Tamoxifen for Prevention of Breast Cancer

2003 ◽  
Vol 37 (2) ◽  
pp. 268-273 ◽  
Author(s):  
Robert J Cersosimo
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Literature Search ◽  
Data Sources ◽  
Data Synthesis ◽  
Increased Risk ◽  
Key Words Tamoxifen ◽  
Not At Risk ◽  
Prevention Of Breast Cancer ◽  
Common Malignancy

OBJECTIVE: To review data on the use of tamoxifen for primary prevention of breast cancer. DATA SOURCES: A literature search was performed through MEDLINE (1992–May 2002) using the key words tamoxifen, breast cancer, and prevention. DATA SYNTHESIS: Breast cancer is the most common malignancy detected in American women. Attempts to reduce morbidity and mortality include early detection programs and chemoprevention. Clinical trials of tamoxifen for reduction of breast cancer risk are reviewed. CONCLUSIONS: Tamoxifen may reduce the risk of primary breast cancer in women at increased risk. The benefit of tamoxifen in women who are not at risk is uncertain. The risks of developing thromboembolic disorders or endometrial cancer must be considered before tamoxifen is prescribed. Women should be given all of the information about the benefits and risks of tamoxifen use so that they can make an informed decision based on the best data available.

scholarly journals Hormone therapy in menopausal women with fibroids: is it safe? (Literature review)

2019 ◽  
Vol 2 (14) ◽  
pp. 38-44
Author(s):  
Ya. Z. Zaydieva
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Hormone Therapy ◽  
Literature Search ◽  
Effective Treatment Option ◽  
Estrogen Receptor Modulators ◽  
Increased Risk ◽  
Menopausal Women ◽  
Receptor Modulators ◽  
Higher Doses

Hormone therapy is an effective treatment option for menopausal women, although prolonged use of hormone therapy is associated with a slightly increased risk of breast cancer, thromboembolism, and stroke. A literature search for studies evaluating the effects of hormone therapy in menopausal women with asymptomatic fibroids demonstrated variable effects of hormone therapy on the volume and size of the fibroids. Some studies have demonstrated an increase in size of pre-existing asymptomatic fibroids and formation of new fibroids with higher doses of progestogen in combination therapy. Selective estrogen receptor modulators having tissue-specific estrogen agonistic and antagonistic actions such as raloxifene have a favorable clinical profile and may be better alternatives in women with asymptomatic fibroids.

Tamoxifen for the Prevention of Breast Cancer: Psychosocial Impact on Women Participating in Two Randomized Controlled Trials

2001 ◽  
Vol 19 (7) ◽  
pp. 1885-1892 ◽  
Author(s):  
Lesley Fallowfield ◽  
Anne Fleissig ◽  
Rob Edwards ◽  
Andrea West ◽  
Trevor J. Powles ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Group ◽  
Randomized Controlled Trials ◽  
Sexual Functioning ◽  
Self Report ◽  
Controlled Trials ◽  
Double Blind ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Prevention Of Breast Cancer

PURPOSE: The purpose of this study was to evaluate the psychosocial implications of tamoxifen versus placebo in women who are at increased risk of breast cancer. PATIENTS AND METHODS: The 488 women in the psychosocial study were recruited from participants in two placebo-controlled, double-blind, randomized, controlled trials that investigated the efficacy of tamoxifen in the prevention of breast cancer in women who are at high familial risk. During a 5-year period, repeated assessments were made of anxiety, psychological distress, and sexual functioning using standardized questionnaires before treatment at baseline and at 6-month intervals during the trial. RESULTS: Questionnaire completion over 5 years was good, with 71.1% of women returning at least 8 of 10 follow-up assessments. Although scores from individuals showed considerable fluctuation and variation over time, changes in anxiety, mood, and sexual functioning were not associated with treatment group. The number of symptoms reported at 48 months via a self-report cheklist were not associated with treatment group, but vasomotor symptoms were more frequent among tamoxifen-treated women. Symptoms of low energy, breast sensitivity, and visual blurring were reported most frequently in the placebo group. CONCLUSION: In general, these results are comparable to those from the National Surgical Adjuvant Breast and Bowel Project psychosocial study despite differences in study populations, methodology, and instruments. The long-term use of tamoxifen and other selective estrogen response modulators as preventive agents in high-risk groups has been questioned, but we found no evidence of treatment-related side effects that affect women’s psychosocial and sexual functioning.

