Kilburn ◽  
Robert E. Coleman ◽  
John F. Forbes ◽  
Alan S. Coates ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Endocrine Therapy ◽  
Early Stage ◽  
Group Analysis ◽  
Group Versus ◽  
Post Treatment ◽  
Adjuvant Endocrine Therapy ◽  
Er Positive

Purpose Intergroup Exemestane Study (IES), an investigator-led study in 4,724 postmenopausal patients with early-stage breast cancer has demonstrated clinically important benefits from switching adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane. Now, with longer follow-up, a large number of non–breast cancer–related events have been reported. Exploratory analyses describe breast cancer–free survival (BCFS) and explore incidence and patterns of the different competing events. Patients and Methods Patients who were disease-free after 2 to 3 years of adjuvant tamoxifen were randomly assigned to continue tamoxifen or switch to exemestane to complete 5 years of adjuvant endocrine therapy. At this planned analysis, the median follow-up was 91 months. Principal analysis focuses on 4,052 patients with estrogen receptor (ER) –positive and 547 with ER-unknown tumors. Results In all, 930 BCFS events have been reported (exemestane, 423; tamoxifen, 507), giving an unadjusted hazard ratio (HR) of 0.81 (95% CI, 0.71 to 0.92; P = .001) in favor of exemestane in the ER-positive/ER unknown group. Analysis partitioned at 2.5 years after random assignment showed that the on-treatment benefit of switching to exemestane (HR, 0.60; 95% CI, 0.48 to 0.75; P < .001) was not lost post-treatment, but that there was no additional gain once treatment had ceased (HR, 0.94; 95% CI, 0.80 to 1.10; P = .60). Improvement in overall survival was demonstrated, with 352 deaths in the exemestane group versus 405 deaths in the tamoxifen group (HR, 0.86; 95% CI, 0.75 to 0.99; P = .04). Of these, 222 were reported as intercurrent deaths (exemestane, 107; tamoxifen, 115). Conclusion The protective effect of switching to exemestane compared with continuing on tamoxifen on risk of relapse or death was maintained for at least 5 years post-treatment and was associated with a continuing beneficial impact on overall survival.

Primary non-adherence to adjuvant endocrine therapy in older women with breast cancer.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 285-285
Author(s):  
Vanina Tchuente ◽  
Donna Stern ◽  
Jaroslav Prchal ◽  
Judy Martin ◽  
Robyn Tamblyn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Drug Use ◽  
Real Time ◽  
Endocrine Therapy ◽  
Surgical Care ◽  
Clinical Information ◽  
Adjuvant Endocrine Therapy ◽  
Administrative Claims ◽  
Patient Level

285 Background: Adjuvant endocrine therapy (AET) improves survival in hormone receptor positive breast cancer (HR+BC). Challenges with adherence to AET in seniors are well documented; however, there is limited knowledge on primary non-adherence (PNAD). PNAD is defined as non-initiation of a prescribed medication. Our aim is to characterize PNAD rates in women aged ≥ 65 with HR+BC and identify potential predictors, using real-time treatment information. Methods: Optimum is an e-health platform integrating real-time analysis of administrative claims data combined to patient-level clinical information on breast cancer. Optimum tracks care trajectories to identify deviations from best practice, using data from Quebec’s universal health insurance plan that covers all medical and pharmaceutical care. In this single-center feasibility study, we characterized PNAD as a non-initiation of AET within 10 days from the first prescription. Descriptive analyses were used to assess potential predictors. Results: Of the 57 patients enrolled, 9 were excluded due to lack of > 30 day follow up. In the remaining 48 patients, PNAD was 21 %. Baseline Charlson comorbidity index (0 vs 13 %), psychotropic drug use (20 % vs 26 %) and polypharmacy rate (10 % vs 11 %) were lower in PNAD patients, compared to primary-adherent patients. PNAD patients had larger average tumor size (1.8 cm vs 1.6 cm), more often overexpressing HER2NEU (10 % vs 3 %), more negative progesterone receptor (10 % vs 5 %). They also more often had lumpectomy (70 % vs 65 %), SLNB (70 % vs 58 %) and more frequent margin revisions (30 % vs 16 %). They more often received chemotherapy (30 % vs 0 %). At 30-day follow-up, 40 % of PNAD patients had not yet initiated AET. Conclusions: This study confirms the feasibility of combining real-time administrative data and patient-level clinical information to assess breast cancer quality care. PNAD in women with HR+BC was higher than expected. PNAD patients had less comorbidities and drug use, but more aggressive cancers and more often also had quality challenges with surgical care (margin revision). PNAD predictors can potentially be used to identify patients that may require additional support to optimize disease management.

