Effectiveness of adjuvant chemotherapy in combination with tamoxifen for node-positive postmenopausal breast cancer patients.

1997 ◽  
Vol 15 (4) ◽  
pp. 1385-1394 ◽  
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Disease Free Survival ◽  
Postmenopausal Breast Cancer ◽  
Breast Cancer Patients ◽  
Node Positive ◽  
Increased Risk ◽  
Node Positive Disease ◽  
Er Positive ◽  
Risk Of Relapse

PURPOSE Adjuvant tamoxifen has been shown to reduce relapse and mortality among node-positive post-menopausal breast cancer patients. The value of adding chemotherapy to tamoxifen is controversial. PATIENTS AND METHODS Between July 1986 and April 1993, 1,266 postmenopausal breast cancer patients with node-positive disease were randomly assigned to receive one of four adjuvant therapy regimens: (A) tamoxifen alone for 5 years; (B) tamoxifen plus three courses of early cyclophosphamide, methotrexate, and fluorouracil (CMF) on months 1, 2, and 3; (C) tamoxifen plus delayed single courses of CMF on months 9, 12, and 15; (D) tamoxifen plus early and delayed CMF on months 1, 2, 3, 9, 12, and 15. The two-by-two factorial design allowed two direct comparisons: early CMF (B and D) versus no early CMF (A and C), and delayed CMF (C and D) versus no delayed CMF (A and B). Estrogen receptor (ER) status was known for all patients and was used to stratify the randomization. A total of 1, 212 patients (96%) were eligible and assessable. The median follow-up duration was 60 months. RESULTS The results of the two-by-two factorial comparisons were as follows: (1) early CMF added to tamoxifen significantly improved 5-year disease-free survival (DFS; 64% v 57%; hazards ratio [HR], 0.79; 95% confidence interval [CI], 0.66 to 0.95; P = .01); and (2) delayed CMF added to tamoxifen did not improve DFS (5-year DFS, 61% v 60%; HR, 0.97; 95% CI, 0.81 to 1.17; P = .77). For patients with ER-positive tumors, the addition of CMF, either early or delayed or both, reduced the relative risk of relapse by 22% to 36%. In contrast, for patients with ER-negative tumors, tamoxifen with delayed CMF was associated with a nonsignificant increased risk of relapse (HR, 1.27; 95% CI, 0.92 to 1.76; P = .15). CONCLUSION Postmenopausal patients with node-positive breast cancer should be offered combination chemotherapy in addition to tamoxifen. Tamoxifen should not be initiated before CMF, as this might be detrimental, especially for patients with ER-negative tumors.

Duration and reintroduction of adjuvant chemotherapy for node-positive premenopausal breast cancer patients.

1996 ◽  
Vol 14 (6) ◽  
pp. 1885-1894 ◽  
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Disease Free Survival ◽  
Additional Benefit ◽  
Breast Cancer Patients ◽  
Premenopausal Breast Cancer ◽  
Primary Tumors ◽  
Node Positive ◽  
Increased Risk

PURPOSE The optimal duration and timing of adjuvant chemotherapy for breast cancer patients remain uncertain and were prospectively studied. PATIENTS AND METHODS We randomly assigned 1,554 premenopausal breast cancer patients with node-positive disease in a 2 x 2 factorial design to receive the following: (A) cyclophosphamide, methotrexate, and fluorouracil for 6 consecutive courses on months 1 to 6 (CMF x 6); (B) CMFx6 plus three single courses of reintroduction CMF given on months 9, 12, and 15; (C) CMF for three consecutive courses on months 1 to 3 (CMFx3); or (D) CMFx3 plus three single courses of reintroduction CMF given on months 6, 9, and 12. Accrual was between July 1986 and April 1993. A total of 1,475 patients (95%) were eligible and assessable. The median follow-up duration was 60 months. RESULTS Patients who received CMFx3 without reintroduction had a 5-year disease-free survival (DFS) rate of 53% compared with 58% for the other three treatment groups (hazards ratio [HR], 1.20; 95% confidence interval [CI], 1.00 to 1.45; P = .04). The increased risk of relapse with CMFx3 was more marked for women aged less than 40 years (308 patients; HR, 1.32; 95% CI, 0.94 to 1.84; P = .11) and for patients with estrogen receptor (ER)-negative tumors (455 patients; HR, 1.45; 95% CI, 1.06 to 2.00; P = .02). Reintroduction chemotherapy provided additional benefit (HR, 0.86; 95% CI, 0.73 to 1.01; p = .07), especially for women > or = 40 years of age (1,167 patients; HR, 0.82; 95% CI, 0.68 to 0.99; P = .04). CONCLUSION Three courses of adjuvant CMF chemotherapy are not sufficient compared with longer duration CMF chemotherapy, especially in younger women and in patients with ER-negative primary tumors. Reintroduction chemotherapy showed some evidence of additional benefit, but remains investigational.

