Practice patterns in the use of adjuvant therapy for post-menopausal early-stage breast cancer in the pre- and post-Oncotype DX era.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e21032-e21032
Author(s):  
Asma Latif ◽  
Alexander C. Small ◽  
Erin L. Moshier ◽  
Kerin B. Adelson ◽  
George Raptis ◽  
...  

e21032 Background: Personalized oncology offers the promise of selectively applying therapeutics to patients most likely to benefit, while sparing those unlikely to benefit from potentially toxic therapies. Oncotype DX is a 21-gene assay utilized to identify hormone-receptor positive (HR+), node negative, breast cancer (Br CA) patients who may be successfully treated with adjuvant hormonal therapy alone. We hypothesized that practice patterns with adjuvant therapy have changed since the commercial availability of Oncotype DX in 2004. Methods: The Public National Cancer Database was queried to identify patients age ≥ 50 with stage I or II Br CA diagnosed from 2000 to 2008. Patients were classified by adjuvant therapy including hormone, chemotherapy, hormone and chemotherapy, and no hormone or chemotherapy. Log-binomial regression was used to estimate prevalence ratios for the proportion of patients receiving adjuvant therapies from 2000-2003 compared to 2004-2008. Results: 833,018 patients age ≥ 50 with stage I or II Br CA were identified. The application of adjuvant therapies for the periods pre- and post-availability of Oncotype DX are detailed in the Table. Conclusions: There has been significant increase (13%) in the use of hormonal therapy alone as adjuvant therapy for patients age ≥ 50 with HR+ stage I-II Br CA since commercial availability of Oncotype DX. While this has been slightly offset by a decrease in the use of chemotherapy plus hormonal therapy, there has been a larger decrease in the use of “no adjuvant therapy”. Data regarding predictive biomarkers should be captured by registries in an effort to determine the true impact of these tests on treatment utilization. [Table: see text]

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12520-e12520
Author(s):  
Keerthi Tamragouri ◽  
Ethan M. Ritz ◽  
Ruta D. Rao ◽  
Cristina O'Donoghue

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.


2006 ◽  
Vol 24 (6) ◽  
pp. 872-877 ◽  
Author(s):  
Linda C. Harlan ◽  
Limin X. Clegg ◽  
Jeffrey Abrams ◽  
Jennifer L. Stevens ◽  
Rachel Ballard-Barbash

Purpose We describe trends in the use of chemotherapy and hormonal therapy by nodal and estrogen receptor (ER) status in women with early-stage breast cancer. Methods Cases were randomly sampled from the population-based Surveillance, Epidemiology and End Results (SEER) program and physician verified treatment was examined. A total of 9,481 women, aged 20 years and older, diagnosed with early-stage breast cancer in 1987 to 1991, 1995, and 2000 were included in the study. Results The use of chemotherapy plus tamoxifen increased between 1995 and 2000 for women with node-negative, ER-positive breast cancer ≥ 1 cm (8% to 21%). Nearly 23% of women with node-negative and ER-positive tumors ≥ 1 cm received no adjuvant therapy. The use of chemotherapy alone increased to nearly 60% in women with node-negative, ER-negative tumors ≥ 1 cm (48% to 59%). However, in 2000, 16% of women with node-positive and ER-negative tumors received no adjuvant therapy and an additional 6% received tamoxifen alone. The influence of age can clearly be seen. Chemotherapy is given much less often in women 70 years or older. Conclusion The results from SEER areas across the United States suggest that physicians quickly responded to publications and guidelines regarding breast cancer therapy. The lack of definitive findings from clinical trials on the use of adjuvant therapy in women 70 years and older may explain the lower use in this group of women.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18590-e18590
Author(s):  
Tess King ◽  
Catherine R. Fedorenko ◽  
Li Li ◽  
Rachel Lynn Yung