scholarly journals Association of Cardiovascular Risk Factors With Cardiac Events and Survival Outcomes Among Patients With Breast Cancer Enrolled in SWOG Clinical Trials

2018 ◽  
Vol 36 (26) ◽  
pp. 2710-2717 ◽  
Author(s):  
Dawn L. Hershman ◽  
Cathee Till ◽  
Sherry Shen ◽  
Jason D. Wright ◽  
Scott D. Ramsey ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Cardiovascular Disease ◽  
Overall Survival ◽  
Clinical Trials ◽  
Survival Outcomes ◽  
Cardiac Events ◽  
Free Survival ◽  
Increased Risk

Background Cardiovascular disease is the primary cause of death among patients with breast cancer. However, the association of cardiovascular-disease risk factors (CVD-RFs) with long-term survival and cardiac events is not well studied. Methods We examined SWOG (formerly the Southwest Oncology Group) breast cancer trials from 1999 to 2011. We identified baseline diabetes, hypertension, hypercholesterolemia, and coronary artery disease by linking trial records to Medicare claims. The primary outcome was overall survival. Patients with both baseline and follow-up claims were examined for cardiac events. Cox regression was used to assess the association between CVD-RFs and outcomes. Results We identified 1,460 participants older than 66 years of age from five trials; 842 were eligible for survival outcomes analysis. At baseline, median age was 70 years, and median follow-up was 6 years. Hypertension (73%) and hypercholesterolemia (57%) were the most prevalent conditions; 87% of patients had one or more CVD-RF. There was no association between any of the individual CVD-RFs and overall survival except for hypercholesterolemia, which was associated with improved overall survival (hazard ratio [HR], 0.73; 95% CI, 0.57 to 0.93; P = .01). With each additional CVD-RF, there was an increased risk of death (HR, 1.23; 95% CI, 1.08 to 1.40; P = .002), worse progression-free survival (HR, 1.12; 95% CI, 1.00 to 1.25; P = .05), and marginally worse cancer-free survival (HR, 1.15; 95% CI, 0.99 to 1.34; P = .07). The relationship between baseline CVD-RFs and cardiac events was analyzed in 736 patients. A strong linear association between the number of CVD-RFs and cardiac event was observed (HR per CVD-RF, 1.41; 95% CI, 1.17 to 1.69; P < .001). Conclusion Among participants in clinical trials, each additional baseline CVD-RF was associated with an increased risk of cardiac events and death. Efforts to improve control of modifiable CVD-RFs are needed, especially among those with multiple risk factors.

scholarly journals National Cancer Institute of Canada – Clinical Trials Group (NCIC CTG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 373-401
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Postmenopausal Women ◽  
Primary Breast Cancer ◽  
Randomized Study ◽  
Phase Iii ◽  
Adjuvant Tamoxifen ◽  
Double Blind ◽  
Node Negative ◽  
Increased Risk