scholarly journals Level of Combined Estrogen and Progesterone Receptor Expression Determines the Eligibility for Adjuvant Endocrine Therapy in Breast Cancer Patients

Cancers ◽  
2021 ◽  
Vol 13 (19) ◽  
pp. 5007
Author(s):  
Jee Hyun Ahn ◽  
Soon Bo Choi ◽  
Jung Min Park ◽  
Jee Ye Kim ◽  
Hyung Seok Park ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Progesterone Receptor ◽  
Endocrine Therapy ◽  
Adjuvant Endocrine Therapy ◽  
Receptor Expression ◽  
Breast Cancers ◽  
Breast Cancer Patients ◽  
Limited Data ◽  
Single Receptor

Hormone receptor (HR)-positive breast cancer has a heterogeneous pattern according to the level of receptor expression. Patients whose breast cancers express low levels of estrogen receptor (ER) or progesterone receptor (PgR) may be eligible for adjuvant endocrine therapy, but limited data are available to support this notion. We aimed to determine whether HR expression level is related to prognosis. Tumors from 6042 patients with breast cancer were retrospectively analyzed for combined HR levels of ER and PgR. Low expression was defined as ER 1–10% and PgR 1–20%. Four HR groups were identified by combining ER and PgR expression levels. Patients whose tumors expressed high levels of a single receptor showed the worst survival outcomes, and their risk continuously increased even after the 10-year follow-up. Endocrine therapy had a significant benefit for patients whose tumors expressed high HR levels and a favorable tendency for patients with tumors expressing low HR levels. We established the possible benefit of endocrine therapy for patients whose breast tumors expressed low HR levels. Thus, HR level was a prognostic factor and might be a determinant of extended therapy, especially for patients with high expression of a single receptor.

scholarly journals Long-Term Follow-Up of the Intergroup Exemestane Study

2017 ◽  
Vol 35 (22) ◽  
pp. 2507-2514 ◽  
Author(s):  
James P. Morden ◽  
Isabel Alvarez ◽  
Gianfilippo Bertelli ◽  
Alan S. Coates ◽  
Robert Coleman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Endocrine Therapy ◽  
Estrogen Receptor Status ◽  
Adjuvant Endocrine Therapy ◽  
Absolute Difference ◽  
Receptor Status ◽  
Estrogen Receptor Positive ◽  
The Absolute

