Safety and Efficacy Results of a Randomized Trial Comparing Adjuvant Toremifene and Tamoxifen in Postmenopausal Patients With Node-Positive Breast Cancer

2000 ◽  
Vol 18 (20) ◽  
pp. 3487-3494 ◽  
Author(s):  
Kaija Holli ◽  
Ritva Valavaara ◽  
Guillermo Blanco ◽  
Vesa Kataja ◽  
Päivi Hietanen ◽  
...  

PURPOSE: In this multicenter trial, toremifene 40 mg/d was compared with tamoxifen 20 mg/d, both given orally for 3 years to postmenopausal, axillary node–positive women after breast surgery. PATIENTS AND METHODS: The first 899 patients (toremifene, n = 459; tamoxifen, n = 440) of the total of 1,480 patients accrued to the trial were included in this scheduled safety analysis. The mean follow-up time was 3.4 years. RESULTS: The two treatment groups were well balanced with respect to patient and disease characteristics. The subjective side-effect profile was similar in both treatment groups. Slightly more vascular complications (deep vein thromboses, cerebrovascular events, and pulmonary embolisms) were seen among tamoxifen-treated patients (5.9%) as compared with toremifene-treated patients (3.5%) (P = .11), whereas bone fractures (P = .09) and vaginal leukorrhea (P = .05) were more common in the toremifene group. The number of subsequent second cancers was similar. The breast cancer recurrence rate was 23.1% (n = 106) in the toremifene group and 26.1% (n = 115) in the tamoxifen group (P = .31). When only patients with estrogen receptor (ER)–positive cancer were considered (n = 556), the risk for breast cancer recurrence was nonsignificantly lower among the toremifene-treated women, with a hazards ratio of 0.74 (90% confidence interval, 0.52 to 1.04; P = .14). The mean time to breast cancer recurrence and overall survival were similar in both groups. CONCLUSION: The side-effect profile of toremifene resembles that of tamoxifen. The efficacy of toremifene seems to be no less than that of tamoxifen. The trend for fewer breast cancer recurrences in the ER-positive subgroup is encouraging, but a longer follow-up is needed to confirm this.

Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 578 ◽  
Author(s):  
Tianying Wu ◽  
Fang-Chi Hsu ◽  
Shunran Wang ◽  
David Luong ◽  
John P. Pierce

Background: Metabolic acidosis promotes cancer metastasis. No prospective studies have examined the association between dietary acid load and breast cancer recurrence among breast cancer survivors, who are susceptible to metabolic acidosis. Hyperglycemia promotes cancer progression and acid formation; however, researchers have not examined whether hyperglycemia can modify the association between dietary acid load and breast cancer recurrence. Methods: We studied 3081 early-stage breast cancer survivors enrolled in the Women’s Healthy Eating and Living study who provided dietary information through 24-h recalls at baseline and during follow-up and had measurements of hemoglobin A1c (HbA1c) at baseline. We assessed dietary acid load using two common dietary acid load scores, potential renal acid load (PRAL) score and net endogenous acid production (NEAP) score. Results: After an average of 7.3 years of follow-up, dietary acid load was positively associated with recurrence when baseline HbA1c levels were ≥ 5.6% (median level) and ≥5.7% (pre-diabetic cut-point). In the stratum with HbA1c ≥ 5.6%, comparing the highest to the lowest quartile of dietary acid load, the multivariable-adjusted hazard ratio was 2.15 (95% confidence interval [CI] 1.34-3.48) for PRAL and was 2.31 (95% CI 1.42-3.74) for NEAP. No associations were observed in the stratum with HbA1c levels were <5.6%. P-values for interactions were 0.01 for PRAL and 0.05 for NEAP. Conclusions: Our study demonstrated for the first time that even at or above normal to high HbA1c levels, dietary acid load was associated with increased risk of breast cancer recurrence among breast cancer survivors. Impacts: Our study provides strong evidence for developing specific dietary acid load guidelines based on HbA1c levels.


