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.

Relative worth of estrogen or progesterone receptor and pathologic characteristics of differentiation as indicators of prognosis in node negative breast cancer patients: findings from National Surgical Adjuvant Breast and Bowel Project Protocol B-06.

1988 ◽  
Vol 6 (7) ◽  
pp. 1076-1087 ◽  
Author(s):  
B Fisher ◽  
C Redmond ◽  
E R Fisher ◽  
R Caplan
Keyword(s):  
Breast Cancer ◽  
Progesterone Receptor ◽  
Cancer Patients ◽  
Systemic Therapy ◽  
Disease Free Survival ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
Disease Free

This study correlates the disease-free survival (DFS), distant disease-free survival (DDFS), and survival (S) of 1,157 histologically node negative breast cancer patients with the estrogen and/or progesterone receptor (ER, PR) and with the nuclear or histologic grade (NG, HG) of their tumors. All were treated by operation without systemic adjuvant therapy. The DFS, DDFS, and S were significantly greater (P = .005, .004, less than .001) in patients with ER positive than ER negative tumors but the magnitude of the differences after 5 years of follow-up was slight (8% in both DFS and DDFS and 10% in S). Differences of that magnitude are insufficient to discriminate clearly between patients who should or should not receive systemic therapy. As with ER, there were outcome differences in favor of PR positive tumors but only in S was the difference significant (8% at 5 years; P = .002). When combined with ER, PR made no independent contribution in the outcome prediction. Regression analysis indicated that NG was the most important single marker of outcome. The prognosis of women with unknown ER or PR was equivalent to or better than that in those with ER or PR positive tumors. This finding seems to be related to tumor size in that a higher proportion of tumors with unknown receptors were less than 1.0 cm, thus having insufficient tissue for analysis. Our findings disclose that in node negative breast cancer patients, NG is a better marker of prognosis than is tumor ER, and that PR is of little or no value. Tumor NG may also be useful for selecting the type of systemic therapy to be used in these patients.

The analyses of disease free survival and overall survival in premenopausal and postmenopausal axillary node negative breast cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10757-10757
Author(s):  
N. D. Bajic ◽  
D. D. Scepanovic
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Prognostic Factors ◽  
Disease Free Survival ◽  
Axillary Node ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
Significant Difference

10757 Background: The aim of this study was to analyse in which order known traditional prognostic factors predict disease free survival (DFS) and overall survival (OS) in breast cancer patients (pts) who are patohystologicaly axillary node negative. Methods: From 1998 till 2004, 258 patients were treated of axillary node negative breast cancer. We analysed 3 and 5 years (yrs) DFS and 3 and 5 yrs OS for all patients as well as for premenopausal (96 pts, 37%) and postmenopausal (162 pts, 63%). The mean follow-up time for DFS was 60 months (mo) (min 30, max 136 mo) and for OS was 66 mo (min 36, max 140 mo). As prognostic factors for DFS and OS, age, tumour size, HG as well as adjuvant treatment (locoregional and systemic) were analysed accordingly. Fifty two patients (20%) were HG1 while 190 pts (74%), were HG2 & 3; 30 pts (11%) had tumour up to 1cm and 157 pts (61%) had tumours up to 3cm and 71 pts (28%) above 3cm. Radical mastectomy was performed in 92 pts (36%) while conservative surgery were performed in 166 pts (64%). Systemic therapy was applied in 224 pts (87% of which 57% were treated with hormonotherapy). Results: 3 yrs DFS for 258 treated pts were 87% - there was no statistically significant difference among pre- and postmenopausal pts; 5 yrs DFS were 73% with no statistically significant difference among pre- and postmenopausal group of pts (p > 0.05). 3 yrs overall survival were 94% and 5 yrs 80% with no statistically significant difference among pre- and postmenopausal pts (p > 0.05). There were statistically different DFS and OS among those pts treated with adjuvant radiotherapy as well as for those with adjuvant systemic therapy in both group of pts (p < 0.001). Also as independent prognostic factor for DFS and OS were HG (Cox regression model). Conclusions: Although, HG and adjuvant therapy are the most important prognostic factors for DFS and OS in premenopausal and postmenopausal patients, we found that there is no statistically significant difference between the groups respectively. However, life-expectancy for premenopausal patients is longer. Therefore further adjuvant therapy research is needed to achieve better DFS and OS in this group of pts. No significant financial relationships to disclose.

