Long-Term Follow-Up of the Intergroup Exemestane Study.

Purpose The Intergroup Exemestane Study, an investigator-led study of 4,724 postmenopausal patients with early breast cancer (clinical trial information: ISRCTN11883920), has previously demonstrated that a switch from adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane was associated with clinically relevant improvements in efficacy. Here, we report the final efficacy analyses of this cohort. Patients and Methods Patients who remained disease free after 2 to 3 years of adjuvant tamoxifen were randomly assigned to continue tamoxifen or switch to exemestane to complete a total of 5 years of adjuvant endocrine therapy.

Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer.

Background: The stress of a breast cancer diagnosis and its treatment can produce a variety of psychosocial sequelae including impaired immune responses. Mindfulness Based Stress Reduction (MBSR) is a structured complementary program that incorporates meditation, yoga and mind-body exercises. Despite promising empirical evidence for the efficacy of MBSR, there is a need for randomized controlled trials (RCT).

Dose-tailoring of FEC adjuvant chemotherapy based on leukopenia is feasible and well tolerated. Toxicity and dose intensity in the Scandinavian Breast Group phase 3 adjuvant Trial SBG 2000-1.

Unlabelled: The SBG 2000-1 trial is a randomised study that investigates if dose-tailored adjuvant FEC therapy based on the individual's leukocyte nadir value can improve outcome. The study has included 1535 women with medium and high-risk breast cancer.

Patients And Methods: After a first standard dosed FEC course (5-fluorouracil 600 mg/m(2), epirubicin 60 mg/mg(2) and cyclophosphamide 600 mg/m(2)), patients who did not reach leukopenia grade III or IV were randomised to standard doses (group standard) or doses tailored to achieve grade III leukopenia (group tailored) at courses 2-7.

Adjuvant! Online estimation of chemotherapy effectiveness when added to ovarian function suppression plus tamoxifen for premenopausal women with estrogen-receptor-positive breast cancer.

Adjuvant! Online (Adjuvant!) is a user-friendly, web-based tool that provides estimates of adjuvant therapy outcomes for individual patients. While reliable evidence underpins estimates for most patient cohorts, there is a paucity of data on the effect of adding chemotherapy to complete estrogen blockade for premenopausal women with estrogen-receptor positive breast cancer. International Breast Cancer Study Group (IBCSG) Trial 11-93 enrolled 174 premenopausal women with estrogen-receptor positive, node-positive breast cancer.

Changes in health-related quality of life may predict recurrent breast cancer.

Background: Patient-reported outcomes incorporated in cancer clinical trials, are increasingly hypothesized to be predictors of disease-free survival. Previous research supports health-related quality of life (HRQoL) as an independent predictor of survival in patients with advanced or metastatic breast cancer. In contrast, recent studies provide evidence that baseline HRQoL scores are not associated with increased risk of relapse or survival in women with early-stage breast cancer.

Patterns of recurrence of early breast cancer according to estrogen receptor status: a therapeutic target for a quarter of a century.

The current therapeutic strategy in breast cancer is to identify a target, such as estrogen receptor (ER) status, for tailoring treatments. We investigated the patterns of recurrence with respect to ER status for patients treated in two randomized trials with 25 years' median follow-up. In the ER-negative subpopulations most breast cancer events occurred within the first 5-7 years after randomization, while in the ER-positive subpopulations breast cancer events were spread through 10 years.

Is adjuvant chemotherapy of benefit for postmenopausal women who receive endocrine treatment for highly endocrine-responsive, node-positive breast cancer? International Breast Cancer Study Group Trials VII and 12-93.

To compare the efficacy of chemoendocrine treatment with that of endocrine treatment (ET) alone for postmenopausal women with highly endocrine responsive breast cancer. In the International Breast Cancer Study Group (IBCSG) Trials VII and 12-93, postmenopausal women with node-positive, estrogen receptor (ER)-positive or ER-negative, operable breast cancer were randomized to receive either chemotherapy or endocrine therapy or combined chemoendocrine treatment. Results were analyzed overall in the cohort of 893 patients with endocrine-responsive disease, and according to prospectively defined categories of ER, age and nodal status.

Are patients who are found deeply unconscious, without having suffered a cardiac arrest, always breathing normally?

Aim: To evaluate how often an ambulance crew reports abnormal breathing among patients who are found deeply unconscious but without having suffered a cardiac arrest.

Methods: Patients with Glasgow Coma Scale (GCS) 3 (1+1+1) and without cardiac arrest were retrospectively evaluated, via ambulance records, for signs of abnormal breathing.

Results: Of 45 patients who fulfilled inclusion criteria, 24 (53%) had signs of abnormal breathing, as reported by the ambulance crew.

