Using the 21‐gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: A multicenter trial

Objective We hypothesized that the Oncotype Dx® 21‐gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS) for hormone receptor positive (HR+) breast cancers. Methods This study enrolled patients with HR+, HER2‐negative, invasive breast...

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Published inJournal of surgical oncology Vol. 115; no. 8; pp. 917 - 923
Main Authors Bear, Harry D., Wan, Wen, Robidoux, André, Rubin, Peter, Limentani, Steven, White, Richard L., Granfortuna, James, Hopkins, Judith O., Oldham, Dwight, Rodriguez, Angel, Sing, Amy P.
Format Journal Article
LanguageEnglish
Published United States Wiley Subscription Services, Inc 15.06.2017
Subjects
Adult
Aged
Aged, 80 and over
Antineoplastic Agents - therapeutic use
Aromatase Inhibitors - therapeutic use
Biopsy
Biopsy, Large-Core Needle
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - genetics
Breast Neoplasms - pathology
Breast Neoplasms - surgery
Cancer surgery
chemotherapy
Chemotherapy, Adjuvant
Clinical Decision-Making
Female
gene expression
Gene Expression Profiling - methods
hormonal therapy
Humans
Mastectomy, Segmental
Middle Aged
neoadjuvant
Neoadjuvant Therapy
Pilot Projects
Prospective Studies
Receptors, Estrogen
Receptors, Progesterone
Tumors
hormonal therapy
breast cancer
neoadjuvant
chemotherapy
gene expression
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Abstract Objective We hypothesized that the Oncotype Dx® 21‐gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS) for hormone receptor positive (HR+) breast cancers. Methods This study enrolled patients with HR+, HER2‐negative, invasive breast cancers not suitable for BCS (size ≥ 2 cm). Core needle biopsy blocks were tested. For tumors with RS < 11, patients received hormonal therapy (NHT); patients with RS > 25 tumors received chemotherapy (NCT); patients with RS 11‐25 were randomized to NHT or NCT. Primary endpoint was whether 1/3 or more of randomized patients refused assigned treatment. Results Sixty‐four patients were enrolled. Of 33 patients with RS 11‐25, 5 (15%) refused assignment to NCT. This was significantly lower than the 33% target (binomial test, P = 0.0292). Results for clinical outcomes (according to treatment received for 55 subjects) included successful BCS for 75% of tumors with RS < 11 receiving NHT, 72% for RS 11‐25 receiving NHT, 64% for RS 11‐25 receiving NCT, and 57% for RS > 25 receiving NCT. Conclusions Using the RS to guide NST is feasible. These results suggest that for patients with RS < 25 NHT is a potentially effective strategy.
AbstractList We hypothesized that the Oncotype Dx® 21-gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS) for hormone receptor positive (HR+) breast cancers.OBJECTIVEWe hypothesized that the Oncotype Dx® 21-gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS) for hormone receptor positive (HR+) breast cancers.This study enrolled patients with HR+, HER2-negative, invasive breast cancers not suitable for BCS (size ≥ 2 cm). Core needle biopsy blocks were tested. For tumors with RS < 11, patients received hormonal therapy (NHT); patients with RS > 25 tumors received chemotherapy (NCT); patients with RS 11-25 were randomized to NHT or NCT. Primary endpoint was whether 1/3 or more of randomized patients refused assigned treatment.METHODSThis study enrolled patients with HR+, HER2-negative, invasive breast cancers not suitable for BCS (size ≥ 2 cm). Core needle biopsy blocks were tested. For tumors with RS < 11, patients received hormonal therapy (NHT); patients with RS > 25 tumors received chemotherapy (NCT); patients with RS 11-25 were randomized to NHT or NCT. Primary endpoint was whether 1/3 or more of randomized patients refused assigned treatment.Sixty-four patients were enrolled. Of 33 patients with RS 11-25, 5 (15%) refused assignment to NCT. This was significantly lower than the 33% target (binomial test, P = 0.0292). Results for clinical outcomes (according to treatment received for 55 subjects) included successful BCS for 75% of tumors with RS < 11 receiving NHT, 72% for RS 11-25 receiving NHT, 64% for RS 11-25 receiving NCT, and 57% for RS > 25 receiving NCT.RESULTSSixty-four patients were enrolled. Of 33 patients with RS 11-25, 5 (15%) refused assignment to NCT. This was significantly lower than the 33% target (binomial test, P = 0.0292). Results for clinical outcomes (according to treatment received for 55 subjects) included successful BCS for 75% of tumors with RS < 11 receiving NHT, 72% for RS 11-25 receiving NHT, 64% for RS 11-25 receiving NCT, and 57% for RS > 25 receiving NCT.Using the RS to guide NST is feasible. These results suggest that for patients with RS < 25 NHT is a potentially effective strategy.CONCLUSIONSUsing the RS to guide NST is feasible. These results suggest that for patients with RS < 25 NHT is a potentially effective strategy.
