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1.
BMC Womens Health ; 21(1): 8, 2021 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-33407389

RESUMO

BACKGROUND: Generic preference-based measures (PBM), though commonly used, may not be optimal for use in economic evaluations of breast cancer interventions. No breast cancer-specific PBM currently exists, and the generic PBMs fail to capture the unique concerns of women with breast cancer (e.g., body image, appearance, treatment-specific adverse effects). Hence, the objective of this study was to develop a breast cancer-specific PBM, the BREAST-Q Utility module. METHODS: Women diagnosed with breast cancer (stage 0-4, any treatment) were recruited from two tertiary hospitals in Canada and one in the US. The study followed an exploratory sequential mixed methods approach, whereby semi-structured interviews were conducted and at the end of the interview, participants were asked to list their top five health-related quality of life (HRQOL) concerns and to rate the importance of each item on the BREAST-Q. Interviews were audio-recorded, transcribed verbatim, and coded. Constant comparison was used to refine the codes and develop a conceptual framework. Qualitative and quantitative data were triangulated to develop the content of the Utility module  that was refined through 2 rounds of cognitive debriefing interviews with women diagnosed with breast cancer and feedback from experts. RESULTS: Interviews were conducted with 57 women aged 55 ± 10 years. A conceptual framework was developed from 3948 unique codes specific to breasts, arms, abdomen, and cancer experience. Five top-level domains were HRQOL (i.e., physical, psychological, social, and sexual well-being) and appearance. Data from the interviews, top 5 HRQOL concerns, and BREAST-Q item ratings were used to inform dimensions for inclusion in the Utility module. Feedback from women with breast cancer (N = 9) and a multidisciplinary group of experts (N = 27) was used to refine the module. The field-test version of the HSCS consists of 10 unique dimensions. Each dimension is measured with 1 or 2 candidate items that have 4-5 response levels each. CONCLUSION: The field-test version of the BREAST-Q Utility module was derived from extensive patient and expert input. This comprehensive approach ensured that the content of the Utility module is relevant, comprehensive, and includes concerns that matter the most to women with breast cancer.

2.
BMJ Open Sport Exerc Med ; 6(1): e000922, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33178447

RESUMO

Introduction: The burden of breast cancer in Canada is steadily growing. More women are surviving breast cancer, yet, survivors live with side effects for years after treatments have ended. The benefits of exercise for women with breast cancer are well established and include improvement in treatment-related physical and emotional side effects. Despite these benefits, few survivors meet exercise guidelines. Exercise programmes are needed within the cancer institution in Canada to bridge the current knowledge to practice gap. The purpose of this study is to test the effects of a novel implementation strategy that includes institution-based exercise plus self-management (SM) or SM alone versus usual care in improving exercise level, quality of life, aerobic capacity, muscle strength and use of healthcare services over 12 months for women with breast cancer receiving chemotherapy. Methods and analysis: Participants: Women with stages I-III breast cancer undergoing chemotherapy. Intervention: Group 1: institution-based exercise and SM (8 exercise sessions plus 8 SM modules); Group 2: SM alone; Group 3: usual care. Outcomes: The primary effectiveness outcome is minutes per week of moderate to vigorous physical activity. Secondary outcomes include quality of life, aerobic capacity, muscle strength, and use of healthcare services. Randomisation: Participants will be randomised (1:1:1) to one of the three groups by a blinded statistician and will be stratified based on age of participant (<40, 40-60, and >60 years). Statistical analysis: Outcomes will be measured at baseline, post-intervention, 6-month and 12-month follow-up using an analysis of covariance to test changes between groups over time adjusted for age. Ethics and Dissemination: This study addresses a long-standing need to help women with breast cancer undergoing chemotherapy become and stay more active by implementing novel rehabilitation strategies into real-world practice. This is vital in order for this population to minimise the lingering side effects of treatment, improve function and quality of life and prevent cancer recurrence. Trial registration number: The study protocol (v1: July 2020) has been registered on ClinicalTrials.gov (NCT04109274).

