Biomedical subjects

E A Perez

Publications and source records attributed to E A Perez.

At least 19 recordsLinked to original sources

PubMed2006

Phase II trial of oral vinorelbine for the treatment of metastatic breast cancer in patients > or = 65 years of age: an NCCTG study.

BACKGROUND: A one-stage phase II trial was conducted to assess the tumor response rate and toxicity profile of single agent oral vinorelbine as first or second-line chemotherapy for women at least 65 years of age with metastatic breast cancer. PATIENTS AND METHODS: Twenty-five patients with metastatic breast cancer aged > or = 65 years of age were enrolled to receive oral vinorelbine on a weekly basis. The oral vinorelbine was given at 60 mg/m2 weekly for the first four doses and was increased to 70 mg/m2 for the subsequent administrations if there was no grade 4 neutropenia or no more than one episode of grade 3 neutropenia. Therapy was continued until progression or intolerable toxicity. RESULTS: Twenty-five patients were included and evaluable for analysis. One patient (4%) achieved a partial response (PR) that lasted for more than 13 months. Two additional patients remained stable for at least 6 months for a clinical benefit rate (PR + stable disease) of 12%. The 1-year survival rate was estimated to be 48% (95% CI 30% to 74.5%). Median time to progression was estimated to be 4.7 months (95% CI 2.0-5.5 months) and the 9-month disease progression-free rate was estimated to be 8% (95% CI 30.9% to 74.5%). The treatment was fairly well tolerated with grade 3 neutropenia in 12.5%, fatigue in 12.5% of the patients, and grade 2 neuromotor and neurosensory toxicities in 12.5% and 8.3%, respectively. CONCLUSION: Oral vinorelbine as a single agent at these dose and schedule in this population of women > or = 65 years is well tolerated but has a low level of objective efficacy for the treatment of metastatic breast cancer.

Administration, Oral↗

PubMed2005

A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: an NCCTG study.

PURPOSE: This phase II study was undertaken to define the efficacy and toxicity of pemetrexed in combination with gemcitabine in patients with metastatic breast cancer. PATIENTS AND METHODS: Patients with measurable metastatic breast cancer who had previously received an anthracycline and a taxane in either the adjuvant or metastatic setting were treated with gemcitabine 1250 mg/m2 (intravenous; days 1 and 8) and pemetrexed 500 mg/m2 (intravenous; day 8) every 21 days. RESULTS: Fifty-nine patients received a median of five cycles (range one to 22) of treatment and were followed until death or for a median of 28 months (range 19.4-36.6) among living patients. Fourteen partial responses for an overall response rate of 24% [95% confidence interval (CI) 16% to 39%] were documented. Nine (15%; CI 5% to 32%) patients had stable disease for >6 months. The median survival time was 10.3 months (95% CI 8.3-18.9) and the 1 year survival rate was 49% (95% CI 38% to 64%). The median time to progression was estimated to be 3.7 months (95% CI 2.3-5.3). The most common grade 3 or 4 toxicities were neutropenia and thrombocytopenia in 83% and 27% of patients, respectively. Fourteen percent of patients experienced febrile neutropenia. Other common grade 3 or 4 non-hematological toxicities included fatigue (17%), dyspnea (15%), rash (7%) and anorexia (5%). CONCLUSIONS: The combination of pemetrexed and gemcitabine is clinically active, with an overall response rate of 24% in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane. Myelosuppression (66% grade 4 neutropenia and 14% febrile neutropenia) was the major treatment-related toxicity observed for this combination.

Adult↗

PubMed2005

The influence of letrozole on serum lipid concentrations in postmenopausal women with primary breast cancer who have completed 5 years of adjuvant tamoxifen (NCIC CTG MA.17L).