scholarly journals AGR2 Predicts Tamoxifen Resistance in Postmenopausal Breast Cancer Patients

2013 ◽  
Vol 35 ◽  
pp. 207-212 ◽  
Author(s):  
Roman Hrstka ◽  
Veronika Brychtova ◽  
Pavel Fabian ◽  
Borivoj Vojtesek ◽  
Marek Svoboda
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Optimal Algorithm ◽  
Endocrine Resistance ◽  
Postmenopausal Breast Cancer ◽  
Progression Free Survival ◽  
Tamoxifen Treatment ◽  
Mrna Levels ◽  
Breast Cancer Patients ◽  
Er Positive

Endocrine resistance is a significant problem in breast cancer treatment. Thus identification and validation of novel resistance determinants is important to improve treatment efficacy and patient outcome. In our work, AGR2 expression was determined by qRT-PCR in Tru-Cut needle biopsies from tamoxifen-treated postmenopausal breast cancer patients. Our results showed inversed association of AGR2 mRNA levels with primary treatment response (P=0.0011) and progression-free survival (P=0.0366) in 61 ER-positive breast carcinomas. As shown by our experimental and clinical evaluations, elevated AGR2 expression predicts decreased efficacy of tamoxifen treatment. From this perspective, AGR2 is a potential predictive biomarker enabling selection of an optimal algorithm for adjuvant hormonal therapy in postmenopausal ER-positive breast cancer patients.

Adjuvant Clodronate Treatment Does Not Reduce the Frequency of Skeletal Metastases in Node-Positive Breast Cancer Patients: 5-Year Results of a Randomized Controlled Trial

2001 ◽  
Vol 19 (1) ◽  
pp. 10-17 ◽  
Author(s):  
Tiina Saarto ◽  
Carl Blomqvist ◽  
Pekka Virkkunen ◽  
Inkeri Elomaa
Keyword(s):  
Breast Cancer ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Disease Free Survival ◽  
Skeletal Metastases ◽  
Breast Cancer Patients ◽  
Control Groups ◽  
Node Positive ◽  
Final Population ◽  
Positive Breast Cancer

PURPOSE: Bisphosphonates have effectively reduced the development and progression of bone metastases in advanced breast cancer. The aim of this study was to determine whether bone metastases could be prevented by adjuvant clodronate treatment in patients with primary breast cancer. PATIENTS AND METHODS: Between 1990 and 1993, 299 women with primary node-positive breast cancer were randomized to clodronate (n = 149) or control groups (n = 150). Clodronate 1,600 mg daily was given orally for 3 years. All patients received adjuvant therapy: premenopausal six cycles of CMF chemotherapy and postmenopausal antiestrogens (randomized to tamoxifen 20 mg or toremifene 60 mg/d for 3 years). Seventeen patients were excluded from the analyses because of major protocol violations. The final population was 282 patients. Intent-to-treat analyses were also performed for all major end points. The follow-up time was 5 years for all patients. RESULTS: Bone metastases were detected equally often in the clodronate and control groups: 29 patients (21%) versus 24 patients (17%) (P = .27). The development of nonskeletal recurrence was significantly higher in the clodronate group compared with controls: 60 patients (43%) versus 36 patients (25%) (P = .0007). The overall survival (OS) and disease-free survival (DFS) rates were also significantly lower in the clodronate group than in the controls (OS, 70% v 83%, P = .009; DFS, 56% v 71%, P = .007, respectively). In multivariate analyses, clodronate remained significantly associated with DFS (P = .009). CONCLUSION: Adjuvant clodronate treatment does not prevent the development of bone metastases in node-positive breast cancer patients. However, clodronate seems to have a negative effect on DFS by increasing the development of nonskeletal metastases.

