Integration of clinical variables for the prediction of late distant recurrence in patients with estrogen receptor-positive breast cancer treated with 5 years of endocrine therapy: CTS5

Mitch Dowsett, Ivana Sestak, Meredith M. Regan, Andrew Dodson, Giuseppe Viale, Beat Thurlimann, Marco Colleoni, Jack Cuzick

Research output: Contribution to journalArticle

Abstract

Purpose Estimating risk of late distant recurrence (DR) is an important goal for managing women with hormone receptor-positive breast cancer after 5 years of endocrine treatment without recurrence. We developed and validated a simple clinicopathologic tool (Clinical Treatment Score post-5 years [CTS5]) to estimate residual risk of DR after 5 years of endocrine treatment. Patients and Methods The ATAC (Arimidex, Tamoxifen, Alone or in Combination) data set (N = 4,735) was used to create a prognostic score for post-5-year risk of DR. Validity of CTS5 (ATAC) was tested in the BIG 1-98 data set (N = 6,711). Time to late DR, 5 years after finishing scheduled endocrine therapy, was the primary end point. Cox regression models estimated the prognostic performance of CTS5 (ATAC). Results CTS5 (ATAC) was significantly prognostic for late DR in the ATAC cohort (hazard ratio, 2.47; 95% CI, 2.24 to 2.73; P <.001) and BIG 1-98 validation cohort (hazard ratio, 2.07; 95% CI, 1.88 to 2.28; P <.001). CTS5 (ATAC) risk stratification defined in the training cohort as low (, 5% DR risk, years 5 to 10), intermediate (5% to 10%), or high (. 10%) identified 43% of the validation cohort as low risk, with an observed DR rate of 3.6% (95% CI, 2.7% to 4.9%) during years 5 to 10. From years 5 to 10, 63% of node-negative patients were low risk, with a DR rate of 3.9% (95% CI, 2.9% to 5.3%), and 24% with one to three positive nodes were low risk, with a DR rate of 1.5% (95% CI, 0.5% to 3.8%). A final CTS5 for future use was derived from pooled data from ATAC and BIG 1-98. Conclusion CTS5 is a simple tool based on information that is readily available to all clinicians. CTS5 was validated as highly prognostic for late DR in the independent BIG 1-98 study. The final CTS5 algorithm identified 42% of women with<1% per-year risk of DR who could be advised of the limited potential value of extended endocrine therapy.

Original languageEnglish
Pages (from-to)1941-1948
Number of pages8
JournalJournal of Clinical Oncology
Volume36
Issue number19
DOIs
Publication statusPublished - Jul 1 2018

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Estrogen Receptors
Breast Neoplasms
Recurrence
Tamoxifen
Therapeutics
anastrozole
Proportional Hazards Models
Hormones

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Integration of clinical variables for the prediction of late distant recurrence in patients with estrogen receptor-positive breast cancer treated with 5 years of endocrine therapy : CTS5. / Dowsett, Mitch; Sestak, Ivana; Regan, Meredith M.; Dodson, Andrew; Viale, Giuseppe; Thurlimann, Beat; Colleoni, Marco; Cuzick, Jack.

In: Journal of Clinical Oncology, Vol. 36, No. 19, 01.07.2018, p. 1941-1948.

Research output: Contribution to journalArticle

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title = "Integration of clinical variables for the prediction of late distant recurrence in patients with estrogen receptor-positive breast cancer treated with 5 years of endocrine therapy: CTS5",
abstract = "Purpose Estimating risk of late distant recurrence (DR) is an important goal for managing women with hormone receptor-positive breast cancer after 5 years of endocrine treatment without recurrence. We developed and validated a simple clinicopathologic tool (Clinical Treatment Score post-5 years [CTS5]) to estimate residual risk of DR after 5 years of endocrine treatment. Patients and Methods The ATAC (Arimidex, Tamoxifen, Alone or in Combination) data set (N = 4,735) was used to create a prognostic score for post-5-year risk of DR. Validity of CTS5 (ATAC) was tested in the BIG 1-98 data set (N = 6,711). Time to late DR, 5 years after finishing scheduled endocrine therapy, was the primary end point. Cox regression models estimated the prognostic performance of CTS5 (ATAC). Results CTS5 (ATAC) was significantly prognostic for late DR in the ATAC cohort (hazard ratio, 2.47; 95{\%} CI, 2.24 to 2.73; P <.001) and BIG 1-98 validation cohort (hazard ratio, 2.07; 95{\%} CI, 1.88 to 2.28; P <.001). CTS5 (ATAC) risk stratification defined in the training cohort as low (, 5{\%} DR risk, years 5 to 10), intermediate (5{\%} to 10{\%}), or high (. 10{\%}) identified 43{\%} of the validation cohort as low risk, with an observed DR rate of 3.6{\%} (95{\%} CI, 2.7{\%} to 4.9{\%}) during years 5 to 10. From years 5 to 10, 63{\%} of node-negative patients were low risk, with a DR rate of 3.9{\%} (95{\%} CI, 2.9{\%} to 5.3{\%}), and 24{\%} with one to three positive nodes were low risk, with a DR rate of 1.5{\%} (95{\%} CI, 0.5{\%} to 3.8{\%}). A final CTS5 for future use was derived from pooled data from ATAC and BIG 1-98. Conclusion CTS5 is a simple tool based on information that is readily available to all clinicians. CTS5 was validated as highly prognostic for late DR in the independent BIG 1-98 study. The final CTS5 algorithm identified 42{\%} of women with<1{\%} per-year risk of DR who could be advised of the limited potential value of extended endocrine therapy.",
author = "Mitch Dowsett and Ivana Sestak and Regan, {Meredith M.} and Andrew Dodson and Giuseppe Viale and Beat Thurlimann and Marco Colleoni and Jack Cuzick",
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T1 - Integration of clinical variables for the prediction of late distant recurrence in patients with estrogen receptor-positive breast cancer treated with 5 years of endocrine therapy