BACKGROUND: The purpose of this study was to evaluate changes in serum lipid parameters {cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides and lipoprotein(a) [Lp(a)]}, in postmenopausal women receiving letrozole or placebo after adjuvant tamoxifen for early stage breast cancer (NCIC CTG MA.17L). PATIENTS AND METHODS: MA.17L is a substudy of MA.17, a randomized, double-blind, placebo-controlled trial of letrozole 2.5 mg taken daily for 5 years in postmenopausal women with primary breast cancer completing approximately 5 years of prior adjuvant tamoxifen. Patients consenting to participate in this companion study had blood drawn and lipid parameters (total cholesterol, HDL cholesterol, LDL cholesterol, Lp(a), triglycerides) evaluated at baseline, 6 months, 12 months and yearly thereafter until completion of protocol therapy. It was required that women be non-hyperlipidemic and not taking lipid-lowering drugs at time of entry on this trial. RESULTS: Three hundred and forty seven women were enrolled in the study. The letrozole and the placebo groups demonstrated marginally significant differences in the percentage change from baseline in HDL cholesterol at 6 months (P=0.049), in LDL cholesterol at 12 months (P=0.033) and triglycerides at 24 months (P=0.036). All comparisons of lipid parameters at other time points were not significantly different between the two treatment groups. No statistically significant differences in the number of patients exceeding the thresholds defined for the lipid parameters were found between the two treatment groups. CONCLUSIONS: The MA.17 trial demonstrated a significant improvement in disease-free survival with the use of letrozole as extended adjuvant therapy post tamoxifen. Results from this study suggests that letrozole does not significantly alter serum cholesterol, HDL cholesterol, LDL cholesterol, triglycerides or Lp(a) in non-hyperlidiemic postmenopausal women with primary breast cancer treated up to 36 months following at least 5 years of adjuvant tamoxifen therapy. These findings further support the tolerability of extended adjuvant letrozole in postmenopausal women following standard tamoxifen therapy.

Aged↗

PubMed2002

A randomized phase II study of sequential docetaxel and doxorubicin/cyclophosphamide in patients with metastatic breast cancer.

BACKGROUND: Docetaxel has yielded promising response rates as a component of doxorubicin-based combination schedules in patients with metastatic breast cancer, including docetaxel/doxorubicin and docetaxel/doxorubicin/cyclophosphamide (AC). This randomized two-stage phase II study was conducted to evaluate sequential treatment with docetaxel and AC as first-line treatment in patients with recurrent or metastatic breast cancer previously untreated with chemotherapy for metastatic disease. PATIENTS AND METHODS: Thirty-three patients were randomized to either docetaxel (100 mg/m(2)) on day 1 of a 21-day cycle for three cycles followed by AC (60/600 mg/m(2)) on day 1 of a 21-day cycle for three cycles (n = 17) or vice-versa (n = 16), without prophylactic granulocyte colony-stimulating factor support. In addition, we compared pre-treatment serum sErbB1 and sErbB2 protein concentrations with that of an age- and menopausal status-matched group of healthy women, and examined changes in serum sErbB1 and sErbB2 protein concentrations in these two treatment schedules. Data from each one of the two arms of the trial (docetaxel then AC, or AC and then docetaxel) were analyzed separately. RESULTS: Enrollment was suspended after the first-stage of accrual, based on statistical design. Confirmed objective response rates after six cycles of treatment were 35% [95% confidence interval (CI) 14% to 62%] with docetaxel then AC and 38% (95% CI 15% to 65%) with AC then docetaxel. Dose reductions were frequent and mostly due to grade 4 neutropenia. Median survival time was 2.5 years in the docetaxel then AC group, and 1.1 years in the AC then docetaxel group. Serum sErbB1 concentrations were not significantly different between the study patients and healthy women, and did not change significantly after three and six cycles of treatment. In contrast, serum sErbB2 concentrations were significantly higher in the study patients compared with healthy women and tended to decrease after three and six cycles of treatment. CONCLUSIONS: Response rates at the end of six cycles of treatment, which led to termination of accrual after the first stage using either the sequence of docetaxel first or docetaxel after AC chemotherapy, were lower than anticipated. However, median survival times and median progression-free survival times are similar to those reported in other studies. These data further suggest that additional studies to assess whether serum sErbB2 concentrations are useful predictors of responsiveness to chemotherapy are warranted.

Adenocarcinoma↗

PubMed2001

Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer.

