Short-course FAC-M versus 1 year of CMFVP in node-positive, hormone receptor-negative breast cancer: an intergroup study.

1995 ◽  
Vol 13 (4) ◽  
pp. 831-839 ◽  
Author(s):  
G T Budd ◽  
S Green ◽  
R M O'Bryan ◽  
S Martino ◽  
M D Abeloff ◽  
...  

PURPOSE To compare 1 year of therapy with continuous cyclophosphamide, methotrexate, fluorouracil (5-FU), vincristine, and prednisone (CMFVP) with a short course of treatment with a doxorubicin-based regimen in the postsurgical adjuvant treatment of patients with hormone receptor-negative, node-positive breast cancer. PATIENTS AND METHODS Five-hundred thirty-one eligible women with hormone receptor-negative, node-positive breast cancer were randomized to receive either 1 year of therapy with CMFVP or 20 weeks of therapy with four 5-week courses of treatment with 5-FU, doxorubicin, cyclophosphamide, and methotrexate (FAC-M). RESULTS At a median follow-up time of 4.9 years, the two treatment arms cannot be demonstrated to be different with respect to overall survival (stratified log-rank, P = .27). The 5-year survival rate is 64% on the CMFVP arm and 61% on the FAC-M arm. CMFVP produces marginally superior disease-free survival (P = .06). The estimated 5-year disease-free survival rate is 55% for patients treated with CMFVP as opposed to 50% for patients treated with FAC-M. CONCLUSION Neither regimen was shown to be superior in terms of overall survival. Because the disease-free survival produced by CMFVP is marginally superior to that produced by FAC-M, we do not recommend FAC-M for further investigation or for routine use. Possible implications of this study are discussed in the context of other adjuvant chemotherapy trials.

2010 ◽  
Vol 28 (18) ◽  
pp. 2974-2981 ◽  
Author(s):  
Sherry X. Yang ◽  
Joseph P. Costantino ◽  
Chungyeul Kim ◽  
Eleftherios P. Mamounas ◽  
Dat Nguyen ◽  
...  

Purpose We tested the hypothesis that Akt-Ser473 phosphorylation (pAkt) predicts benefit from the sequential addition of paclitaxel to adjuvant doxorubicin plus cyclophosphamide (AC) chemotherapy in patients with node-positive breast cancer participating in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-28 trial. Patients and Methods Primary tumors from the NSABP B-28 trial tissue microarray were available from 1,581 of 3,060 patients who were randomly assigned to receive either four cycles of AC alone or followed by four cycles of paclitaxel. Immunohistochemistry and quantitative analysis of pAkt were performed at the National Cancer Institute blinded to clinical outcome. Association between pAkt and clinical outcome was assessed using multivariate Cox modeling adjusting for age, tumor size, number of positive nodes, tumor grade, estrogen receptor status, and human epidermal growth factor receptor 2 status. Results With a median follow-up of 9.1 years, there were no differences in disease-free survival (adjusted hazard ratio [HR], 1.02; P = .81) or overall survival (HR, 0.97; P = .80) with and without receiving paclitaxel among 975 patients with pAkt-negative tumors. In 606 patients with pAkt-positive tumors, the sequential addition of paclitaxel resulted in a 26% improvement in disease-free survival (HR, 0.74; P = .02) or a 20% improvement in overall survival (HR, 0.80; P = .17). Conclusion pAkt significantly predicts disease-free benefit from the sequential addition of paclitaxel to AC chemotherapy in patients with node-positive breast cancer. Patients with pAkt-negative breast tumors do not appear to benefit from the addition of paclitaxel.