3.
Gynecol Oncol ; 159(3): 820-826, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33010967

RESUMO

OBJECTIVE: BRCA mutation carriers face a high lifetime risk of developing ovarian cancer. The strong inverse association between breastfeeding and the risk of ovarian cancer is established in the general population but is less well studied among women with a germline BRCA1 or BRCA2 mutation. METHOD: Thus, we conducted a matched case-control analysis to evaluate the association between breastfeeding history and the risk of developing ovarian cancer. After matching for year of birth, country of residence, BRCA gene and personal history of breast cancer, a total of 1650 cases and 2702 controls were included in the analysis. Conditional logistic regression was used to estimate the odds ratio (OR) and 95% confidence intervals (CI) associated with various breastfeeding exposures. RESULTS: A history of ever-breastfeeding was associated with a 23% reduction in risk (OR = 0.77; 95%CI 0.66-0.90; P = 0.001). The protective effect increased with breastfeeding from one month to seven months after which the association was relatively stable. Compared to women who never breastfed, breastfeeding for seven or more months was associated with a 32% reduction in risk (OR = 0.68; 95%CI 0.57-0.81; P < 0.0001) and did not vary by BRCA gene or age at diagnosis. The combination of breastfeeding and oral contraceptive use was strongly protective (0.47; 95%CI 0.37-0.58; P < 0.0001). CONCLUSIONS: These findings support a protective effect of breastfeeding for at least seven months among women with a BRCA1 or BRCA2 mutation, that is independent of oral contraceptive use.

4.
Oncol Nurs Forum ; 47(4): E86-E106, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32555553

RESUMO

PROBLEM IDENTIFICATION: Hot flashes are common and bothersome in patients with breast and prostate cancer and can adversely affect patients' quality of life. LITERATURE SEARCH: Databases were searched for randomized controlled trials (RCTs) evaluating the effects of one or more interventions for hot flashes in patients with a history of breast or prostate cancer. DATA EVALUATION: Outcomes of interest included changes in hot flash severity, hot flash frequency, quality of life, and harms. Pairwise meta-analyses and network meta-analyses were performed where feasible, with narrative synthesis used where required. SYNTHESIS: 40 RCTs were included. Findings from network meta-analysis for hot flash frequency suggested that several therapies may offer benefits compared to no treatment, but little data suggested differences between active therapies. Findings from network meta-analysis for hot flash score were similar. IMPLICATIONS FOR RESEARCH: Although many interventions may offer improvements for hot flashes versus no treatment, minimal data suggest important differences between therapies. SUPPLEMENTARY MATERIALS CAN BE FOUND BY VISITING&NBSP;HTTPS: //bit.ly/2WGzi30.

5.
BMJ Open ; 10(1): e034451, 2020 01 07.
Artigo em Inglês | MEDLINE | ID: mdl-31915176

RESUMO

INTRODUCTION: Concerns unique to women with breast cancer can include impact of cancer on body image, sexual well-being and changes in breast appearance and sensation. These important issues are not captured by the existing generic preference-based measures (PBMs) and no breast cancer-specific PBM currently exists. This Phase 1 protocol describes a mixed-methods study to develop and validate the descriptive health state classification system for a breast cancer-specific PBM, called the BREAST-Q Utility module. METHODS AND ANALYSIS: A heterogeneous sample of women aged 18 years and older diagnosed with breast cancer who are undergoing or have had treatment for breast cancer will be invited to participate in qualitative interviews. Participants will be asked to describe impact of their diagnosis and treatment(s) on their health-related quality of life (HRQOL). Interviews will be audio recorded, transcribed verbatim and coded using a line-by-line approach. At the end of each interview, based on each participant's cancer treatment history, patients will complete the mastectomy, breast-conserving therapy or reconstruction module of BREAST-Q, with modified 5-point Likert scale to measure importance of the BREAST-Q concepts. Both sources of data will be analysed to identify the most important HRQOL concerns.A conceptual framework and item pool will be developed from the qualitative dataset. Preliminary version of the BREAST-Q Utility module will be created and refined at an in-person meeting of multidisciplinary experts. Content validity of the Utility module will be examined (cognitive debriefing, expert feedback). Psychometric properties of Utility module will be evaluated in a large sample of women with breast cancer. ETHICS AND DISSEMINATION: The study has been approved by Hamilton Integrated Research Ethics Board, Canada. Results of this study will be presented at international conferences and published in peer-reviewed journals.