Objective We hypothesized that the Oncotype Dx® 21‐gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS) for hormone receptor positive (HR+) breast cancers. Methods This study enrolled patients with HR+, HER2‐negative, invasive breast cancers not suitable for BCS (size ≥ 2 cm). Core needle biopsy blocks were tested. For tumors with RS < 11, patients received hormonal therapy (NHT); patients with RS > 25 tumors received chemotherapy (NCT); patients with RS 11‐25 were randomized to NHT or NCT. Primary endpoint was whether 1/3 or more of randomized patients refused assigned treatment. Results Sixty‐four patients were enrolled. Of 33 patients with RS 11‐25, 5 (15%) refused assignment to NCT. This was significantly lower than the 33% target (binomial test, P = 0.0292). Results for clinical outcomes (according to treatment received for 55 subjects) included successful BCS for 75% of tumors with RS < 11 receiving NHT, 72% for RS 11‐25 receiving NHT, 64% for RS 11‐25 receiving NCT, and 57% for RS > 25 receiving NCT. Conclusions Using the RS to guide NST is feasible. These results suggest that for patients with RS < 25 NHT is a potentially effective strategy.
Objective We hypothesized that the Oncotype Dx 21-gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS) for hormone receptor positive (HR+) breast cancers. Methods This study enrolled patients with HR+, HER2-negative, invasive breast cancers not suitable for BCS (size≥2cm). Core needle biopsy blocks were tested. For tumors with RS<11, patients received hormonal therapy (NHT); patients with RS>25 tumors received chemotherapy (NCT); patients with RS 11-25 were randomized to NHT or NCT. Primary endpoint was whether 1/3 or more of randomized patients refused assigned treatment. Results Sixty-four patients were enrolled. Of 33 patients with RS 11-25, 5 (15%) refused assignment to NCT. This was significantly lower than the 33% target (binomial test, P=0.0292). Results for clinical outcomes (according to treatment received for 55 subjects) included successful BCS for 75% of tumors with RS<11 receiving NHT, 72% for RS 11-25 receiving NHT, 64% for RS 11-25 receiving NCT, and 57% for RS>25 receiving NCT. Conclusions Using the RS to guide NST is feasible. These results suggest that for patients with RS<25 NHT is a potentially effective strategy.
We hypothesized that the Oncotype Dx 21-gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS) for hormone receptor positive (HR+) breast cancers. This study enrolled patients with HR+, HER2-negative, invasive breast cancers not suitable for BCS (size ≥ 2 cm). Core needle biopsy blocks were tested. For tumors with RS < 11, patients received hormonal therapy (NHT); patients with RS > 25 tumors received chemotherapy (NCT); patients with RS 11-25 were randomized to NHT or NCT. Primary endpoint was whether 1/3 or more of randomized patients refused assigned treatment. Sixty-four patients were enrolled. Of 33 patients with RS 11-25, 5 (15%) refused assignment to NCT. This was significantly lower than the 33% target (binomial test, P = 0.0292). Results for clinical outcomes (according to treatment received for 55 subjects) included successful BCS for 75% of tumors with RS < 11 receiving NHT, 72% for RS 11-25 receiving NHT, 64% for RS 11-25 receiving NCT, and 57% for RS > 25 receiving NCT. Using the RS to guide NST is feasible. These results suggest that for patients with RS < 25 NHT is a potentially effective strategy.
