First Prospective Multicenter Italian Study on the Impact of the 21-Gene Recurrence Score in Adjuvant Clinical Decisions for Patients with ER Positive/HER2 Negative Breast Cancer

Maria Vittoria Dieci, Valentina Guarneri, Tommaso Giarratano, Marta Mion, Giampaolo Tortora, Costanza De Rossi, Stefania Gori, Cristina Oliani, Laura Merlini, Felice Pasini, Giorgio Bonciarelli, Gaia Griguolo, Enrico Orvieto, Silvia Michieletto, Tania Saibene, Paola Del Bianco, Gian Luca De Salvo, PierFranco Conte

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

BACKGROUND: The Breast DX Italy prospective study evaluated the impact of the 21-gene recurrence score (RS) result on adjuvant treatment decisions for patients with early breast cancer.

MATERIALS AND METHODS: Nine centers (two Hub and seven Spoke centers of the Veneto Oncology Network) participated. Consecutive patients with estrogen receptor positive, human epidermal growth receptor negative, T1-T3, N0-N1 early breast cancer were prospectively registered; only those meeting protocol-defined clinicopathological "intermediate risk" criteria were eligible for the RS test. Pre-RS and post-RS physicians' treatment recommendations and treatment actually received were collected.

RESULTS: A total ofn = 124 N0 andn = 126 N1 patients underwent the RS assay. The majority had Grade 2 tumors (71%); median age was 55 years, median tumor size was 16 mm, and median Ki67 expression was 20%. Patients enrolled at Hub centers presented higher-risk features. The distribution of RS results was <18 (60.8%), 18-30 (32.4%), and >30 (6.8%). The indication before RS was hormonal therapy (HT) alone in 52% of cases. An indication before RS of chemotherapy (CT)+HT was more frequent for patients with N1 versus N0 tumors (57% vs. 39%,p = .0035) and for patients enrolled at Hub versus Spoke centers (54% vs. 36%,p = .007).The overall rate of change in treatment decision was 16% (n = 40), mostly from CT+HT to HT (n = 30). According to nodal status, rate of change in treatment decision was 12% for the N0 cohort and 20% for the N1 cohort. The proportion of patients recommended to CT+HT was significantly reduced from before to after RS (48% to 40%,p < .0016), especially in the N1 cohort (57% to 45%,p = .0027) and at Hub centers (54% to 44%,p = .001).

CONCLUSION: Despite frequent indication of HT before RS, the use of the RS assay further contributed to sparing CT, especially for patients with N1 tumors and at Hub centers.

IMPLICATIONS FOR PRACTICE: This study shows that, although a high proportion of patients were recommended to endocrine treatment alone before knowing the recurrence score (RS) assay, the RS test further contributed in sparing chemotherapy for some of these patients, especially in case of the N1 stage or for patients enrolled at referral centers. These data highlight the need for further work in collaboration with health authorities and companies in order to define strategies for the implementation of the use of RS testing in clinical practice in the Italian setting.

Original languageEnglish
JournalThe oncologist
DOIs
Publication statusE-pub ahead of print - Nov 13 2017

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Multicenter Studies
Breast Neoplasms
Recurrence
Genes
Drug Therapy
Therapeutics
Neoplasms
Estrogen Receptors
Italy
Breast
Referral and Consultation
Prospective Studies
Physicians

Keywords

  • Journal Article
  • Early Breast Cancer
  • Adjuvant Chemotherapy
  • Estrogen receptor positive
  • Treatment changes
  • recurrence score

Cite this

First Prospective Multicenter Italian Study on the Impact of the 21-Gene Recurrence Score in Adjuvant Clinical Decisions for Patients with ER Positive/HER2 Negative Breast Cancer. / Dieci, Maria Vittoria; Guarneri, Valentina; Giarratano, Tommaso; Mion, Marta; Tortora, Giampaolo; De Rossi, Costanza; Gori, Stefania; Oliani, Cristina; Merlini, Laura; Pasini, Felice; Bonciarelli, Giorgio; Griguolo, Gaia; Orvieto, Enrico; Michieletto, Silvia; Saibene, Tania; Del Bianco, Paola; De Salvo, Gian Luca; Conte, PierFranco.

In: The oncologist, 13.11.2017.

