RESUMEN
PURPOSE: As more biosimilars become available in the United States, postapproval noninterventional studies describing biosimilar switching and comparing effectiveness and/or safety between switchers and nonswitchers will play a key role in generating real-world evidence to inform clinical practices and policy decisions. Ensuring sound methodology is critical for making valid inferences from these studies. METHODS: The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) convened a workgroup consisting of academic researchers, industry scientists, and practicing clinicians to establish best practice recommendations for the conduct of noninterventional studies of biosimilar and reference biologic switching. The workgroup members participated in eight teleconferences between August 2017 and February 2018 to discuss specific topics and build consensus. RESULTS: This report provides workgroup recommendations covering five main considerations relating to noninterventional studies describing reference biologic to biosimilar switching and comparing reference biologic to biosimilars for safety and effectiveness in the presence of switching at treatment initiation and during follow-up: (a) selecting appropriate data sources from a range of available options including insurance claims, electronic health records, and registries; (b) study designs; (c) outcomes of interest including health care utilization and clinical endpoints; (d) analytic approaches including propensity scores, disease risk scores, and instrumental variables; and (e) special considerations including avoiding designs that ignore history of biologic use, avoiding immortal time bias, exposure misclassification, and accounting for postindex switching. CONCLUSION: Recommendations provided in this report provide a framework that may be helpful in designing and critically evaluating postapproval noninterventional studies involving reference biologic to biosimilar switching.
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Biosimilares Farmacéuticos , Guías como Asunto , Proyectos de Investigación , HumanosRESUMEN
BACKGROUND: The Personal Patient Profile-Prostate (P3P), a web-based decision aid, was demonstrated to reduce decisional conflict in English-speaking men with localized prostate cancer early after initial diagnosis. The purpose of this study was to explore and enhance usability and cultural appropriateness of a Spanish P3P by Latino men with a diagnosis of prostate cancer. METHODS: P3P was translated to Spanish and back-translated by three native Spanish-speaking translators working independently. Spanish-speaking Latino men with a diagnosis of localized prostate cancer, who had made treatment decisions in the past 24 months, were recruited from two urban clinical care sites. Individual cognitive interviews were conducted by two bilingual research assistants as each participant used the Spanish P3P. Notes of user behavior, feedback, and answers to direct questions about comprehension, usability and perceived usefulness were analyzed and categorized. RESULTS: Seven participants with a range of education levels identified 25 unique usability issues in navigation, content comprehension and completeness, sociocultural appropriateness, and methodology. Revisions were prioritized to refine the usability and cultural and linguistic appropriateness of the decision aid. CONCLUSIONS: Usability issues were discovered that are potential barriers to effective decision support. Successful use of decision aids requires adaptation and testing beyond translation. Our findings led to revisions further refining the usability and linguistic and cultural appropriateness of Spanish P3P.
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Técnicas de Apoyo para la Decisión , Hispánicos o Latinos , Neoplasias de la Próstata/terapia , Telemedicina , Humanos , Masculino , TraducciónRESUMEN
Annual surveillance mammograms in older long-term breast cancer survivors are recommended, but this recommendation is based on little evidence and with no guidelines on when to stop. Surveillance mammograms should decrease breast cancer mortality by detecting second breast cancer events at an earlier stage. We examined the association between surveillance mammography beyond 5 years after diagnosis on breast cancer-specific mortality in a cohort of women aged ≥ 65 years diagnosed 1990-1994 with early stage breast cancer. Our cohort included women who survived disease free for ≥ 5 years (N = 1,235) and were followed from year 6 through death, disenrollment, or 15 years after diagnosis. Asymptomatic surveillance mammograms were ascertained through medical record review. We used Cox proportional hazards regression stratified by follow-up year to calculate the association between time-varying surveillance mammography and breast cancer-specific and other-than-breast mortality adjusting for site, stage, primary surgery type, age and time-varying Charlson Comorbidity Index. The majority (85 %) of the 1,235 5-year breast cancer survivors received ≥ 1 surveillance mammogram in years 5-9 (yearly proportions ranged from 48 to 58 %); 82 % of women received ≥ 1 surveillance mammogram in years 10-14. A total of 120 women died of breast cancer and 393 women died from other causes (average follow-up 7.3 years). Multivariable models and lasagna plots suggested a modest reduction in breast cancer-specific mortality with surveillance mammogram receipt in the preceding year (IRR 0.82, 95 % CI 0.56-1.19, p = 0.29); the association with other-cause mortality was 0.95 (95 % CI 0.78-1.17, p = 0.64). Among older breast cancer survivors, surveillance mammography may reduce breast cancer-specific mortality even after 5 years of disease-free survival. Continuing surveillance mammography in older breast cancer survivors likely requires physician-patient discussions similar to those recommended for screening, taking into account comorbid conditions and life-expectancy.
