A multicenter randomized study comparing 6 versus 12 months of trastuzumab in combination with dose-dense docetaxel following FEC as adjuvant treatment of women with axillary node–positive or high-risk, node-negative breast cancer overexpressing HER2.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 623-623
Author(s):  
Dimitrios Mavroudis ◽  
Nikolaos A. Malamos ◽  
Stylianos Kakolyris ◽  
Ioannis Boukovinas ◽  
Pavlos Papakotoulas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Treatment ◽  
Randomized Study ◽  
Axillary Node ◽  
Node Negative ◽  
Node Positive ◽  
Node Negative Breast Cancer ◽  
Dose Dense

scholarly journals Cyclophosphamide, Epirubicin, and Fluorouracil Versus Dose-Dense Epirubicin and Cyclophosphamide Followed by Paclitaxel Versus Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Node-Positive or High-Risk Node-Negative Breast Cancer

2010 ◽  
Vol 28 (1) ◽  
pp. 77-82 ◽  
Author(s):  
Margot Burnell ◽  
Mark N. Levine ◽  
Judith-Anne W. Chapman ◽  
Vivien Bramwell ◽  
Karen Gelmon ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Axillary Node ◽  
High Dose ◽  
Node Negative ◽  
Node Positive ◽  
Node Negative Breast Cancer ◽  
Dose Dense

Purpose Cyclophosphamide, epirubicin, and fluorouracil (CEF) and doxorubicin and cyclophosphamide (AC) followed by paclitaxel (T) are commonly used adjuvant regimens in women with early breast cancer. In a previous trial in women with locally advanced breast cancer, 3 months of high-dose epirubicin and cyclophosphamide (EC) administered every 2 weeks (dose-dense) was equivalent to 6 months of CEF. We hypothesized that 3 months of paclitaxel after dose-dense EC (EC/T) would be superior to CEF or AC/T. Methods After lumpectomy or mastectomy, women 60 years of age or younger with axillary node-positive or high-risk node-negative breast cancer were randomly assigned to receive CEF, EC/T, or AC/T for 6 months. This article reports the interim analysis for recurrence-free survival (RFS), which was planned after 227 recurrences. Results A total of 2,104 patients were enrolled. The median follow-up is 30.4 months. Hazard ratios for recurrence are as follows: AC/T versus CEF, 1.49 (95% CI, 1.12 to 1.99), P = .005; AC/T versus EC/T, 1.68 (95% CI, 1.25 to 2.27), P = .0006; and EC/T versus CEF, 0.89 (95% CI, 0.64 to 1.22), P = .46. Three-year RFS rates for CEF, EC/T, and AC/T are 90.1%, 89.5%, and 85.0%, respectively. There was more febrile neutropenia with CEF (22.3%) and EC/T (16.4%) compared with AC/T (4.8%), but more neuropathy with the last two regimens. Conclusion Three-weekly AC/T is significantly inferior to CEF or EC/T in terms of RFS. It is too early to detect any difference between CEF and dose-dense EC/T.

A phase III adjuvant trial of sequenced EC + filgrastim + epoetin-alpha followed by paclitaxel compared to sequenced AC followed by paclitaxel compared to CEF in women with node-positive or high-risk node-negative breast cancer (NCIC CTG MA.21)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 550-550 ◽  
Author(s):  
M. J. Burnell ◽  
M. N. Levine ◽  
J. A. Chapman ◽  
V. Bramwell ◽  
T. Vandenberg ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Phase Iii ◽  
Free Survival ◽  
Node Negative ◽  
Node Positive ◽  
Node Negative Breast Cancer ◽  
Dose Dense

550 Background: CEF and AC followed by paclitaxel (AC/T) are commonly used adjuvant regimens in women with early breast cancer. In a trial conducted by the EORTC, NCIC CTG, and SAKK three months of dose-dense EC was equivalent to six months of CEF in women with locally advanced breast cancer. We hypothesized that three months of a taxane following dose-dense EC would be superior to CEF alone or AC/T. The results of a planned interim analysis were presented in San Antonio 2006 (Abstract #53). We now present more detailed results on efficacy and toxicity. Methods: Women 60 years of age or younger, with axillary node positive or high risk node negative breast cancer were randomized to CEF, EC/T or AC/T for six months. Results: Between December 2000 and April 2005, 2104 patients were enrolled. The median follow-up is 30.4 months. Hazard ratios for recurrence are: AC/T vs. CEF, 1.49 (95% CI, 1.12–1.99), p=0.005; AC/T vs. EC/T, 1.68 (95% CI, 1.25–2.27), p=0.0006; and EC/T vs. CEF, 0.89 (95% CI, 0.64–1.22), p=0.46. Three year recurrence-free survival rates for CEF, EC/T, and AC/T are 90.1, 89.5 and 85.0%, respectively. There was no significant interaction between ER status and treatment. Multivariate analysis of predictive factors will be presented. The numbers of deaths are 50 (CEF), 47 (EC/T) and 65 (AC/T). There was more toxicity in CEF and EC/T compared to AC/T. Conclusion: AC/T given every three weeks, although less toxic is significantly inferior to CEF or EC/T in terms of relapse-free survival. It is too early to detect any difference between CEF and dose-dense EC/T. Our results indicate that there is still room to explore anthracycline and taxane adjuvant chemotherapy regimens. Supported by: NCI Canada and Canadian Cancer Society, Pfizer, Bristol-Myers Squibb, Amgen, Janssen Ortho, Ortho Biotech, and NCI US. [Table: see text] No significant financial relationships to disclose.

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.

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