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OBJECTIVE: This study investigates Enhanced Recovery After Surgery (ERAS®) protocols' impact on long-term opioid and sedative use following mastectomy with or without implant-based breast reconstruction (IBBR). SUMMARY BACKGROUND DATA: ERAS® protocols for patients undergoing mastectomy with or without IBBR are associated with decreased length of stay, increased rate of same-day discharge, decreased postoperative pain, and decreased postoperative opioid requirements. However, less is known about their effect on opioid and sedative use beyond 90 days after surgery. METHODS: A retrospective review of all patients undergoing mastectomy with or without IBBR at a single institution between January 2013 and December 2019. Mastectomy ERAS® protocols were implemented in February 2017, creating two groups: pre-ERAS® and ERAS®. Baseline characteristics and prevalence of chronic opioid and sedative use were compared. Univariable and multivariable logistic regression predicted factors associated with increased odds of chronic opioid and sedative use. RESULTS: 756 patients were evaluated: 405 pre-ERAS® and 351 ERAS®. Post-ERAS®, chronic opioid use decreased in opioid-naïve (40% vs. 30%, P=0.024) and opioid-tolerant patients (58% vs. 37%, P=0.002), with no increase in chronic sedative use. There were decreased odds of chronic opioid use for all ERAS® patients (OR=0.57, 95% CI: 0.42-0.76)), and of IBBR patients, those receiving subcutaneous implants (OR=0.31, 95% CI: 0.20-0.48). There was increased chronic opioid-use odds if undergoing bilateral surgery (OR=1.54, 95% CI: 1.14-2.08), two-stage reconstruction (OR=9.78, 95% CI: 5.94-16.09), and for patients with higher PACU pain scores (OR=1.09, 95% CI: 1.03-1.14) or >150 discharge OMEs (OR=2.63, 95% CI: 1.48-4.68). CONCLUSION: ERAS® protocols for mastectomy patients with or without IBR are associated with decreases in chronic opioid use, without concomitant increases in chronic sedative use.
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OBJECTIVES: We aimed to quantify the contributions of patient characteristics (PC), hospital structural characteristics (HC), and hospital operative volumes (HOV) to in-hospital mortality (IHM) after major surgery in the United States (US). BACKGROUND: The volume-outcome relationship correlates higher HOV with decreased IHM. However, IHM after major surgery is multifactorial, and the relative contribution of PC, HC, and HOV to IHM after major surgery is unknown. STUDY DESIGN: Patients undergoing major pancreatic, esophageal, lung, bladder, and rectal operations between 2006 and 2011 were identified from the Nationwide Inpatient Sample linked to the American Hospital Association survey. Multilevel logistic regression models were constructed using PC, HC, and HOV to calculate attributable variability in IHM for each. RESULTS: Eighty thousand nine hundred sixty-nine patients across 1025 hospitals were included. Postoperative IHM ranged from 0.9% for rectal to 3.9% for esophageal surgery. Patient characteristics contributed most of the variability in IHM for esophageal (63%), pancreatic (62.9%), rectal (41.2%), and lung (44.4%) operations. HOV explained < 25% of variability for pancreatic, esophageal, lung, and rectal surgery. HC accounted for 16.9% and 17.4% of the variability in IHM for esophageal and rectal surgery. Unexplained variability in IHM was high in the lung (44.3%), bladder (39.3%), and rectal (33.7%) surgery subgroups. CONCLUSIONS: Despite recent policy focus on the volume-outcome relationship, HOV was not the most important contributor to IHM for the major organ surgeries studied. PC remains the largest identifiable contributor to hospital mortality. Quality improvement initiatives should emphasize patient optimization and structural improvements, in addition to investigating the yet unexplained sources contributing to IHM.
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Hospitais , Humanos , Estados Unidos/epidemiologia , Mortalidade Hospitalar , Modelos LogísticosRESUMO
BACKGROUND: This study aimed to evaluate how enhanced recovery (ER) protocols and same-day discharge (SDD) influences patients' postoperative quality of life (QOL). METHODS: Patients who underwent mastectomy with implant-based breast reconstruction from 2008 to 2020 were identified in a prospective database. The study assessed QOL with BREAST-Q and Was It Worth It? (WIWI) questionnaires. Responses were compared between the ER and pre-ER groups and between the SDD and hospital stay (HS) groups using one-way analysis of variance (ANOVA) and chi-square tests. RESULTS: The inclusion criteria were met by 568 patients, with a 43% response rate, and 217 patients were included for analysis. Chest physical well-being was lower for the ER cohort, but postoperative breast satisfaction was higher. Psychosocial status, sexual well-being, and satisfaction with information given did not differ significantly between the ER group and the pre-ER or SDD group. In the compared groups, QOL did not differ significantly. CONCLUSIONS: Enhanced recovery with SDD after mastectomy using implant-based reconstruction did not have an adverse impact on patient postoperative QOL.