Mammostrat as an immunohistochemical multigene assay for prediction of early relapse risk in the TEAM pathology study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 516-516
Author(s):  
John M. S. Bartlett ◽  
Kenneth J. Bloom ◽  
Tammy Robson ◽  
Thomas J. Lawton ◽  
Cornelis J. H. Van De Velde ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Endocrine Therapy ◽  
Disease Free Survival ◽  
Postmenopausal Breast Cancer ◽  
Nodal Status ◽  
Endocrine Treatment ◽  
Breast Cancer Patients ◽  
Additional Information ◽  
Er Positive

516 Background: Some postmenopausal patients with hormone sensitive early breast cancer remain at high risk of relapse despite endocrine therapy, and might benefit additionally from adjuvant chemotherapy. The challenge is to prospectively identify such patients. The Mammostrat test uses five immunohistochemical markers to stratify patients regarding recurrence risk, and may inform treatment decisions. We tested the efficacy of this panel in the TEAM trial. Methods: Pathology blocks from 4598 TEAM patients were collected and TMAs constructed. The cohort was 47% node positive and 36% were also treated with adjuvant chemotherapy. Triplicate 0.6mm2 TMA cores were stained and positivity for p53, HTF9C, CEACAM5, NDRG1, SLC7A5 assessed. Cases were assigned a Mammostrat risk score, and distant relapse free (DRFS) and disease free survival (DFS) analysed. Results: In multivariate regression analyses, corrected for conventional clinicopathological markers, Mammostrat provided significant additional information on DRFS after endocrine therapy in ER positive node negative patients (N=1226) not receiving chemotherapy (p=0.004). Further analyses in all patients not exposed to chemotherapy, irrespective of nodal status (N=2559) and in the entire cohort (N=3837) showed Mammostrat scores provide additional information on DRFS in these groups (p=0.001 and p<0.0001 respectively; multivariate analyses). No differences were seen between the two endocrine treatment regimens. Conclusions: The Mammostrat score predicts DRFS for both exemestane and tamoxifen-exemestane treated patients irrespective of nodal status and chemotherapy. The ability of this test to provide additional outcome data following treatment provides further evidence for its’ utility in risk stratification of ER positive postmenopausal breast cancer patients.

scholarly journals ΔKi67 proliferation index as independent predictive and prognostic factor of outcome in luminal breast cancer: data from neoadjuvant letrozole-based treatment

Tumor Biology ◽  
2020 ◽  
Vol 42 (6) ◽  
pp. 101042832092530
Author(s):  
A Ianza ◽  
F Giudici ◽  
C Pinello ◽  
SP Corona ◽  
C Strina ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Cancer Patients ◽  
Stable Disease ◽  
Disease Free Survival ◽  
Luminal Breast Cancer ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
Er Positive ◽  
Disease Free

A key tool for monitoring breast cancer patients under neoadjuvant treatment is the identification of reliable predictive markers. Ki67 has been identified as a prognostic and predictive marker in ER-positive breast cancer. Ninety ER-positive, HER2 negative locally advanced breast cancer patients received letrozole (2.5 mg daily) and cyclophosphamide (50 mg daily) with/without Sorafenib (400 mg/bid daily) for 6 months before undergoing surgery. Ki67 expression and tumor size measured with caliber were determined at baseline, after 30 days of treatment and at the end of treatment. Patients were assigned to a clinical response category according to Response Evaluation Criteria in Solid Tumors, both at 30 days and before surgery and further classified as high-responder and low-responder according to the median variation of Ki67 values between biopsy and 30 days and between biopsy and surgery time. The predictive role of Ki67 and its changes with regard to clinical response and survival was analyzed. No differences in terms of survival outcomes emerged between the arms of treatment, while we observed a higher percentage of women with progression or stable disease in arm with the combination containing Sorafenib (20.5% vs 7.1%, p = 0.06). Clinical complete responders experienced a greater overall variation in Ki67 when compared with partial responders and patients with progressive/stable disease (66.7% vs 30.7%, p = 0.009). High responders showed a better outcome than low responders in terms of both disease-free survival ( p = 0.009) and overall survival ( p = 0.002). ΔKi67 score evaluated between basal and residual tumor at definitive surgery showed to be highly predictive of clinical complete response, and a potential parameter to be used for predicting disease-free survival and overall survival in luminal breast cancer treated with neoadjuvant endocrine-based therapy.

scholarly journals Impact of BMI for clinical outcomes in Japanese breast cancer patients