7.
Br J Cancer ; 121(1): 15-21, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30971774

RESUMO

BACKGROUND: Women with a BRCA1 or BRCA2 mutation face high risks of breast and ovarian cancer. In the current study, we report on uptake of cancer screening and risk-reduction options in a cohort of BRCA mutation carriers from ten countries over two time periods (1995 to 2008 and 2009 to 2017). METHODS: Eligible subjects were identified from an international database of female BRCA mutation carriers and included women from 59 centres from ten countries. Subjects completed a questionnaire at the time of genetic testing, which included past use of cancer prevention options and screening tests. Biennial follow-up questionnaires were administered. RESULTS: Six-thousand two-hundred and twenty-three women were followed for a mean of 7.5 years. The mean age at last follow-up was 52.1 years (27-96 years) and 42.3% of the women had a prior diagnosis of breast cancer. In all, 27.8% had a prophylactic bilateral mastectomy and  64.7% had a BSO. Screening with breast MRI increased from 70% before 2009 to 81% at or after 2009. There were significant differences in uptake of all options by country. CONCLUSION: For women who received genetic testing more recently, uptake of prophylactic mastectomy and breast MRI is significantly higher than those who received genetic testing more than 10 years ago. However, uptake of both BSO and breast MRI is not optimal, and interventions to increase uptake are needed.


Assuntos
Neoplasias da Mama/prevenção & controle , Genes BRCA1 , Genes BRCA2 , Mutação , Comportamento de Redução do Risco , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/genética , Feminino , Humanos , Imagem por Ressonância Magnética , Mamografia , Mastectomia , Pessoa de Meia-Idade , Salpingo-Ooforectomia
9.
J Clin Oncol ; 36(32): 3259-3268, 2018 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-30212295

RESUMO

PURPOSE: To provide evidence-based consensus recommendations on choice of end points for clinical trials in metastatic breast cancer, with a focus on biologic subtype and line of therapy. METHODS: The National Cancer Institute Breast Cancer Steering Committee convened a working group of breast medical oncologists, patient advocates, biostatisticians, and liaisons from the Food and Drug Administration to conduct a detailed curated systematic review of the literature, including original reports, reviews, and meta-analyses, to determine the current landscape of therapeutic options, recent clinical trial data, and natural history of four biologic subtypes of breast cancer. Ongoing clinical trials for metastatic breast cancer in each subtype also were reviewed from ClinicalTrials.gov for planned primary end points. External input was obtained from the pharmaceutic/biotechnology industry, real-world clinical data specialists, experts in quality of life and patient-reported outcomes, and combined metrics for assessing magnitude of clinical benefit. RESULTS: The literature search yielded 146 publications to inform the recommendations from the working group. CONCLUSION: Recommendations for appropriate end points for metastatic breast cancer clinical trials focus on biologic subtype and line of therapy and the magnitude of absolute and relative gains that would represent meaningful clinical benefit.

11.
Br J Cancer ; 114(10): 1160-4, 2016 05 10.
Artigo em Inglês | MEDLINE | ID: mdl-26986251

RESUMO

BACKGROUND: Germline mutations in BRCA1 and BRCA2 increase the susceptibility to develop breast and ovarian cancers as well as increase the risk of some other cancers. Primary objective was to estimate the risk of leukaemia in BRCA1 and BRCA2 mutation carriers. METHODS: We followed 7243 women with a BRCA1 or a BRCA2 mutation for incident cases of leukaemia. We used the standardised incidence ratio (SIR) to estimate the relative risk of leukaemia, according to mutation and history of breast cancer. RESULTS: We identified five incident cases of leukaemia (two BRCA1, three BRCA2). All five women had a prior history of breast cancer and four had received chemotherapy. The mean time from breast cancer diagnosis to the development of leukaemia was 10.2 years (range 3-18 years). The SIR for BRCA1 carriers was 0.66 (95% CI: 0.11-2.19, P=0.61) and the SIR for BRCA2 carriers was 2.42 (95% CI: 0.61-6.58, P=0.17). The SIR was significantly higher than expected for women with a BRCA2 mutation and breast cancer (SIR=4.76, 95% CI:1.21-12.96, P=0.03), in particular for women who received chemotherapy (SIR=8.11, 2.06-22.07, P=0.007). CONCLUSIONS: We observed an increased risk of leukaemia in women with a BRCA2 mutation who receive chemotherapy for breast cancer.