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Neoplasias da Mama , Mamoplastia , Humanos , Feminino , Mastectomia/métodos , Qualidade de Vida , Neoplasias da Mama/cirurgia , Alta do Paciente , Satisfação do Paciente , Mamoplastia/métodosRESUMO
BACKGROUND: Neoadjuvant endocrine therapy (NET) can help downstage certain breast cancers prior to surgical resection. This study measured the accuracy of conventional mammography (MMG), ultrasound (US), magnetic resonance imaging (MRI), and contrast-enhanced mammography (CEM) for assessing breast tumor size in response to NET. PATIENTS AND METHODS: Patients who underwent surgery after NET from 2013 to 2021 were identified. The maximal dimension of residual tumor on imaging was compared with the maximal dimension on final pathology. Lin's concordance correlation coefficient (rc) and Spearman's rank correlation coefficient (r) were used to assess agreement. RESULTS: In total, 119 patients with invasive breast cancer underwent NET, posttreatment imaging, and surgery. Tumor size reported on posttreatment CEM correlated with size on final pathology to within 1 cm in n = 42 (58%) of patients, equivalent to the accuracy of MRI (n = 35, 58%). Size was accurately predicted by US in 54% and in 48% of MMG. Posttreatment imaging tumor size was moderately correlated with final tumor size on pathology CEM (r = 0.49; rc = 0.38), MRI (r = 0.52; rc = 0.45), and US (r = 0.41; rc = 0.28). MMG was weakly correlated (r = 0.21; rc = 0.16). Similar findings were shown in subgroup analysis; in those who received all four post-NET imaging, CEM and MRI again performed comparably, with r = 0.36 and 0.41, respectively, US (r = 0.43) and MMG (r = 0.28). CONCLUSIONS: Compared with mammography and US, CEM and MRI had higher accuracy in estimating final tumor size for breast cancers treated with NET. Contrast-enhanced imaging is a helpful adjunct when response to preoperative therapy will impact clinical management.
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Neoplasias da Mama , Terapia Neoadjuvante , Mama/patologia , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/cirurgia , Feminino , Humanos , Imageamento por Ressonância Magnética/métodos , Mamografia/métodos , Neoplasia Residual/diagnóstico por imagem , Neoplasia Residual/patologiaRESUMO
BACKGROUND: Enhanced recovery after surgery (ERAS) protocols following mastectomy with or without implant-based breast reconstruction (IBBR) include ketorolac for multimodal perioperative analgesia. There are concerns that ketorolac could be associated with increased risk of postoperative hematoma formation. METHODS: Retrospective review of patients undergoing mastectomy with or without IBBR between January 2013 and December 2019 at a single institution. Patients received 15 mg, 30 mg, or no ketorolac depending on ERAS protocol adherence, patient characteristics, and surgeon preference. Clinically significant hematoma was defined as requiring surgical intervention on day of surgery or postoperative day 1. Patients were compared by demographics, surgical characteristics, ketorolac dose, and hematoma prevalence. Univariable and multivariable logistic regression evaluated hematoma formation odds. RESULTS: Eight hundred patients met inclusion criteria: 477 received ketorolac. Those who received ketorolac were younger, had lower ASA scores, were more likely to have bilateral procedures and undergo concomitant IBBR, had longer operative times, were less likely to take antiplatelet or anticoagulation medications, had higher PACU pain scores, and had higher incidence of hematomas requiring surgical intervention. Of the cohort, 4.4% had clinically significant hematomas. The 15 mg and 30 mg ketorolac groups had similar prevalence (6.0% vs 5.8%, p = 0.95). On univariable regression, there were increased odds of hematoma formation in patients who were younger, had bilateral procedures, had longer OR times, and who received ketorolac. On multivariable regression, none of the prior variables remained significant. CONCLUSION: After accounting for associations with longer operative times, concomitant IBBR, and bilateral procedures, ketorolac administration did not remain an independent risk factor for hematoma formation.
