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Search Results: 1 - 10 of 7478 matches for " for the International Breast Cancer Study Group and BIG 1-98 Collaborative Group "
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Interpreting breast international group (BIG) 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer
Meredith M Regan, Karen N Price, Anita Giobbie-Hurder, Beat Thürlimann, Richard D Gelber, for the International Breast Cancer Study Group and BIG 1-98 Collaborative Group
Breast Cancer Research , 2011, DOI: 10.1186/bcr2837
Abstract: Clinicaltrials.gov ID: NCT00004205.Reports of large trials of breast cancer confirm the value of aromatase inhibitors as adjuvant systemic therapy for postmenopausal women with endocrine-responsive early breast cancer [1-9]. The inclusion of an aromatase inhibitor in the adjuvant treatment program for this population has been recommended by both the American Society of Clinical Oncology and St. Gallen guidelines [10,11]. Studies have shown that 5 years of adjuvant therapy with an aromatase inhibitor alone improved disease-free survival (DFS) and time to distant recurrence (TDR) in comparison with 5 years of tamoxifen in this population [1-3,12], and recently the Breast International Group (BIG) 1-98 trial showed improved overall survival (OS) with the aromatase inhibitor letrozole [13]. Other studies have shown that switching to an aromatase inhibitor after 2 years of tamoxifen improves outcome [4-8]. Results were confirmed in an overview analysis [9].The BIG 1-98 study is a double-blind, four-arm trial comparing 5 years of monotherapy with tamoxifen or with letrozole or with sequences of 2 years of one of these agents followed by 3 years of the other (Figure 1). Centers participated in one of two randomization options (two-arm or four-arm). Between 1998 and 2003, 8,010 patients were enrolled. The trial is designed to answer two questions concerning how best to use endocrine agents for the treatment of early breast cancer in postmenopausal women with hormone receptor-positive tumors, the first to compare letrozole monotherapy with tamoxifen monotherapy and the second to determine the benefit of letrozole in sequence with tamoxifen. Table 1 presents a summary of the study subpopulations contributing to various data analyses of efficacy questions. In BIG 1-98, the primary endpoint is DFS, defined as the time from random assignment to the earliest time of invasive recurrence in local, regional, or distant sites; a new invasive breast cancer in the contralateral breast;
Clinical trial update: International Breast Cancer Study Group
Karen N Price, Aron Goldhirsch, the International Breast Cancer Study Group
Breast Cancer Research , 2005, DOI: 10.1186/bcr1334
Abstract: The International Breast Cancer Study Group (IBCSG) opened its first generation of trials in 1978. The IBCSG includes both participating cooperative groups and individual institutions from all over the world. The groups are from Switzerland (Swiss Group for Clinical Cancer Research, 38 centers), Sweden (West Sweden Breast Cancer Study Group, 11 centers), Australia and New Zealand (Australian New Zealand Breast Cancer Trials Group, 56 centers), and Chile (GOCCHI, a Chilean cooperative group, 23 centers). Individual centers are located in Italy (14 centers), Slovenia, Hungary (2 centers), Spain, Romania, Austria, United Kingdom, Belgium (2 centers), Brazil, Peru, Hong Kong, India, South Africa (2 centers), and Canada.The IBCSG is conducting trials of tailored treatment approaches for these subpopulations: patients with endocrine non-responsive early breast cancer; older patients with endocrine non-responsive early breast cancer who are not candidates for