Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry

Salomon M. Stemmer; Mariana Steiner; Shulamith Rizel; Lior Soussan-Gutman; Noa Ben-Baruch; Avital Bareket-Samish; David B. Geffen; Bella Nisenbaum; Kevin Isaacs; Georgeta Fried; Ora Rosengarten; Beatrice Uziely; Christer Svedman; Debbie McCullough; Tara Maddala; Shmuel H. Klang; Jamal Zidan; Larisa Ryvo; Bella Kaufman; Ella Evron; Natalya Karminsky; Hadassah Goldberg; Steven Shak; Nicky Liebermann

doi:10.1038/S41523-017-0034-6

Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry

Salomon M. Stemmer, Mariana Steiner, Shulamith Rizel, Lior Soussan-Gutman, Noa Ben-Baruch, Avital Bareket-Samish, David B. Geffen, Bella Nisenbaum, Kevin Isaacs, Georgeta Fried, Ora Rosengarten, Beatrice Uziely, Christer Svedman, Debbie McCullough, Tara Maddala, Shmuel H. Klang, Jamal Zidan, Larisa Ryvo, Bella Kaufman, Ella EvronNatalya Karminsky, Hadassah Goldberg, Steven Shak, Nicky Liebermann

Research output: Contribution to journal › Article › peer-review

Abstract

The 21-gene Recurrence Score® (RS) assay is a validated prognostic/predictive tool in ER + early-stage breast cancer. However, clinical outcome data from prospective studies in RS ≥ 11 patients are lacking, as are relevant real-life clinical practice data. In this retrospective analysis of a prospectively designed registry, we evaluated treatments/clinical outcomes in patients undergoing RStesting through Clalit Health Services. The analysis included N0 ER + HER2-negative breast cancer patients who were RS-tested from 1/2006 through 12/2010. Medical records were reviewed to verify treatments/recurrences/survival. The cohort included 1801 patients (median follow-up, 6.2 years). Median age was 60 years, 50.4% were grade 2 and 81.1% had invasive ductal carcinoma; 48.9% had RS < 18, 40.7% RS 18–30, and 10.4% RS ≥ 31, with chemotherapy use of 1.4, 23.7, and 87.2%, respectively. The 5-year Kaplan–Meier estimates for distant recurrence were 0.8, 3.0, and 8.6%, for patients with RS < 18, RS 18–30 and RS ≥ 31, respectively; the corresponding 5-year Kaplan–Meier estimates for breast cancer death were 0.0, 0.9, and 6.2%. Chemotherapy-untreated patients with RS < 11 (n = 304) and 11–25 (n = 1037) (TAILORx categorization) had 5-year Kaplan–Meier estimates for distant recurrence risk/breast cancer death of 1.0%/0.0% and 1.3%/0.4%, respectively. Our results extend those of the prospective TAILORx trial: the 5-year Kaplan–Meier estimates for distant recurrence and breast cancer death rate for the RS < 18 patients were very low supporting the use of endocrine therapy alone. Furthermore, in chemotherapy-untreated patients with RS 11–25 (where TAILORx patients were randomized to chemoendocrine or endocrine therapy alone), 5-year distant recurrence rates were also very low, suggesting that chemotherapy would not have conferred clinically meaningful benefit.

Original language	English
Article number	33
Pages (from-to)	33
Journal	npj Breast Cancer
Volume	3
Issue number	1
DOIs	https://doi.org/10.1038/S41523-017-0034-6
State	Published - 18 Sep 2017
Externally published	Yes

Bibliographical note

Funding Information:
This work was supported by grant 1132 from Teva Pharmaceuticals Ltd that was awarded to Dr. Stemmer via Mor Research Applications Ltd (a company that manages research grants secured by Clalit Health Services doctors/researchers) for the purpose of this work.