2020 ◽  
Vol 50 (3) ◽  
pp. 230-240
Author(s):  
Naomi Gondo ◽  
Masataka Sawaki ◽  
Masaya Hattori ◽  
Akiyo Yoshimura ◽  
Haruru Kotani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Disease Free Survival ◽  
Overweight And Obesity ◽  
The Body ◽  
Breast Cancer Patients ◽  
Cancer Specific Survival ◽  
Er Positive ◽  
The Impact

Abstract Objective The relationship between the body mass index (BMI) at the time of breast cancer diagnosis and the prognosis of breast cancer patients has not yet been clarified. We investigated the impact of obesity for clinical outcomes in Japanese breast cancer patients. Methods Women with primary breast cancer operated between 2002 and 2014 were identified. All patients are categorized into four groups according to BMI. The range of BMI is &lt;18.5 kg/m2, from 18.5 to 24.9 kg/m2, 25 to 29.9 kg/m2, &gt;30 kg/m2 in underweight, normal, overweight and obesity groups, respectively. The correlation between BMI and overall survival (OS), breast cancer-specific survival (BCSS) and disease-free survival (DFS) were statistically analyzed. Results From the database of our institution, we identified 3223 patients. The median follow-up period was 57 months (1–149). We categorized 2257 (70.0%), 318 (9.9%), 545 (16.9%) and 103 (3.2%) patients into normal, underweight, overweight obesity groups respectively. There were189 patients (5.9%) deaths due to breast cancer recurrence (137 patients) and other disease (52 patients). Obesity groups was significantly high compared with normal groups for OS (adjusted HR, 2.43; 95% CI, 1.38–4.28; P &lt; 0.001), BCSS (adjusted HR, 2.73; 95% CI, 1.15–6.44; P = 0.02) and DFS (adjusted HR, 1.83; 95% CI, 1.11–3.02; P = 0.017) by multivariate analysis. Especially, OS (adjusted HR, 4.87; 95% CI, 2.15–11.04; P &lt; 0.001), BCSS (adjusted HR, 4.51; 95% CI, 1.52–13.34; P &lt; 0.001) and DFS (adjusted HR, 4.87; 95% CI, 1.02–4.89; P = 0.04) were statistically insignificant in postmenopausal ER-positive breast cancer patients. Conclusion Obesity might be risk factor for OS, BCSS and DFS, especially postmenopausal ER-positive women.

Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, estrogen receptor-positive breast cancer patients: results of a multicentric Italian study. Breast Cancer Adjuvant Chemo-Hormone Therapy Cooperative Group.

1990 ◽  
Vol 8 (8) ◽  
pp. 1310-1320 ◽  
Author(s):  
F Boccardo ◽  
A Rubagotti ◽  
P Bruzzi ◽  
M Cappellini ◽  
G Isola ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Postmenopausal Women ◽  
Cancer Patients ◽  
Combined Treatment ◽  
Tamoxifen Treatment ◽  
Breast Cancer Patients ◽  
Node Positive ◽  
Er Positive ◽  
Positive Breast Cancer

Between November 1, 1983 and June 30, 1987, 510 node-positive, estrogen receptor (ER)-positive breast cancer patients have been randomly allocated to receive either chemotherapy (six intravenous [IV] cyclophosphamide, methotrexate, and fluorouracil [CMF] courses followed by four IV epirubicin courses) or 5 years of tamoxifen treatment or a combination of both therapies. After a median follow-up of 40 months, patients receiving the combined treatment achieved the best results, and those treated with chemotherapy alone achieved the worst, the difference being particularly evident in postmenopausal women. However, while the concurrent use of chemotherapy and tamoxifen did improve the results achieved by chemotherapy alone, particularly in postmenopausal women and in those with four or more involved nodes, it did not significantly improve the results achieved by tamoxifen alone, particularly in patients with higher ER tumor concentrations. Side effects were more numerous and more severe in patients receiving chemotherapy (with or without tamoxifen). Our findings, although still preliminary, confirm that tamoxifen should be the treatment of choice for postmenopausal breast cancer patients with node-positive, ER-positive tumors. In addition, the findings suggest that tamoxifen may represent a safe alternative to chemotherapy (at least to the cytotoxic regimen we used) for younger women, provided they have ER-positive tumors. In patients with ER-positive tumors, the addition of chemotherapy to tamoxifen does not seem to improve significantly the effectiveness of tamoxifen alone.

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