e18590 Background: The use of platinum agents (PT) in neoadjuvant chemotherapy (CTX) for triple negative breast cancer (TNBC) has been debated in research and practice guidelines. In high risk patients, the addition of PT to standard anthracycline and taxane regimens improves pathological complete response without definitive evidence of survival benefit (Korde JCO 2021). Due to PT’s toxicities and unclear benefit in early stage breast cancer, this study aimed to elucidate the real world practice patterns of PT use and overuse in breast cancer patients. Methods: The cohort was defined as women with stage I-III TNBC (ER, PR, and Her2 negative) who received curative intent surgery between 2011-2018. We utilized the Hutchinson Institute for Cancer Outcomes Research (HICOR) database, which links enrollment and claims records from commercial and public health insurance plans with clinical information from Washington state cancer registries (Manohar JACR 2020). We hypothesized there was overuse of PT CTX in this cohort. Overuse was defined as PT use in stage I, in the adjuvant period (NCCN 2020), and in nonstandard CTX regimens (PT use without taxane and anthracycline (NCCN 2020)). Results: Of the 910 women in the cohort, average age was 63, 90% were white, 682 (75%) received CTX, and 36% had commercial insurance, versus 53% with public insurance (Medicare 45%, Medicaid 8%). Of those receiving CTX, 39% received neoadjuvant and 67% adjuvant. Of those receiving CTX, 85 (13%) received PT, and 28 (4%) received PT without anthracycline. Of those receiving PT, 20% had stage I disease, and of those receiving adjuvant CTX, 43 (9%) received PT in the adjuvant period. Conclusions: We found there was overuse and nonstandard use of PT in this real world data. This overuse was demonstrated by the fact that 20% of women receiving PT had low risk stage I disease, and 9% of women receiving adjuvant CTX received PT in the adjuvant period. Additionally, there was nonstandard use, with 4% of women getting CTX receiving PT without anthracycline. Next steps in this research are to evaluate factors influencing overuse and nonstandard use, as well as complication rates with PT use and overuse.[Table: see text]


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.


1997 ◽  
Vol 15 (6) ◽  
pp. 2338-2344 ◽  
Author(s):  
E Guadagnoli ◽  
C Shapiro ◽  
J H Gurwitz ◽  
R A Silliman ◽  
J C Weeks ◽  
...  

PURPOSE To assess whether the use of adjuvant systemic therapy in postmenopausal women with early-stage breast cancer is influenced by patient age. METHODS A retrospective cohort study based on data collected from medical records and from patients and their surgeons was performed among 746 postmenopausal patients diagnosed with early-stage breast cancer at 30 hospitals located throughout Minnesota. The adjusted odds of receiving hormonal therapy, chemotherapy, and both hormonal therapy and chemotherapy as a function of age was determined. RESULTS Among women with negative lymph nodes, 62% received some form of adjuvant drug therapy. For these women, the likelihood of receiving hormonal therapy or both hormonal therapy and chemotherapy did not vary with patient age and the likelihood of receiving chemotherapy declined with age. Among women with positive lymph nodes, 92% received some form of adjuvant therapy. For these women, the likelihood of receiving hormonal therapy increased with age and the likelihood of receiving chemotherapy declined with age, as did the likelihood of receiving both hormonal therapy and chemotherapy. CONCLUSION The observed associations between age and the use of adjuvant systemic therapy appear to reflect, in general, available information about treatment efficacy and do not suggest underuse among elderly women with early-stage breast cancer. The use of adjuvant therapy depends on clinical factors that predict the increased risk of metastases or the increased likelihood of response to treatment, rather than other sociodemographic factors. Our results also suggest that younger postmenopausal women with positive lymph nodes compared with older women may be undertreated with respect to tamoxifen because of the substitution of chemotherapy for hormonal therapy.


2020 ◽  
Author(s):  
Soo Youn Cho ◽  
Jeong Hoon Lee ◽  
Jai Min Ryu ◽  
Jeong Eon Lee ◽  
Eun Yoon Cho ◽  
...  

Abstract Background: The predictive value of adjuvant chemotherapy for early-stage hormone receptor-positive breast cancer has been only validated by a 21-gene expression assay. We hypothesized that deep-learning prediction from HE images, called Lunit-SCOPE, is a potential prognostic and predictive biomarker of adjuvant chemotherapy.Methods: We retrospectively collected HE slides from 1153 de-identified breast cancer patients at the Samsung Medical Center (SMC) in order to develop a deep-learning algorithm called Lunit-SCOPE. The histological parameters from 255 patients, deciphered by Lunit-SCOPE, were trained to predict the recurrence score (RS) using the 21-gene assay from Oncotype DX. We validated the model’s performance using the recurrence survival of 898 patients and The Cancer Genome Atlas (TCGA) cohort, and examined related biological functions through RNA sequence data.Results: The histologic parameter-based RS prediction model predicted the oncotype DX score (R2=0.96) and the recurrence survival analysis on the validation (p<0.01) and TCGA cohort (p<0.01), where the most important variables were the nuclear grade and the mitotic cells in the cancer epithelium. Of the 85 patients classified as the high-risk group, 72 patients who received adjuvant therapy had a significantly better survival (p<0.01). The functions of the top 300 highly correlated genes with a predicted RS were enriched for cell cycle, nuclear division and cell division. Of the 21-genes from the Oncotype DX, the predicted RS had positive correlations with the proliferation category genes and was negatively correlated with the prognostic genes in the estrogen category.Conclusion: An integrative analysis using Lunit-SCOPE predicts a high risk of recurrence and those who would benefit from adjuvant chemotherapy for early-stage hormone-positive breast cancer.