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Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/mortalidad , Mamografía , Sobrevivientes , Factores de Edad , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Invasividad Neoplásica , Estadificación de Neoplasias , Vigilancia de la Población , Estudios Prospectivos , Factores de RiesgoRESUMEN
OBJECTIVES: To examine the effect of breast cancer and its treatment on fracture risk in older breast cancer survivors. DESIGN: A 10-year prospective cohort study beginning 5 years after a diagnosis of breast cancer for survivors and match date for comparison women. SETTING: Six integrated healthcare systems. PARTICIPANTS: Women aged 65 and older (1,286 survivors, 1,286 comparison women, mean age 77.7 in both groups, white, non-Hispanic: survivors, 81.6%; comparison women, 85.2%) who were alive and recurrence free 5 years after a diagnosis of early-stage breast cancer and matched on age, study site, and enrollment year to a comparison cohort without breast cancer. MEASUREMENTS: Cox proportional hazards models were used to estimate the association between fracture risk and survivor-comparison status, adjusting for drugs and risk factors associated with bone health. A subanalysis was used to evaluate the association between tamoxifen exposure and fracture risk. RESULTS: No difference was observed in fracture rates between groups (hazard ratio (HR) = 1.1, 95% confidence interval (CI) = 0.9-1.3). The protective effect of tamoxifen was not statistically significant (HR = 0.9, 95% CI = 0.6-1.2). CONCLUSION: Long-term survivors of early-stage breast cancer diagnosed at age 65 and older are not at greater risk of osteoporotic fractures than age-matched women without breast cancer. There appears to be no long-term protection from fractures with tamoxifen use.
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Neoplasias de la Mama/complicaciones , Detección Precoz del Cáncer , Fracturas Óseas/epidemiología , Estadificación de Neoplasias , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Fracturas Óseas/etiología , Humanos , Incidencia , Recurrencia Local de Neoplasia/epidemiología , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Factores de Riesgo , Tasa de Supervivencia/tendencias , Sobrevivientes , Factores de Tiempo , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Clinical interpretation of health related quality of life (HRQOL) scores is challenging. The purpose of this analysis was to interpret score changes and identify minimal clinically important differences (MCID) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) before (T1) and during (T2) cancer treatment. METHODS: Patients (N = 627) in stem cell transplant (SCT) and medical (MED) or radiation (RAD) oncology at two comprehensive cancer centers, enrolled in the Electronic Self-Report Assessment-Cancer study and completed the QLQ-C30 at T1 and T2. Perceived changes in five QOL domains, physical (PF), emotional (EF), social (SF), cognitive functioning (CF) and global quality of life (QOL), were reported using the Subject Significance Questionnaire (SSQ) at T2. Anchored on SSQ ratings indicating "improvement", "the same", or "deterioration", means and effect sizes were calculated for QLQ-C30 score changes. MCID was calculated as the mean difference in QLQ-C30 score changes reflecting one category change on SSQ rating, using a two-piece linear regression model. RESULTS: A majority of SCT patients (54%) perceived deteriorating global HRQOL versus improvement (17%), while approximately equal proportions of MED/RAD patients perceived improvement (25%) and deterioration (26%). Global QOL decreased 14.2 (SCT) and 2.0 (MED/RAD) units, respectively, among patients reporting "the same" in the SSQ. The MCID ranged 5.7-11.4 (SCT) and 7.2-11.8 (MED/RAD) units among patients reporting deteriorated HRQOL; ranged 2.7-3.4 units among MED/RAD patients reporting improvement. Excepting for the global QOL (MCID =6.9), no meaningful MCID was identified among SCT patients reporting improvement. CONCLUSIONS: Cancer treatment has greater impact on HRQOL among SCT patients than MED/RAD patients. The MCID for QLQ-C30 score change differed across domains, and differed for perceived improvement and deterioration, suggesting different standards for self-evaluating changes in HRQOL during cancer treatment. Specifically, clinical attention can be focused on patients who report at least a 6 point decrease, and for patients who report at least a 3 point increase on QLQ-C30 domains. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov: NCT00852852.