standard chemotherapy regimens; and younger patients with endocrine responsive early breast cancer. Because each of these three populations is somewhat rare, treatment decisions tend to be based on the findings from the largest breast cancer population: middle-aged (median age 55) women with endocrine responsive breast cancer (i.e. estrogen receptor-positive and/or progesterone receptor-positive) who were included in trials of chemotherapy and of endocrine therapy across the board. Through subgroup analyses of these large heterogeneous trials we have identified distinct responsiveness features, and the current generation of IBCSG trials investigates treatments tailored to populations based on these features (Table 1). Examples of such trials are described below.The CM-Maintenance Trial (IBCSG 22-00) studies a tailored chemotherapy approach for patients with endocrine non-responsive tumors. The role of prolonged, low-dose chemotherapy after a standard adjuvant chemotherapy regimen to reduce the risk of relapse and impr
Birth Size and Breast Cancer Risk: Re-analysis of Individual Participant Data from 32 Studies
Isabel dos Santos Silva equal contributor ,Bianca De Stavola equal contributor,Valerie McCormack,Collaborative Group on Pre-Natal Risk Factors and Subsequent Risk of Breast Cancer
PLOS Medicine , 2008, DOI: 10.1371/journal.pmed.0050193
Abstract: Background Birth size, perhaps a proxy for prenatal environment, might be a correlate of subsequent breast cancer risk, but findings from epidemiological studies have been inconsistent. We re-analysed individual participant data from published and unpublished studies to obtain more precise estimates of the magnitude and shape of the birth size–breast cancer association. Methods and Findings Studies were identified through computer-assisted and manual searches, and personal communication with investigators. Individual participant data from 32 studies, comprising 22,058 breast cancer cases, were obtained. Random effect models were used, if appropriate, to combine study-specific estimates of effect. Birth weight was positively associated with breast cancer risk in studies based on birth records (pooled relative risk [RR] per one standard deviation [SD] [= 0.5 kg] increment in birth weight: 1.06; 95% confidence interval [CI] 1.02–1.09) and parental recall when the participants were children (1.02; 95% CI 0.99–1.05), but not in those based on adult self-reports, or maternal recall during the woman's adulthood (0.98; 95% CI 0.95–1.01) (p for heterogeneity between data sources = 0.003). Relative to women who weighed 3.000–3.499 kg, the risk was 0.96 (CI 0.80–1.16) in those who weighed < 2.500 kg, and 1.12 (95% CI 1.00–1.25) in those who weighed ≥ 4.000 kg (p for linear trend = 0.001) in birth record data. Birth length and head circumference from birth records were also positively associated with breast cancer risk (pooled RR per one SD increment: 1.06 [95% CI 1.03–1.10] and 1.09 [95% CI 1.03–1.15], respectively). Simultaneous adjustment for these three birth size variables showed that length was the strongest independent predictor of risk. The birth size effects did not appear to be confounded or mediated by established breast cancer risk factors and were not modified by age or menopausal status. The cumulative incidence of breast cancer per 100 women by age 80 y in the study populations was estimated to be 10.0, 10.0, 10.4, and 11.5 in those who were, respectively, in the bottom, second, third, and top fourths of the birth length distribution. Conclusions This pooled analysis of individual participant data is consistent with birth size, and in particular birth length, being an independent correlate of breast cancer risk in adulthood.