PURPOSE: We evaluated the safety and efficacy of weekly paclitaxel therapy in women with metastatic breast cancer in a phase II multicenter trial. Entry criteria were relatively liberal to reflect the heterogeneity of metastatic breast cancer in clinical practice. PATIENTS AND METHODS: Patients had histologically confirmed and measurable metastatic breast cancer. Up to two prior chemotherapy regimens for metastatic disease, including prior therapy with anthracyclines and taxanes and prior high-dose therapy, were allowed. Paclitaxel 80 mg/m(2) was administered weekly for 4 weeks per 4-week cycle. RESULTS: We enrolled 212 patients; 211 were assessable for toxicity and 177 were assessable for response. Ninety percent of patients had received prior chemotherapy (adjuvant, metastatic, or both), 46% of patients had three or more involved metastatic sites, and 60% of patients had visceral-dominant disease. Responses were documented on two occasions and were independently reviewed. The overall response rate (complete plus partial response) was 21.5% (95% confidence interval, 15.4% to 27.5%), with 41.8% of patients having disease stabilization. Median time to progression was 4.7 months, and overall survival in all 212 patients enrolled was 12.8 months. Therapy was well tolerated, with a 15% incidence of grade 3/4 hematologic toxicity and a 9% incidence of grade 3 neurotoxicity; other serious toxicities were rare. The response rate and toxicity profile in the 34% of patients > or = 65 years of age were similar to that of younger patients. CONCLUSION: Weekly paclitaxel therapy was well tolerated and demonstrated reasonable activity in this relatively heavily pretreated population with advanced disease. Further study of weekly paclitaxel in combination therapy is warranted.

Adult↗

PubMed2001

Role of axillary node dissection in patients with T1a and T1b breast cancer: Mayo Clinic experience.

HYPOTHESIS: The incidence of nodal positivity in patients with early breast cancer is low, and axillary lymph node dissection may not be justified in all such patients. DESIGN: Retrospective case series. SETTING: Tertiary institution. PATIENTS: All patients with T1a and T1b breast cancer who had both primary breast surgery and axillary lymph node dissection at Mayo Clinic in Jacksonville, Fla, from January 1, 1992, through February 28, 1998. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Tumor size and biological grade, estrogen and progesterone receptor status, number of nodes harvested, and number of nodes positive for disease. RESULTS: Of 163 patients studied, 39 had T1a and 124 had T1b tumors. Node positivity was 0% for T1a and 11.3% for T1b tumors (P =.03). Lymph node involvement and estrogen receptor status were not related (P =.29). However, the risk of lymph node positivity for progesterone receptor-negative (P =.01) and estrogen receptor-negative/progesterone receptor-negative tumors was significantly higher than for progesterone and estrogen/progesterone receptor-positive tumors (P =.04). Furthermore, the risk of lymph node positivity was significantly higher as tumor size increased (P =.002). Finally, higher tumor grade conferred a higher risk of lymph node involvement (P =.02). CONCLUSIONS: T1a tumors have minimal risk of nodal positivity and may not require subsequent axillary lymph node dissection in the future. T1b tumors should be managed with routine analysis of axillary lymph node status. Whether sentinel node mapping can change this standard awaits further study.

Adult↗

PubMed2001

Activity of high-dose toremifene plus cisplatin in platinum-treated non-small-cell lung cancer: a phase II California Cancer Consortium Trial.