Research output: Contribution to journalArticle

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title = "First Prospective Multicenter Italian Study on the Impact of the 21-Gene Recurrence Score in Adjuvant Clinical Decisions for Patients with ER Positive/HER2 Negative Breast Cancer",
abstract = "BACKGROUND: The Breast DX Italy prospective study evaluated the impact of the 21-gene recurrence score (RS) result on adjuvant treatment decisions for patients with early breast cancer.MATERIALS AND METHODS: Nine centers (two Hub and seven Spoke centers of the Veneto Oncology Network) participated. Consecutive patients with estrogen receptor positive, human epidermal growth receptor negative, T1-T3, N0-N1 early breast cancer were prospectively registered; only those meeting protocol-defined clinicopathological {"}intermediate risk{"} criteria were eligible for the RS test. Pre-RS and post-RS physicians' treatment recommendations and treatment actually received were collected.RESULTS: A total ofn = 124 N0 andn = 126 N1 patients underwent the RS assay. The majority had Grade 2 tumors (71{\%}); median age was 55 years, median tumor size was 16 mm, and median Ki67 expression was 20{\%}. Patients enrolled at Hub centers presented higher-risk features. The distribution of RS results was <18 (60.8{\%}), 18-30 (32.4{\%}), and >30 (6.8{\%}). The indication before RS was hormonal therapy (HT) alone in 52{\%} of cases. An indication before RS of chemotherapy (CT)+HT was more frequent for patients with N1 versus N0 tumors (57{\%} vs. 39{\%},p = .0035) and for patients enrolled at Hub versus Spoke centers (54{\%} vs. 36{\%},p = .007).The overall rate of change in treatment decision was 16{\%} (n = 40), mostly from CT+HT to HT (n = 30). According to nodal status, rate of change in treatment decision was 12{\%} for the N0 cohort and 20{\%} for the N1 cohort. The proportion of patients recommended to CT+HT was significantly reduced from before to after RS (48{\%} to 40{\%},p < .0016), especially in the N1 cohort (57{\%} to 45{\%},p = .0027) and at Hub centers (54{\%} to 44{\%},p = .001).CONCLUSION: Despite frequent indication of HT before RS, the use of the RS assay further contributed to sparing CT, especially for patients with N1 tumors and at Hub centers.IMPLICATIONS FOR PRACTICE: This study shows that, although a high proportion of patients were recommended to endocrine treatment alone before knowing the recurrence score (RS) assay, the RS test further contributed in sparing chemotherapy for some of these patients, especially in case of the N1 stage or for patients enrolled at referral centers. These data highlight the need for further work in collaboration with health authorities and companies in order to define strategies for the implementation of the use of RS testing in clinical practice in the Italian setting.",
keywords = "Journal Article, Early Breast Cancer, Adjuvant Chemotherapy, Estrogen receptor positive, Treatment changes, recurrence score",
author = "Dieci, {Maria Vittoria} and Valentina Guarneri and Tommaso Giarratano and Marta Mion and Giampaolo Tortora and {De Rossi}, Costanza and Stefania Gori and Cristina Oliani and Laura Merlini and Felice Pasini and Giorgio Bonciarelli and Gaia Griguolo and Enrico Orvieto and Silvia Michieletto and Tania Saibene and {Del Bianco}, Paola and {De Salvo}, {Gian Luca} and PierFranco Conte",
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language = "English",
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TY - JOUR

T1 - First Prospective Multicenter Italian Study on the Impact of the 21-Gene Recurrence Score in Adjuvant Clinical Decisions for Patients with ER Positive/HER2 Negative Breast Cancer

AU - Dieci, Maria Vittoria

AU - Guarneri, Valentina

AU - Giarratano, Tommaso

AU - Mion, Marta

AU - Tortora, Giampaolo

AU - De Rossi, Costanza

AU - Gori, Stefania

AU - Oliani, Cristina

AU - Merlini, Laura

AU - Pasini, Felice

AU - Bonciarelli, Giorgio

AU - Griguolo, Gaia

AU - Orvieto, Enrico

AU - Michieletto, Silvia

AU - Saibene, Tania

AU - Del Bianco, Paola

AU - De Salvo, Gian Luca

AU - Conte, PierFranco

N1 - © AlphaMed Press 2017.