Funding Information:
Competing Interests: Dr. Stemmer reports receiving grant funding from Teva and travel expenses (flights, accommodation) from Genomic Health, Inc. Dr. Soussan-Gutman reports being employed by and holding stock options in Teva Pharmaceutical Industries Ltd. Dr. Bareket-Samish reports being a consultant for Teva Pharmaceutical Industries Ltd. and Genomic Health Inc. Dr. Ben Baruch reports receiving personal fees from Genomic Health Inc (for participating in the Speaker’s Bureau program). Dr. Rosengarten reports receiving payments for lectures and grants for traveling to conferences from Teva Pharmaceutical Industries Ltd. Dr. Svedman, Ms. McCullough, Dr. Maddala, and Dr. Shak report being employed by and stock ownership in Genomic Health, Inc. Dr. Shak also reports having multiple patents for the Oncotype DX assay (for which all rights were assigned to Genomic Health, Inc.). Drs. Steiner, Rizel, Geffen, Nisenbaum, Isaacs, Fried, Uziely, Klang, Zidan, Ryvo, Kaufman, Evron, Karminsky, Goldberg, and Liebermann report no conflict of interest.

Publisher Copyright:
© The Author(s) 2017.

ASJC Scopus subject areas

Oncology
Radiology Nuclear Medicine and imaging
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1038/S41523-017-0034-6

Cite this

Stemmer, S. M., Steiner, M., Rizel, S., Soussan-Gutman, L., Ben-Baruch, N., Bareket-Samish, A., Geffen, D. B., Nisenbaum, B., Isaacs, K., Fried, G., Rosengarten, O., Uziely, B., Svedman, C., McCullough, D., Maddala, T., Klang, S. H., Zidan, J., Ryvo, L., Kaufman, B., ... Liebermann, N. (2017). Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry. npj Breast Cancer, 3(1), 33. [33]. https://doi.org/10.1038/S41523-017-0034-6

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title = "Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry",

abstract = "The 21-gene Recurrence Score{\textregistered} (RS) assay is a validated prognostic/predictive tool in ER + early-stage breast cancer. However, clinical outcome data from prospective studies in RS ≥ 11 patients are lacking, as are relevant real-life clinical practice data. In this retrospective analysis of a prospectively designed registry, we evaluated treatments/clinical outcomes in patients undergoing RStesting through Clalit Health Services. The analysis included N0 ER + HER2-negative breast cancer patients who were RS-tested from 1/2006 through 12/2010. Medical records were reviewed to verify treatments/recurrences/survival. The cohort included 1801 patients (median follow-up, 6.2 years). Median age was 60 years, 50.4% were grade 2 and 81.1% had invasive ductal carcinoma; 48.9% had RS < 18, 40.7% RS 18–30, and 10.4% RS ≥ 31, with chemotherapy use of 1.4, 23.7, and 87.2%, respectively. The 5-year Kaplan–Meier estimates for distant recurrence were 0.8, 3.0, and 8.6%, for patients with RS < 18, RS 18–30 and RS ≥ 31, respectively; the corresponding 5-year Kaplan–Meier estimates for breast cancer death were 0.0, 0.9, and 6.2%. Chemotherapy-untreated patients with RS < 11 (n = 304) and 11–25 (n = 1037) (TAILORx categorization) had 5-year Kaplan–Meier estimates for distant recurrence risk/breast cancer death of 1.0%/0.0% and 1.3%/0.4%, respectively. Our results extend those of the prospective TAILORx trial: the 5-year Kaplan–Meier estimates for distant recurrence and breast cancer death rate for the RS < 18 patients were very low supporting the use of endocrine therapy alone. Furthermore, in chemotherapy-untreated patients with RS 11–25 (where TAILORx patients were randomized to chemoendocrine or endocrine therapy alone), 5-year distant recurrence rates were also very low, suggesting that chemotherapy would not have conferred clinically meaningful benefit.",

author = "Stemmer, {Salomon M.} and Mariana Steiner and Shulamith Rizel and Lior Soussan-Gutman and Noa Ben-Baruch and Avital Bareket-Samish and Geffen, {David B.} and Bella Nisenbaum and Kevin Isaacs and Georgeta Fried and Ora Rosengarten and Beatrice Uziely and Christer Svedman and Debbie McCullough and Tara Maddala and Klang, {Shmuel H.} and Jamal Zidan and Larisa Ryvo and Bella Kaufman and Ella Evron and Natalya Karminsky and Hadassah Goldberg and Steven Shak and Nicky Liebermann",