Distinct clinical and prognostic features of infiltrating lobular carcinoma of the breast: combined results of 15 International Breast Cancer Study Group clinical trials.

Purpose: To determine how patients with infiltrating lobular carcinoma (ILC) differ from patients with the more common infiltrating ductal carcinoma (IDC) with regard to patient and tumor factors, local treatment, and patterns of recurrence.

Patients And Methods: Twelve thousand two hundred six breast cancer patients entered onto 15 International Breast Cancer Study Group trials between 1978 and 2002 were categorized as having ILC, IDC, or other/mixed types.

Results: Seven hundred sixty-seven tumors (6.

Is chemotherapy necessary for premenopausal women with lower-risk node-positive, endocrine responsive breast cancer? 10-year update of International Breast Cancer Study Group Trial 11-93.

Introduction: International Breast Cancer Study Group (IBCSG) Trial 11-93 is the largest trial evaluating the role of the addition of chemotherapy to ovarian function suppression/ablation (OFS) and tamoxifen in premenopausal patients with endocrine-responsive early breast cancer.

Methods: IBCSG Trial 11-93 is a randomized trial comparing four cycles of adjuvant chemotherapy (AC: doxorubicin or epirubicin, plus cyclophosphamide) added to OFS and 5 years of tamoxifen versus OFS and tamoxifen without chemotherapy in premenopausal patients with node-positive, endocrine-responsive early breast cancer. There were 174 patients randomized from May 1993 to November 1998.

Characteristics of cardiac arrest and resuscitation by age group: an analysis from the Swedish Cardiac Arrest Registry.

Aim: The objective of this study was to describe patients who experienced an out-of-hospital cardiac arrest (OHCA) by age group.

Methods: All patients who suffered from an OHCA between 1990 and 2005 and are included in the Swedish Cardiac Arrest Registry (n = 40,503) were classified into the following age groups: neonates, younger than 1 year; young children, between 1 and 4 years; older children, between 5 and 12 years; adolescents, between 13 and 17 years; young adults, between 18 and 35 years; adults not retired, between 36 and 64 years; adults retired, between 65 and 79 years; and older adults, 80 years or older.

Results: Ventricular fibrillation was lowest in young children (3%) and highest in adults (35%).

Anemia during adjuvant non-taxane chemotherapy for early breast cancer: Incidence and risk factors from two trials of the International Breast Cancer Study Group.

Unlabelled: GOAL OF THE WORK: Anemia is a common side effect of chemotherapy. Limited information exists about its incidence and risk factors. The objective of this study was to evaluate the incidence of anemia and risk factors for anemia occurrence in patients with early breast cancer who received adjuvant chemotherapy.

The role of the number of uninvolved lymph nodes in predicting locoregional recurrence in breast cancer.

Purpose: To identify groups of early breast cancer patients with substantial risk (10-year risk > 20%) for locoregional failure (LRF) who might benefit from postmastectomy radiotherapy (RT).

Patients And Methods: Prognostic factors for LRF were evaluated among 6,660 patients (2,588 node-negative patients, 4,072 node-positive patients) in International Breast Cancer Study Group Trials I to IX treated with chemotherapy and/or endocrine therapy, and observed for a median of 14 years. In total, 1,251 LRFs were detected.

Cost-effectiveness of exemestane versus tamoxifen as adjuvant therapy for early-stage breast cancer after 2-3 years treatment with tamoxifen in Sweden.

Aromatase inhibitors are rapidly becoming the cornerstone of endocrine treatment for advanced disease and are now also used as adjuvant treatment in early-stage disease. The objective of this study was to assess the cost-effectiveness of adjuvant treatment with exemestane versus tamoxifen for early-stage breast cancer after 2-3 years treatment with tamoxifen in Sweden. The results are based on findings in the Intergroup Exemestane Study (IES).

A nationwide survey of CPR training in Sweden: foreign born and unemployed are not reached by training programmes.

Aim: To determine the number of CPR trained adults in Sweden, and the willingness of the non-trained population to attend a CPR course. An additional purpose was to investigate differences related to sex, age, residential area, socio-economic classification and country of origin.

Methods: Five thousand adults in Sweden were surveyed, which yielded 3167 valid responses, a response rate of 63%.

Ocular toxicity during adjuvant chemoendocrine therapy for early breast cancer: results from International Breast Cancer Study Group trials.

Background: Others have reported ocular toxicity after adjuvant chemoendocrine therapy, but this study looked at ocular toxicity in similarly treated patients from large randomized clinical trials.