Randomized, Controlled Trial of Cyclophosphamide, Methotrexate, and Fluorouracil Versus Cyclophosphamide, Doxorubicin, and Fluorouracil With and Without Tamoxifen for High-Risk, Node-Negative Breast Cancer: Treatment Results of Intergroup Protocol INT-0102

2005 ◽  
Vol 23 (33) ◽  
pp. 8313-8321 ◽  
Author(s):  
Laura F. Hutchins ◽  
Stephanie J. Green ◽  
Peter M. Ravdin ◽  
Danika Lew ◽  
Silvana Martino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cox Regression ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
P 16 ◽  
Better Than

Purpose We evaluated the efficacy of cyclophosphamide, methotrexate, and fluorouracil (CMF) versus cyclophosphamide, doxorubicin, and fluorouracil (CAF) in node-negative breast cancer patients with and without tamoxifen (TAM), overall and by hormone receptor (HR) status. Patients and Methods Node-negative patients identified by tumor size (> 2 cm), negative HR, or high S-phase fraction (n = 2,690) were randomly assigned to CMF, CAF, CMF + TAM (CMFT), or CAF + TAM (CAFT). Cox regression evaluated overall survival (OS) and disease-free survival (DFS) for CAF versus CMF and TAM versus no TAM separately. Two-sided CIs and one-sided P values for planned comparisons were calculated. Results Ten-year estimates indicated that CAF was not significantly better than CMF (P = .13) for the primary outcome of DFS (77% v 75%; HR = 1.09; 95% CI, 0.94 to 1.27). CAF had slightly better OS than CMF (85% v 82%, HR = 1.19 for CMF v CAF; 95% CI, 0.99 to 1.43); values were statistically significant in the planned one-sided test (P = .03). Toxicity was greater with CAF and did not increase with TAM. Overall, TAM had no benefit (DFS, P = .16; OS, P = .37), but the TAM effect differed by HR groups. For HR-positive patients, TAM was beneficial (DFS, HR = 1.32 for no TAM v TAM; 95% CI, 1.09 to 1.61; P = .003; OS, HR = 1.26; 95% CI, 0.99 to 1.61; P = .03), but not for HR-negative patients (DFS, HR = 0.81 for no TAM v TAM; 95% CI, 0.64 to 1.03; OS, HR = 0.79; 95% CI, 0.60 to 1.05). Conclusion CAF did not improve DFS compared with CMF; there was a slight effect on OS. Given greater toxicity, we cannot conclude CAF to be superior to CMF. TAM is effective in HR-positive disease, but not in HR-negative disease.

Demographic and clinicopathologic characteristics of breast cancer patients with history of oral alendronate use.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11093-e11093
Author(s):  
Sercan Aksoy ◽  
Mehmet Ali Nahit Sendur ◽  
Sebnem Yaman ◽  
Zafer Arik ◽  
Nuriye Ozdemir ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Survival Data ◽  
Lower Incidence ◽  
Disease Free Survival ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
One Year ◽  
Disease Free

e11093 Background: Bisphosphonates therapy reduces the risk of skeletally related complications in patients with bone metastases due to malignancy and bisphosphonates are the most common used agents in the treatment of osteoporosis. However, the effect on clinical and pathological properties of breast cancer with using oral alendronate has not been reported. We investigate retrospectively the demographic and clinico-pathological characteristics of patients with oral alendronate users for longer than 1 year, compared to non-users. Methods: Patients with breast cancer diagnosed from 1998 to 2010 in our clinic were retrospectively analyzed. Patient’s demographics including survival data and tumor characteristics were obtained from medical charts. Breast cancer patients who were taking oral alendronate more than 12 months at the time of breast cancer diagnosis were enrolled as an alendronate users (n=44), where the patients matched with the same age who were not taking oral alendronate were included as a control group (n=444). Results: A total of 488 patients were included in this study. Forty-four patients received an oral alendronate treatment more than one year and 444 patients were considered as nonusers. Median age of both alendronate users and nonusers was 57 (33-89). Lower incidence histological grade III, T3-T4 tumor, and node positivity was seen in alendronate users but not statistically significant. A similar trend for lower incidence of triple negative and higher incidence ER (P=0.13), PR (P=0.12) and HER2 positivity (P=0.21) was also seen in alendronate users but not statistically significant. Disease free survival rate was 150±28 months in alendronate users where as 70±24 months in nonusers (P=0.015). Median overall survival rates could not be obtained but higher in alendronate users but not statistically significant (P=0.13). Conclusions: The use of oral alendronate for longer than one year before the diagnosis of breast cancer was associated with better clinico-pathological properties and significantly improved disease free survival in breast cancer patients.

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