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by National Cancer Institute of Canada – Clinical Trials Group (NCIC CTG). Clinical trials include: Double-blind randomized trial of tamoxifen versus placebo in patients with node-positive or high-risk node-negative (tumor ≥ 1 cm and either higher histological grade (poorly differentiated, or SBR grade III or MSBR grade V) or lymphatic/vascular invasion or both) breast cancer who have completed CMF, CEF or AC adjuvant chemotherapy. NCIC CTG Trial MA.12A randomized trial of antiestrogen therapy versus combined antiestrogen and octreotide LAR therapy in the adjuvant treatment of breast cancer in postmenopausal women. NCIC CTG Trial MA.14A phase III randomized double blind study of letrozole versus placebo in women with primary breast cancer completing five or more years of adjuvant tamoxifen. BIG 01-97/NCIC CTG MA.17NCIC CTG MA.17 Companion study (2): The influence of letrozole on bone mineral density in women with primary breast cancer completing five or more years of adjuvant tamoxifen. BIG 01-97/NCIC MA.17BNCIC CTG MA.17 Companion study (1): The influence of letrozole on serum lipid concentrations in women with primary breast cancer who have completed 5 years of adjuvant tamoxifen. BIG 01-97/NCIC CTG MA.17LNCIC CTG MA.17R A double blind re-randomization to letrozole or placebo for women completing 5 years of adjuvant letrozole in the MA.17 study.A phase III study of regional radiation therapy in early breast cancer. NCIC CTG trial MA.20A phase III adjuvant trial of sequenced EC + GCSF Taxol versus sequenced AC → Taxol versus CEF as therapy for premenopausal women and early postmenopausal women who have had potentially curative surgery for node positive or high-risk node negative breast cancer. NCIC CTG Trial MA.21A phase I/II study of increasing doses of epirubicin and docetaxel + pegfilgrastim for locally advanced or inflammatory breast cancer. NCIC CTG Trial MA.22A randomized phase III trial of exemestane versus anastrozole with or without celecoxib in postmenopausal women with receptor positive primary breast cancer. NCIC CTG Trial MA.27A randomized feasibility study of letrozole in postmenopausal women at increased risk for development of breast cancer as evidenced by high breast density. NCIC CTG Trial MAP.1A randomized study of the effect of exemestane (Aromasin) versus placebo on breast density in postmenopausal women at increased risk for development of breast cancer. NCIC CTG Trial: MAP.2A phase III randomized study of exemestane versus placebo in postmenopausal women at increased risk of developing breast cancer. NCIC CTG Trial: MAP.3

Association of baseline cardiovascular risk factors and health care utilization and costs in elderly breast cancer patients enrolled in SWOG clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11508-11508
Author(s):  
Dawn L. Hershman ◽  
Cathee Till ◽  
Jason Dennis Wright ◽  
Melissa Kate Accordino ◽  
Riha Vaidya ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Healthcare Costs ◽  
Disease Risk ◽  
Breast Cancer Patients ◽  
Increased Risk ◽  
Clinical Records ◽  
The Impact

11508 Background: Cardiovascular-disease risk factors (CVD-RFs) increase the risk of cardiac events in women undergoing chemotherapy. Less is known about the impact of CVD-RFs on healthcare utilization and costs. Methods: We examined breast cancer patients treated uniformly on SWOG clinical trials from 1999-2011. We identified baseline diabetes, hypertension, hypercholesterolemia, and coronary artery disease (CAD) by linking trial records to Medicare claims; obesity was identified using clinical records. The outcomes were emergency room visits (ER), hospitalizations and costs. Multivariable logistic and linear regression were used. Results: Among the 708 patients included in the analysis, 160 (22.6%) experienced 234 separate hospitalizations, and 193 (27.3%) experienced 311 separate ER visits. Diabetes, hypertension, hypercholesterolemia, and CAD were all associated with increased risk of hospitalizations and ER visit. Hypertension had the strongest association, with more than a threefold risk of hospitalization for those with hypertension compared to those without (OR [95% CI], 3.16 [1.85-5.40], p<0.001). For those with ≥3 CVD-RFs, the risk of hospitalization was greater compared to 0 or 1 CVD-RFs (OR [95% CI], 2.74 [1.71-4.38], p<0.001). Similar results were seen for ER visits. In the first 12 months after trial registration, patients with diabetes ($38,324 vs $30,923, 23.9% increase, p=0.05), hypercholesterolemia ($34,168 vs $30,661, 11.4% increase, p=0.02), and CAD ($37,781 vs $31,698, 19.2% increase, p=0.04) had statistically significantly higher total healthcare costs. Additionally, those with 2 significant CVD-RFs ($35,353 vs. $28,899, 22.3% increase, p=.005) had higher total healthcare costs. Conclusions: Our study demonstrates that the presence of both CVD-RFs and ER visits and hospitalizations are frequent among elderly BC patients. The risk of ER visits and hospitalizations is higher among patients with CVD-RFs, and increases with the number of RFs. Better management of CVD-RFs and more aggressive symptom management may be required to reduce both physical and financial toxicities to elderly patients undergoing BC therapy.

