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

M.V. Dieci, V. Guarneri, T. Giarratano, M. Mion, G. Tortora, C. De Rossi, Stefania Gori, C. Oliani, L. Merlini, F. Pasini, G. Bonciarelli, G. Griguolo, E. Orvieto, S. Michieletto, T. Saibene, P. Del Bianco, G.L. De Salvo, P. Conte

Research output: Contribution to journalArticle

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 of n = 124 N0 and n = 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 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
Original languageEnglish
Pages (from-to)297-305
Number of pages9
JournalOncologist
Volume23
Issue number3
DOIs
Publication statusPublished - Mar 2018

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Multicenter Studies
Breast Neoplasms
Recurrence
Genes
Therapeutics
Drug Therapy
Neoplasms
Estrogen Receptors
Italy
Breast
Prospective Studies
Physicians
Growth

Keywords

  • Ki 67 antigen, adjuvant therapy
  • adult
  • aged
  • Article
  • cancer staging
  • clinical decision making
  • clinical practice
  • community hospital
  • disease free survival
  • estrogen receptor positive breast cancer
  • female
  • histology
  • human
  • Italy
  • major clinical study
  • multicenter study
  • observational study
  • postmenopause
  • premenopause
  • priority journal
  • prospective study
  • questionnaire
  • sample size
  • tumor volume
  • very elderly

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, M.V.; Guarneri, V.; Giarratano, T.; Mion, M.; Tortora, G.; De Rossi, C.; Gori, Stefania; Oliani, C.; Merlini, L.; Pasini, F.; Bonciarelli, G.; Griguolo, G.; Orvieto, E.; Michieletto, S.; Saibene, T.; Del Bianco, P.; De Salvo, G.L.; Conte, P.

In: Oncologist, Vol. 23, No. 3, 03.2018, p. 297-305.

Research output: Contribution to journalArticle

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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 of n = 124 N0 and n = 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 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",
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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, M.V.

AU - Guarneri, V.

AU - Giarratano, T.

AU - Mion, M.

AU - Tortora, G.

AU - De Rossi, C.

AU - Gori, Stefania

AU - Oliani, C.

AU - Merlini, L.

AU - Pasini, F.

AU - Bonciarelli, G.

AU - Griguolo, G.

AU - Orvieto, E.

AU - Michieletto, S.

AU - Saibene, T.

AU - Del Bianco, P.

AU - De Salvo, G.L.

AU - Conte, P.

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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 of n = 124 N0 and n = 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 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

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 of n = 124 N0 and n = 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 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

KW - Ki 67 antigen, adjuvant therapy

KW - adult

KW - aged

KW - Article

KW - cancer staging

KW - clinical decision making

KW - clinical practice

KW - community hospital

KW - disease free survival

KW - estrogen receptor positive breast cancer

KW - female

KW - histology

KW - human

KW - Italy

KW - major clinical study

KW - multicenter study

KW - observational study

KW - postmenopause

KW - premenopause

KW - priority journal

KW - prospective study

KW - questionnaire

KW - sample size

KW - tumor volume

KW - very elderly

U2 - 10.1634/theoncologist.2017-0322

DO - 10.1634/theoncologist.2017-0322

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VL - 23

SP - 297

EP - 305

JO - Oncologist

JF - Oncologist

SN - 1083-7159

IS - 3

ER -