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Neoplasias da Mama , Cetorolaco , Anti-Inflamatórios não Esteroides/efeitos adversos , Neoplasias da Mama/complicações , Neoplasias da Mama/cirurgia , Feminino , Hematoma/epidemiologia , Hematoma/etiologia , Humanos , Cetorolaco/efeitos adversos , Mastectomia/efeitos adversos , Pacientes Ambulatoriais , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/etiologia , Estudos RetrospectivosRESUMO
In 17 women with newly diagnosed breast cancer who underwent contrast-enhanced mammography (CEM) and MRI, both modalities were found to be concordant for the index cancer. In six of the 17 women, CEM showed an additional lesion that was confirmed by MRI. Of these six additional lesions, three were multifocal, one was multicentric, and two were contralateral; two of the six were malignant. MRI did not identify any additional cancers that were not identified on CEM. CEM may have a role in women with breast augmentation and either a contraindication or limited access to MRI.
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Neoplasias da Mama/diagnóstico por imagem , Meios de Contraste , Mamoplastia , Mamografia/métodos , Carcinoma in Situ/diagnóstico por imagem , Carcinoma Ductal de Mama/diagnóstico por imagem , Carcinoma Lobular/diagnóstico por imagem , Contraindicações de Procedimentos , Feminino , Humanos , Imageamento por Ressonância Magnética/efeitos adversos , Estudos RetrospectivosRESUMO
Study conducted to determine frequency and timing of unplanned breast implant removal after mastectomy, reconstruction, and postmastectomy radiation (PMRT). From 2010-2017, 52 patients underwent mastectomy, reconstruction, and PMRT. With median follow-up of 3.1 years, 23 patients (44%) experienced implant removal. Implant removal occurred in 9 (17%) patients before starting PMRT and 14 (27%) patients after starting PMRT. Implant removal rates were similar for hypofractionated PMRT compared with standard fractionation and for proton compared with photon PMRT. Implant removal is common for women undergoing mastectomy and reconstruction followed by PMRT. The risk is clinically significant even before starting radiation.
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Implantes de Mama , Neoplasias da Mama , Mamoplastia , Implantes de Mama/efeitos adversos , Neoplasias da Mama/radioterapia , Neoplasias da Mama/cirurgia , Feminino , Seguimentos , Humanos , Mamoplastia/efeitos adversos , Mastectomia , Complicações Pós-Operatórias , Radioterapia Adjuvante , Resultado do TratamentoRESUMO
BACKGROUND: Same-day discharge after mastectomy is a recently described treatment approach. Limited data exist investigating whether same-day discharge can be successfully implemented in patients undergoing mastectomy with immediate implant-based breast reconstruction (IBR). METHODS: Patients having mastectomy with IBR from 2013 to 2019 were reviewed. Enhanced recovery with same-day discharge was implemented in 2017. Patient characteristics, oncologic treatments, surgical techniques, and 90-day postoperative complications and reoperations were analyzed comparing enhanced recovery patients with historical controls. RESULTS: A total of 363 patients underwent nipple-sparing (214, 59%) or skin-sparing (149, 41%) mastectomy with 1-stage (270, 74%) or tissue expander (93, 26%) IBR. Enhanced recovery was used for 151 patients, with 79 of these patients (52%) discharged same-day. Overall, enhanced recovery patients experienced a significantly lower rate of 90-day complications (21% vs 41%, P < 0.001), including hematoma (3% vs 11%, P = 0.002), mastectomy flap necrosis (7% vs 15%, P = 0.02), seroma (1% vs 9%, P < 0.001), and wound breakdown (3% vs 9%, P = 0.05). Postoperative complication rates did not significantly differ among enhanced recovery patients discharged same day. Postoperative admissions significantly decreased after enhanced recovery implementation (100% to 48%, P < 0.001), and admitted enhanced recovery patients experienced a lower length of stay (1.2 vs 1.8, P < 0.001). Enhanced recovery patients experienced a lower incidence of ≥1 unplanned reoperation (22% vs 33%, P = 0.01); overall average unplanned and total reoperations did not significantly differ between groups. CONCLUSIONS: In conjunction with enhanced recovery practices, same-day discharge after mastectomy with IBR is a safe and feasible treatment approach.
