Randomized Clinical Trial of Adjuvant Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy for Patients With Fast-Proliferating, Node-Negative Breast Cancer

2001 ◽  
Vol 19 (19) ◽  
pp. 3929-3937 ◽  
Author(s):  
Angelo Paradiso ◽  
Francesco Schittulli ◽  
Giovanni Cellamare ◽  
Annita Mangia ◽  
Franco Marzullo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Proliferative Activity ◽  
Disease Free Survival ◽  
Control Group ◽  
Consecutive Series ◽  
Primary Tumors ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
The Impact

PURPOSE: The prospective applicability of new biologic tumor information to personalize adjuvant treatment of women with operable breast cancer remains to be demonstrated. The aim of the present study was to investigate whether patients with fast-proliferating, node-negative breast cancer could benefit from adjuvant chemotherapy with fluorouracil, epirubicin, and cyclophosphamide (FEC). PATIENTS AND METHODS: Beginning in November 1989, we analyzed the proliferative activity of primary tumors in a consecutive series of women with node-negative breast cancer to identify subgroups of patients with a worse prognosis and who were therefore suitable candidates for adjuvant systemic therapy. Proliferative activity was determined by means of the [3H]-thymidine incorporation assay using an autoradiographic technique. Women with fast-proliferating breast cancer ([3H]-thymidine labeling index, > 2.3%) were randomized to receive either six cycles of adjuvant FEC or no adjuvant therapy until disease progression. RESULTS: One-hundred twenty-five and 123 patients treated with radical surgery for pT1 to T2, N0, M0 breast cancer were randomized to the FEC and control arms, respectively. After a median follow-up of 70 months, 27 events (21.6%) were observed in the FEC arm and 39 (32.2%) in the control arm, with a significantly lower number of locoregional relapses in the FEC group. Five-year disease-free survival (DFS) was 81% in the FEC group and 69% in the control group (P < .02 by log-rank test). Cox multivariate analysis described the impact of adjuvant therapy with FEC on DFS as independent of the patients’ main clinical-pathologic characteristics. CONCLUSION: FEC adjuvant polychemotherapy seems able to significantly improve the clinical outcome of patients with fast-proliferating, node-negative breast cancer.

scholarly journals Is Adjuvant Tamoxifen Recommended in Post-Menopausal Node-Negative Breast Cancer Patients with High Estrogen Receptor Values?

2000 ◽  
Vol 15 (2) ◽  
pp. 135-138 ◽  
Author(s):  
J.-L. Floiras ◽  
K. Hacene ◽  
F. Turpin ◽  
F. Spyratos
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Disease Free Survival ◽  
Adjuvant Tamoxifen ◽  
Breast Cancer Patients ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
Post Menopausal ◽  
The Impact

The impact of ER levels on the response to tamoxifen was evaluated in 1,623 postmenopausal primary breast cancer patients treated at our center (median follow-up 8.2 years). In patients receiving adjuvant tamoxifen a significantly longer disease-free survival (DFS) was observed when ER levels were elevated (p<0.00001). Very high ER (>424 fmol/mg protein) appeared to be detrimental in node-negative patients not treated with tamoxifen.

Disease-Free Survival Advantage of Adjuvant Cyclophosphamide, Methotrexate, and Fluorouracil in Patients With Node-Negative, Rapidly Proliferating Breast Cancer: A Randomized Multicenter Study

2000 ◽  
Vol 18 (17) ◽  
pp. 3125-3134 ◽  
Author(s):  
Dino Amadori ◽  
Oriana Nanni ◽  
Maurizio Marangolo ◽  
Paolo Pacini ◽  
Alberto Ravaioli ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Disease Free Survival ◽  
Distant Metastases ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
Node Negative ◽  
Randomized Clinical Study ◽  
Node Negative Breast Cancer ◽  
Disease Free