2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 171-171 ◽  
Author(s):  
K. K. L. Yap ◽  
D. N. Efiom-Ekaha

171 Background: Oncotype DX Score is a 21-gene expression analysis that has been validated clinically as a reliable predictor of breast cancer recurrence for ER-positive, node-negative breast cancers. Obesity is recognized as a risk factor for many cancers, including breast cancer. Additionally obesity has been shown to be an independent prognostic factor in breast cancer. The primary objective of this study is to determine the correlation between obesity and Oncotype DX score, hence the relationship between obesity and breast cancer recurrence in ER-positive breast cancer. The secondary objective is to investigate the association between weight gain after diagnosis and breast cancer recurrence. Methods: An IRB-exempted retrospective chart review of female patients at Wellspan Group with ER-positive breast cancer who had Oncotype DX analysis in 2008 and 2009. Data collected included Oncotype DX score and BMI (at diagnosis, 6 months and 12 months). Data were analyzed to determine the correlation between Oncotype DX score and BMI at diagnosis, at 6 months and at 12 months. The correlation between Oncotype DX score and BMI changes at 12 months also was determined. Results: A total of 125 patients were identified; 103 had BMI recorded at diagnosis, 88 had BMI recorded at 6 months and 87 had BMI recorded at 12 months. Of these, we were able to determine the BMI changes at 12 months for 82 patients. The Pearson correlation scores were 0.091 (p = 0.361), 0.074 (p = 0.492), and 0.047 (p = 0.669) for BMI at diagnosis, at 6 months and at 12 months respectively. The Pearson correlation score was 0.007 (p = 0.948) for BMI changes at 12 months. Conclusions: Obesity and weight gain are not independent predictors of recurrence in patients with ER-positive breast cancer. The reported adverse prognostic associations may be more prominent in ER-negative breast cancers. This is consistent with the reports suggesting a higher rate of ER-negative, high-grade cancers in obese women as well as a greater magnitude of benefit from dietary and weight reduction interventions seen in women with ER-negative cancers.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12508-e12508
Author(s):  
Cecilia Munguti ◽  
Miriam Claire Mutebi ◽  
Mukuhi Ng'ang'a ◽  
Ronald Wasike

e12508 Background: Recurrence rates for early breast cancer vary in different studies from 7% to 18%. Recurrent breast cancer is associated with poorer outcome and higher mortality rates. The recurrence rate in the Kenyan population remains unknown despite high prevalence of known risk factors. Methods: Single institution retrospective study of all women (18 -75 years) treated for early breast cancer at a single center private tertiary unit from 2009 to 2017. Results: 239 patient records were reviewed. The mean age at diagnosis was 51 (SD13.1). 98% of women presented with a palpable breast lesion. The molecular sub-type’s prevalence was: ER/PR+ (76%), triple negative (12.1%), HER2+ (2.9%). The overall recurrence rate was 7.2%, 66% recurrences were loco-regional, while 27% were metastatic disease, with 61% of the recurrences being detected initially on clinical/ self-breast examination. 77% of the recurrences were in women with ER/PR+ molecular sub-types. Recurrences in women with DCIS (2/27) were invasive breast cancers. There were no identified risk factors on uni-variate and multivariate regression analysis which conferred a risk of breast cancer recurrence. Discussion: The mean age at diagnosis in this group is younger than the western average (65 - 75 years). Majority of the women presented with symptoms – a presentation that differs from that of countries with a national breast cancer screening program. The molecular distribution of breast cancers is comparable to western populations. Conclusions: Recurrence rate for early breast cancer in this series is 7.2%, which is comparable with documented western data, with majority of the recurrences being detected initially on clinical/self-breast examination.


2021 ◽  
Vol 10 (22) ◽  
pp. 5452
Author(s):  
Grażyna E. Będkowska ◽  
Ewa Gacuta ◽  
Monika Zbucka-Krętowska ◽  
Paweł Ławicki ◽  
Maciej Szmitkowski ◽  
...  

Breast cancer is the most common malignancy in women globally. The increasing worldwide incidence of this type of cancer illustrates the challenge it represents for healthcare providers. Therefore, new tumor markers are constantly being sought. The aim of this study was to assess plasma concentrations and the diagnostic power of VEGF in 100 patients with early-stage breast cancer, both before and after surgical treatment and during a three-year follow-up. The control groups included 50 subjects with benign breast tumors (fibroadenoma) and 50 healthy women. The VEGF concentration was determined using enzyme-linked immunosorbent assay (ELISA) and the CA 15-3 concentration was determined by chemiluminescent microparticle immunoassay (CMIA). We observed significantly higher preoperative plasma concentrations of VEGF and CA 15-3 in patients with breast cancer. VEGF, similar to CA 15-3, demonstrated high diagnostic utility in the assessment of the long-term efficacy of surgical removal of the tumor. Determinations of VEGF had the highest diagnostic usefulness in the detection of breast cancer recurrence (SE 40%, SP 92%, PPV 67%, NPV 79%). Additionally, the highest values of SE, NPV and AUC were observed during the combined analysis with CA 15-3 (60%; 84%; 0.7074, respectively). Our study suggests a promising diagnostic utility of VEGF in the early stages of breast cancer and in the evaluation of the efficacy of the surgical treatment of breast cancer as well as the detection of breast cancer recurrence, particularly in a combined analysis with CA 15-3 as a new diagnostic panel.