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Autoevaluación Diagnóstica , Neoplasias/psicología , Neoplasias/terapia , Calidad de Vida/psicología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Cognición , Emociones , Femenino , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Participación Social , Estadísticas no Paramétricas , Trasplante de Células Madre , Encuestas y Cuestionarios , Estados Unidos , Adulto JovenRESUMEN
BACKGROUND: Of the approximately 2.4 million American women with a history of breast cancer, 43% are aged ≥ 65 years and are at risk for developing subsequent malignancies. METHODS: Women from 6 geographically diverse sites included 5-year breast cancer survivors (N = 1361) who were diagnosed between 1990 and 1994 at age ≥ 65 years with stage I or II disease and a comparison group of women without breast cancer (N = 1361). Women in the comparison group were age-matched and site-matched to breast cancer survivors on the date of breast cancer diagnosis. Follow-up began 5 years after the index date (survivor diagnosis date or comparison enrollment date) until death, disenrollment, or through 15 years after the index date. Data were collected from medical records and electronic sources (cancer registry, administrative, clinical, National Death Index). Analyses included descriptive statistics, crude incidence rates, and Cox proportional hazards regression models for estimating the risk of incident malignancy and were adjusted for death as a competing risk. RESULTS: Survivors and women in the comparison group were similar: >82% were white, 55% had a Charlson Comorbidity Index of 0, and ≥ 73% had a body mass index ≤ 30 kg/m(2) . Of all 306 women (N = 160 in the survivor group, N = 146 in the comparison group) who developed a first incident malignancy during follow-up, the mean time to malignancy was similar (4.37 ± 2.81 years vs 4.03 ± 2.76 years, respectively; P = .28), whereas unadjusted incidence rates were slightly higher in survivors (1882 vs 1620 per 100,000 person years). The adjusted hazard of developing a first incident malignancy was slightly elevated in survivors in relation to women in the comparison group, but it was not statistically significant (hazard ratio, 1.17; 95% confidence interval, 0.94-1.47). CONCLUSIONS: Older women who survived 5 years after an early stage breast cancer diagnosis were not at an elevated risk for developing subsequent incident malignancies up to 15 years after their breast cancer diagnosis.
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Neoplasias de la Mama/epidemiología , Factores de Edad , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/patología , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Estudios Longitudinales , Factores de Riesgo , Sobrevivientes , Estados Unidos/epidemiologíaAsunto(s)
Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/prevención & control , Presentación de Datos , Interpretación Estadística de Datos , Estudios Longitudinales/métodos , Mamografía/estadística & datos numéricos , Anciano , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana EdadRESUMEN
BACKGROUND: Men diagnosed with localized prostate cancer (LPC) can choose from multiple treatment regimens and are faced with a decision in which medical factors and personal preferences are important. The Personal Patient Profile-Prostate (P3P) is a computerized decision aid for men with LPC that focuses on personal preferences. We determined whether the P3P intervention improved the concordance of treatment choice with self-reported influential side-effects compared with a control group. METHODS: English/Spanish-speaking men diagnosed with LPC (2007-2009) from four US cities were enrolled into a randomized trial and followed through 6-months via mailed or online questionnaire. Men were randomized to receive the P3P intervention or standard education plus links to reputable websites. We classified choice as concordant if men were concerned with (a) sexual function and chose external beam radiotherapy or brachytherapy, (b) bowel function and chose prostatectomy, (c) sex, bowel, and/or bladder function and chose active surveillance, or (d) not concerned with any side effect and chose any treatment. Using logistic regression, we calculated odds ratios (OR) and 95% confidence intervals (CI) for the association between the P3P intervention and concordance. RESULTS: Of 448 men, most were <65 years, non-Hispanic white, had multiple physician consultations prior to enrollment, and chose a treatment discordant with concerns about potential side effects. There was no significant difference in concordance between the intervention (45%) and control (50%) group (OR = 0.82; 95%CI = 0.56, 1.2). CONCLUSIONS: The P3P intervention did not improve concordance between potential side effects and treatment choice. Information and/or physician consultation immediately after diagnosis was likely to influence decisions despite concerns about side effects. The intervention may be more effective before the first treatment options consultation. TRIAL REGISTRATION: NCT00692653 http://clinicaltrials.gov/ct2/show/NCT00692653.
