Impact of TAILORx on chemotherapy prescribing and 21‐gene recurrence score–guided treatment costs in a population‐based cohort of patients with breast cancer

Cancer ◽  
2021 ◽  
Author(s):  
Megan E. Tesch ◽  
Caroline Speers ◽  
Rekha M. Diocee ◽  
Lovedeep Gondara ◽  
Stuart J. Peacock ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Recurrence Score ◽  
Population Based ◽  
Treatment Costs

scholarly journals The influence of 21-gene recurrence score assay on chemotherapy use in a population-based sample of breast cancer patients

2016 ◽  
Vol 161 (3) ◽  
pp. 587-595 ◽  
Author(s):  
Yun Li ◽  
Allison W. Kurian ◽  
Irina Bondarenko ◽  
Jeremy M. G. Taylor ◽  
Reshma Jagsi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Recurrence Score ◽  
Population Based ◽  
Breast Cancer Patients

Association between standard clinical and pathological breast cancer characteristics and the 21-gene recurrence score: A population-based study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11002-11002
Author(s):  
I. Wolf ◽  
N. Ben-Baruch ◽  
R. Shapira-Frommer ◽  
S. Rizel ◽  
H. Goldberg ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Validation Study ◽  
Tumor Size ◽  
Ductal Carcinoma ◽  
Age Distribution ◽  
Recurrence Score ◽  
Population Based ◽  
Her2 Expression ◽  
Study Population ◽  
Risk Categories

11002 Background: The 21-gene recurrence score (RS) aims to quantify chemotherapy benefit in lymph node-negative, estrogen receptor (ER)-positive breast cancer (BC) patients. We aimed to elucidate the association between the RS and clinical-pathological features in a population-based Israeli cohort. Methods: Study population included all Israeli BC female patients referred to the RS assay from October 2004 until October 2006. Clinical and pathology data were collected upon referral, RS risk was categorized as previously defined (low < 18, intermediate 18–30, high = 31) and chemotherapy benefit was also assessed for each patient using NCCN guidelines, St. Gallen recommendations and Adjuvant! Online. Results: 300 patients were referred to the assay by 70 physicians from 16 institutions. Low, intermediate and high RS were noted in 109 (36 %), 134 (45 %) and 57 (19%) of the patients respectively, compared to 54%, 21% and 25% respectively, in the validation study (JCO;24:3726). Median age was 54 and median tumor size was 1.6 cm. Similar age distribution, tumor size and ER staining intensity were noted in all risk categories. Interestingly, no association has been identified between the RS and the presence of lymph nodes micrometastases. High tumor grade was noted in 15%, 20% and 56%; progesterone expression in 88% 72% 43%; non-infiltrative ductal carcinoma (IDC) 24%, 12% and 6%; and Her2 expression in 2%, 3% and 19% of the low, intermediate and high risk categories respectively (p<0.0001 for all variables). Risk assessment according to clinical guidelines or Adjuvant! Online correlated poorly with the RS. Conclusions: Risk stratification of referred Israeli patients differs from that of the validation study population. Moreover, the RS did not correlate with age, tumor size and ER intensity. The RS correlated with histology, grade, PR and Her2 expression and may be predicted, in specific subsets of patients, using these features. However, RS categorization cannot be predicted by commonly-used clinical predicting tools. No significant financial relationships to disclose.

The performance of the 21-gene assay standard cutpoints of 18 and 31 in HR+, HER2- invasive breast cancer (BC), while waiting for TAILORx mid-range recurrence score results.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 537-537 ◽  
Author(s):  
Dave P. Miller ◽  
Valentina I. Petkov ◽  
Steven Shak
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Hormonal Therapy ◽  
Invasive Breast Cancer ◽  
Recurrence Score ◽  
Population Based ◽  
Additional Benefit ◽  
Gene Assay ◽  
Specific Mortality ◽  
Prior Malignancy

537 Background: The Recurrence Score (RS) was shown in NSABP B-20 to predict chemotherapy (CT) benefit for RS ≥31 and no CT benefit for RS <18. The TAILORx results for RS <11 (NEJM 2015) reported excellent outcomes with no opportunity for CT to add additional benefit. As we await TAILORx results for RS 11-25, we characterized BC specific mortality (BCSM) for RS groups (cutoffs of 11, 18, 25, and 31) in the population-based SEER study of pts treated based on RS. Methods: RS results were provided to SEER registries per their methods (npj Breast Cancer 2016). Pts diagnosed (Jan 2004 - Dec 2012) with N0 HR+ HER2- negative BC, and no prior malignancy were eligible. BCSM estimates by CT use were computed using standard cutpoints of 18 and 31 and TAILORx cutpoints of 11 and 25. Results: Among 49,681 with a RS, 9,486 (19%) had RS <11, 17,988 (36%) had RS 11-17, 14,541 (29%) had RS 18-25, 3,805 (8%) had RS 26-30, and 3,861 (8%) had RS ≥31. Reported CT use and 5-y BCSM increased with increasing RS. For pts with both RS <11 and RS 11-17, CT use was uncommon and 5-y BCSM was low regardless of CT use. For pts with RS 18-25, CT use was more common and the 5-y BCSM was about 1% regardless of CT use. For pts with RS of 26-30 or ≥31, CT was common, and lower 5-y BCSM was observed with CT reported yes than with CT reported no or unknown. Conclusions: Pts in real-world clinical practice with RS <11, consistent with TAILORx, and pts with RS 11-17 have low 5-y BCSM with limited CT use, supporting hormonal therapy alone for pts with RS <18. The high end of the TAILORx mid-range (18-25) also showed good 5-y BCSM both with and without CT, highlighting the importance of the randomized results of TAILORx. [Table: see text]

scholarly journals Breast-cancer-specific mortality in patients treated based on the 21-gene assay: a SEER population-based study