2016 ◽  
Vol 23 (3) ◽  
pp. 164 ◽  
Author(s):  
S. Lupichuk ◽  
D. Tilley ◽  
X. Kostaras ◽  
A.A. Joy

Purpose We compared the efficacy, toxicity, and use of granulocyte colony–stimulating factor (G-CSF) with TAC (docetaxel–doxorubicin–cyclophosphamide) and FEC-D (5-fluorouracil–epirubicin–cyclophosphamide followed by docetaxel) in women less than 50 years of age.Methods The study included all women more than 18 years but less than 50 years of age with her2-negative, node-positive, stage II or III breast cancer diagnosed in Alberta between 2008 and 2012 who received TAC (n = 198) or FEC-D (n = 274).Results The patient groups were well-balanced, except that radiotherapy use was higher in the TAC group (91.9% vs. 79.9%, p < 0.001). At a median follow-up of 49.6 months, disease-free survival was 91.4% for TAC and 92.0% for FEC-D (p = 0.76). Overall survival (OS) was 96% with TAC and 95.3% with FEC-D (p = 0.86).The incidences of grades 3 and 4 toxicities were similar in the two groups (all p > 0.05). Overall, febrile neutropenia (FN) was reported in 11.6% of TAC patients and 15.7% of FEC-D patients (p = 0.26). However, use of G-CSF was higher in the TAC group than in the FEC-D group (96.4% vs. 71.5%, p < 0.001). Hospitalization for FN was required in 10.5% of TAC patients and 13.0% of FEC-D patients (p = 0.41). In G-CSF–supported and –unsupported patients receiving tac, FN occurred at rates of 11.1% and 33.3% respectively (p = 0.08); in patients receiving the FEC portion of FEC-D, those proportions were 2.9% and 8.1% respectively (p = 0.24); and in patients receiving docetaxel after FEC, the proportions were 4.1% and 17.6% respectively (p < 0.001).Conclusions In women less than 50 years of age receiving adjuvant TAC or FEC-D, we observed no differences in efficacy or other nonhematologic toxicities. Based on the timing and rates of FN, use of prophylactic G-CSF should be routine for the docetaxel-containing portion of treatment; however, prophylactic G-CSF could potentially be avoided during the FEC portion of FEC-D treatment.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11628-e11628
Author(s):  
M. Gumus ◽  
B. O. Ustaalioglu ◽  
M. Seker ◽  
A. Bilici ◽  
T. Salman ◽  
...  

e11628 Background: Neoadjuvant chemotherapy is one of the standard treatment options for patients with locally advanced breast cancer for twenty five years. In this study, we evaluate results of neoadjuvant chemotherapy in breast cancer patients. Methods: We retrospectively analyzed 68 patients with locally advanced breast cancer. Anthracycline/taxane-based chemotherapy regimens were prescribed mostly for neoadjuvant chemotherapy. Before chemotherapy was given, patients were examined for distant metastasis by radiologic methods thereafter if patient had distant metastasis, they were excluded. Patients with breast cancer received neoadjuvant chemotherapy were analyzed according to age, menopausal status, type of surgery, response to the treatment, histopathological properties and survival. After 3 to 6 cycle of chemotherapy patients were reevaluated by clinically and radiologically for response. Surgery was performed for appropriate patient thereafter adjuvant locoregional and systemic chemotherapy were continued. Results: Median age was 47 (29–43) years. 17,6 % of them were younger than 35 years and 42,6 % were premenopausal. Median follow-up time was 19 month. After 3 to 6 cycle of neoadjuvant chemotherapy 64 of patients responded to therapy (94,1 %). Breast conserving surgery was performed for 15,6 % patients. In histopathologic analysis most of patients were invasive ductal carcinoma and there was lymph node invasion for 84,9 %. Estrogen and progesterone receptor status were negative for 18,6 % of patients and cerbB2 was positive for 14,8 % of patients. Median disease free survival time was 44 month (SE: 9; 95% CI: 25–62) but median overall survival time could not be reached. Three years disease free survival rate and overall survival rate were 55,3% and 90,1% respectively. According to Cox regression analyses; we did not find any demographic and pathologic characteristic of breast cancer that is related to prognosis. Conclusions: In recent years neoadjuvant chemotherapy in breast cancer is increasingly being used for early stage disease. Further study will be facilitated establishment of guidelines for preselecting patients for neoadjuvant chemotherapy and will provide beneficial effect on treatment option and survival. No significant financial relationships to disclose.


1995 ◽  
Vol 191 (10) ◽  
pp. 982-990 ◽  
Author(s):  
M. Aubele ◽  
G. Auer ◽  
A. Voss ◽  
U. Falkmer ◽  
L. Rutquist ◽  
...  

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