Using tumor genomic profile testing and comorbidity level to personalize chemotherapy decisions among older patients with early-stage breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12055-e12055
Author(s):  
Young Chandler ◽  
Claudine Isaacs ◽  
Jinani Jayasekera ◽  
Clyde B. Schechter ◽  
Christopher Cadham ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Older Women ◽  
Early Stage ◽  
Breast Cancer Mortality ◽  
Oncotype Dx ◽  
Sensitivity Analyses ◽  
Breast Cancers ◽  
Life Years ◽  
The Impact

e12055 Background: Under-representation of women ages 65+ (“older”) in the trials may limit clinical translation of results to this growing population. We used simulation modeling to estimate chemotherapy outcomes by age and comorbidity level among older women with early stage, estrogen-receptor+/HER2- breast cancers with an Oncotype DX score of 26+. Methods: A discrete-time stochastic state-transition model synthesized data from population studies and clinical trials to estimate outcomes over a 25-year horizon for subgroups of women based on age (65-69, 70-74, 75-79, and 80-89) and comorbidity levels (no/low, moderate, and severe). Age-, comorbidity-specific non-cancer survival was derived from a random 5% sample of women enrolled in the Medicare Part A and B program from 1992 to 2005 and included in the SEER areas. Outcomes included life years (LYs), quality-adjusted life years (QALYs), and breast cancer and other-cause mortality with chemoendocrine therapy or endocrine therapy alone. Sensitivity analysis tested the impact on outcomes of varying values of uncertain parameters. Results: Women with life expectancies of ≥ 7 years had net gains of 0.17 to 0.45 LYs (2.0-5.4 months) with chemotherapy; this group was mainly women aged 65-69 and 70-74 with no/low or moderate comorbidity. Women destined to develop distant recurrence gained between 4.2-10.4 months. LYs were reduced by chemotherapy toxicity. The majority of women died of other causes, ranging from 59% to 98% across all age groups and comorbidity levels, but chemotherapy reduced breast cancer mortality by 14.5% and 25.7% among women ages 65-69 and 70-74 with no/low comorbidity, respectively. Results were robust in sensitivity analyses, and chemotherapy improved all outcomes as treatment efficacy increased, assuming no change in toxicity. Conclusions: Older women with early stage, estrogen-receptor+/HER2- breast cancers with Oncotype DX scores of 26+ may benefit from chemotherapy, when both conditions of age <75 and comorbidity at no/low or moderate level can be met. Personalized treatment decisions for older women will ultimately depend on comorbidity-specific lifespan and individual preferences for the balance of benefits and harms of chemotherapy.

scholarly journals Simulation of Chemotherapy Effects in Older Breast Cancer Patients With High Recurrence Scores

2019 ◽  
Vol 112 (6) ◽  
pp. 574-581 ◽  
Author(s):  
Young Chandler ◽  
Jinani C Jayasekera ◽  
Clyde B Schechter ◽  
Claudine Isaacs ◽  
Christopher J Cadham ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Expression Profile ◽  
Early Stage ◽  
Breast Cancer Mortality ◽  
Sensitivity Analyses ◽  
Absolute Difference ◽  
Breast Cancer Patients ◽  
Genomic Expression ◽  
Life Years

