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

Harry D. Bear; Wen Wan; André Robidoux; Peter Rubin; Steven Limentani; Richard L. White; James Granfortuna; Judith O. Hopkins; Dwight Oldham; Angel Rodriguez; Amy P. Sing

doi:10.1002/jso.24610

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

Harry D. Bear, Wen Wan, André Robidoux, Peter Rubin, Steven Limentani, Richard L. White, James Granfortuna, Judith O. Hopkins, Dwight Oldham, Angel Rodriguez, Amy P. Sing

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

74 Scopus citations

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.

Original language	English (US)
Pages (from-to)	917-923
Number of pages	7
Journal	Journal of Surgical Oncology
Volume	115
Issue number	8
DOIs	https://doi.org/10.1002/jso.24610
State	Published - Jun 15 2017

Keywords

breast cancer
chemotherapy
gene expression
hormonal therapy
neoadjuvant

ASJC Scopus subject areas

Surgery
Oncology

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10.1002/jso.24610

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@article{8e46f72dd05842cf828e8d9532949585,

title = "Using the 21-gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: A multicenter trial",

abstract = "Objective: We hypothesized that the Oncotype Dx{\textregistered} 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.",

keywords = "breast cancer, chemotherapy, gene expression, hormonal therapy, neoadjuvant",

author = "Bear, {Harry D.} and Wen Wan and Andr{\'e} Robidoux and Peter Rubin and Steven Limentani and White, {Richard L.} and James Granfortuna and Hopkins, {Judith O.} and Dwight Oldham and Angel Rodriguez and Sing, {Amy P.}",

note = "Funding Information: This trial was supported by a grant from Genomic Health, Inc. Services in support of the research project were also generated by the VCU Massey Cancer Center, supported in part with funding from NIH-NCI Cancer Center Support Grant P30 CA016059. HDB has received speaking and advisory board honoraria from Genomic Health, Inc. AS is employed by Genomic Health, Inc. The remaining authors declare that they have no conflict of interest. The trial was funded, in part, by Genomic Health, Inc. Funding Information: This trial was supported by a grant from Genomic Health, Inc. Services in support of the research project were also generated by the VCU Massey Cancer Center, supported in part with funding from NIH-NCI Cancer Center Support Grant P30 CA016059. Publisher Copyright: {\textcopyright} 2017 Wiley Periodicals, Inc.",

year = "2017",

month = jun,

day = "15",

doi = "10.1002/jso.24610",

language = "English (US)",

volume = "115",

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journal = "Journal of Surgical Oncology",

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T1 - Using the 21-gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer

T2 - A multicenter trial

AU - Bear, Harry D.

AU - Wan, Wen

AU - Robidoux, André

AU - Rubin, Peter

AU - Limentani, Steven

AU - White, Richard L.

AU - Granfortuna, James

AU - Hopkins, Judith O.

AU - Oldham, Dwight

AU - Rodriguez, Angel

AU - Sing, Amy P.

N1 - Funding Information: This trial was supported by a grant from Genomic Health, Inc. Services in support of the research project were also generated by the VCU Massey Cancer Center, supported in part with funding from NIH-NCI Cancer Center Support Grant P30 CA016059. HDB has received speaking and advisory board honoraria from Genomic Health, Inc. AS is employed by Genomic Health, Inc. The remaining authors declare that they have no conflict of interest. The trial was funded, in part, by Genomic Health, Inc. Funding Information: This trial was supported by a grant from Genomic Health, Inc. Services in support of the research project were also generated by the VCU Massey Cancer Center, supported in part with funding from NIH-NCI Cancer Center Support Grant P30 CA016059. Publisher Copyright: © 2017 Wiley Periodicals, Inc.

PY - 2017/6/15

Y1 - 2017/6/15

N2 - 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.

AB - 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.

KW - breast cancer

KW - chemotherapy

KW - gene expression

KW - hormonal therapy

KW - neoadjuvant

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ER -

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

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