Assuntos
Proteína BRCA1/genética , Proteína BRCA2/genética , Neoplasias da Mama/complicações , Leucemia/epidemiologia , Leucemia/genética , Mutação , Adulto , Idoso , Neoplasias da Mama/tratamento farmacológico , Feminino , Predisposição Genética para Doença , Humanos , Incidência , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco
12.
J Clin Oncol ; 34(10): 1065-71, 2016 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-26598746

RESUMO

PURPOSE: To evaluate the 21-gene recurrence score (RS) on decision-making in a population-based cohort. PATIENTS AND METHODS: Patients with axillary node-negative or nodal micrometastases, estrogen receptor-positive, and human epidermal growth factor receptor 2-negative breast cancer being considered for chemotherapy were eligible. All cancer treatment centers in Ontario, Canada, participated. Oncologists made a preliminary recommendation for endocrine therapy with or without chemotherapy on the basis of Adjuvant! Online (AOL) risk estimation. Patients were asked for their preference regarding chemotherapy. After RSs were available, patients returned for final decision-making. Patient satisfaction was measured by using the decisional conflict scale. RESULTS: Between January 2012 and July 2013, 1,000 patients were recruited. RSs were available for 979 patients. In 58% of patients, risk was categorized as low (RS, 0 to 18); in 33%, intermediate (RS, 19 to 30); and in 9%, high (RS, ≥ 31). Oncologists' recommendations pretest and post-test remained the same in 464 patients (48%), changed from unsure or chemotherapy to no chemotherapy in 365 (38%), and changed from unsure or no chemotherapy to chemotherapy in 143 (15%). After the test, oncologists recommended chemotherapy for 236 patients, 81% of whom received chemotherapy. Of 151 patients in whom risk was classified as intermediate by means of AOL, 41% were a low risk and 44% intermediate risk with RS. Of 298 patients at high risk with AOL, 16% had a high risk RS. None of 236 patients with grade I tumors had a high-risk RS. Mean total decisional conflict scale score significantly improved from pretest to post-test from 34 to 19 (P < .001). CONCLUSION: The RS substantially influenced both oncologists' recommendations and patients' preferences for chemotherapy. The major effect was avoidance of chemotherapy when AOL indicated high or intermediate risk.


Assuntos
Biomarcadores Tumorais/análise , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Tomada de Decisão Clínica , Tomada de Decisões , Perfilação da Expressão Gênica , Recidiva Local de Neoplasia/prevenção & controle , Adulto , Idoso , Antineoplásicos Hormonais/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Axila , Neoplasias da Mama/química , Neoplasias da Mama/genética , Neoplasias da Mama/prevenção & controle , Neoplasias da Mama/cirurgia , Neoplasias da Mama Masculina/tratamento farmacológico , Neoplasias da Mama Masculina/patologia , Tomada de Decisão Clínica/métodos , Feminino , Genótipo , Humanos , Linfonodos/patologia , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Micrometástase de Neoplasia , Estadiamento de Neoplasias , Ontário , Satisfação do Paciente , Valor Preditivo dos Testes , Estudos Prospectivos , Receptor ErbB-2/análise , Receptores Estrogênicos/análise , Medição de Risco , Fatores de Risco , Incerteza
13.
Syst Rev ; 4: 114, 2015 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-26307105

