Using the NADA protocol to manage menopausal side-effects in women with early breast cancer

Author(s):  
B De Valois ◽  
T Young ◽  
N Robinson ◽  
C McCourt ◽  
R Ashford ◽  
...  
2002 ◽  
Vol 20 (24) ◽  
pp. 4628-4635 ◽  
Author(s):  
W. Jonat ◽  
M. Kaufmann ◽  
W. Sauerbrei ◽  
R. Blamey ◽  
J. Cuzick ◽  
...  

PURPOSE: Current adjuvant therapies have improved survival for premenopausal patients with breast cancer but may have short-term toxic effects and long-term effects associated with premature menopause. PATIENTS AND METHODS: The Zoladex Early Breast Cancer Research Association study assessed the efficacy and tolerability of goserelin (3.6 mg every 28 days for 2 years; n = 817) versus cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy (six 28-day cycles; n = 823) for adjuvant treatment in premenopausal patients with node-positive breast cancer. RESULTS: Analysis was performed when 684 events had been achieved, and the median follow-up was 6 years. A significant interaction between treatment and estrogen receptor (ER) status was found (P = .0016). In ER-positive patients (approximately 74%), goserelin was equivalent to CMF for disease-free survival (DFS) (hazard ratio [HR], 1.01; 95% confidence interval [CI], 0.84 to 1.20). In ER-negative patients, goserelin was inferior to CMF for DFS (HR, 1.76; 95% CI, 1.27 to 2.44). Amenorrhea occurred in more than 95% of goserelin patients by 6 months versus 58.6% of CMF patients. Menses returned in most goserelin patients after therapy stopped, whereas amenorrhea was generally permanent in CMF patients (22.6% v 76.9% amenorrheic at 3 years). Chemotherapy-related side effects such as nausea/vomiting, alopecia, and infection were higher with CMF than with goserelin during CMF treatment. Side effects related to estrogen suppression were initially higher with goserelin, but when goserelin treatment stopped, reduced to a level below that observed in the CMF group. CONCLUSION: Goserelin offers an effective, well-tolerated alternative to CMF in premenopausal patients with ER-positive and node-positive early breast cancer.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10597-10597 ◽  
Author(s):  
C. Massacesi ◽  
L. Zepponi ◽  
M. B. Rocchi ◽  
S. Rossini ◽  
L. Burattini

10597 Background: To determine how menopausal symptoms and quality of life changed when adjuvant tamoxifen has been suspended for any reason in favor of anastrozole in early breast cancer (BC) patients (pts). Methods: Major inclusion criteria: severe side effects or serious potential diseases caused by tamoxifen (20 mg die) that switched to anastrozole (1 mg die); confirmed early BC radically resected and with positive hormonal receptors; postmenopausal status; adjuvant chemo and/or radiotherapy suspended at least 4 wks before the hormonal switch. Exclusion criteria: discontinuation of tamoxifen for endocrine symptoms. Menopausal symptoms and health-related quality of life were assessed by the series of Functional Assessment of Cancer Therapy-Breast (FACT-B) plus endocrine subscale (ES) questionnaires at the switch and 3, 6, 9, and 12 months later. Sample size was decided by the effect size method (SD fixed as 0.5, effect of medium value). Score modifications were evaluated by one-way ANOVAS. Results: From Feb 2002 to Jun 2003, a total of 44 women were enrolled into the study. Discontinuation of tamoxifen was for: asymptomatic uterine problems (endometrium thickening or fibromatosis) in 56% of pts; cardiovascular disorders (mainly leg thrombosis and phlebitis) in 18%; patient’s refusal in 9%; GI persistent side effects in 5%; other reasons in 12% of pts. Endocrine symptoms ameliorated between baseline and 3 months, and stabilized thereafter. Mean ES scores improvement from baseline test was +3 (95% CI, 1 to 5), +4 (95% CI, 3 to 6), +5 (95% CI, 3 to 7), and +4 (95% CI, 3 to 6) at 3, 6, 9 and 12 months, respectively. FACT-ES global score had a mean improvement during 1-yr period of 9 points (95% CI 6 to 13, p < .0005), with 22 patients (50%) ever reaching an increase ≥ 5% of the baseline score. There also was a significant improvement in TOI score (+4 points, 95% CI 2 to 6, p < .0005), and physical and breast cancer subscales (+2, 95% CI 1 to 2, p < .001, and +1, 95% CI, 1 to 2, p < .001, respectively). Pts receiving anastrozole reported higher rate of mild arthritic and bone pain (27% vs 7%, p = .021). Conclusion: When a patient develops an endocrine symptom while on tamoxifen, a change in favor of anastrozole should be considered to minimize those symptoms and to improve quality of patient’s life. No significant financial relationships to disclose.


1999 ◽  
pp. 231-234 ◽  
Author(s):  
M Baum

The value of endocrine treatment of early breast cancer has been illustrated by the antioestrogen, tamoxifen, which has now been available for nearly 30 years. However, if the recognised side effects and pharmacological properties of tamoxifen are taken into consideration, it is possible that other endocrine treatments that are now available can provide equal or superior efficacy, along with improved tolerability. One such group of agents is the aromatase inhibitors specifically the new-generation triazole aromatase inhibitors, such as anastrozole and letrozole, which have both shown tolerability and efficacy advantages over standard treatments in postmenopausal women with advanced breast cancer. There are convincing reasons why the new generation of aromatase inhibitors have advantages over tamoxifen. For instance, from their agonist properties, the effects on the endometrium and tumour stimulation seen with tamoxifen would not be expected, nor would the visual disturbances that have been associated with the triphenylethylene compounds, including tamoxifen. A number of aromatase inhibitors, for instance, anastrozole, letrozole and exemestane, are currently being investigated for treatment of early breast cancer. The results of the trials of aromatase inhibitors and tamoxifen will, in the next few years, define whether or not the new-generation aromatase inhibitors have a role to play in the treatment of postmenopausal women with early breast cancer.


The Breast ◽  
2015 ◽  
Vol 24 ◽  
pp. S149-S153 ◽  
Author(s):  
Jessica J. Tao ◽  
Kala Visvanathan ◽  
Antonio C. Wolff

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