PURPOSE: According to one of the most recent key scientific questions concerning the use of biomarkers in clinical trials, we investigated whether node-negative breast cancer patients, defined as high-risk cases on the basis of tumor cell proliferation, could benefit from cyclophosphamide, methotrexate, and fluorouracil (CMF) adjuvant therapy. PATIENTS AND METHODS: Two hundred eighty-one patients with negative nodes and rapidly proliferating tumors, defined according to thymidine labeling index (TLI), were randomized to receive six cycles of CMF or no further treatment after surgery ± radiotherapy. RESULTS: The 5-year disease-free survival (DFS) was 83% for patients treated with CMF compared with 72% in the control group (P = .028). Adjuvant treatment reduced both locoregional and distant metastases. When clinical outcome was analyzed in cell kinetic subgroups characterized according to tertile criteria, compared with patients in the control arm, 5-year DFS was significantly higher after adjuvant CMF in patients with TLI values in the second (78% v 88%, respectively; P = .037) and third tertiles (58% v 78%, respectively; P = .024). CONCLUSION: The results from this randomized clinical study indicate that patients with node-negative, rapidly proliferating tumors significantly benefit from adjuvant CMF.

scholarly journals A population-based study of the impact of the St-Gallen treatment guidelines on survival of women with node-negative breast cancer

The Breast ◽  
2003 ◽  
Vol 12 ◽  
pp. S17-S18
Author(s):  
N. Hebert-Croteau ◽  
J. Brisson ◽  
J. Latreille ◽  
M. Rivard ◽  
G. Martin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Guidelines ◽  
Population Based ◽  
Population Based Study ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
The Impact

Time Trends in Systemic Adjuvant Treatment for Node-Negative Breast Cancer

1999 ◽  
Vol 17 (5) ◽  
pp. 1458-1458 ◽  
Author(s):  
Nicole Hébert-Croteau ◽  
Jacques Brisson ◽  
Jean Latreille ◽  
Gilles Gariépy ◽  
Caty Blanchette ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Adjuvant Treatment ◽  
Minimal Risk ◽  
Node Negative ◽  
Risk Of Recurrence ◽  
Consensus Recommendations ◽  
Node Negative Breast Cancer ◽  
Systemic Adjuvant Therapy

PURPOSE: We conducted a population-based study in Quebec, Canada, to assess longitudinal changes in systemic adjuvant therapy for node-negative breast cancer. MATERIALS AND METHODS: A stratified random sample was selected among women with newly diagnosed node-negative breast cancer in 1988, 1991, and 1993. Information on the patient, her tumor, source of care, and treatment was abstracted from medical charts. Patients were classified as being at minimal, moderate, or high risk of recurrence on the basis of criteria proposed at the 4th International Conference on Adjuvant Therapy of Primary Breast Cancer (St. Gallen, Switzerland, 1992), and systemic adjuvant treatment received was dichotomized as being consistent or not consistent with consensus recommendations. RESULTS: Overall, 1,578 cases of invasive breast carcinoma were reviewed. The proportion of patients who were given hormonal or cytotoxic treatment increased from 51.7% to 73.1% from 1988 to 1993. Virtually all women at minimal risk were treated in 1991 and 1993 according to the consensus statement. The proportions of women so treated were 75.0% and 65.4% in the moderate- and high-risk categories, respectively, in 1991. In 1993, these proportions were 71.4% and 67.0%, respectively. Omission of chemotherapy, especially in high-risk women with estrogen receptor–negative tumors who were 50 to 69 years of age, was the most frequent inconsistency with guidelines. CONCLUSION: Systemic adjuvant therapy for node-negative breast cancer has gained acceptance. Better understanding of the decision-making process, of the perception of the risks and benefits involved, and of the impact of alternative strategies for the dissemination of consensus recommendations are needed to promote the use of chemotherapy in specific categories of women who are at high risk of recurrence.

Appropriateness of adjuvant systemic therapy for axillary node-negative breast cancer: a physician opinion survey.