The influence of genetic variation in 30 selected genes on the clinical characteristics of early onset breast cancer
William Tapper, Victoria Hammond, Sue Gerty, Sarah Ennis, Peter Simmonds, Andrew Collins, the Prospective study of Outcomes in Sporadic versus Hereditary breast cancer (POSH) Steering Group, Diana Eccles
Breast Cancer Research , 2008, DOI: 10.1186/bcr2213
Abstract: We selected 1,001 women with early onset nonfamilial invasive breast cancer from the Prospective study of Outcomes in Sporadic versus Hereditary breast cancer (POSH) cohort and genotyped 206 single nucleotide polymorphisms (SNPs) across 30 candidate genes. After quality control, 899 cases and 133 SNPs remained. Survival analyses were used to identify SNPs associated with prognosis and determine their interdependency with recognized prognostic factors. To identify SNPs that alter breast cancer risk, association tests were used to compare cases with controls from the Wellcome Trust Case Control Consortium. To search for SNPs affecting tumour biology, cases were stratified into subgroups according to oestrogen receptor (ER) status and grade and tested for association.We confirmed previous associations between increased breast cancer risk and SNPs in CASP8, TOX3 (previously known as TNRC9) and ESR1. Analysis of prognosis identified eight SNPs in six genes (MAP3K1, DAPK1, LSP1, MMP7, TOX3 and ESR1) and one region without genes on 8q24 that are associated with survival. For MMP7, TOX3 and MAP3K1 the effects on survival are independent of the main recognized clinical prognostic factors. The SNP in 8q24 is more weakly associated with independent effects on survival. Once grade and pathological nodal status (pN stage) were taken into account, SNPs in ESR1 and LSP1 showed no independent survival difference, whereas the effects of the DAPK1 SNP were removed when correcting for ER status. Interestingly, effects on survival for SNPs in ESR1 were most significant when only ER-positive tumours were examined. Stratifying POSH cases by tumour characteristics identified SNPs in FGFR2 and TOX3 associated with ER-positive disease and SNPs in ATM associated with ER-negative disease.We have demonstrated that several SNPs are associated with survival. In some cases this appears to be due to an effect on tumour characteristics known to have a bearing on prognosis; in other cases the effect
Hormone Replacement Therapy after Prophylactic Adnexectomy
Pascale This, Rémy J Salmon, Sylvie Dolbeault, Anne de la Rochefordière, Brigitte Sigal-Zafrani, Dominique Stoppa-Lyonnet, the Institut Curie Breast and Ovarian Cancer Risk Study Group
Hereditary Cancer in Clinical Practice , 2005, DOI: 10.1186/1897-4287-3-4-181
Abstract: At the Curie Institute, we take into account the preferences of women after they have been thoroughly informed:1. We recommend PA to women at 40 years of age if they have a BRCA1 mutation, or a BRCA2 mutation and a family history of ovarian cancer, and at 50 years of age if they have a BRCA2 mutation without a family history of ovarian cancer.2. In women unaffected by breast cancer, we give very complete information on the benefits and risks of HRT and alternatives, such as symptomatic treatments for hot flushes, vaginal oestrogens, and non-hormonal treatment for osteoporosis.3. We always propose psychological support to allow each woman to estimate and anticipate the consequences of PA.4. In case of uterine diseases such as fibroma, surgeons may propose a hysterectomy as well as PA, in which case oestrogens can be prescribed alone and progestins can be avoided (4).5. After PA, a gynaecological consultation is offered: HRT is given only to thoroughly informed women who really want it and have accepted PA with the assurance that they would have HRT afterwards. HRT is also offered to women who have had a prophylactic bilateral mastectomy. For other cases, clinical follow-up is proposed, and osteodensitometry is prescribed. If menopausal problems occur, alternative treatments are proposed first. For persistent problems, HRT is prescribed at the lowest dose for as long as the woman wishes. It is strongly recommended that treatment be stopped at the natural age of menopause, around 50 years of age.We think that over-alarmist information on menopause and strongly held beliefs against HRT lead some young women to refuse or delay an intervention that may save their life. Therefore, we advocate clear information, honest dialogue, and shared decision making with each woman.