2019 ◽  
Vol 49 (11) ◽  
pp. 1029-1036
Author(s):  
Po-Sheng Yang ◽  
Yi-Hsuan Lee ◽  
Chi-Feng Chung ◽  
Yuan-Ching Chang ◽  
Ming-Yang Wang ◽  
...  

Abstract Background The information of Oncotype DX applied in Asian breast cancer patients is limited. A recurrence index for distant recurrence (RI-DR) has been developed for early-stage breast cancer (EBC) from tumor samples in Chinese patients. In this study, we compared the prognostic performance of the Oncotype DX (ODx) recurrence score (RS) with the RI-DR for any recurrence risk type. Materials and methods One hundred thirty-eight (138) patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative EBC who were previously tested with ODx were included for testing with the RI-DR. The cutoff score to partition the low- and high-risk patients was 26 for RS and 36 for RI-DR. The primary endpoint was recurrence-free survival (RFS). Results The concordance between the RI-DR and RS was 83% in N0 patients and 81% in node-positive patients when the RS score cutoff was set at 26. With a median follow-up interval of 36.8 months, the 4-year RFS for the high- and low-risk groups categorized by the RS were 61.9% and 95.0%, respectively (hazard ratio: 10.6, 95.0% confidence interval [CI]: 1.8–62.9). The 4-year RFS in the high- and low-risk groups categorized by the RI-DR were 72.6% and 98.5%, respectively (hazard ratio: 18.9, 95% CI: 1.8–138.8). Conclusion This paper illustrated the performance of RI-DR and ODx RS in breast cancer women in Taiwan. There was high concordance between the RI-DR and RS. The RI-DR is not inferior to the RS in predicting RFS in EBC patients. This study will fill the gap between the current and best practice in Chinese patients.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11084-e11084
Author(s):  
Stephanie A. Williams ◽  
Talar Tatarian ◽  
Christine B. Teal ◽  
Anita P. McSwain ◽  
Robert S. Siegel ◽  
...  

e11084 Background: Oncotype DX is a 21-gene assay developed for early stage, hormone receptor positive breast cancer that generates a Recurrence Score which estimates response to chemotherapy and the likelihood of systemic recurrence at 10 years. It differentiates between patients who would benefit from chemotherapy plus hormonal therapy versus hormonal therapy alone. This study’s goal was to determine if the Recurrence Score affected clinical management at our institution and physicians’ accuracy at predicting Recurrence Scores. Methods: A retrospective review was conducted of 116 breast cancer patients treated over a 7 year period. Clinic notes, pathology reports, and additional relevant information were presented to breast surgeons, oncologists, radiation oncologists, and surgical pathologists. Individual physicians estimated recurrence risks and recommended treatment based on those estimates. The Recurrence Score was revealed and changes in therapeutic recommendations were recorded. Results: Treatment recommendations changed in 43% of patients. 29% had a change from chemotherapy followed by hormone therapy to hormone therapy alone due to a low recurrence score, while 14% initially recommended hormonal therapy were changed to chemotherapy plus hormonal therapy due to an intermediate range score. Surgical oncologists accurately predicted Recurrence Scores 52% of the time, medical oncologists 46%, radiation oncologists 45%, and surgical pathologists 15%. A nested mixed model showed that pathologists were statistically significantly worse at predicting recurrence scores than surgical oncologists, medical oncologists, and radiation oncologists. Conclusions: The Oncotype DX assay changes management of breast cancer patients at our institution, frequently downgrading the intensity of systemic therapy. Clinicians were able to accurately estimate recurrence categories about 50% of the time. We recommend the use of Oncotype DX assay along with assessment of clinicopathologic features of an individual’s disease in eligible patients to enhance the selection of appropriate adjuvant therapy.


Sign in / Sign up

Export Citation Format

Share Document