PURPOSE: Although cisplatin is an important agent in non-small-cell lung cancer (NSCLC), de novo resistance is common and acquired resistance emerges rapidly during therapy. Proposed mediators of platinum resistance include the protein kinase C (PKC) signal transduction pathway and associated c-FOS overexpression. While estrogen administration has been reported to upregulate PKC and c-FOS expression, the triphenylethylenes tamoxifen and toremifene potentiate platinum cytotoxicity by inhibition of PKC. Downregulation of c-FOS expression has been reported to result from PKC inhibition. In view of these findings, we hypothesized that toremifene would reverse platinum resistance and that this interaction would be influenced by tumor estrogen receptor (ER) status. MATERIALS AND METHODS: A phase II trial of high-dose toremifene (600 mg orally daily on days 1-7) plus cisplatin (50 mg/m2 intravenously on days 4 and 11) every 28 days in NSCLC patients was conducted. A group of 30 patients with metastatic NSCLC who had been previously treated with platinum-based therapy were enrolled. RESULTS: All of the 30 patients were assessable for toxicity and 28 for tumor response. Therapy was well tolerated with minimal hematologic and non-hematologic toxicity. Common toxicity criteria grade 3 hematologic toxicity was seen in only three patients. Five patients achieved a partial response for an overall response rate of 18% (95% CI 6-37). Median overall survival was 8.1 months (95% CI 5.4-17). To assess PKC, ER, and c-Fos expression by immunohistochemistry, 12 informative pretreatment patient tumor specimens were obtained. Four patient tumor specimens were positive for one or both PKC isoforms (alpha and epsilon) while c-Fos was overexpressed in three. None of the responding patient tumors exhibited c-FOS or PKC-epsilon overexpression. ER expression was found to be infrequent (8%), contrasting with previous reports in this tumor type. CONCLUSION: While this phase II study indicates that high-dose toremifene plus cisplatin is feasible, active, and well tolerated in NSCLC patients previously treated with platinum compounds, the mechanism of action remains unclear. Further study of this regimen is warranted.

Adult↗

PubMed2001

The role of adjuvant monoclonal antibody therapy for breast cancer: rationale and new studies.

HER2 is a member of the epidermal growth factor receptor (EGFR) family of tyrosine kinases and is involved in the growth, invasion, metastasis, and prognosis of breast cancer. The rationale for prospective trials evaluating the role of anti-HER2 monoclonal antibody therapy for patients with high-risk HER2-positive resected breast cancer is based on several factors. These include 1) the relative and absolute poor prognosis of patients with node-positive, HER2-positive breast cancer; 2) the emerging data of potential importance concerning anthracyclines as a component of adjuvant therapy for patients with HER2-positive breast cancer; 3) the role of taxanes in the management of patients with HER2-positive metastatic breast cancer; and 4) the feasibility and efficacy of molecularly targeted anti-HER2 monoclonal antibody treatment alone or in combination with chemotherapy for patients with advanced breast cancer.

Antibiotics, Antineoplastic↗

PubMed2001

Metastatic bone disease in breast cancer: the patient's perspective.

Bone metastases represent a common source of morbidity and disability and are the cause of a significant decrease in quality of life in patients with advanced disease. Because the clinical course of metastatic bone disease can be long, effective palliative therapy is essential to maintain a good quality of life. Bisphosphonates have been proven as beneficial agents in the management of patients with lytic metastatic disease to bone. Although no effect on survival has been consistently shown, bisphosphonates can provide specific symptom control and prevent the progression of bone metastases and their complications. Bisphosphonates also have an established role in the prevention and treatment of osteoporosis, which is a significant problem in women with breast cancer, with or without bone metastases. Because bisphosphonate treatment is not designed to be curative, tolerability and patient friendliness are very important factors in bisphosphonate therapy. Highly potent third-generation bisphosphonates offer significant advantages from the patient's perspective, such as the possibility of outpatient treatment through shortened infusion times for intravenous (IV) formulations, and the availability of once-daily oral formulations.

Attitude to Health↗

PubMed2001

Integration of trastuzumab into adjuvant systemic therapy of breast cancer: ongoing and planned clinical trials.

Clinical trials using the humanized version of the anti-HER2 murine monoclonal antibody 4D5, trastuzumab, have shown antitumor activity in patients with HER2-positive metastatic breast cancer. Improved response and survival rates have been shown when trastuzumab was added to first-line combination chemotherapy with anthracycline/cyclophosphamide or paclitaxel compared with the same chemotherapy alone. Because of the promising safety and efficacy profile of trastuzumab in the metastatic setting, this novel biologic has now entered adjuvant breast cancer trials in both the United States and Europe. Five clinical trials are discussed in this report, capturing the evolving role of trastuzumab as adjuvant therapy for breast cancer.

