Improved use of clinical variables for prognosis of distant recurrence in patients with ER+ breast cancer treated with 5 years endocrine therapy.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 566-566
Author(s):  
Ivana Sestak ◽  
Belinda Yeo ◽  
Andrew Dodson ◽  
Mitch Dowsett ◽  
Jack M. Cuzick
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Distant Recurrence ◽  
Clinical Variables

scholarly journals Development and Validation of a Simulation Model–Based Clinical Decision Tool: Identifying Patients Where 21-Gene Recurrence Score Testing May Change Decisions

2021 ◽  
pp. JCO.21.00651
Author(s):  
Jinani Jayasekera ◽  
Joseph A. Sparano ◽  
Suzanne O'Neill ◽  
Young Chandler ◽  
Claudine Isaacs ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Simulation Model ◽  
Endocrine Therapy ◽  
External Validation ◽  
Recurrence Score ◽  
Clinical Decision ◽  
Recurrence Risk ◽  
Distant Recurrence ◽  
Decision Tool ◽  
Life Years

PURPOSE There is a need for industry-independent decision tools that integrate clinicopathologic features, comorbidities, and genomic information for women with node-negative, invasive, hormone receptor–positive, human epidermal growth factor receptor-2–negative (early-stage) breast cancer. METHODS We adapted an extant Cancer Intervention and Surveillance Modeling Network simulation model to estimate the 10-year risk of distant recurrence, breast cancer–specific mortality, other-cause mortality, and life-years gained with chemoendocrine versus endocrine therapy. We simulated outcomes for 1,512 unique patient subgroups based on all possible combinations of age, tumor size, grade, and comorbidity level; simulations were performed with and without 21-gene recurrence scores (RSs). Model inputs were derived from clinical trials, large US cohort studies, registry, and claims data. External validation was performed by comparing results to observed rates in two independent sources. We highlight results for one scenario where treatment choice may be uncertain. RESULTS Chemoendocrine versus endocrine therapy in a 65-69-year-old woman with a small (≤ 2 cm), intermediate-grade tumor, and mild comorbidities provides a 1.3% absolute reduction in 10-year distant recurrence risk, with 0.23 life-years gained. With these tumor features, a woman like this will have a 28% probability of having an RS 16-20, 18% RS 21-25, and 11% RS 26+. If testing is done, and her RS is 16-20, chemoendocrine therapy reduces 10-year distant recurrence risk to 1%, with 0.20 life-years gained, a similar result as without testing. The absolute benefits would increase to 4.8%-5.5% if the RS was 26+. The model closely reproduced observed rates in both independent data sets. CONCLUSION Our validated clinical decision tool is flexible, readily adaptable to include new therapies, and can support discussions about genomic testing and early breast cancer treatment.

Cholesterol, Cholesterol-Lowering Medication Use, and Breast Cancer Outcome in the BIG 1-98 Study

2017 ◽  
Vol 35 (11) ◽  
pp. 1179-1188 ◽  
Author(s):  
Signe Borgquist ◽  
Anita Giobbie-Hurder ◽  
Thomas P. Ahern ◽  
Judy E. Garber ◽  
Marco Colleoni ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Early Stage ◽  
Cancer Recurrence ◽  
Disease Free Survival ◽  
Distant Recurrence ◽  
Cholesterol Lowering ◽  
Hormone Receptor Positive ◽  
Cholesterol Levels ◽  
Free Interval

Purpose Cholesterol-lowering medication (CLM) has been reported to have a role in preventing breast cancer recurrence. CLM may attenuate signaling through the estrogen receptor by reducing levels of the estrogenic cholesterol metabolite 27-hydroxycholesterol. The impact of endocrine treatment on cholesterol levels and hypercholesterolemia per se may counteract the intended effect of aromatase inhibitors. Patients and Methods The Breast International Group (BIG) conducted a randomized, phase III, double-blind trial, BIG 1-98, which enrolled 8,010 postmenopausal women with early-stage, hormone receptor–positive invasive breast cancer from 1998 to 2003. Systemic levels of total cholesterol and use of CLM were measured at study entry and every 6 months up to 5.5 years. Cumulative incidence functions were used to describe the initiation of CLM in the presence of competing risks. Marginal structural Cox proportional hazards modeling investigated the relationships between initiation of CLM during endocrine therapy and outcome. Three time-to-event end points were considered: disease-free-survival, breast cancer–free interval, and distant recurrence–free interval. Results Cholesterol levels were reduced during tamoxifen therapy. Of 789 patients who initiated CLM during endocrine therapy, the majority came from the letrozole monotherapy arm (n = 318), followed by sequential tamoxifen-letrozole (n = 189), letrozole-tamoxifen (n = 176), and tamoxifen monotherapy (n = 106). Initiation of CLM during endocrine therapy was related to improved disease-free-survival (hazard ratio [HR], 0.79; 95% CI, 0.66 to 0.95; P = .01), breast cancer–free interval (HR, 0.76; 95% CI, 0.60 to 0.97; P = .02), and distant recurrence–free interval (HR, 0.74; 95% CI, 0.56 to 0.97; P = .03). Conclusion Cholesterol-lowering medication during adjuvant endocrine therapy may have a role in preventing breast cancer recurrence in hormone receptor–positive early-stage breast cancer. We recommend that these observational results be addressed in prospective randomized trials.