Exploring cancer register data to find risk factors for recurrence of breast cancer – application of Canonical Correlation Analysis
Amir R Razavi, Hans Gill, Olle St?l, Marie Sundquist, Sten Thorstenson, Hans ?hlfeldt, Nosrat Shahsavar, the South-East Swedish Breast Cancer Study Group
BMC Medical Informatics and Decision Making , 2005, DOI: 10.1186/1472-6947-5-29
Abstract: One essential outcome after breast cancer treatment is recurrence of the disease. It is important to understand the relationship between different predictors and recurrence, including the time interval until recurrence. This study describes the application of CCA to find important predictors for two different outcomes for breast cancer patients, loco-regional recurrence and occurrence of distant metastasis and to decrease the number of variables in the sets of predictors and outcomes without decreasing the predictive strength of the model.Data for 637 malignant breast cancer patients admitted in the south-east region of Sweden were analyzed. By using CCA and looking at the structure coefficients (loadings), relationships between tumor specifications and the two outcomes during different time intervals were analyzed and a correlation model was built.The analysis successfully detected known predictors for breast cancer recurrence during the first two years and distant metastasis 2–4 years after diagnosis. Nottingham Histologic Grading (NHG) was the most important predictor, while age of the patient at the time of diagnosis was not an important predictor.In cancer registers with high dimensionality, CCA can be used for identifying the importance of risk factors for breast cancer recurrence. This technique can result in a model ready for further processing by data mining methods through reducing the number of variables to important ones.Breast cancer is the most common type of cancer diagnosed in women in Western countries. Sweden has had a high incidence of breast cancer for several decades, although mortality rates have been lower than in most other Western countries [1].Breast cancer prognosis is influenced by many factors such as morphological and pathological tumor specifications and biological tumor markers. Studying these predictors and finding those of most importance can give clinicians better insight regarding the prognosis.As a rule, data on cancer patients h
PRACTICE POINTS: Breast cancer guidelines for Uganda
The Uganda Breast Cancer Working Group
African Health Sciences , 2003,
Abstract: INTRODUCTION Breast cancer in Uganda is the third commonest cancer in women coming only next to cancer of the cervix and Kaposi's sarcoma. The incidence of breast cancer in Uganda has doubled from 11:100,000 in 1961 to 22:100,000 in 1995. Unfortunately the cases are often seen in late stages thus the outcome of treatment is inevitably unsatisfactory. The present day knowledge of this disease does not have any effective primary prevention. It is thus imperative that efforts should be made to detect the disease in its early stages. Mammography has been found to be useful but it is not applicable as a means of mass screening in Uganda (there are only 2 mammography units in Uganda. Public education towards Breast Self Examination (BSE) should be propagated because it is practical and affordable. African Health Sciences 2003 3(1); 47-52
The INIS Study. International Neonatal Immunotherapy Study: non-specific intravenous immunoglobulin therapy for suspected or proven neonatal sepsis: an international, placebo controlled, multicentre randomised trial
The INIS Study Collaborative Group
BMC Pregnancy and Childbirth , 2008, DOI: 10.1186/1471-2393-8-52
Abstract: This study will assess reliably whether treatment of neonatal sepsis with intravenous immunoglobulin reduces mortality and adverse neuro-developmental outcome.A randomised, placebo controlled, double blind trial. Babies with suspected or proven neonatal sepsis will be randomised to receive intravenous immunoglobulin therapy or placebo.Eligibility criteriaBabies must be receiving antibiotics and have proven or suspected serious infection AND have at least one of the following: birthweight less than 1500 g OR evidence of infection in blood culture, cerebrospinal fluid or usually sterile body fluid OR be receiving respiratory support via an endotracheal tube AND there is substantial uncertainty that intravenous immunoglobulin is indicated.Exclusion criteriaBabies are excluded if intravenous immunoglobulin has already been given OR intravenous immunoglobulin is thought to be needed OR contra-indicated.Trial treatmentBabies will be given either 10 ml/kg of intravenous immunoglobulin or identical placebo solution over 4–6 hours, repeated 48 hours later.Primary outcomeMortality or major disability at two years, corrected for gestational age.Data collectionData will be collected at discharge from hospital and at 2 years of age (corrected for gestation) using a parental questionnaire and a health status questionnaire completed during a face-to-face follow-up appointment with the child's paediatrician.Current Controlled Trials ISCRTN94984750.This protocol is for a large, simple-in-design, double blind, placebo controlled, pragmatic, multicentre randomised trial.That, in infants receiving antibiotics for clinical sepsis, the addition of non-specific, polyclonal intravenous immunoglobulin IgG (IVIG) therapy reduces mortality and major morbidity compared with antibiotics alone.Neonatal sepsis is a major cause of mortality and morbidity and has been implicated in the causation of perinatal brain damage and cerebral palsy, both in term and preterm infants [1,2]. Although antibioti