Antibodies, Monoclonal↗

PubMed2001

Doxorubicin and paclitaxel in the treatment of advanced breast cancer: efficacy and cardiac considerations.

Doxorubicin and paclitaxel are highly active agents in the treatment of advanced breast cancer. Although early trials of the combination reported high response rates, an unexpectedly high incidence of congestive heart failure observed on two of the early trials was cause for much concern. More recently, clinical trials that have limited the cumulative doxorubicin dose to 400 mg/m2 or below when given in combination with paclitaxel have not observed an increase in cardiac toxicity. In addition, a retrospective review of over 600 women with advanced breast cancer treated with doxorubicin and paclitaxel concluded that the combination could be administered safely up to a cumulative doxorubicin dose of 340-380 mg/m2. It is likely that a pharmacokinetic interaction between doxorubicin and paclitaxel is, in large part, responsible for the higher than expected incidence of congestive heart failure observed in some studies. It appears that paclitaxel decreases the clearance of doxorubicin by approximately 30% when the two drugs are administered in close succession. Because the use of combination of doxorubicin and paclitaxel may benefit women with advanced breast cancer, a review of pertinent clinical studies and the implications of the pharmacokinetic interaction is provided. Particular attention has been paid to cardiac toxicities. It can be concluded that the use of combination doxorubicin and paclitaxel is safe up to a cumulative doxorubicin dose of 340-380 mg/m2. This would allow for up to six courses of therapy with doxorubicin 60 mg/m2 and paclitaxel 175 mg/m2 by 3-hour infusion. Therapy can be continued with single-agent paclitaxel. In order to minimize cardiac risk, patients should be selected carefully and be monitored for adverse cardiac effects.

Antineoplastic Agents↗

PubMed2001

A preliminary study of serum concentrations of soluble epidermal growth factor receptor (sErbB1), gonadotropins, and steroid hormones in healthy men and women.

Soluble ErbB (sErbB) growth factor receptors are being investigated as cancer biomarkers. Gonadotropic and steroid hormones have been shown to modulate the expression of ERBB family members in vivo. Accordingly, the range of sErbB1 values and their relationship to gonadotropic and steroid hormones need to be established in healthy subjects to provide a baseline for future clinical studies. We assayed sera from healthy men and women to determine p110 sErbB1 concentrations by acridinium-linked immunosorbent assay (ALISA). Follicle-stimulating hormone (FSH), estradiol, and testosterone concentrations were measured using the ACS:180 Immunoassay Analyzer. Luteinizing hormone (LH) and progesterone concentrations were quantified using the Access Immunoassay System. Unadjusted for age, p110 sErbB1 concentrations in healthy men and women do not differ significantly. However, sErbB1 concentrations show a strong age-gender interaction, increasing with age in men but decreasing with age in women. Consequently, sErbB1 concentrations are significantly higher in premenopausal women compared with either postmenopausal women or age-matched men and in age-matched men compared with postmenopausal women. Serum sErbB1 concentrations show significant negative associations with both FSH and LH concentrations in healthy women and a significant positive association with FSH concentrations in healthy men. Univariate linear regression models show that these respective gonadotropic hormones and age are independent predictors of sErbB1 concentrations in men and women. Multivariate models show that when age and FSH and LH concentrations are mutually adjusted for each other, they account for 22% of the variability observed in sErbB1 concentrations in healthy women. These data support the hypothesis that gonadotropic and steroid hormones may modulate ERBB1 expression in vivo and suggest that age- and gonadotropin-adjusted sErbB1 concentrations may be of clinical utility. Furthermore, these data demonstrate that gender, age, menstrual cycle phase, menopausal status, and exogenous hormone use must be considered when using serum p110 sErbB1 concentrations as cancer biomarkers.

Adult↗

PubMed2000

A phase II study of paclitaxel plus carboplatin as first-line chemotherapy for women with metastatic breast carcinoma.