2013 ◽  
Vol 16 (3) ◽  
pp. A150
Author(s):  
J. Kraeima ◽  
I. Vliegen ◽  
S. Siesling ◽  
J. Klaase ◽  
M.J. Jzerman

2003 ◽  
pp. 347-357 ◽  
Author(s):  
R E Smith ◽  
B C Good

The idea of breast cancer prevention by hormonal means stemmed from the results of treatment trials, many of them carried out by the National Surgical Adjuvant Breast and Bowel Project (NSABP). Over the years, a number of NSABP treatment studies demonstrated that breast cancer recurrence was reduced in women with the disease who were given tamoxifen, a selective estrogen receptor (ER) modulator (SERM). Five subsequent tamoxifen prevention trials with this agent have shown a 48% reduction in ER-positive cancers, but no effect for ER-negative cancers, and an increase in endometrial cancer and thromboembolic events. The drug raloxifene, another SERM, originally examined as an osteoporosis agent, has also shown promise for the prevention of breast cancer, although, as with tamoxifen, the drug carries a risk for thromboembolic events. There is recent evidence in a large treatment trial that the aromastase inhibitor anastrazole, a 'pure anti-estrogen', holds promise as a breast cancer preventive agent. Longer follow-up and the testing of additional agents is required before these drugs can be used widely for prevention. In addition, future research should focus on the identification of at-risk women who can perhaps be targeted for specific prevention agents.


Author(s):  
David Preen ◽  
Anna Kemp-Casey ◽  
Elizabeth Roughead ◽  
Derrick Lopez ◽  
Max Bulsara ◽  
...  

ABSTRACTObjectivesAlthough outcomes for the majority of women diagnosed with primary breast cancer are good, with five-year survival exceeding 90%, some women will experience cancer recurrence and ultimately die from the disease. It is important for patients, clinicians and health service planners to know the risk of recurrence once initial treatment for primary breast cancer is completed. However, none of Australia’s State or Territory cancer registries routinely report on cancer recurrence which could be used to evaluate this issue. To address this absence of direct reporting, we aimed to determine the incidence of cancer recurrence in Australian clinical practice after completion of treatment for primary breast cancer, using a range of linked health data sources. ApproachWe performed a retrospective cohort study using linked health data from New South Wales (NSW), Australia. Data were linked from six data collections: i) Cancer Registry, ii) Admitted Patient Data Collection, iii) Pharmaceutical Benefits Scheme claims, iv) Medicare (outpatient) claims, v) Death Registry; and the vi) NSW 45 and Up Study. We identified 2416 women diagnosed with primary invasive breast cancer during 2003-2008 in NSW who had not had a recurrence by 18 months post-diagnosis. Unit-level hospital, pharmacy and outpatient claims were used to identify services indicative of recurrence. Incidence of recurrence was calculated and multivariate Cox regression used to identify baseline and active treatment characteristics predictive of cancer recurrence up to six years post-diagnosis. ResultsA total of 217 women (9.0%) had a hospital, pharmacy or outpatient claim indicating breast cancer recurrence between 18 months and six years post-diagnosis. Overall annual cumulative incidence of recurrence was 3.3%. Recurrence was significantly higher for women with node-positive (4.8% vs. 2.5% annually, adjHR=1.7, 95%CI=1.3-2.3) or hormone receptor-negative (3.8% vs. 3.1% annually, adjHR=1.3, 95%CI=1.0-1.7) tumours. Women with tumours >2cm at diagnosis were more likely to experience recurrence within six years compared with those with a smaller initial tumour (4.8% vs. 2.7 annually, adjHR=1.5; 95%CI=1.1-2.0). ConclusionsWomen with breast cancer in this Australian cohort experienced recurrence at 3.3%pa in the years following completion of treatment. Those at greatest risk of recurrence were women with node-positive or hormone-receptor negative tumours, or tumours >2cm at initial diagnosis, consistent with international findings. This method for ascertaining breast cancer recurrence can be used to assess population-level changes over time and to investigate the impact of specific treatments on outcomes in the absence of available Cancer Registry data.


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