Abstract Background Tumor genomic expression profile data are used to guide chemotherapy choice, but there are gaps in evidence for women aged 65 years and older. We estimate chemotherapy effects by age and comorbidity level among women with early-stage, hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancers and Oncotype DX scores of 26 or higher. Methods A discrete-time stochastic state transition simulation model synthesized data from population studies and clinical trials to estimate outcomes over a 25-year horizon for subgroups based on age (65–69, 70–74, 75–79, and 80–89 years) and comorbidity levels (no or low, moderate, severe). Outcomes were discounted at 3%, and included quality-adjusted life-years (QALYs), life-years, and breast cancer and other-cause mortality with chemoendocrine vs endocrine therapy. Sensitivity analysis tested the effect of varying uncertain parameters. Results Women aged 65–69 years with no or low comorbidity gained 0.16 QALYs with chemo-endocrine and reduced breast cancer mortality from 34.8% to 29.7%, for an absolute difference of 5.1%; this benefit was associated with a 12.8% rate of grade 3–4 toxicity. Women aged 65–69 years with no or low or moderate comorbidity levels, and women aged 70–74 years with no or low comorbidity had small chemotherapy benefits. All women aged 75 years and older experienced net losses in QALYs with chemo-endocrine therapy. The results were robust in sensitivity analyses. Chemotherapy had greater benefits as treatment effectiveness increased, but toxicity reduced the QALYs gained. Conclusion Among women aged 65–89 years whose tumors indicate a high recurrence risk, only those aged 65–74 years with no or low or moderate comorbidity have small benefits from adding chemotherapy to endocrine therapy. Genomic expression profile testing (and chemotherapy use) should be reserved for women aged younger than 75 years without severe comorbidity.

Prospective study of the impact of using the 21-gene recurrence score assay on clinical decision making in women with estrogen receptor-positive, HER2-negative, early-stage breast cancer in France.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 568-568 ◽  
Author(s):  
Joseph Gligorov ◽  
Xavier B. Pivot ◽  
Herve L. Naman ◽  
William Jacot ◽  
Dominique Spaeth ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Early Stage ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Early Stage Breast Cancer ◽  
Treatment Recommendation ◽  
Endocrine Treatment ◽  
Estrogen Receptor Positive ◽  
The Impact

568^ Background: The 21-gene Oncotype DX Recurrence Score (RS) is a validated assay to help inform the appropriate treatment of estrogen receptor-positive (ER+), early stage breast cancer in the adjuvant setting. Treatment traditions regarding choice of adjuvant treatment vary significantly in different countries. This prospective multicenter study is the first to assess the impact of using the Oncotype DX assay in the French clinical setting. Methods: A total of 100 consecutive patients with ER+, HER2-negative, node negative or pN1 (mi) breast cancer were enrolled. Overall treatment recommendation change, change from chemoendocrine to endocrine alone and change from endocrine alone to chemoendocrine treatment were recorded. Medical oncologists completed questionnaires regarding their confidence in their recommendation before and after knowing the patient’s RS. A preliminary analysis was conducted on the first 92 evaluable patients with data available at the time of abstract submission. Final data will be presented at the meeting. Results: Prior to Oncotype DX 49% of patients were recommended chemoendocrine treatment and 51% endocrine treatment alone. After having the RS, 26% were recommended chemoendocrine treatment and 74% endocrine treatment alone. The overall reduction in chemotherapy recommendation from 49% to 26% was significant (p<0.001). Of patients originally recommended chemoendocrine treatment, 58% were changed to endocrine treatment alone after having the RS. Of patients originally recommended endocrine treatment, 11% were changed to chemoendocrine treatment after receiving the RS. There was a significant improvement in physician confidence in treatment recommendations (p=0.002) when using Oncotype DX. Conclusions: These are the first prospective data regarding the impact of using Oncotype DX in France. Using Oncotype DX was associated with a significant change in treatment decisions and an overall reduction in chemotherapy use. The data are consistent with those presented from Germany, Spain, the UK and the US.

scholarly journals Expected Monetary Impact of Oncotype DX Score-Concordant Systemic Breast Cancer Therapy Based on the TAILORx Trial

2019 ◽  
Vol 112 (2) ◽  
pp. 154-160 ◽  
Author(s):  
Angela Mariotto ◽  
Jinani Jayasekerea ◽  
Valentina Petkov ◽  
Clyde B Schechter ◽  
Lindsey Enewold ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Oncotype Dx ◽  
Sensitivity Analyses ◽  
Estimation Methods ◽  
Breast Cancers ◽  
Hormone Receptor Positive ◽  
Initial Care ◽  
Personalized Cancer ◽  
The Impact ◽  
Care Costs