BACKGROUND: This Phase II multicenter study evaluated the efficacy and toxicity of paclitaxel (200 mg/m(2) by 3-hour infusion) with carboplatin (area under the curve 6 mg/mL per minute) administered every 3 weeks as first-line therapy for women with metastatic breast carcinoma. METHODS: Eligible patients had measurable metastatic disease and an Eastern Cooperative Oncology Group performance status of 0-2. Prior adjuvant chemotherapy, including anthracycline-based therapy, was allowed, as was prior hormonal therapy as part of either adjuvant treatment or treatment for metastasis. Prior therapy with taxanes or platinum was not allowed. RESULTS: A total of 53 patients were enrolled in this study, with 50 patients evaluable for response and toxicity. The overall response rate was 62% (95% confidence interval ¿CI, 48-75%); 16% of patients had complete responses and 46% had partial responses. The median time to progression was 7.3 months (95% CI, 5.9-12.9), and the 12-month survival estimate was 72% (95% CI, 61-86%). Therapy was generally well tolerated. Grade 3-4 neutropenia was the predominant toxicity, observed in 82% of patients, but there were no episodes of febrile neutropenia or sepsis. Hematopoietic growth factors were not routinely necessary. Grade 3 peripheral neuropathy occurred in 16% of patients. CONCLUSIONS: Paclitaxel (200 mg/m(2)) with carboplatin (area under the curve 6 mg/mL per minute) demonstrated substantial efficacy in patients with metastatic breast carcinoma, and the 12-month survival rate of 72% was encouraging. This therapy represents a viable option for patients with metastatic disease.

Adult↗

PubMed2000

Control of high-dose-cisplatin-induced emesis with an all-oral three-drug antiemetic regimen.

In this pilot trial, the antiemetic efficacy and tolerability of an all-oral antiemetic combination in the prevention of both acute and delayed nausea and vomiting following high-dose cisplatin was evaluated. Fifty-two patients receiving cisplatin (median dose 100 mg/m2) were entered. Patients received (1) 60 min prior to cisplatin: prochlorperazine spansule 15 mg, dexamethasone 20 mg, granisetron 2 mg; (2) 12 h after cisplatin: prochlorperazine spansule 15 mg, dexamethasone 10 mg; (3) on days 2 and 3: prochlorperazine spansule 15 mg b.i.d., dexamethasone 8 mg b.i.d.; (4) on days 4 and 5: dexamethasone 4 mg b.i.d. All antiemetics were administered orally. The study period was the 120 h after cisplatin administration. The primary efficacy end-point was complete control (no vomiting, retching or antiemetic rescue) of delayed emesis (24-120 h after cisplatin). Complete control of delayed emesis was achieved in 26 patients (53%). Nineteen patients (39%) noted no delayed nausea. Complete control of acute emesis (24 h after cisplatin) was attained in 44 patients (86%). The no nausea rate during the first 24 h was 74%. Overall, 39 patients (80%) were satisfied or very satisfied with their outcome. Treatment was well tolerated with infrequent and minor adverse events. In conclusion, an all-oral combination of granisetron, dexamethasone and prochlorperazine is a highly effective and well-tolerated regimen for preventing acute cisplatin-induced emesis. Control of delayed emesis was not better than with current standard treatment, and more effective approaches are needed.

Administration, Oral↗

PubMed2000

Breast cancer prevention trials.

A new option for women at increased risk for breast cancer is chemoprevention--namely, an attempt to decrease breast cancer incidence by means of drug therapy. The efficacy of tamoxifen as a chemopreventive agent has been studied to date in three randomized, controlled trials, with varying results. Investigators with the National Surgical Adjuvant Breast and Bowel Project (NSABP) Breast Cancer Prevention Trial found that tamoxifen reduced the incidence of breast cancer by almost half, whereas British and Italian researchers found no significant benefit. This disparity is due, in part, to differences in the baseline breast cancer risk characteristics among the study populations, differing cohort sizes, variable use of hormone replacement therapy, and other factors. In this article, we review the eligibility criteria, treatment plans, and results from the three published randomized trials of tamoxifen versus placebo. We also review the data on raloxifene and breast cancer incidence. Chemoprevention with tamoxifen, in a non-study setting, is one option for women at increased risk for breast cancer. The ongoing Study of Tamoxifen and Raloxifene (STAR) is a randomized, double-blinded trial comparing the effectiveness of raloxifene with that of tamoxifen in postmenopausal women at increased risk for developing breast cancer. Until the results of this trial are available, it is premature to use raloxifene for primary breast cancer prevention.