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Conducta de Elección , Sistemas de Apoyo a Decisiones Clínicas , Prioridad del Paciente/psicología , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/terapia , Grupos Control , Incontinencia Fecal/complicaciones , Conocimientos, Actitudes y Práctica en Salud , Humanos , Modelos Logísticos , Masculino , Prioridad del Paciente/estadística & datos numéricos , Neoplasias de la Próstata/complicaciones , Calidad de Vida , Disfunciones Sexuales Fisiológicas/complicaciones , Factores Socioeconómicos , Encuestas y Cuestionarios , Estados Unidos , Incontinencia Urinaria de Esfuerzo/complicaciones , Interfaz Usuario-ComputadorRESUMEN
Previous studies have suggested that metabolic syndrome may be associated with an increased risk of breast cancer, particularly in postmenopausal women, but U.S. black women have not been assessed. We examined the associations of abdominal obesity, type 2 diabetes, hypertension, and high cholesterol individually and in combination with breast cancer incidence in the Black Women's Health Study. By means of Cox regression models, we estimated incidence rate ratios (IRR) and 95 % confidence intervals (CI) for the associations of baseline and time-dependent values of self-reported abdominal obesity, type 2 diabetes, hypertension, and high cholesterol with breast cancer incidence. During 516,452 person years of follow-up (mean years = 10.5; standard deviation = 2.9) from 1995 to 2007, 1,228 breast cancer cases were identified. After adjustment for age, education, body mass index at age 18, physical activity, and individual cardiometabolic factors, neither individual nor combinations of cardiometabolic factors were associated with breast cancer incidence overall; the multivariable IRR was 1.04 (95 % CI 0.86-1.25) for the combination of ≥3 factors relative to the absence of all factors, and 1.17 (0.85-1.60) for having all four factors. Among postmenopausal women, however, the comparable IRRs were 1.23 (0.93-1.62) and 1.63 (1.12-2.37), respectively. Our findings provide some support for an association between cardiometabolic factors and breast cancer incidence among postmenopausal U.S. black women.
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Negro o Afroamericano , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/etiología , Riesgo , Adulto , Anciano , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Estados Unidos/epidemiología , Adulto JovenRESUMEN
PURPOSE: To evaluate use of specific antiepileptic drugs (AEDs) in pregnancy in relation to specific birth defects. METHODS: Using data from the National Birth Defects Prevention Study, we assessed use of AEDs and the risk of neural tube defects (NTDs), oral clefts (OCs), heart defects (HDs), hypospadias, and other major birth defects, taking specific agent, timing, and indication into consideration. RESULTS: Drug-specific increased risks were observed for valproic acid in relation to NTDs [adjusted odds ratio (aOR), 9.7;, 95% confidence interval (CI), 3.4-27.5], OCs (aOR, 4.4; 95% CI, 1.6-12.2), HDs (aOR, 2.0; 95% CI, 0.78-5.3), and hypospadias (aOR. 2.4; 95% CI, 0.62-9.0), and for carbamazapine in relation to NTDs (aOR, 5.0; 95% CI, 1.9-12.7). Epilepsy history without AED use did not seem to increase risk. CONCLUSIONS: Valproic acid, which current guidelines suggest should be avoided in pregnancy, was most notable in terms of strength and breadth of its associations. Carbamazapine was associated with NTDs, even after controlling for folic acid use. Sample sizes were still too small to adequately assess risks of less commonly used AEDs, but our findings support further study to identify lower risk options for pregnant women.