Author Limentani, Steven
White, Richard L.
Granfortuna, James
Oldham, Dwight
Rodriguez, Angel
Rubin, Peter
Robidoux, André
Hopkins, Judith O.
Bear, Harry D.
Wan, Wen
Sing, Amy P.
AuthorAffiliation 3 Cone Health Cancer Center, Greensboro, NC, USA
5 Forsyth Regional Cancer Center, Winston Salem, NC, USA
6 Lynchburg Hematology Oncology Clinic, Lynchburg, VA, USA
1 Virginia Commonwealth University and Massey Cancer Center, Richmond, VA, USA
2 Centre Hospitalier de l’Universite de Montreal, Montreal, Quebec, Canada
4 Carolinas Medical Center, Charlotte, NC, USA
8 Genomic Health, Inc, Redwood City, CA, USA
7 Methodist Hospital, Houston, TX, USA
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– name: 5 Forsyth Regional Cancer Center, Winston Salem, NC, USA
– name: 8 Genomic Health, Inc, Redwood City, CA, USA
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  organization: Virginia Commonwealth University and Massey Cancer Center
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  organization: Centre Hospitalier de l'Universite de Montreal
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  organization: Methodist Hospital
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  surname: Sing
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  organization: Genomic Health, Inc
BackLink https://www.ncbi.nlm.nih.gov/pubmed/28407247$$D View this record in MEDLINE/PubMed
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Keywords hormonal therapy
breast cancer
neoadjuvant
chemotherapy
gene expression
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2017 Wiley Periodicals, Inc.
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Dr. Rubin is currently at Southern Maine Health Care, Biddeford, ME USA; Dr. Wan is currently at University of Chicago. Chicago, IL, USA; Dr. Limentani is currently at Novant Health, Charlotte, NC, USA
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PublicationTitle Journal of surgical oncology
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Publisher Wiley Subscription Services, Inc
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2017; 24
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2015; 32
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2016; 36
2016; 34
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2015; 24
2004; 351
2014; 106
2016; 2
2006; 24
2010; 119
2005; 365
1997; 15
2013; 31
2015; 154
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2016; 42
2008; 26
2014; 19
2007; 3
2014; 384
2011; 29
2005; 11
2003; 21
2007; 25
2009; 18
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SSID ssj0009964
Score 2.4763815
Snippet Objective We hypothesized that the Oncotype Dx® 21‐gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving...
We hypothesized that the Oncotype Dx 21-gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS)...
Objective We hypothesized that the Oncotype Dx 21-gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving...
We hypothesized that the Oncotype Dx® 21-gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery...
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wiley
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Publisher
StartPage 917
SubjectTerms Adult
Aged
Aged, 80 and over
Antineoplastic Agents - therapeutic use
Aromatase Inhibitors - therapeutic use
Biopsy
Biopsy, Large-Core Needle
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - genetics
Breast Neoplasms - pathology
Breast Neoplasms - surgery
Cancer surgery
chemotherapy
Chemotherapy, Adjuvant
Clinical Decision-Making
Female
gene expression
Gene Expression Profiling - methods
hormonal therapy
Humans
Mastectomy, Segmental
Middle Aged
neoadjuvant
Neoadjuvant Therapy
Pilot Projects
Prospective Studies
Receptors, Estrogen
Receptors, Progesterone
Tumors
Title Using the 21‐gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: A multicenter trial
URI https://onlinelibrary.wiley.com/doi/abs/10.1002%2Fjso.24610
https://www.ncbi.nlm.nih.gov/pubmed/28407247
https://www.proquest.com/docview/1913944575
https://www.proquest.com/docview/1888684149
https://pubmed.ncbi.nlm.nih.gov/PMC5481477
Volume 115
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