Divalproex Sodium Therapy in Elderly with Dementia-Related Agitation

2002 ◽  
Vol 36 (10) ◽  
pp. 1625-1628 ◽  
Author(s):  
Crystal E Pratt ◽  
Steven M Davis
Keyword(s):  
Clinical Trials ◽  
Elderly Patients ◽  
Statistical Significance ◽  
Data Sources ◽  
Controlled Trials ◽  
Divalproex Sodium ◽  
Data Synthesis ◽  
Medline Search ◽  
Potential Benefits

OBJECTIVE: To review available literature regarding the use of divalproex sodium in the treatment of agitation in elderly patients with dementia. DATA SOURCES: Clinical trials and review articles were identified by MEDLINE search (1966 — March 2002). DATA SYNTHESIS: The literature provides information regarding the potential benefits and tolerability of divalproex sodium in the treatment of dementia-related agitation. This article analyzes 7 studies to better understand the role of divalproex sodium in the treatment of dementia. CONCLUSIONS: Divalproex sodium may offer a slight benefit to elderly patients suffering from dementia-related agitation. Until better-controlled trials demonstrate statistical significance and comparisons with established treatments are performed, practitioners should use divalproex sodium cautiously.

Exemestane for primary prevention of breast cancer in postmenopausal women: NCIC CTG MAP.3—A randomized, placebo-controlled clinical trial.

2011 ◽  
Vol 29 (18_suppl) ◽  
pp. LBA504-LBA504 ◽  
Author(s):  
P. E. Goss ◽  
J. N. Ingle ◽  
J. Ales-Martinez ◽  
A. Cheung ◽  
R. T. Chlebowski ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Primary Prevention ◽  
Postmenopausal Women ◽  
Bone Fractures ◽  
Annual Incidence ◽  
Controlled Clinical Trial ◽  
Breast Cancers ◽  
Increased Risk ◽  
Prevention Of Breast Cancer

LBA504 Background: Limited efficacy and serious toxicities have limited uptake of tamoxifen or raloxifene as preventatives of breast cancer. Aromatase inhibitors (AIs) prevent contralateral breast cancers more than tamoxifen in adjuvant trials and have fewer serious side effects. This is the first report of an AI used in primary prevention. Methods: NCIC CTG MAP.3 is a randomized trial designed to detect a 65% reduction in annual incidence of invasive breast cancer (IBC) on exemestane (E) versus placebo (P). Eligible postmenopausal women had ≥ one of the following risk factors: Gail score >1.66%, prior ADH, ALH, LCIS or DCIS with mastectomy, age over 60. Health-related and menopause-specific quality of life (QOL) were assessed by SF-36 and MENQOL questionnaires. Results: From 2004-2010, 4,560 women were randomized: age 62.5 yrs (37-90); Gail Score 2.3 % (0.6-21); BMI 28.0 kg/m2 (15.9-65.4). Risk factors included: age >60 yrs (49%); Gail score >1.66 (40%); and prior ADH, ALH, LCIS or DCIS with mastectomy (11%). At median follow-up of 35 months there were 11 IBCs on E and 32 on P (annual incidence 0.19% vs 0.55%; HR= 0.35, 95% CI 0.18-0.70, p = 0.002); ductal (10E/27P), lobular (1E/5P). Most tumors were ER positive (7E/27P); Her2/neu negative (10E/26P); TNM stage T1 (8E/28P), N0 (7E/22P), M0 (11E/30P). E was superior in all subgroups: by Gail score, age, BMI, prior LCIS and DCIS. The annual incidence rate of IBC or DCIS was 0.35% E and 0.77% P (HR=0.47;95% CI 0.27-0.79; p = 0.004) based on 64 IBCs or DCISs (20E/44P). Clinical bone fractures, osteoporosis, hypercholesterolemia or cardiovascular events were equal in both arms. No clinically meaningful differences in QOL were detected. Conclusions: Exemestane significantly reduced invasive and pre-invasive breast cancers in postmenopausal women at increased risk for breast cancer with no serious toxicities. Exemestane should be considered a new option for primary prevention of breast cancer. Supported by the Canadian Cancer Society; Pfizer Inc. PEG supported in part by Avon Foundation.