2016 ◽  
Vol 2 (1) ◽  
Author(s):  
Valentina I Petkov ◽  
Dave P Miller ◽  
Nadia Howlader ◽  
Nathan Gliner ◽  
Will Howe ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Tumor Size ◽  
Recurrence Score ◽  
Population Based ◽  
Node Negative ◽  
Node Positive ◽  
Breast Cancer Specific Mortality ◽  
Specific Mortality ◽  
Size Grade ◽  
Cancer Specific Mortality

Abstract The 21-gene Recurrence Score assay is validated to predict recurrence risk and chemotherapy benefit in hormone-receptor-positive (HR+) invasive breast cancer. To determine prospective breast-cancer-specific mortality (BCSM) outcomes by baseline Recurrence Score results and clinical covariates, the National Cancer Institute collaborated with Genomic Health and 14 population-based registries in the the Surveillance, Epidemiology, and End Results (SEER) Program to electronically supplement cancer surveillance data with Recurrence Score results. The prespecified primary analysis cohort was 40–84 years of age, and had node-negative, HR+, HER2-negative, nonmetastatic disease diagnosed between January 2004 and December 2011 in the entire SEER population, and Recurrence Score results (N=38,568). Unadjusted 5-year BCSM were 0.4% (n=21,023; 95% confidence interval (CI), 0.3–0.6%), 1.4% (n=14,494; 95% CI, 1.1–1.7%), and 4.4% (n=3,051; 95% CI, 3.4–5.6%) for Recurrence Score <18, 18–30, and ⩾31 groups, respectively (P<0.001). In multivariable analysis adjusted for age, tumor size, grade, and race, the Recurrence Score result predicted BCSM (P<0.001). Among patients with node-positive disease (micrometastases and up to three positive nodes; N=4,691), 5-year BCSM (unadjusted) was 1.0% (n=2,694; 95% CI, 0.5–2.0%), 2.3% (n=1,669; 95% CI, 1.3–4.1%), and 14.3% (n=328; 95% CI, 8.4–23.8%) for Recurrence Score <18, 18–30, ⩾31 groups, respectively (P<0.001). Five-year BCSM by Recurrence Score group are reported for important patient subgroups, including age, race, tumor size, grade, and socioeconomic status. This SEER study represents the largest report of prospective BCSM outcomes based on Recurrence Score results for patients with HR+, HER2-negative, node-negative, or node-positive breast cancer, including subgroups often under-represented in clinical trials.

scholarly journals Impact of Recurrence Score on type and duration of chemotherapy in breast cancer

2019 ◽  
Vol 27 (2) ◽  
Author(s):  
K. Willemsma ◽  
W. Yip ◽  
N. LeVasseur ◽  
K. Dobosz ◽  
C. Illmann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Recurrence Score ◽  
Population Based ◽  
Oncotype Dx ◽  
Myelosuppressive Chemotherapy ◽  
Hormone Receptor Positive ◽  
Short Course ◽  
Long Course ◽  
Selection Of

Background The use of Oncotype dx (Genomic Health, Redwood City, CA, U.S.A.) testing has been shown to change treatment decisions in approximately 30% of breast cancer (bca) cases, but research on how Recurrence Score testing has affected the type of chemotherapy offered is limited. We sought to determine if the availability of Oncotype dx testing resulted in a change to the type and duration of chemotherapy regimens used in the treatment of early-stage hormone receptor–positive bca. Methods In a population-based cohort study, patients treated in the 2 years before the availability of Oncotype dx testing were compared with patients treated in the 2 years after testing availability. Charts were audited and divided into 2 groups: pre-Oncotype dx and post-Oncotype dx. The groups were compared for differences in duration of chemotherapy (12 weeks vs. >12 weeks), types of agents used (anthracycline vs. non-anthracycline), and myelosuppressive potential of the chosen regimen. Results Of 834 patients who fulfilled the enrolment criteria, 360 fell into the pre-Oncotype dx era, and 474, into the post-Oncotype dx era. An increase of 11.2 percentage points, to 69.5% from 58.3%, was observed in the proportion of patients receiving short-course compared with long-course chemotherapy (p = 0.068). The proportion of patients prescribed anthracycline-containing regimens declined in the post-Oncotype dx era (47.7% pre vs. 32.2% post, p = 0.016). The selection of more-myelosuppressive chemotherapy protocols increased in the post-Oncotype dx era (67.4% pre vs. 78.8% post, p = 0.044). Conclusions In the present study, the availability of Oncotype dx testing was observed to influence the choice of chemotherapy type in the setting of early-stage bca.