Abstract Background TAILORx demonstrated that women with node-negative, hormone receptor-positive, HER2-negative breast cancers and Oncotype DX recurrence scores (RS) of 0–25 had similar 9-year outcomes with endocrine vs chemo-endocrine therapy; evidence for women aged 50 years and younger and RS 16–25 was less clear. We estimated how expected changes in practice following the trial might affect US costs in the initial 12 months of care (initial costs). Methods Data from Surveillance, Epidemiology, and End Results (SEER), SEER-Medicare, and SEER-Genomic Health Inc datasets were used to estimate Oncotype DX testing and chemotherapy rates and mean initial costs pre- and post-TAILORx (in 2018 dollars), assuming all women received Oncotype DX testing and score-suggested therapy posttrial. Sensitivity analyses tested the impact on costs of assumptions about compliance with testing and score-suggested treatment and estimation methods. Results Pretrial mean initial costs were $2.816 billion. Posttrial, Oncotype DX testing costs were projected to increase from $115 to $231 million and chemotherapy use to decrease from 25% to 17%, resulting in initial care costs of $2.766 billion, or a net savings of $49 million (1.8% decrease). A small net savings was seen under most assumptions. The one exception was if all women aged 50 years and younger with tumors with RS 16–25 elected to receive chemotherapy, initial care costs could increase by $105 million (4% increase). Conclusions Personalizing breast cancer treatment based on tumor genetic profiles could result in small cost decreases in the initial 12 months of care. Studies are needed to evaluate the long-term costs and nonmonetary benefits of personalized cancer care.

Impact of disruptions in breast cancer control due to the COVID-19 pandemic on breast cancer mortality in the United States: Estimates from collaborative simulation modeling.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6562-6562
Author(s):  
Oguzhan Alagoz ◽  
Kathryn P. Lowry ◽  
Allison W. Kurian ◽  
Jeanne S. Mandelblatt ◽  
Mehmet Ali Ergun ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Mortality ◽  
Early Stage ◽  
Breast Cancer Mortality ◽  
Cancer Control ◽  
The United States ◽  
Sensitivity Analyses ◽  
The Impact ◽  
Excess Deaths ◽  
Breast Cancer Control

6562 Background: The COVID-19 pandemic has disrupted breast cancer control through short-term declines in screening, delays in diagnosis and reduced/delayed treatments. We projected the impact of COVID-19 on future breast cancer mortality.Methods: Three established Cancer Intervention and Surveillance Modeling Network (CISNET) models projected the impact of pandemic-related care disruptions on breast cancer mortality between 2020 and 2030 vs. pre-pandemic care patterns. Based on Breast Cancer Surveillance Consortium data, we modeled reductions in mammography screening utilization, delays in symptomatic cancer diagnosis, and reduced use of chemotherapy for women with early-stage disease for the first six months of the pandemic with return to pre-pandemic patterns after that time. Sensitivity analyses were performed to determine the effect of key model parameters, including the duration of the pandemic impact. Results: By 2030, the models project 1,297 (model range: 1,054-1,900) cumulative excess deaths related to reduced screening; 1,325 (range: 266-2,628) deaths from delayed diagnosis of symptomatic women, and 207 (range: 146-301) deaths from reduced chemotherapy use for early-stage cancer. Overall, the models predict 2,487 (range 1,713-4,875) excess deaths, representing a 0.56% (range: 0.36%-0.99%) cumulative increase over deaths that would be expected by 2030 in the absence of the pandemic’s disruptions. Sensitivity analyses indicated that the impact on mortality would approximately double if the disruptions lasted for a 12-month period. Conclusions: The impact of the initial pandemic-related disruptions in breast cancer care will have a small long-term cumulative impact on breast cancer mortality. The impact of the initial pandemic-related disruptions on breast cancer mortality will largely be mitigated by the rapid return to usual care. As the pandemic continues it will be important to monitor trends in care and reassess the mortality impact.[Table: see text]