Pain Management with Intravenous Ketorolac

1993 ◽  
Vol 27 (3) ◽  
pp. 307-308 ◽  
Author(s):  
Lisa J. Miller ◽  
Mark A. Kramer
Keyword(s):  
Literature Search ◽  
Antiinflammatory Drug ◽  
Nonsteroidal Antiinflammatory Drug ◽  
Data Sources ◽  
Compatibility Studies ◽  
Data Synthesis ◽  
Intravenous Injections ◽  
Study Selection ◽  
Pain Models ◽  
Intravenous Ketorolac

OBJECTIVE: To report a case in which intravenous ketorolac was used successfully on a chronic basis to treat cancer pain. DATA SOURCES: Clinical and compatibility studies obtained through a computer literature search. STUDY SELECTION: We identified five reports that specifically addressed intravenous dosing of ketorolac. DATA SYNTHESIS: A 41-year-old man received pain relief from intravenous injections of ketorolac for 11 months. As far as we know, there are no other reports in the literature in which intravenous ketorolac has been used on a chronic basis. CONCLUSIONS: Experience at our institution indicates that intravenous ketorolac is a useful, well-tolerated nonsteroidal antiinflammatory drug that should be investigated further for use in selected pain models.

scholarly journals Effect of Pretreatment Renal Function on Treatment and Clinical Outcomes in the Adjuvant Treatment of Older Women With Breast Cancer: Alliance A171201, an Ancillary Study of CALGB/CTSU 49907

2016 ◽  
Vol 34 (7) ◽  
pp. 699-705 ◽  
Author(s):  
Stuart M. Lichtman ◽  
Constance T. Cirrincione ◽  
Arti Hurria ◽  
Aminah Jatoi ◽  
Maria Theodoulou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Renal Function ◽  
Renal Insufficiency ◽  
Early Stage ◽  
Single Agent ◽  
Hematologic Toxicity ◽  
End Points ◽  
Increased Risk ◽  
The Relationship

Purpose CALGB 49907 showed the superiority of standard therapy, which included either cyclophosphamide/doxorubicin (AC) or cyclophosphamide/methotrexate/fluorouracil over single-agent capecitabine in the treatment of patients age ≥ 65 with early-stage breast cancer. The treatment allowed dosing adjustments of methotrexate and capecitabine for pretreatment renal function. The purpose of the current analysis was to assess the relationship between pretreatment renal function and five end points: toxicity, dose modification, therapy completion, relapse-free survival, and overall survival. Methods Pretreatment renal function was defined as creatinine clearance (CrCl) using the Cockcroft-Gault equation. Multivariable logistic and proportional hazards regression were used to model separately for each regimen the relationship between CrCl and the first three binary end points and the last two time-to-event end points, respectively, after adjusting for variables of prognostic importance. Results Six hundred nineteen assessable patients were analyzed. The incidence of stage III (moderate) or stage IV (severe) renal dysfunction was 72%, 64%, and 75% for treatment with cyclophosphamide/methotrexate/fluorouracil, AC, and capecitabine, respectively. There was no relationship for any regimen between pretreatment renal function and the five end points. For AC, as CrCl increased, the odds of nonhematologic toxicity decreased (P = .008), whereas for capecitabine, as CrCl increased, the odds of experiencing toxicity of any type also increased (P = .035). Patients with renal insufficiency who received dose modifications were not at increased risk for complications compared with those who did not have renal insufficiency and received a full dose. Conclusion Excluding from clinical trials patients with renal insufficiency but good performance status on the basis of concern of excessive hematologic toxicity or poor outcomes may not be justified with appropriate dosing modifications. Results should be considered in the design of clinical trials for older patients.

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