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Anomalías Inducidas por Medicamentos/epidemiología , Anticonvulsivantes/efectos adversos , Epilepsia/tratamiento farmacológico , Complicaciones del Embarazo/tratamiento farmacológico , Anomalías Inducidas por Medicamentos/etiología , Adolescente , Adulto , Anticonvulsivantes/administración & dosificación , Carbamazepina/administración & dosificación , Carbamazepina/efectos adversos , Femenino , Humanos , Masculino , Embarazo , Estados Unidos/epidemiología , Ácido Valproico/administración & dosificación , Ácido Valproico/efectos adversos , Adulto JovenRESUMEN
BACKGROUND: The definitive local therapy options for early-stage breast cancer are mastectomy and breast-conserving surgery followed by radiation therapy. Older women and those with comorbidities frequently receive breast-conserving surgery alone. The interaction of age and comorbidity with breast cancer severity and their impact on receipt of definitive therapy have not been well-studied. STUDY DESIGN: In a cohort of 1,837 women aged 65 years and older receiving treatment for early-stage breast cancer in 6 integrated health care delivery systems in 1990-1994 and followed for 10 years, we examined predictors of receiving nondefinitive local therapy and assessed the impact on breast cancer recurrence within levels of severity, defined as level of risk for recurrence. RESULTS: Age and comorbidity were associated with receipt of nondefinitive therapy. Compared with those at low risk, women at the highest risk were less likely to receive nondefinitive therapy (odds ratio = 0.32; 95% CI, 0.22-0.47), and women at moderate risk were about half as likely (odds ratio = 0.54; 95% CI, 0.35-0.84). Nondefinitive local therapy was associated with higher rates of recurrence among women at moderate (hazard ratio = 5.1; 95% CI, 1.9-13.5) and low risk (hazard ratio = 3.2; 95% CI, 1.1-8.9). The association among women at high risk was weak (hazard ratio = 1.3; 95% CI, 0.75-2.1). CONCLUSIONS: Among these older women with early-stage breast cancer, decisions about therapy partially balanced breast cancer severity against age and comorbidity. However, even among women at low risk, omitting definitive local therapy was associated with increased recurrence.
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Neoplasias de la Mama/patología , Neoplasias de la Mama/terapia , Recurrencia Local de Neoplasia/patología , Factores de Edad , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/complicaciones , Estudios de Cohortes , Femenino , Humanos , Mastectomía , Estadificación de Neoplasias , Radioterapia Adyuvante , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Epidemiologic studies have yet to provide consistent evidence to support a protective effect of aspirin and other non-steroidal anti-inflammatory drugs (NSAID) on the incidence of breast cancer. OBJECTIVE: We evaluated the relations of current use of aspirin, non-aspirin NSAIDs, and acetaminophen with breast cancer incidence in the Black Women's Health Study. METHODS: Biennial follow-up of 59,000 study participants began in 1995. During 558,600 person-years of follow-up through 2007, 1,275 breast cancer cases were identified. Using Cox proportional hazards regression, we estimated incidence rate ratios (IRR) and 95% confidence intervals (CI) for associations of current and former use of aspirin, other NSAIDs, and acetaminophen with incident breast cancer. RESULTS: After adjustment for age, education, body mass index at age 18, physical activity, female hormone use, current smoking, and other NSAID use, the IRRs were 0.79 (95% CI = 0.66, 0.95) for current aspirin use and 0.68 (95% CI = 0.50, 0.92) for ≥5 years of aspirin use. Similar associations were observed for acetaminophen use. CONCLUSIONS: Both aspirin and acetaminophen use were inversely associated with breast cancer incidence in the present study. Reasons for the association with acetaminophen use are unclear, given that acetaminophen has very weak anti-inflammatory effects.