RESUMO

BACKGROUND: Breast and prostate cancers are the most commonly diagnosed non-dermatologic malignancies in Canada. Agents including endocrine therapies (e.g., aromatase inhibitors, gonadotrophin-releasing hormone analogs, anti-androgens, tamoxifen) and chemotherapy have improved survival for both conditions. As endocrine manipulation is a mainstay of treatment, it is not surprising that hot flashes are a common and troublesome adverse effect. Hot flashes can cause chills, night sweats, anxiety, and insomnia, lessening patients' quality of life. These symptoms impact treatment adherence, worsening prognosis. While short-term estrogen replacement therapy is frequently used to manage hot flashes in healthy menopausal women, its use is contraindicated in breast cancer. Similarly, testosterone replacement therapy is contraindicated in prostate cancer. It is therefore not surprising that non-hormonal pharmacological treatments (anti-depressants, anti-epilectics, anti-hypertensives), physical/behavioral treatments (e.g., acupuncture, yoga/exercise, relaxation techniques, cognitive behavioral therapy), and natural health products (e.g., black cohosh, flax, vitamin E, ginseng) have been studied for control of hot flashes. There is a need to identify which interventions minimize the frequency and severity of hot flashes and their impact on quality of life. This systematic review and network meta-analysis of randomized studies will synthesize available evidence addressing this knowledge gap. METHODS/DESIGN: An electronic search of Medline, Embase, AMED, PsycINFO, and the Cochrane Register of Controlled Trials has been designed by an information specialist and peer reviewed by a second information specialist. Study selection and data collection will be performed by two reviewers independently. Risk of bias assessments will be completed using the Cochrane Risk of Bias Scale. Outcomes of interest will include validated measures of hot flash severity, hot flash frequency, quality of life, and harms. Bayesian network meta-analyses will be performed where judged appropriate based on review of clinical and methodologic features of included studies. DISCUSSION: Our review will include a broad range of interventions that patients with breast and prostate cancer have attempted to use to manage hot flashes. Our work will establish the extent of evidence underlying these interventions and will employ an inclusive approach to analysis to inform comparisons between them. Our findings will be shared with Cancer Care Ontario for consideration in the development of guidance related to supportive care in these patients. PROSPERO: CRD42015024286.


Assuntos
Neoplasias da Mama/complicações , Terapias Complementares , Fogachos/terapia , Neoplasias da Próstata/complicações , Projetos de Pesquisa , Feminino , Fogachos/tratamento farmacológico , Humanos , Masculino , Revisões Sistemáticas como Assunto
16.
Diabetes Care ; 37(5): 1360-6, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24574355

RESUMO

OBJECTIVE Epidemiologic studies linking insulin glargine and glucose-lowering therapies to cancers and n-3 fatty acids to cancer prevention have not been confirmed. We aimed to assess the effect of insulin glargine and n-3 fatty acids on incident cancers within the context of the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial. RESEARCH DESIGN AND METHODS The ORIGIN trial is an international, long-term, randomized two-by-two factorial study comparing insulin glargine with standard care and n-3 fatty acids with placebo (double blind) in people with dysglycemia at high risk for cardiovascular events. The primary outcome measure (cancer substudy) was the occurrence of any new or recurrent adjudicated cancer. Cancer mortality and cancer subtypes were also analyzed. RESULTS Among 12,537 people (mean age 63.5 years, SD 7.8; 4,388 females), 953 developed a cancer event during the median follow-up of 6.2 years. In the glargine and standard care groups, the incidence of cancers was 1.32 and 1.32 per 100 person-years, respectively (P = 0.97), and in the n-3 fatty acid and placebo groups, it was 1.28 and 1.36 per 100 person-years, respectively (P = 0.39). No difference in the effect of either intervention was noted within predefined subgroups (P for all interactions ≥0.17). Cancer-related mortality and cancer-specific outcomes also did not differ between groups. Postrandomization HbA1c levels, glucose-lowering therapies (including metformin), and BMI did not affect cancer outcomes. CONCLUSIONS Insulin glargine and n-3 fatty acids have a neutral association with overall and cancer-specific outcomes, including cancer-specific mortality. Exposure to glucose-lowering therapies, including metformin, and HbA1c level during the study did not alter cancer risk.


Assuntos
Antineoplásicos/administração & dosagem , Diabetes Mellitus Tipo 2/complicações , Ácidos Graxos Ômega-3/administração & dosagem , Hipoglicemiantes/administração & dosagem , Insulina de Ação Prolongada/administração & dosagem , Neoplasias/etiologia , Diabetes Mellitus Tipo 2/mortalidade , Diabetes Mellitus Tipo 2/prevenção & controle , Método Duplo-Cego , Feminino , Hemoglobina A Glicada/metabolismo , Humanos , Insulina Glargina , Metformina/administração & dosagem , Pessoa de Meia-Idade , Neoplasias/mortalidade , Neoplasias/prevenção & controle
17.
BMJ Open ; 3(3)2013 Mar 13.
Artigo em Inglês | MEDLINE | ID: mdl-23485718