Purpose The Intergroup Exemestane Study, an investigator-led study of 4,724 postmenopausal patients with early breast cancer (clinical trial information: ISRCTN11883920), has previously demonstrated that a switch from adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane was associated with clinically relevant improvements in efficacy. Here, we report the final efficacy analyses of this cohort. Patients and Methods Patients who remained disease free after 2 to 3 years of adjuvant tamoxifen were randomly assigned to continue tamoxifen or switch to exemestane to complete a total of 5 years of adjuvant endocrine therapy. Given the large number of non–breast cancer–related deaths now reported, breast cancer–free survival (BCFS), with censorship of intercurrent deaths, was the primary survival end point of interest. Analyses focus on patients with estrogen receptor-positive or unknown tumors (n = 4,599). Results At the time of the data snapshot, median follow-up was 120 months. In the population that was estrogen receptor positive or had unknown estrogen receptor status, 1,111 BCFS events were observed with 508 (22.1%) of 2,294 patients in the exemestane group and 603 (26.2%) of 2,305 patients in the tamoxifen group. The data corresponded to an absolute difference (between exemestane and tamoxifen) at 10 years of 4.0% (95% CI, 1.2% to 6.7%), and the hazard ratio (HR) of 0.81 (95% CI, 0.72 to 0.92) favored exemestane. This difference remained in multivariable analysis that was adjusted for nodal status, prior use of hormone replacement therapy, and prior chemotherapy (HR, 0.80; 95% CI, 0.71 to 0.90; P < .001). A modest improvement in overall survival was seen with exemestane; the absolute difference (between exemestane and tamoxifen) at 10 years in the population that was estrogen receptor positive or had unknown estrogen receptor status was 2.1% (95% CI, −0.5% to 4.6%), and the HR was 0.89 (95% CI, 0.78 to 1.01; P = .08). For the intention-to-treat population, the absolute difference was 1.6% (95% CI, −0.9% to 4.1%); the HR was 0.91 (95% CI, 0.80 to 1.03, P = .15). No statistically significant difference was observed in the proportion of patients who reported a fracture event in the post-treatment period. Conclusion The Intergroup Exemestane Study and contemporaneous studies have established that a strategy of switching to an aromatase inhibitor after 2 to 3 years of tamoxifen can lead to sustained benefits in terms of reduction of disease recurrence and breast cancer mortality.

scholarly journals Association between early discontinuation of endocrine therapy and recurrence of breast cancer among premenopausal women in a Danish population-based cohort

2020 ◽  
Author(s):  
Lindsay J Collin ◽  
Deirdre P Cronin-Fenton ◽  
Thomas P Ahern ◽  
Michael Goodman ◽  
Lauren E McCullough ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Regression Models ◽  
Cancer Recurrence ◽  
Premenopausal Women ◽  
Adjuvant Endocrine Therapy ◽  
Breast Cancer Recurrence ◽  
Time Varying ◽  
Early Discontinuation

ABSTRACTPurposePremenopausal women diagnosed with estrogen receptor (ER) positive breast cancer are prescribed 5–10 years of endocrine therapy to prevent or delay recurrence. Many women who initiate endocrine therapy fail to complete the recommended course of treatment. In this study, we evaluated the association between early discontinuation of adjuvant endocrine therapy and breast cancer recurrence in a cohort of premenopausal women.Patients and MethodsWe identified 4,503 premenopausal ER+ breast cancer patients who initiated adjuvant endocrine therapy and were registered in the Danish Breast Cancer Group clinical database (2002–2011). Women were excluded if they had a recurrence or were lost to follow-up less than 1.5 years after breast cancer surgery. Endocrine therapy was considered complete if the patient received at least 4.5 years of treatment or discontinued medication less than 6 months before recurrence. Exposure status was updated annually and modeled as a time-dependent variable. We accounted for baseline and time-varying confounders via time-varying weights, which we calculated from multivariable logistic regression models and included in regression models to estimate hazard ratios (HR) and accompanying 95% confidence intervals (CI) associating early discontinuation with breast cancer recurrence.ResultsOver the course of follow-up, 1,001 (22%) women discontinued endocrine therapy. We observed 202 (20%) recurrences among those who discontinued endocrine therapy, and 388 (11%) among those who completed the recommended treatment. The multivariable-adjusted estimated rate of recurrence was higher in women who discontinued endocrine therapy relative to those who completed their treatment (HR=1.67, 95% CI 1.25, 2.14).ConclusionThese results highlight the importance of clinical follow-up and behavioral interventions that support persistence of adjuvant endocrine therapy to prevent breast cancer recurrence.

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