SOLE (Study of Letrozole Extension): A phase III randomized clinical trial of continuous vs intermittent letrozole in postmenopausal women who have received 4-6 years of adjuvant endocrine therapy for lymph node-positive, early breast cancer (BC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 503-503 ◽  
Author(s):  
Marco Colleoni ◽  
Weixiu Luo ◽  
Per Karlsson ◽  
Jacqueline H. Chirgwin ◽  
Stefan Paul Aebi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Lymph Node ◽  
Postmenopausal Women ◽  
Endocrine Therapy ◽  
Distant Recurrence ◽  
Adjuvant Endocrine Therapy ◽  
Node Positive ◽  
Free Interval ◽  
Lymph Node Positive

503 Background: In animal models of hormone receptor positive (HR+) breast cancer, acquired resistance to continued letrozole was shown to be reversed by estrogen-induced apoptosis. Sensitization to reintroduction of estrogen withdrawal by letrozole was hypothesized to improve treatment outcome. SOLE tested the hypothesis that 3 mos treatment-free intervals during extended adjuvant therapy will improve disease-free survival (DFS). Methods: SOLE enrolled 4884 postmenopausal women with HR+ lymph node-positive BC who had completed 4-6 yrs of adjuvant endocrine therapy (19% SERM, 43% AI, 38% both; stratification factor). Pts were randomly assigned to an additional 5 yrs continuous letrozole (2.5 mg daily; n = 2441) vs 5 yrs intermittent letrozole (taken for the first 9 mos of yrs 1-4, and 12 mos in yr 5; n = 2443). The primary endpoint was DFS (randomization until invasive local, regional, distant recurrence or contralateral BC; 2nd malignancy; death). Final analysis was at 665 DFS events, after 2 interim analyses. SOLE required 4800 pts for 80% power to detect a 20% DFS hazard reduction with 2-sided α = 0.05 using a stratified log rank test. Analysis is by intention-to-treat. Results: At 60 mos median follow-up, 5 yr DFS from randomization was 85.8% vs 87.5% for patients assigned intermittent vs continuous letrozole (HR = 1.08; 95% CI 0.93-1.26; P = 0.31). Similar outcome was observed for breast cancer-free interval (HR = 0.98; 95% CI 0.81-1.19), distant recurrence-free interval (HR = 0.88; 95% CI 0.71-1.09), and overall survival (HR = 0.85; 95% CI 0.68-1.07). AEs of grade > 3 were reported for 43.5% vs 41.6% of pts assigned intermittent vs continuous letrozole. Overall 24% pts discontinued letrozole early in both groups. Conclusions: Among postmenopausal women with HR+ BC, extended intermittent letrozole did not improve DFS vs continuous letrozole. The similar observed outcomes and incidence of AEs provides clinically relevant information on the intermittent administration of extended letrozole for patients who could benefit from temporary treatment breaks. Clinical trial information: NCT00553410.

scholarly journals 1577 Using CTS5 Calculator to Predict The 5-10-Year Risk of Late Distant Recurrence for Women With ER-Positive Breast Cancer Who Are Recurrence-Free 5 Years After Endocrine Therapy and To Reduce the Number of Patients Needing Discussion for The Extended Endocrine Therapy in The Breast MDTs: A Quality Improvement Project

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
S Ahmed ◽  
P Kiruparan ◽  
D Debnath
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Maximum Level ◽  
Distant Recurrence ◽  
Evidence Based ◽  
Breast Cancer Patients ◽  
Improvement Project ◽  
Number Of Patients ◽  
Er Positive ◽  
Extended Endocrine Therapy

Abstract Introduction The increasing number of patients has created a pressure on the services provided that aim to ensure the maximum level of care, particularly MDT meetings. Using the CTS5 calculator can readily reduce the number of patients needing discussion for EET. This is will prevent delays in decisions made for patients and more importantly, an evidence-based tool will be used for more accurate results. Method A retrospective data collection was undertaken from the Breast MDT records, initially dating from January to December 2018. Then when the optional use of CTS5 was established, data were retrieved from August to October 2019. As per guidance for the use of the CTS5 calculator; Women were deemed low risk if their 5–10-year risk is less than 5%, intermediate if between 5–10%, and high risk if their 5–10-year risk is more than 10%. Finally, a prospective data collected from January to March 2020 where an agreement was made for all involved Surgeons to use the CTS5 calculator. Results Before Introducing the CTS5 Calculator, in 2018, the number of patients was 1523 from which 66 were for EET 4.3%. When CTS5 Calculator was first introduced, 1st of August - 31st October 2019, the percentage reduced to 4.1% and from January to March 2020, a further reduction 3.9% was noticed. Conclusions The CTS5 calculator is an effective evidence-based tool used to predict the risk of 5-10 years recurrence in breast cancer patients. Implementing it will reduce the number of patients needing discussion in Breast MDTs, sparing meetings’ and patients’ time.

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