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

被引：12

作者：

Dieci, Maria Vittoria ^{[1
,2
]}

Guarneri, Valentina ^{[1
,2
]}

Giarratano, Tommaso ^{[1
]}

Mion, Marta ^{[5
]}

Tortora, Giampaolo ^{[6
]}

De Rossi, Costanza ^{[7
,8
]}

Gori, Stefania ^{[9
]}

Oliani, Cristina ^{[10
]}

Merlini, Laura ^{[11
]}

Pasini, Felice ^{[12
]}

Bonciarelli, Giorgio ^{[13
]}

Griguolo, Gaia ^{[1
]}

Orvieto, Enrico ^{[14
]}

Michieletto, Silvia ^{[3
]}

Saibene, Tania ^{[3
]}

Del Bianco, Paola ^{[4
]}

De Salvo, Gian Luca ^{[4
]}

Conte, PierFranco ^{[1
,2
]}

机构：

[1] Univ Padua, Dept Surg Oncol & Gastroenterol, Padua, Italy

[2] Ist Oncol Veneto IRCCS, Med Oncol 2, Padua, Italy

[3] Ist Oncol Veneto IRCCS, Breast Surg Unit, Padua, Italy

[4] Ist Oncol Veneto IRCCS, Clin Trials & Biostat Unit, Padua, Italy

[5] Osped Civile, Med Oncol, Camposampiero, Italy

[6] Azienda Osped Univ Integrata, Dept Med Oncol, Verona, Italy

[7] Angelo Gen Hosp, Med Oncol Dept, Venice, Italy

[8] SS Giovanni e Paolo Gen Hosp, Venice, Italy

[9] Osped Sacro Cuore Don Calabria, Oncol Unit, Negrar, Italy

[10] AULSS8 Berica Distretto Ovest, Oncol Unit, Vicenza, Italy

[11] Osped Civile S Bortolo, Dept Med Oncol, Vicenza, Italy

[12] Osped Civile, Dept Oncol, Rovigo, Italy

[13] Azienda Euganea 6, Med Oncol, Padova Sud, Monselice, Italy

[14] Azienda Osped Padova, Dept Pathol, Padua, Italy

来源：

ONCOLOGIST | 2018年 / 23卷 / 03期

关键词：

Early breast cancer; Adjuvant chemotherapy; Estrogen receptor positive; Recurrence score; Treatment change; INTERNATIONAL EXPERT CONSENSUS; PRIMARY THERAPY; ASSAY; WOMEN; CHEMOTHERAPY; TAMOXIFEN; EXPRESSION; BIOMARKERS; GUIDELINES; DIAGNOSIS;

D O I：

10.1634/theoncologist.2017-0322

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 < 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.

引用

页码：297 / 305

页数：9

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