1995 ◽  
Vol 13 (6) ◽  
pp. 1459-1469 ◽  
Author(s):  
C A Sawka ◽  
A M O'Connor ◽  
H A Llewellyn-Thomas ◽  
T To ◽  
S P Pinfold ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Combination Chemotherapy ◽  
Current Knowledge ◽  
Menopausal Status ◽  
Specific Treatment ◽  
Patient Specific ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
Clinical Scenarios

PURPOSE To examine variations in physicians' recommendations for systemic adjuvant therapy in the treatment of women with node-negative breast cancer (NNBC) and to determine factors used in making specific recommendations. MATERIALS AND METHODS A questionnaire was sent by mail to all 149 Ontario physicians who actively treated breast cancer in 1993. The questionnaire described 48 clinical scenarios of women with NNBC, which included all possible combinations of the following factors: menopausal status, tumor size, hormone receptor status, histologic and nuclear grade, and lymphatic and/or vascular invasion. Respondents rated the appropriateness of administering tamoxifen, combination chemotherapy, or both tamoxifen and combination chemotherapy on a nine-point scale from extremely inappropriate to extremely appropriate. Respondent agreement and disagreement were tabulated for each scenario, and factors associated with specific treatment ratings were analyzed by logistic regression. RESULTS The response rate was 87%. Agreement for the appropriateness of specific therapies was most evident where clinical trials have demonstrated efficacy, whereas disagreement was observed in scenarios in which support for a specific treatment is not available in the current literature. Relevant tumor- and patient-specific factors were used in decision-making; personal characteristics of the respondents had no statistically significant impact on appropriateness ratings. CONCLUSION The physicians surveyed had good knowledge of NNBC prognostic factors, but had a range of opinion on optimal therapy for many clinical scenarios, which reflects current knowledge of the benefits of adjuvant therapy for NNBC.

The prognostic value of oncogenic antigen 519 (OA-519) expression and proliferative activity detected by antibody MIB-I in node-negative breast cancer

1995 ◽  
Vol 176 (4) ◽  
pp. 343-352 ◽  
Author(s):  
Vibeke Jensen ◽  
Morten Ladekarl ◽  
Peter Holm-Nielsen ◽  
Flemming Melsen ◽  
Flemming Brandt Sœrensen
Keyword(s):  
Breast Cancer ◽  
Proliferative Activity ◽  
Prognostic Value ◽  
Node Negative ◽  
Node Negative Breast Cancer

Clinical significance of proliferative activity evaluated by MIB-1 in the treatment and postoperative follow-up of early breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 21054-21054
Author(s):  
R. Nishimura ◽  
N. Arima
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Recurrence Rate ◽  
Clinical Significance ◽  
Proliferative Activity ◽  
Disease Free Survival ◽  
Her2 Status ◽  
City Hospital ◽  
Mib 1

21054 Background: To evaluate a clinical significance of proliferative activity in breast cancer, we studied relationships between proliferative activity and recurrence rate, the time of recurrence or adjuvant therapy. Methods: We analyzed 2448 patients with primary breast cancer between 1987 and 2004 in the Kumamoto City Hospital, and 437 cases out of the patients developed recurrence. Furthermore, the rate of recurrence before and after 1999 when postoperative adjuvant therapy (such as CEF or Taxanes) was started as standard treatment was investigated. Proliferative activity was judged by immunostaining for MIB-1. The fraction of proliferating cells was classified into 3 degrees (=19%, 20–49%, 50%=). Median observation period was 70 months. Results: 1) Distribution of patients by proliferation was as follows; =19%:1215 cases(50%), 20–49%: 870 cases(35%), or 50%=: 363 cases(15%). There was a significant relationship between proliferative activity and tumor size, nodal status, ER, PgR, p53 or HER2 status. 2) Multivariate analysis for disease-free survival revealed that a proliferative activity was one of significant factors in node-negative and positive cases. Recurrence rate was 11.6% in cases with low proliferation and 31.0% in high proliferation. The mean period from operation to recurrence in cases with low proliferation was 50.2 months, whereas 19.9 months in high proliferation (p<0.0001). Moreover, 74% of recurrent cases with high proliferation recurred within 2 years after operation, and there were few recurrences from the fifth year. 3) Patients with low proliferation frequently developed bone metastasis. In local recurrence, diffuse skin recurrence was often seen in cases with high proliferation. 4) The prognosis of patients in the later period (standard therapy group) was significantly better than that of patients in the earlier period, especially in high proliferation group. Conclusions: Proliferative activity might reflect aggressive behavior of breast cancer and predict the time of recurrence. The standard adjuvant therapy was effective in inhibiting early recurrence with high proliferation. It is important to take proliferative activity into consideration in the treatment and follow-up of breast cancer. No significant financial relationships to disclose.

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