Comparing practice patterns and outcomes for early-stage hormone receptor-positive and node-positive breast cancer patients with high-intermediate-risk Oncotype Dx scores in the National Cancer Database.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12520-e12520
Author(s):  
Keerthi Tamragouri ◽  
Ethan M. Ritz ◽  
Ruta D. Rao ◽  
Cristina O'Donoghue
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Predictive Value ◽  
Practice Patterns ◽  
Early Stage ◽  
Oncotype Dx ◽  
Breast Cancer Patients ◽  
Node Positive ◽  
The Impact ◽  
Positive Breast Cancer

e12520 Background: Oncotype Dx (ODX) is a commercial diagnostic test primarily used to predict the likely benefit from chemotherapy in ER+, HER2-, and node negative breast cancer. The prognostic value (recurrence risk) has also been demonstrated to apply to early stage lymph node positive (LN+) disease in a number of retrospective and prospective studies. The ongoing RxPONDER trial aims to clarify the predictive value of RS in LN+ population. In light of the initial results, we analyzed the practice patterns and outcomes for HR+/Her2 -/node positive breast cancer patients receiving ODX testing in the years from 2010-2017 with RS 14-25 in a retrospective observational study of the NCDB. Methods: Women with HR+/Her2 -/node positive breast cancer receiving ODX testing from 2010-2017 were identified in the NCDB using TAILORx and RxPONDER patients’ inclusion criteria: ages 18-75, 6-50mm invasive tumors, N1, M0, ER+/HER2 -. The impact of ODX results in the high-intermediate range (14-25) and other clinico-pathologic variables on the receipt of chemotherapy were compared. Additionally, we examined the impact of chemotherapy on overall survival (OS). Frequencies, Kaplain-Meier analysis, and changepoint analysis using the Contal and O’Quigley method were utilized. Results: There were 109,652 T1-2 and N1 patients of whom 32,506 (29.6%) received ODX testing. 13,461 (41.4%%) women had scores in the high-intermediate (14-25) range. The majority tended to have only 1 LN involved (1LN: 77.2%, 2LNs: 17.5%, 3LNs: 5.3%), had a mean age of 57.8y, were Caucasian (86.4%), and were preferentially tested at academic or comprehensive community cancer programs (79.2%). 6,610 (49.3%) patients were recommended chemotherapy, the median ODX score for all women who were recommended chemotherapy was 20 compared to 17 for those whom chemotherapy was not recommended. 5,068 (76.7%) women had documentation of receiving chemotherapy which correlated with improved OS regardless of age. Conclusions: In the group of women with HR+/Her2 -/node positive breast cancer, clinicians appear to utilize ODX testing in less than one-third of patients, possibly finding RS to be most useful in guiding adjuvant therapy recommendations when only 1LN is involved. Both the recommendation and receipt of chemotherapy correlated linearly with increasing RS, as expected based on the current NCCN guideline recommendations. We identified an OS benefit when chemotherapy was administered, regardless of patient age. Long-term follow-up in the RxPONDER trial will likely continue to clarify the predictive value of RS < 25 in the ER+/HER2-/node positive breast cancer population.

Hormonal Therapy for the Treatment of Postmenopausal Breast Cancer Patients

2008 ◽  
Vol 21 (1) ◽  
pp. 36-45
Author(s):  
Rebecca E. Greene ◽  
Vivian Tsang
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Postmenopausal Women ◽  
Hormonal Therapy ◽  
Early Stage ◽  
Postmenopausal Breast Cancer ◽  
Breast Cancers ◽  
Breast Cancer Patients ◽  
Hormone Receptor Positive ◽  
Receptor Modulator

Breast cancer is the most common cancer diagnosed and the second leading cause of cancer-related death in women. The majority of breast cancers diagnosed in postmenopausal women are hormone receptor positive and involve therapy with hormonal agents. Tamoxifen, a selective estrogen-receptor modulator, has been the mainstay of hormonal therapy since the 1970s. The more recent approval and success of aromatase inhibitors, such as anastrozole, letrozole, and exemestane, have seen these agents move to the front line of therapy for postmenopausal women with hormone-positive breast cancer in the adjuvant and metastatic settings. Fulvestrant, a selective estrogen receptor— downregulator, provides an additional hormonal therapy with a novel mechanism of action. This article reviews the current literature available regarding the use of these agents for postmenopausal women with early stage or advanced breast cancer.

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