T2 - CTS5

AU - Dowsett, Mitch

AU - Sestak, Ivana

AU - Regan, Meredith M.

AU - Dodson, Andrew

AU - Viale, Giuseppe

AU - Thurlimann, Beat

AU - Colleoni, Marco

AU - Cuzick, Jack

PY - 2018/7/1

Y1 - 2018/7/1

N2 - Purpose Estimating risk of late distant recurrence (DR) is an important goal for managing women with hormone receptor-positive breast cancer after 5 years of endocrine treatment without recurrence. We developed and validated a simple clinicopathologic tool (Clinical Treatment Score post-5 years [CTS5]) to estimate residual risk of DR after 5 years of endocrine treatment. Patients and Methods The ATAC (Arimidex, Tamoxifen, Alone or in Combination) data set (N = 4,735) was used to create a prognostic score for post-5-year risk of DR. Validity of CTS5 (ATAC) was tested in the BIG 1-98 data set (N = 6,711). Time to late DR, 5 years after finishing scheduled endocrine therapy, was the primary end point. Cox regression models estimated the prognostic performance of CTS5 (ATAC). Results CTS5 (ATAC) was significantly prognostic for late DR in the ATAC cohort (hazard ratio, 2.47; 95% CI, 2.24 to 2.73; P <.001) and BIG 1-98 validation cohort (hazard ratio, 2.07; 95% CI, 1.88 to 2.28; P <.001). CTS5 (ATAC) risk stratification defined in the training cohort as low (, 5% DR risk, years 5 to 10), intermediate (5% to 10%), or high (. 10%) identified 43% of the validation cohort as low risk, with an observed DR rate of 3.6% (95% CI, 2.7% to 4.9%) during years 5 to 10. From years 5 to 10, 63% of node-negative patients were low risk, with a DR rate of 3.9% (95% CI, 2.9% to 5.3%), and 24% with one to three positive nodes were low risk, with a DR rate of 1.5% (95% CI, 0.5% to 3.8%). A final CTS5 for future use was derived from pooled data from ATAC and BIG 1-98. Conclusion CTS5 is a simple tool based on information that is readily available to all clinicians. CTS5 was validated as highly prognostic for late DR in the independent BIG 1-98 study. The final CTS5 algorithm identified 42% of women with<1% per-year risk of DR who could be advised of the limited potential value of extended endocrine therapy.

AB - Purpose Estimating risk of late distant recurrence (DR) is an important goal for managing women with hormone receptor-positive breast cancer after 5 years of endocrine treatment without recurrence. We developed and validated a simple clinicopathologic tool (Clinical Treatment Score post-5 years [CTS5]) to estimate residual risk of DR after 5 years of endocrine treatment. Patients and Methods The ATAC (Arimidex, Tamoxifen, Alone or in Combination) data set (N = 4,735) was used to create a prognostic score for post-5-year risk of DR. Validity of CTS5 (ATAC) was tested in the BIG 1-98 data set (N = 6,711). Time to late DR, 5 years after finishing scheduled endocrine therapy, was the primary end point. Cox regression models estimated the prognostic performance of CTS5 (ATAC). Results CTS5 (ATAC) was significantly prognostic for late DR in the ATAC cohort (hazard ratio, 2.47; 95% CI, 2.24 to 2.73; P <.001) and BIG 1-98 validation cohort (hazard ratio, 2.07; 95% CI, 1.88 to 2.28; P <.001). CTS5 (ATAC) risk stratification defined in the training cohort as low (, 5% DR risk, years 5 to 10), intermediate (5% to 10%), or high (. 10%) identified 43% of the validation cohort as low risk, with an observed DR rate of 3.6% (95% CI, 2.7% to 4.9%) during years 5 to 10. From years 5 to 10, 63% of node-negative patients were low risk, with a DR rate of 3.9% (95% CI, 2.9% to 5.3%), and 24% with one to three positive nodes were low risk, with a DR rate of 1.5% (95% CI, 0.5% to 3.8%). A final CTS5 for future use was derived from pooled data from ATAC and BIG 1-98. Conclusion CTS5 is a simple tool based on information that is readily available to all clinicians. CTS5 was validated as highly prognostic for late DR in the independent BIG 1-98 study. The final CTS5 algorithm identified 42% of women with<1% per-year risk of DR who could be advised of the limited potential value of extended endocrine therapy.

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