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Neoplasias da Mama , Mamoplastia , Neoplasias da Mama/cirurgia , Feminino , Humanos , Mastectomia , Alta do Paciente , Complicações Pós-Operatórias/epidemiologia , Estudos RetrospectivosRESUMO
BACKGROUND: The purpose of this study is to evaluate how prior breast augmentation impacts rates of complications and risk for reoperation after mastectomy with concurrent breast reconstruction. METHODS: Patients undergoing nipple-sparing, skin-sparing, or simple mastectomy with implant-based reconstruction from 2008 to 2018 were identified in a prospective database. Postoperative complications and reoperations were then analyzed comparing patients with prior augmentation to patients without history of previous breast surgery. RESULTS: A total of 468 patients were identified with a median follow-up of 4 years. Of these, 72 had prior augmentation mammoplasty. These patients underwent nipple-sparing (52, 72%), skin-sparing (15, 21%), or simple (5, 7%) mastectomy with immediate direct-to-implant (46, 61%) or tissue expander (26, 35%) reconstruction. On univariate analysis, this cohort had a lower body mass index (23.3 vs 25.3, P = 0.003), a higher rate of nipple-sparing mastectomy (72% vs 54%, P = 0.01), and a higher prevalence of stage I disease (44% vs 33%, P = 0.04). Differences in age, comorbidities, reconstructive techniques, tumor size, and neoadjuvant/adjuvant therapies were not significant. Overall complication rate between patients with or without prior augmentation did not significantly differ (51% vs 50%, P = 0.83); no significant differences in rates of surgical site infection, hematoma, mastectomy skin flap/wound necrosis, nipple complications, implant loss, or capsular contracture were found. Analysis of reoperations between patients with and without prior augmentation revealed no significant differences in average number of subsequent planned, unplanned, or total reoperations. On multivariate analysis, prior breast augmentation was found to be associated with significantly increased risk for undergoing ≥1 unplanned reoperation (odds ratio, 2.28; 95% confidence interval, 1.28-4.05, P = 0.005). CONCLUSIONS: Prior augmentation mammoplasty does not significantly affect rates of postoperative complications after mastectomy with concurrent reconstruction. Although prior augmentation does not affect number of subsequent reoperations on average, it does increase the risk of experiencing 1 or more unplanned reoperation after mastectomy with reconstruction.
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Implantes de Mama , Neoplasias da Mama , Mamoplastia , Implantes de Mama/efeitos adversos , Neoplasias da Mama/cirurgia , Seguimentos , Humanos , Mamoplastia/efeitos adversos , Mastectomia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Reoperação , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Enhanced recovery after surgery (ERAS®) principles have been beneficial in major abdominal surgery. ERAS® was instituted in our breast surgery practice in 2017. The goal of this study was to evaluate the feasibility of outpatient mastectomies before and after ERAS®. METHODS: A retrospective review of all mastectomies between 1/2013 and 6/2018 was performed. Patients receiving autologous flap reconstruction were excluded. The institution-specific ERAS® pathway began on February 1, 2017. Patient characteristics, operative intervention, and postoperative outcomes were compared between pre-ERAS® and post-ERAS® groups and between outpatient and inpatient subgroups. Continuous and categorical variables were compared using Wilcoxon rank-sum and Chi-square analyses. RESULTS: A total of 487 patients were analyzed. Three hundred and forty-seven (71%) were prior to ERAS® and 140 after (29%). The two groups were not significantly different in background characteristics. Same-day discharge occurred in 58.6% of post-ERAS® patients versus 7.2% of pre-ERAS® patients (p < 0.001). Liposomal bupivacaine block was used for pain control more in the post-ERAS® group, 62.1% versus 6.1% (p < 0.001). Reconstruction type differed with 45.7% of the post-ERAS® group undergoing direct-to-implant reconstruction versus 34.3% of pre-ERAS® patients (p < 0.001) and with higher rates of submuscular implant and tissue expander placement in the pre-ERAS® versus post-ERAS® group (p < 0.001). Complications rates were lower in the post-ERAS® group versus pre-ERAS® group, 32.9% versus 52.4% (p < 0.001). The outpatient subgroup had higher rates of liposomal bupivacaine administration 74.4% versus 44.8% (p < 0.001). Baseline characteristics and complication rates did not differ between outpatient and admitted subgroups. CONCLUSION: ERAS® principles can be applied to breast cancer patients and allow for outpatient mastectomies with no increase in postoperative morbidity.