note = "Funding Information: This work was supported by grant 1132 from Teva Pharmaceuticals Ltd that was awarded to Dr. Stemmer via Mor Research Applications Ltd (a company that manages research grants secured by Clalit Health Services doctors/researchers) for the purpose of this work. Funding Information: Competing Interests: Dr. Stemmer reports receiving grant funding from Teva and travel expenses (flights, accommodation) from Genomic Health, Inc. Dr. Soussan-Gutman reports being employed by and holding stock options in Teva Pharmaceutical Industries Ltd. Dr. Bareket-Samish reports being a consultant for Teva Pharmaceutical Industries Ltd. and Genomic Health Inc. Dr. Ben Baruch reports receiving personal fees from Genomic Health Inc (for participating in the Speaker{\textquoteright}s Bureau program). Dr. Rosengarten reports receiving payments for lectures and grants for traveling to conferences from Teva Pharmaceutical Industries Ltd. Dr. Svedman, Ms. McCullough, Dr. Maddala, and Dr. Shak report being employed by and stock ownership in Genomic Health, Inc. Dr. Shak also reports having multiple patents for the Oncotype DX assay (for which all rights were assigned to Genomic Health, Inc.). Drs. Steiner, Rizel, Geffen, Nisenbaum, Isaacs, Fried, Uziely, Klang, Zidan, Ryvo, Kaufman, Evron, Karminsky, Goldberg, and Liebermann report no conflict of interest. Publisher Copyright: {\textcopyright} The Author(s) 2017.",

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doi = "10.1038/S41523-017-0034-6",

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volume = "3",

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journal = "npj Breast Cancer",

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Stemmer, SM, Steiner, M, Rizel, S, Soussan-Gutman, L, Ben-Baruch, N, Bareket-Samish, A, Geffen, DB, Nisenbaum, B, Isaacs, K, Fried, G, Rosengarten, O, Uziely, B, Svedman, C, McCullough, D, Maddala, T, Klang, SH, Zidan, J, Ryvo, L, Kaufman, B, Evron, E, Karminsky, N, Goldberg, H, Shak, S & Liebermann, N 2017, 'Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry', npj Breast Cancer, vol. 3, no. 1, 33, pp. 33. https://doi.org/10.1038/S41523-017-0034-6

TY - JOUR

T1 - Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results

T2 - evidence from a large prospectively designed registry

AU - Stemmer, Salomon M.

AU - Steiner, Mariana

AU - Rizel, Shulamith

AU - Soussan-Gutman, Lior

AU - Ben-Baruch, Noa

AU - Bareket-Samish, Avital

AU - Geffen, David B.

AU - Nisenbaum, Bella

AU - Isaacs, Kevin

AU - Fried, Georgeta

AU - Rosengarten, Ora

AU - Uziely, Beatrice

AU - Svedman, Christer

AU - McCullough, Debbie

AU - Maddala, Tara

AU - Klang, Shmuel H.

AU - Zidan, Jamal

AU - Ryvo, Larisa

AU - Kaufman, Bella

AU - Evron, Ella

AU - Karminsky, Natalya

AU - Goldberg, Hadassah

AU - Shak, Steven

AU - Liebermann, Nicky

N1 - Funding Information: This work was supported by grant 1132 from Teva Pharmaceuticals Ltd that was awarded to Dr. Stemmer via Mor Research Applications Ltd (a company that manages research grants secured by Clalit Health Services doctors/researchers) for the purpose of this work. Funding Information: Competing Interests: Dr. Stemmer reports receiving grant funding from Teva and travel expenses (flights, accommodation) from Genomic Health, Inc. Dr. Soussan-Gutman reports being employed by and holding stock options in Teva Pharmaceutical Industries Ltd. Dr. Bareket-Samish reports being a consultant for Teva Pharmaceutical Industries Ltd. and Genomic Health Inc. Dr. Ben Baruch reports receiving personal fees from Genomic Health Inc (for participating in the Speaker’s Bureau program). Dr. Rosengarten reports receiving payments for lectures and grants for traveling to conferences from Teva Pharmaceutical Industries Ltd. Dr. Svedman, Ms. McCullough, Dr. Maddala, and Dr. Shak report being employed by and stock ownership in Genomic Health, Inc. Dr. Shak also reports having multiple patents for the Oncotype DX assay (for which all rights were assigned to Genomic Health, Inc.). Drs. Steiner, Rizel, Geffen, Nisenbaum, Isaacs, Fried, Uziely, Klang, Zidan, Ryvo, Kaufman, Evron, Karminsky, Goldberg, and Liebermann report no conflict of interest. Publisher Copyright: © The Author(s) 2017.