Adult↗

PubMed2000

Rationale and design of a phase III trial of adjuvant sequential epirubicin/ cyclophosphamide and taxane versus concurrent epirubicin/taxane in operable node-positive breast cancer.

The sequential use of a doxorubicin combination followed by paclitaxel has been reported to improve disease-free and overall survival in patients with node-positive breast cancer beyond that obtained with doxorubicin/cyclophosphamide combinations. Epirubicin is associated with less cardiotoxicity than doxorubicin and can be used at cumulative dose levels or intensities that cannot be safely achieved with doxorubicin. Epirubicin/taxane combinations have exhibited significant activity when used in the treatment of metastatic breast cancer. Based on these safety and efficacy data, a phase III adjuvant trial will compare the efficacy of a concurrent epirubicin/taxane regimen with sequential epirubicin/cyclophosphamide followed by taxane treatment in patients with operable node-positive breast cancer.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2000

History of the development of antiemetic guidelines at Mayo Clinic Rochester.

This article describes the historic experience of the development of antiemetic guidelines for patients taking chemotherapy drugs at Mayo Clinic Rochester. The initial guidelines for the use of serotonin (5-hydroxytryptamine3) receptor antagonists for the prevention of chemotherapy-induced nausea and vomiting were developed in early 1995 and implemented in September 1995. In February 1997, the guidelines were reviewed and modified. In the spring of 1998, major changes were made based on new data from the literature and discussions with antiemetic authorities in the United States. These guidelines were implemented in July 1998. The guidelines were again reviewed and modified in December 1998. In addition, we compared costs associated with the 1997 guidelines and the December 1998 guidelines. The developed guidelines, utilizing clinically available agents, seem to provide high-quality patient care at a reasonable cost.

Antiemetics↗

PubMed2000

Prevention and treatment of osteoporosis in women with breast cancer.

Women who have had breast cancer may be at higher risk for osteoporosis than other women. First, they are more likely to undergo early menopause, due to chemotherapy-induced ovarian failure or oopherectomy. In addition, chemotherapy may have a direct adverse effect on bone mineral density (BMD), and osteoclastic activity may increase from the breast cancer itself. While estrogen therapy is considered standard for the prevention and treatment of osteoporosis, use of estrogen in women with a history of breast cancer is usually contraindicated. The approach to osteoporosis in women with breast cancer is also affected by the use of tamoxifen in many, as this drug appears to have opposite effects on BMD in premenopausal and postmenopausal women. We have reviewed therapeutic alternatives for the prevention and treatment of osteoporosis, focusing on patients with a history of breast cancer. Alendronate and raloxifene are currently approved in the United States for the prevention of osteoporosis; alendronate, raloxifene, and calcitonin are approved for treatment. Alendronate has the greatest positive effect on BMD and reduces the incidence of vertebral and nonvertebral fractures. Raloxifene and calcitonin appear to reduce the incidence of vertebral fractures; their effects on the incidence of nonvertebral fractures are not yet proven. Although no published studies specifically address the use of these approved agents for osteoporosis in women with breast cancer, understanding their relative effects on BMD in postmenopausal women in general will facilitate therapy selection in this population. Postmenopausal women with a history of breast cancer should undergo bone mineral analysis. Normal results and absence of other risk factors ensure that calcium and vitamin D intake are adequate. If osteopenia or other risk factors are present, preventive therapy with alendronate or raloxifene should be considered. For osteoporosis, treatment with alendronate should be strongly considered. Raloxifene and calcitonin are alternatives when alendronate is contraindicated. Further studies are needed to evaluate the optimal timing of initial bone mineral analysis in premenopausal women after breast cancer diagnosis and to determine the value of preventive treatment in women scheduled to undergo chemotherapy.

Aged↗