RESUMO

OBJECTIVES: To develop a brief, reliable and valid instrument to screen psychosocial risk among those who are undergoing genetic testing for Adult-Onset Hereditary Disease (AOHD). DESIGN: A prospective two-phase cohort study. SETTING: 5 genetic testing centres for AOHD, such as cancer, Huntington's disease or haemochromatosis, in ambulatory clinics of tertiary hospitals across Canada. PARTICIPANTS: 141 individuals undergoing genetic testing were approached and consented to the instrument development phase of the study (Phase I). The Genetic Psychosocial Risk Instrument (GPRI) developed in Phase I was tested in Phase II for item refinement and validation. A separate cohort of 722 individuals consented to the study, 712 completed the baseline package and 463 completed all follow-up assessments. Most participants were female, at the mid-life stage. Individuals in advanced stages of the illness or with cognitive impairment or a language barrier were excluded. INTERVENTIONS: Phase I: GPRI items were generated from (1) a review of the literature, (2) input from genetic counsellors and (3) phase I participants. Phase II: further item refinement and validation were conducted with a second cohort of participants who completed the GPRI at baseline and were followed for psychological distress 1-month postgenetic testing results. PRIMARY AND SECONDARY OUTCOME MEASURES: GPRI, Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Brief Symptom Inventory (BSI) and Impact of Event Scale (IES). RESULTS: The final 20-item GPRI had a high reliability-Cronbach's α at 0.81. The construct validity was supported by high correlations between GPRI and BSI and IES. The predictive value was demonstrated by a receiver operating characteristic curve of 0.78 plotting GPRI against follow-up assessments using HAM-D and HAM-A. CONCLUSIONS: With a cut-off score of 50, GPRI identified 84% of participants who displayed distress postgenetic testing results, supporting its potential usefulness in a clinical setting.

18.
Breast Cancer (Auckl) ; 7: 1-6, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23440399

RESUMO

We report an extremely rare and complex case of a 44-year-old woman diagnosed with an early stage triple negative breast cancer in the setting of primary autoimmune neutropenia with a pre-existing severe neutropenia. This case-report demonstrates that adjuvant chemotherapy for breast cancer can be administered in a patient with severe neutropenia. The management is however complicated and requires careful monitoring of side-effects related to both chemotherapy and treatment of autoimmune neutropenia. The role of chemotherapy in the treatment of triple negative breast cancer, the approach to autoimmune neutropenia and potential interactions are reviewed. To our knowledge, this is the first case reporting on the use of chemotherapy in a patient with severe pre-existing primary autoimmune neutropenia.