The Million Women Study: design and characteristics of the study population
The Million Women Study Collaborative Group
Breast Cancer Research , 1999, DOI: 10.1186/bcr16
Abstract: Population-based cohort study of women aged 50-64 in the UK.Women are asked to join the Million Women Study when they are invited to routine screening for breast cancer at 61 of the screening centres of the UK National Health Service Breast Screening Programme (NHSBSP). An estimated 71% of women screened by the NHSBSP return a completed questionnaire.800 000 women were recruited between May 1996 and June 1999, and it is planned that an additional 200 000 will be recruited by the year 2000.The characteristics of the first 121 000 women recruited into the Million Women Study are described here. At recruitment 33% of the study population were currently using hormone replacement therapy and 47% had used it at some time. Over half (54%) had used oral contraceptives, and 18% were current smokers at the time of recruitment. Before they were screened 1.4% of the women had been diagnosed with breast cancer in the past, 6% had a mother with a history of breast cancer and 3.7% had a sister with a history of breast cancer. It is estimated that 1 million women will have been recruited by early in the year 2000, and that by the end of the year 2002 there will be 5000 screen-detected breast cancers and 23 000 deaths in the cohort, the majority of which will be attributed to cancer (12 600 deaths) and circulatory disease (8000 deaths).By the end of the year 2002, the Million Women Study will have sufficient statistical power to detect relative risks of 0.8 or less, or of 1.2 or more in current users compared with never users of hormone replacement therapy for mortality from breast cancer, colorectal cancer, lung and ovarian cancer, ischaemic heart disease and stroke.The Million Women Study is a nationwide collaborative research project in the UK, the chief aim of which is to describe the relationship between use of hormone replacement therapy (HRT) and the risk of various conditions, particularly breast cancer. The study began in May 1996 and the plan is to recruit and follow-up a
The effects of cholesterol lowering with simvastatin on cause-specific mortality and on cancer incidence in 20,536 high-risk people: a randomised placebo-controlled trial [ISRCTN48489393]
Heart Protection Study Collaborative Group
BMC Medicine , 2005, DOI: 10.1186/1741-7015-3-6
Abstract: 20,536 UK adults (aged 40–80 years) with vascular disease or diabetes were randomly allocated to receive 40 mg simvastatin daily or matching placebo. Prespecified safety analyses were of cause-specific mortality, and of total and site-specific cancer incidence. Comparisons between all simvastatin-allocated versus all placebo-allocated participants (ie, "intention-to-treat") involved an average difference in blood total cholesterol concentration of 1.2 mmol/L (46 mg/dL) during the scheduled 5-year treatment period.There was a highly significant 17% (95% CI 9–25) proportional reduction in vascular deaths, along with a non-significant reduction in all non-vascular deaths, which translated into a significant reduction in all-cause mortality (p = 0.0003). The proportional reduction in the vascular mortality rate was about one-sixth in each subcategory of participant studied, including: men and women; under and over 70 years at entry; and total cholesterol below 5.0 mmol/L or LDL cholesterol below 3.0 mmol/L. No significant excess of non-vascular mortality was observed in any subcategory of participant (including the elderly and those with pretreatment total cholesterol below 5.0 mmol/L), and there was no significant excess in any particular cause of non-vascular mortality.Cancer incidence rates were similar in the two groups, both overall and in particular subcategories of participant, as well as at particular primary sites. There was no suggestion that any adverse trends in non-vascular mortality or morbidity were beginning to emerge with more prolonged treatment.These findings, which are based on large numbers of deaths and non-fatal cancers, provide considerable reassurance that lowering total cholesterol concentrations by more than 1 mmol/L for an average of 5 years does not produce adverse effects on non-vascular mortality or cancer incidence. Moreover, among the many different types of high-risk individual studied, simvastatin 40 mg daily consistently produced subs
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