Optimal duration of adjuvant chemotherapy for high-risk node-negative (N–) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106)

2017 ◽  
Vol 79 ◽  
pp. 166-175 ◽  
Author(s):  
Pierre Kerbrat ◽  
Isabelle Desmoulins ◽  
Lise Roca ◽  
Christelle Levy ◽  
Alain Lortholary ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Node Negative ◽  
Multicentre Phase ◽  
Optimal Duration

The 70-gene profile and chemotherapy benefit in 1,600 breast cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 512-512 ◽  
Author(s):  
R. A. Bender ◽  
M. Knauer ◽  
E. J. Rutgers ◽  
A. M. Glas ◽  
F. A. de Snoo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Endocrine Therapy ◽  
Hormonal Therapy ◽  
Prognostic Indicator ◽  
Low Risk ◽  
Breast Cancer Patients ◽  
Node Negative

512 Background: The 70-gene expression profile (MammaPrint) is validated as an independent prognostic indicator for breast cancer patients with T1–2 node-negative and positive disease regardless of estrogen receptor status. Here we present the relationship between MammaPrint outcome and chemotherapy benefit in the adjuvant setting. Methods: We performed a pooled analysis of 1,637 patients with MammaPrint outcomes (T1–2, node-negative and positive invasive breast cancer and median FU 7.1 yrs) to determine the chemotherapy benefit of patients treated with adjuvant chemotherapy in addition to endocrine therapy. Patients were collected from 7 large datasets at multiple institutions across Europe. Results: In this meta-analysis, MammaPrint assigned 772 patients (47%) to “low risk” and 865 (53%) to “high risk”. In total 349 patients were treated with endocrine therapy alone, whereas 226 were treated with both chemo- and endocrine therapy. Patients with poor prognosis MammaPrint profile had a substantial benefit from chemotherapy: At 5 years, distant disease-free survival was improved from 69% to 88% (HR 0.28 (95% CI 0.14–0.56, p<0.001) when chemotherapy was added to hormonal therapy. The results remained significant in multivariate analysis including stratification by standard clinico-pathologic prognostic factors. Patients classified by MammaPrint as good prognosis (“low risk”) had no significant benefit from chemotherapy (p=0.962). Conclusions: The 70-gene MammaPrint profile is not only a strong and independent prognostic indicator for patients with early stage breast cancer, but it may also be predictive for the benefit of chemotherapy. While MammaPrint “high risk” classified patients demonstrate a clear benefit from adjuvant chemotherapy added to hormonal therapy, patients classified by MammaPrint as “low risk” for recurrence do not appear to benefit from the addition of chemotherapy to hormonal treatment alone. [Table: see text]

Gruppo Oncologico Nord Ovest – Mammella Intergruppo (GONO MIG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 212-222
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Randomized Study ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Node Negative ◽  
Node Positive ◽  
Positive Breast Cancer

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Gruppo Oncologico Nord Ovest – Mammella Intergruppo (GONO MIG). Clinical trials include: Standard CEF versus accelerated CEF as adjuvant chemotherapy in node-positive or high-risk node-negative (T > 2 cm, age <35 years, G3, negative hormone receptors or high TL1 or S-phase) breast cancer. A phase III randomized trial. MIG-1Epirubicin plus paclitaxel versus cyclophosphamide, epirubicin and 5-fluorouracil as adjuvant chemotherapy in node-positive breast cancer patients. A phase III randomized study. MIG-5A phase III randomized study of sequential epidoxorubicin plus cyclophosp-amide followed by docetaxel (EC D) versus a combination of 5-fluorouracil, epidoxorubicin and cyclophosp-amide (FEC) as adjuvant treatment of node-negative early breast cancer patients.A phase III randomized study of EC followed by paclitaxel versus FEC followed by paclitaxel, all given either every 3 or 2 weeks supported by pegfilgrastim, for node-positive breast cancer patients.Prevention of chemotherapy-induced menopause by temporary ovarian suppression with triptorelin versus control in young breast cancer patients. A randomized phase III multicenter study.Letrozole adjuvant therapy duration (lead) study: standard versus long treatment. A phase III trial in post-menopausal women with early breast cancer.

Evaluation of the prognostic significance of RACGAP1, Ki67, and TOP2A mRNA expression in high-risk early breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 582-582
Author(s):  
Kyriaki Pliarchopoulou ◽  
Helen Gogas ◽  
Christos A. Papadimitriou ◽  
Ralph M Wirtz ◽  
George Kouvatseas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Multivariate Analysis ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Mrna Expression ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Prognostic Significance ◽  
Phase Iii ◽  
Breast Cancer Patients

582 Background: Proliferation is a major process in carcinogenesis. RACGAP1 is a protein involved in cell growth regulation and metastasis, Ki67 is a known proliferation marker and TOP2A has a key role in DNA replication and remodeling. The aim of the present study was to explore the prognostic significance of a signature of proliferation markers, such as RACGAP1, Ki67 and TOP2A on disease-free survival (DFS) and overall survival (OS) in high-risk early breast cancer patients. Methods: A total of 1681high-risk breast cancer patients, enrolled in two consecutive phase III trials, were treated with anthracycline-based adjuvant chemotherapy. Formalin-fixed paraffin-embedded tumor tissue samples from 963 of these patients were extracted using a standardized fully automated isolation method for total RNA based on silica-coated magnetic beads, followed by multiplex RT-qPCR for assessing RACGAP1, Ki67 and TOP2A mRNA expression. CALM2 was included in the same reaction, as a reference gene. Results: After a median follow-up of 107 months, 289 patients (30.0%) demonstrated disease progression and 261 (27.1%) patients died. Univariate analysis revealed that poor OS was associated with high RACGAP1 mRNA expression (p=0.0185, log-rank), high Ki67 (p=0.0219), as well as high TOP2A (p=0.0019) mRNA expression, while in multivariate analysis only TOP2A retained significance (Wald’s p=0.008). In an effort to improve prognostic significance, combinations of the expression of two or all three genes were tested, with low mRNA expression of the three genes being associated with improved DFS (HR=0.74, CI=0.56-0.98, p=0.035) and OS (HR=0.60, CI=0.42-0.85, p=0.004). However, in multivariate analysis, none of the combinations retained prognostic significance, except the combination of high RACGAP1 and TOP2A mRNA expression, which was found to be associated with decreased DFS (HR=1.26, CI=0.96-1.63, p=0.092) and OS (HR=1.49, CI=1.10-2.03, p=0.009). Conclusions: High RACGAP1 and TOP2A mRNA expression was found, in multivariate analysis, to be of adverse prognostic significance in high-risk early breast cancer patients treated with anthracycline-containing adjuvant chemotherapy.

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