PY - 2017/9/18

Y1 - 2017/9/18

N2 - The 21-gene Recurrence Score® (RS) assay is a validated prognostic/predictive tool in ER + early-stage breast cancer. However, clinical outcome data from prospective studies in RS ≥ 11 patients are lacking, as are relevant real-life clinical practice data. In this retrospective analysis of a prospectively designed registry, we evaluated treatments/clinical outcomes in patients undergoing RStesting through Clalit Health Services. The analysis included N0 ER + HER2-negative breast cancer patients who were RS-tested from 1/2006 through 12/2010. Medical records were reviewed to verify treatments/recurrences/survival. The cohort included 1801 patients (median follow-up, 6.2 years). Median age was 60 years, 50.4% were grade 2 and 81.1% had invasive ductal carcinoma; 48.9% had RS < 18, 40.7% RS 18–30, and 10.4% RS ≥ 31, with chemotherapy use of 1.4, 23.7, and 87.2%, respectively. The 5-year Kaplan–Meier estimates for distant recurrence were 0.8, 3.0, and 8.6%, for patients with RS < 18, RS 18–30 and RS ≥ 31, respectively; the corresponding 5-year Kaplan–Meier estimates for breast cancer death were 0.0, 0.9, and 6.2%. Chemotherapy-untreated patients with RS < 11 (n = 304) and 11–25 (n = 1037) (TAILORx categorization) had 5-year Kaplan–Meier estimates for distant recurrence risk/breast cancer death of 1.0%/0.0% and 1.3%/0.4%, respectively. Our results extend those of the prospective TAILORx trial: the 5-year Kaplan–Meier estimates for distant recurrence and breast cancer death rate for the RS < 18 patients were very low supporting the use of endocrine therapy alone. Furthermore, in chemotherapy-untreated patients with RS 11–25 (where TAILORx patients were randomized to chemoendocrine or endocrine therapy alone), 5-year distant recurrence rates were also very low, suggesting that chemotherapy would not have conferred clinically meaningful benefit.

AB - The 21-gene Recurrence Score® (RS) assay is a validated prognostic/predictive tool in ER + early-stage breast cancer. However, clinical outcome data from prospective studies in RS ≥ 11 patients are lacking, as are relevant real-life clinical practice data. In this retrospective analysis of a prospectively designed registry, we evaluated treatments/clinical outcomes in patients undergoing RStesting through Clalit Health Services. The analysis included N0 ER + HER2-negative breast cancer patients who were RS-tested from 1/2006 through 12/2010. Medical records were reviewed to verify treatments/recurrences/survival. The cohort included 1801 patients (median follow-up, 6.2 years). Median age was 60 years, 50.4% were grade 2 and 81.1% had invasive ductal carcinoma; 48.9% had RS < 18, 40.7% RS 18–30, and 10.4% RS ≥ 31, with chemotherapy use of 1.4, 23.7, and 87.2%, respectively. The 5-year Kaplan–Meier estimates for distant recurrence were 0.8, 3.0, and 8.6%, for patients with RS < 18, RS 18–30 and RS ≥ 31, respectively; the corresponding 5-year Kaplan–Meier estimates for breast cancer death were 0.0, 0.9, and 6.2%. Chemotherapy-untreated patients with RS < 11 (n = 304) and 11–25 (n = 1037) (TAILORx categorization) had 5-year Kaplan–Meier estimates for distant recurrence risk/breast cancer death of 1.0%/0.0% and 1.3%/0.4%, respectively. Our results extend those of the prospective TAILORx trial: the 5-year Kaplan–Meier estimates for distant recurrence and breast cancer death rate for the RS < 18 patients were very low supporting the use of endocrine therapy alone. Furthermore, in chemotherapy-untreated patients with RS 11–25 (where TAILORx patients were randomized to chemoendocrine or endocrine therapy alone), 5-year distant recurrence rates were also very low, suggesting that chemotherapy would not have conferred clinically meaningful benefit.

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Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry

Abstract

Bibliographical note

ASJC Scopus subject areas

UN SDGs

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