19.
Lancet Oncol ; 13(3): 275-84, 2012 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-22318095

RESUMO

BACKGROUND: Exemestane can prevent breast cancer in postmenopausal women. Because of potential widespread use, we examined the safety of exemestane on bone health. METHODS: In this nested safety substudy of the MAP.3 trial (a randomised, placebo-controlled, double-blind trial of exemestane 25 mg a day for the primary prevention of breast cancer), we included postmenopausal women from five centres who were eligible to participate in MAP.3, not osteoporotic, not receiving drugs for bone-related disorders, with baseline lumbar spine, total hip, and femoral neck T-scores above -2·0. The primary endpoint was percent change from baseline to 2 years in total volumetric bone mineral density (BMD) at the distal radius by high-resolution peripheral quantitative CT. The primary analysis was per protocol using a non-inferiority margin. This analysis was done earlier than originally planned because of the impending announcement of MAP.3 results and subsequent unmasking of patients to treatment assignment. This study is registered with ClinicalTrials.gov, number NCT01144468, and has been extended to 5 years of unmasked follow-up. FINDINGS: 351 women (176 given exemestane, 175 given placebo; median age 61·3 years [IQR 59·2-64·9]) met our inclusion criteria and completed baseline assessment. At the time of clinical cutoff, 242 women had completed 2-year follow-up (124 given exemestane, 118 given placebo). From baseline to 2 years, the mean percent change in total volumetric BMD at the distal radius was -6·1% (95% CI -7·0 to -5·2) in the exemestane group and -1·8% (-2·4 to -1·2) in the placebo group (difference -4·3%, 95% CI -5·3 to -3·2; p<0·0001). The lower limit of the 95% CI was lower than our non-inferiority margin of negative 4% (one-sided test for non-inferiority p=0·70), meaning the hypothesis that exemestane was inferior could not be rejected. At the distal tibia, the mean percent change in total volumetric BMD from baseline to 2 years was -5·0% (95% CI -5·5 to -4·4) in the exemestane group and -1·3% (-1·7 to -1·0) in the placebo group (difference -3·7%, 95% CI -4·3 to -3·0; p<0·0001). The mean percent change in cortical thickness was -7·9% (SD 7·3) in the exemestane group and -1·1% (5·7) in the placebo group at the distal radius (difference -6·8%, 95% CI -8·5 to -5·0; p<0·0001) and -7·6% (SD 5·9) in the exemestane group and -0·7% (4·9) in the placebo group at the distal tibia (difference -6·9%, -8·4 to -5·5; p<0·0001). Decline in areal BMD, as measured by dual-energy x-ray absorptiometry, in the exemestane group compared with the placebo group occurred at the lumbar spine (-2·4% [95% CI -3·1 to -1·7] exemestane vs -0·5% [-1·1 to 0·2] placebo; difference -1·9%, 95% CI -2·9 to -1·0; p<0·0001), total hip (-1·8% [-2·3 to -1·2] exemestane vs -0·6% [-1·1 to -0·1] placebo; difference -1·2%, -1·9 to -0·4; p=0·004), and femoral neck (-2·4% [-3·2 to -1·7] exemestane vs -0·8% [-1·5 to 0·1] placebo; difference -1·6%, -2·7 to -0·6; p=0·002). INTERPRETATION: 2 years of treatment with exemestane worsens age-related bone loss in postmenopausal women despite calcium and vitamin D supplementation. Women considering exemestane for the primary prevention of breast cancer should weigh their individual risks and benefits. For women taking exemestane, regular bone monitoring plus adequate calcium and vitamin D supplementation are important. To assess the effect of our findings on fracture risk, long-term follow-up is needed. FUNDING: Canadian Breast Cancer Research Alliance (Canadian Institutes of Health Research/Canadian Cancer Society).


Assuntos
Androstadienos/efeitos adversos , Anticarcinógenos/efeitos adversos , Inibidores da Aromatase/efeitos adversos , Densidade Óssea/efeitos dos fármacos , Osso e Ossos/efeitos dos fármacos , Neoplasias da Mama/prevenção & controle , Osteoporose/induzido quimicamente , Pós-Menopausa , Prevenção Primária/métodos , Absorciometria de Fóton , Osso e Ossos/diagnóstico por imagem , Cálcio/administração & dosagem , Canadá , Distribuição de Qui-Quadrado , Suplementos Nutricionais , Método Duplo-Cego , Feminino , Colo do Fêmur/diagnóstico por imagem , Colo do Fêmur/efeitos dos fármacos , Articulação do Quadril/diagnóstico por imagem , Articulação do Quadril/efeitos dos fármacos , Humanos , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/efeitos dos fármacos , Pessoa de Meia-Idade , Osteoporose/diagnóstico por imagem , Seleção de Pacientes , Placebos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Estados Unidos , Vitamina D/administração & dosagem
20.
J Oncol Pharm Pract ; 18(2): 311-5, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22217649

RESUMO

A number of chemotherapy drugs are well known to cause various histopathologic patterns of lung injury. The incidence of chemotherapy-induced infiltrative pneumonitis is rare and the diagnosis is difficult due to the nonspecific clinical and radiological presentations. However, it can cause significant morbidity and mortality in cancer patients. There is no consensus on the treatment of this adverse event, but prompt diagnosis and intervention is important as fatal outcomes have been reported. We present five cases of chemotherapy-induced infiltrative pneumonitis in breast cancer patients involving docetaxel, paclitaxel, gemcitabine and cyclophosphamide.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Doenças Pulmonares Intersticiais/induzido quimicamente , Doenças Pulmonares Intersticiais/diagnóstico , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Neoplasias da Mama/patologia , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Desoxicitidina/análogos & derivados , Docetaxel , Feminino , Humanos , Doenças Pulmonares Intersticiais/patologia , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Taxoides/administração & dosagem , Taxoides/efeitos adversos
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