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Antiinflamatorios no Esteroideos/administración & dosificación , Aspirina/administración & dosificación , Negro o Afroamericano , Neoplasias de la Mama/etnología , Neoplasias de la Mama/epidemiología , Acetaminofén/administración & dosificación , Adulto , Estudios de Cohortes , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Factores de Riesgo , Estados Unidos/epidemiologíaRESUMEN
Maternal diet and nutrition have been thought to play a role in many childhood conditions. Studies using food frequency questionnaires (FFQ) have reported associations with maternal diet, but these findings are difficult to interpret because the reliability and validity of the FFQs for diet during a past pregnancy are not known. We determined the reproducibility of reported diet and supplement use during a past pregnancy in a subset of mothers interviewed for a case-control study of maternal diet in relation to the risk of childhood brain tumours. Cases were Children's Oncology Group patients, diagnosed at age <6 with medulloblastoma or primitive neuroectodermal tumour from 1991 to 1997. Area code, race/ethnicity, and birth date matched controls were selected by random-digit-dialling. Case and control mothers completed a modified Willett FFQ a mean of 5 years after the index child's birth. A mean of 3.6 months later, a subset of mothers consisting of 52 case and 51 control mothers repeated the interview; these comprise the reproducibility study population. The mean intra-class correlation was 0.59 (range 0.41, 0.69) for energy-adjusted nutrients from dietary sources only; it was 0.41 (range 0.06, 0.70) when supplements were included. Agreement for reporting multivitamin use during pregnancy by time period and pattern was good to very good (kappa = 0.66-0.85). Overall, the reproducibility of nutrient estimates and supplement use in pregnancy was good and similar to that reported for adult diet.
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Encuestas sobre Dietas , Dieta , Suplementos Dietéticos , Encuestas y Cuestionarios/normas , Adolescente , Adulto , Estudios de Casos y Controles , Femenino , Humanos , Embarazo , Reproducibilidad de los Resultados , Adulto JovenRESUMEN
OBJECTIVE: To evaluate the effectiveness of methods that control for confounding by indication, we compared breast cancer recurrence rates among women receiving adjuvant chemotherapy with those who did not. STUDY DESIGN AND SETTING: In a medical record review-based study of breast cancer treatment in older women (n=1798) diagnosed between 1990 and 1994, our crude analysis suggested that adjuvant chemotherapy was positively associated with recurrence (hazard ratio [HR]=2.6; 95% confidence interval [CI]=1.9, 3.5). We expected a protective effect, so postulated that the crude association was confounded by indications for chemotherapy. We attempted to adjust for this confounding by restriction, multivariable regression, propensity scores (PSs), and instrumental variable (IV) methods. RESULTS: After restricting to women at high risk for recurrence (n=946), chemotherapy was not associated with recurrence (HR=1.1; 95% CI=0.7, 1.6) using multivariable regression. PS adjustment yielded similar results (HR=1.3; 95% CI=0.8, 2.0). The IV-like method yielded a protective estimate (HR=0.9; 95% CI=0.2, 4.3); however, imbalances of measured factors across levels of the IV suggested residual confounding. CONCLUSION: Conventional methods do not control for unmeasured factors, which often remain important when addressing confounding by indication. PS and IV analysis methods can be useful under specific situations, but neither method adequately controlled confounding by indication in this study.
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Sesgo , Factores de Confusión Epidemiológicos , Anciano , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Quimioterapia Adyuvante/efectos adversos , Interpretación Estadística de Datos , Femenino , Humanos , Puntaje de Propensión , Recurrencia , Resultado del TratamientoRESUMEN
Little is known about the risk of recurrence >5 years after diagnosis among older breast cancer survivors. A community-based population of women >or=65 years diagnosed with early-stage breast cancer who survived disease free for 5 years was followed for 5 additional years or until a diagnosis of breast cancer recurrence, second primary, death, or loss to follow-up. These 5-year disease-free survivors (N = 1,277) had primary breast cancers that were node negative (77%) and estrogen receptor positive or unknown (86%). Five percent (n = 61) developed a recurrence between 5 and 10 years after diagnosis: 25% local, 9.8% regional, and 66% distant. Women who were node positive [hazard ratio (HR), 3.9; 95% confidence interval (95% CI), 1.5-10], had poorly differentiated tumors (HR, 2.5; 95% CI, 0.9-6.6), or who received breast conserving surgery without radiation therapy (HR, 2.4; 95% CI, 1.0-5.8) had higher recurrence rates compared with node negative, well differentiated, and receipt of mastectomy, respectively. Not receiving adjuvant tamoxifen, compared with receiving adjuvant tamoxifen, was also positively associated with late recurrence among women with estrogen receptor-positive/unknown tumors. Although relatively few women experience a late recurrence, most recurrences present as advanced disease, which is difficult to treat in older women. This study of late recurrence emphasizes that the risk, although small, is not negligible even in this group at high risk of death due to competing causes.