The potential economic impact of the 21-gene recurrence score: Guided chemotherapy in a population-based cohort with node-negative and node-positive early-stage breast cancer.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 201-201
Author(s):  
N. W. D. Lamond ◽  
C. Skedgel ◽  
D. Rayson ◽  
L. Lethbridge ◽  
T. Younis
Keyword(s):  
Breast Cancer ◽  
Hormone Receptor ◽  
Early Stage ◽  
Recurrence Score ◽  
Cost Effective ◽  
Population Based ◽  
Early Stage Breast Cancer ◽  
Effective Strategy ◽  
Node Negative ◽  
Hormone Receptor Positive

201 Background: The 21-gene recurrence score (Oncotype DX: RS) appears to augment clinical-pathological prognostication and predicts adjuvant chemotherapy (chemo) benefits in patients with node-negative (N-) and node-positive (N+) hormone-receptor positive early-stage breast cancer. Economic analyses suggest that RS-guided chemo is a cost-effective strategy in N- breast cancer, but no evaluations were reported for N+ disease based on pre RS chemo utilization in clinical practice. We examined the cost-utility (CU) of a RS-guided chemo strategy, compared to current practice without RS in a population based cohort, in N- and N+ early-stage breast cancer. Methods: A generic state-transition model was developed to compute cumulative costs and quality-adjusted life years (QALY) over a 25-year horizon for patients with hormone-receptor positive early-stage breast cancer considered for chemo. We examined outcomes with and without chemo in RS-untested cohorts and in those with low, intermediate and high RS based on the reported prognostic and predictive impact of the RS. Chemo utilizations (current vs RS-guided), costs and utilities were derived from a Nova Scotia population based cohort, local resources and the literature. Sensitivity analyses were conducted for key model assumptions/parameters. Results: RS-guided chemo strategy is associated with incremental costs and QALY gains compared to chemo with no RS testing in both N- and N+ patients. The resultant CU ratios are $17,141/QALY and $5,772/QALY for N- and N+ disease, respectively. These CU ratios are well below commonly quoted thresholds and were most sensitive to RS-distribution, upfront chemo costs, chemo utilization rates and relative benefits of chemo in various RS-strata. Conclusions: RS-guided chemo in a population based cohort appears to be a cost-effective strategy, compared to chemo with no RS testing, in N- and N+ early-stage breast cancer.

Breast cancer-specific survival outcomes among patients based on 21-gene recurrence score.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 537-537
Author(s):  
Wade T. Swenson ◽  
Shantanu Mallick
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Lobular Carcinoma ◽  
Survival Rates ◽  
Recurrence Score ◽  
Population Based ◽  
Low Risk ◽  
Intermediate Risk ◽  
Breast Cancer Specific Survival ◽  
Cancer Specific Survival

537 Background: The 21-gene recurrence assay predicts cancer recurrence rates and benefit from adjuvant chemotherapy among patients with hormone-receptor-positive breast cancer. The National Cancer Institute and Genomic Health collaborated to provide Recurrence Score (RS) results to complement data from 17 population-based cancer registries in the Surveillance, Epidemiology, and End Results (SEER) Program. Methods: Using the SEER database with linked RS results, a cohort of female breast cancer patients, age greater than 20 years, was identified by RS (low: < 18, intermediate: 18-30, high: > 30) diagnosed between the years 2004 and 2007. A retrospective analysis was conducted to determine eight-year breast cancer-specific survival rates based on RS and other variables. Results: 10,318 patients were identified in the cohort. 5,194 had a low risk RS; 4,282 had an intermediate risk RS; 872 had a high risk RS. Histologic subtypes were: 7,459 infiltrating ductal carcinoma, 941 mixed infiltrating and lobular carcinoma, 933 lobular carcinoma, 327 mixed infiltrating ductal and other histology, 244 mucinous adenocarcinoma, 101 tubular adenocarcinoma, 45 mixed lobular and other histology, 268 other histologies. 644 low risk RS patients received chemotherapy (12.4%); 1,608 intermediate risk RS patients received chemotherapy (37.8%); 593 high risk patients received chemotherapy (68.0%). The eight-year breast cancer-specific survival rates (with 95% confidence intervals) among low risk RS patients without known chemotherapy administration was 98.9% (98.5, 99.2), and 98.4% (97.0, 99.1) with chemotherapy; intermediate risk RS patients without known chemotherapy was 97.0% (96.2, 97.6), and 96.9% (95.9, 97.7) with chemotherapy; high risk RS patients without known chemotherapy was 89.7% (85.4, 92.8), and 92.9% (90.4, 94.7) with chemotherapy. Conclusions: Among a large cohort of patients identified in a population-based cancer registry between 2004 and 2007, there was no statistically significant difference in eight-year breast cancer-specific survival rates among those who received chemotherapy and those who did not, regardless of RS risk group.

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