Methods: Information was retrieved on incidence and timing of ocular toxicity from the International Breast Cancer Study Group (IBCSG) database of 4948 eligible patients randomized to receive tamoxifen or toremifene alone or in combination with chemotherapy (either concurrently or sequentially). Case reports of patients with ocular toxicity were evaluated to determine whether ocular toxicity occurred during chemotherapy and/or hormonal therapy.

Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93.

Purpose: Axillary clearance in early breast cancer aims to improve locoregional control and provide staging information but is associated with undesirable morbidity. We therefore investigated whether avoiding axillary surgery in older women would result in improved quality of life (QL) with similar disease-free survival (DFS) and overall survival (OS).

Patients And Methods: Between 1993 and 2002, women > or = 60 years old with clinically node-negative operable breast cancer in whom adjuvant tamoxifen was considered indicated regardless of pathologic nodal status were randomly assigned to primary surgery plus axillary clearance (Sx + Ax) followed by tamoxifen (Tam) versus Sx without Ax followed by Tam for 5 consecutive years.

Prognostic value of extracapsular tumor spread for locoregional control in premenopausal patients with node-positive breast cancer treated with classical cyclophosphamide, methotrexate, and fluorouracil: long-term observations from International Breast Cancer Study Group Trial VI.

Purpose: We sought to determine retrospectively whether extracapsular spread (ECS) might identify a subgroup that could benefit from radiotherapy after mastectomy, especially patients with 1 to 3 positive lymph nodes (LN1-3+).

Patients And Methods: We randomized 1,475 premenopausal women with node-positive breast cancer to three, six, or nine courses of "classical" CMF (cyclophosphamide, methotrexate, and fluorouracil). After a review of all pathology forms, 933 patients (63%) had information on the presence or absence of ECS.

Very high survival among patients defibrillated at an early stage after in-hospital ventricular fibrillation on wards with and without monitoring facilities.

Background: The association between the interval between collapse and defibrillation and outcome is well described in out of hospital cardiac arrest but not as well in in-hospital cardiac arrest. We report the outcome among patients who suffered an in-hospital cardiac arrest and were found in ventricular fibrillation (VF) with the emphasis on the delay to defibrillation.

Methods And Results: In patients who suffered an in-hospital cardiac arrest at Sahlgrenska University Hospital in Göteborg between 1994 and 2002 there were 1.

Efficacy of bystander CPR: intervention by lay people and by health care professionals.

Background: Early cardiopulmonary resuscitation (CPR) by bystanders prior to the arrival of the rescue team has been shown to be associated with increased survival after out-of-hospital cardiac arrest. The aim of this survey was to evaluate the impact on survival of no bystander CPR, lay bystander CPR and professional bystander CPR.

Methods: Patients suffering an out-of-hospital cardiac arrest in Sweden between 1990 and 2002 who were given CPR and were not witnessed by the ambulance crew were included.

Site of primary tumor has a prognostic role in operable breast cancer: the international breast cancer study group experience.

Purpose: Cancer presenting at the medial site of the breast may have a worse prognosis compared with tumors located in external quadrants. For medial tumors, axillary lymph node staging may not accurately reflect the metastatic potential of the disease.

Patients And Methods: Eight-thousand four-hundred twenty-two patients randomly assigned to International Breast Cancer Study Group clinical trials between 1978 and 1999 were classified as medial site (1,622; 19%) or lateral, central, and other sites (6,800; 81%).

Factors associated with an increased chance of survival among patients suffering from an out-of-hospital cardiac arrest in a national perspective in Sweden.

Aim: To describe factors associated with an increased chance of survival among patients suffering from an out-of-hospital cardiac arrest in Sweden.

Patients And Methods: All patients suffering from an out-of-hospital cardiac arrest, which were not crew witnessed, in Sweden and in whom cardiopulmonary resuscitation (CPR) was attempted and who were registered in the Swedish Cardiac Arrest Registry. This registry covers about 85% of the Swedish population and has been running since 1990.

Changes in demographic factors and mortality after out-of-hospital cardiac arrest in Sweden.

Objective: To describe changes between 1992 and 2003 in age, sex, factors at resuscitation and survival among patients suffering from out-of-hospital cardiac arrest in Sweden.

Methods: This was a prospective observational study including various ambulance organizations in Sweden. Patients suffering from out-of-hospital cardiac arrest between 1992 and 2003 included in the Swedish Cardiac Arrest Registry were followed for survival to 1 month.

Decrease in the occurrence of ventricular fibrillation as the initially observed arrhythmia after out-of-hospital cardiac arrest during 11 years in Sweden.

Aim: To describe the change in the occurrence of ventricular fibrillation as initially observed arrhythmia among patients suffering from out-of-hospital cardiac arrest in Sweden.

Patients: All patients included in the Swedish cardiac arrest registry between 1991 until 2001. The registry covers 85% of the population in Sweden.