PY - 2017/11/13

Y1 - 2017/11/13

N2 - BACKGROUND: The Breast DX Italy prospective study evaluated the impact of the 21-gene recurrence score (RS) result on adjuvant treatment decisions for patients with early breast cancer.MATERIALS AND METHODS: Nine centers (two Hub and seven Spoke centers of the Veneto Oncology Network) participated. Consecutive patients with estrogen receptor positive, human epidermal growth receptor negative, T1-T3, N0-N1 early breast cancer were prospectively registered; only those meeting protocol-defined clinicopathological "intermediate risk" criteria were eligible for the RS test. Pre-RS and post-RS physicians' treatment recommendations and treatment actually received were collected.RESULTS: A total ofn = 124 N0 andn = 126 N1 patients underwent the RS assay. The majority had Grade 2 tumors (71%); median age was 55 years, median tumor size was 16 mm, and median Ki67 expression was 20%. Patients enrolled at Hub centers presented higher-risk features. The distribution of RS results was <18 (60.8%), 18-30 (32.4%), and >30 (6.8%). The indication before RS was hormonal therapy (HT) alone in 52% of cases. An indication before RS of chemotherapy (CT)+HT was more frequent for patients with N1 versus N0 tumors (57% vs. 39%,p = .0035) and for patients enrolled at Hub versus Spoke centers (54% vs. 36%,p = .007).The overall rate of change in treatment decision was 16% (n = 40), mostly from CT+HT to HT (n = 30). According to nodal status, rate of change in treatment decision was 12% for the N0 cohort and 20% for the N1 cohort. The proportion of patients recommended to CT+HT was significantly reduced from before to after RS (48% to 40%,p < .0016), especially in the N1 cohort (57% to 45%,p = .0027) and at Hub centers (54% to 44%,p = .001).CONCLUSION: Despite frequent indication of HT before RS, the use of the RS assay further contributed to sparing CT, especially for patients with N1 tumors and at Hub centers.IMPLICATIONS FOR PRACTICE: This study shows that, although a high proportion of patients were recommended to endocrine treatment alone before knowing the recurrence score (RS) assay, the RS test further contributed in sparing chemotherapy for some of these patients, especially in case of the N1 stage or for patients enrolled at referral centers. These data highlight the need for further work in collaboration with health authorities and companies in order to define strategies for the implementation of the use of RS testing in clinical practice in the Italian setting.

AB - BACKGROUND: The Breast DX Italy prospective study evaluated the impact of the 21-gene recurrence score (RS) result on adjuvant treatment decisions for patients with early breast cancer.MATERIALS AND METHODS: Nine centers (two Hub and seven Spoke centers of the Veneto Oncology Network) participated. Consecutive patients with estrogen receptor positive, human epidermal growth receptor negative, T1-T3, N0-N1 early breast cancer were prospectively registered; only those meeting protocol-defined clinicopathological "intermediate risk" criteria were eligible for the RS test. Pre-RS and post-RS physicians' treatment recommendations and treatment actually received were collected.RESULTS: A total ofn = 124 N0 andn = 126 N1 patients underwent the RS assay. The majority had Grade 2 tumors (71%); median age was 55 years, median tumor size was 16 mm, and median Ki67 expression was 20%. Patients enrolled at Hub centers presented higher-risk features. The distribution of RS results was <18 (60.8%), 18-30 (32.4%), and >30 (6.8%). The indication before RS was hormonal therapy (HT) alone in 52% of cases. An indication before RS of chemotherapy (CT)+HT was more frequent for patients with N1 versus N0 tumors (57% vs. 39%,p = .0035) and for patients enrolled at Hub versus Spoke centers (54% vs. 36%,p = .007).The overall rate of change in treatment decision was 16% (n = 40), mostly from CT+HT to HT (n = 30). According to nodal status, rate of change in treatment decision was 12% for the N0 cohort and 20% for the N1 cohort. The proportion of patients recommended to CT+HT was significantly reduced from before to after RS (48% to 40%,p < .0016), especially in the N1 cohort (57% to 45%,p = .0027) and at Hub centers (54% to 44%,p = .001).CONCLUSION: Despite frequent indication of HT before RS, the use of the RS assay further contributed to sparing CT, especially for patients with N1 tumors and at Hub centers.IMPLICATIONS FOR PRACTICE: This study shows that, although a high proportion of patients were recommended to endocrine treatment alone before knowing the recurrence score (RS) assay, the RS test further contributed in sparing chemotherapy for some of these patients, especially in case of the N1 stage or for patients enrolled at referral centers. These data highlight the need for further work in collaboration with health authorities and companies in order to define strategies for the implementation of the use of RS testing in clinical practice in the Italian setting.

KW - Journal Article

KW - Early Breast Cancer

KW - Adjuvant Chemotherapy

KW - Estrogen receptor positive

KW - Treatment changes

KW - recurrence score

U2 - 10.1634/theoncologist.2017-0322

DO - 10.1634/theoncologist.2017-0322

M3 - Article

C2 - 29133514

JO - Oncologist

JF - Oncologist

SN - 1083-7159

ER -