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Neoplasias de la Mama/diagnóstico , Recurrencia Local de Neoplasia/diagnóstico , Anciano , Antineoplásicos Hormonales/uso terapéutico , Neoplasias de la Mama/terapia , Terapia Combinada , Femenino , Humanos , Metástasis Linfática , Mastectomía , Recurrencia Local de Neoplasia/terapia , Estadificación de Neoplasias , Pronóstico , Tasa de Supervivencia , Tamoxifeno/uso terapéutico , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: Some women with early-stage breast cancer are at higher risk of recurrence and can benefit from chemotherapy. We describe patterns of referral, receipt, and completion of chemotherapy among older women at high risk of recurrence. PATIENTS AND METHODS: A total of 2,124 women age 65 years or older who were diagnosed with early-stage breast cancer between 1990 and 1994 and 1996 to 1999 were included; 1,090 of these were at high risk of recurrence. We reviewed medical records to categorize chemotherapy outcomes as follows: did not discuss or were not referred to a medical oncologist (n = 133); discussed and/or referred to a medical oncologist but received no chemotherapy (n = 742); received an incomplete chemotherapy course (n = 29), or received a completed chemotherapy course (n = 186). RESULTS: Overall, 19.7% of high-risk women received any chemotherapy, and 86.5% of these women completed their chemotherapy courses. Just greater than 10% of high-risk women did not have a discussion about chemotherapy as part of breast cancer treatment documented in the medical record; these women also received fewer diagnostic assessments of their initial tumors. CONCLUSION: Individuals who receive chemotherapy for early-stage breast cancer are a select subgroup of patients at high risk of recurrence. This study identifies characteristics of women who were referred for and who received chemotherapy, and this study plays an important role in understanding generalizability of studies that examine chemotherapy treatment effectiveness. Outcomes after breast cancer could continue to be improved with increased receipt of chemotherapy among older women at high risk of breast cancer recurrence.
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Antineoplásicos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Derivación y Consulta , Anciano , Neoplasias de la Mama/patología , Estudios de Cohortes , Femenino , Humanos , Recurrencia Local de Neoplasia/prevención & control , Estadificación de NeoplasiasRESUMEN
BACKGROUND: Limb reduction deficiencies that are accompanied by amniotic bands (AB-Ls) and terminal transverse limb deficiencies (TLDs) have each been attributed to vascular disruption; for the former, however, it is not clear if amniotic bands are the primary cause of or are secondary to vascular disruption. If amniotic bands are secondary to vascular disruption, then a shared pathogenesis for each case group might be exhibited by similar risk factors. METHODS: We evaluated maternal age, education, race/ethnicity, parity, pregnancy wantedness, and vasoactive exposures among 139 AB-L and 373 TLD cases, using interview data collected from mothers in 10 states by the National Birth Defects Prevention Study. Vasoactive exposures included maternal cigarette smoking and use of decongestants, nonsteroid anti-inflammatory drugs, and antihypertensive drugs in the periconceptional period. RESULTS: Increased risk estimates were observed for Black mothers (OR 2.5; 95% CI: 1.5-4.1) and nulliparous mothers (2.1; 1.4-3.0) in relation to AB-L, while neither was associated with TLD. Hispanic women (1.4; 1.0-1.9) and those not wanting the pregnancy (1.5; 1.1-2.1) had increased risks of TLD, but not AB-L. Maternal cigarette smoking and aspirin use each increased the risk of AB-L, but not TLD; while decongestants and possibly antihypertensive medications increased the risk of TLD, but not AB-L. CONCLUSIONS: The lack of consistent findings for the two case groups suggests that AB-L and TLD may be distinct entities. The inconsistencies also suggest that these vasoactive exposures may not be markers for vascular disruption or that vascular disruption may not play a major role in the pathogenesis of these two types of limb deficiencies.