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Procedimentos Cirúrgicos Ambulatórios , Neoplasias da Mama , Recuperação Pós-Cirúrgica Melhorada , Mastectomia , Adulto , Idoso , Neoplasias da Mama/cirurgia , Estudos de Viabilidade , Feminino , Humanos , Tempo de Internação , Mastectomia/métodos , Pessoa de Meia-Idade , Alta do Paciente , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: To help control opioid overprescription, we conducted a large institutional, 3-site initiative to provide discharge prescribing guidelines for different procedures. Our aim is to refine institutional guidelines for parathyroidectomy. METHODS: Patients undergoing parathyroidectomy completed a 28-question survey about opioid consumption. Discharge opioid prescription amounts were converted into morphine milligram equivalents (MMEs) and reported as median and interquartile range (IQR). Consumption was dichotomized into top quartile MME users (Q4) versus standard users (Q1, Q3). Univariate analysis compared opioid consumption. RESULTS: A total of 91 patients were included; 90% were opioid-naive. While the median prescribed was 75 (IQR 75, 150) MME, the median consumed was 0 (IQR 0, 20). Top users reported higher pain scores [median (IQR): 2 (2, 4)] compared to standard users [1 (0, 3), P = 0.01]. However, there was no difference in opioid consumption between unilateral neck exploration, bilateral exploration, or thyroidectomy and parathyroidectomy, P = 0.11. There was no difference in opioid consumption by age, sex, or BMI (all P > 0.05). Of those receiving a prescription, 94.6% had left-over opioids at the time of survey, resulting in 82% of prescribed opioids being unused. CONCLUSIONS: Over half of patients undergoing parathyroidectomy did not consume any opioid, and very few needed more than 2 d of opioid. Moreover, most patients did not dispose the unused opioids, which put these pills at risk of diversion and misuse. Surgical approach did not change consumption, illustrating that these guidelines are applicable to thyroidectomy given the similarity between techniques. We recommend prescribing nonopioid analgesics for patients undergoing parathyroidectomy.
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Analgésicos não Narcóticos/efeitos adversos , Analgésicos Opioides/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Paratireoidectomia/efeitos adversos , Padrões de Prática Médica/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Prescrições de Medicamentos/normas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Epidemia de Opioides/etiologia , Epidemia de Opioides/prevenção & controle , Medição da Dor , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/etiologia , Guias de Prática Clínica como Assunto , Uso Indevido de Medicamentos sob Prescrição/prevenção & controle , Avaliação de Programas e Projetos de Saúde , Estudos Prospectivos , Estudos Retrospectivos , Tireoidectomia/efeitos adversosRESUMO
BACKGROUND AND OBJECTIVES: Neoadjuvant endocrine therapy (NET) for ER+ breast cancer can downstage primary tumors. We evaluated NET efficacy in node-positive patients. METHODS: Node-positive patients undergoing NET for ER+ breast cancer from 2012 to 2019 were reviewed. Primary endpoints included rates of axillary lymphadenectomy (ALND), pathologic complete response (pCR), and final nodal staging. RESULTS: Thirty-nine patients were included. Before NET, all were clinically node-positive (cN1 = 36, 94%; cN2 = 2, 5%; cN3 = 1, 3%; Stage II = 23, 59%, Stage III = 16, 41%). After NET, nine (23%) had clinically persistent axillary disease necessitating ALND. The remaining 30 (77%) underwent sentinel lymph node biopsy (SLNB). Of these, 25 (83%) were SLNB+ on frozen section, undergoing immediate ALND. Five patients were negative on frozen section: one had a confirmed axillary pCR, and four had residual nodal disease on permanent pathology. One underwent delayed ALND, and for the remaining three patients, decision was made to forgo ALND. Final overall axillary staging was: N0 (pCR) = 1, 3%, pN1mic = 1, 3%, pN1 = 20, 51%, pN2 = 12, 30%, pN3 = 5, 13%; Stage II = 16, 41%, Stage III = 23, 59%. CONCLUSIONS: While NET is reported to downstage primary tumors, downstaging of the axilla was unsuccessful in the majority of patients.
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BACKGROUND: Low incidence of breast cancer in men (BCM) (< 1% of all breast cancers) has led to a paucity of outcome data. This study evaluated the impact of age on BCM outcomes. METHODS: For this study, BCM patients treated between 2000 and 2011 were stratified by age (≤ 65 or > 65 years). Kaplan-Meier methods were used to compare overall survival (OS) and breast cancer-specific survival (BCSS). Competing-risk methods analyzed time to second primary cancers (SPCs), with any-cause death treated as a competing risk. RESULTS: The study identified 152 BCM patients with a median age of 64 years (range 19-96 years). The median body mass index (BMI) was 28 kg/m2. Men age 65 years or younger (n = 78, 51%) were more overweight/obese than men older than 65 years (n = 74, 49%) (89% vs 74%, respectively; P = 0.008). Both groups had similar nodal metastases rates (P = 0.4), estrogen receptor positivity (P = 1), and human epidermal growth factor receptor 2 (HER2)neu overexpression (P = 0.6). Men 65 years of age or younger were more likely to receive chemotherapy (P = 0.002). The median follow-up period was 5.8 years (range 0.1-14.4 years). The 5-year OS was 86% (95% confidence interval [CI] 80-93%), whereas the 5-year BCSS was 95% (95% CI 91-99%). The BCM patients 65 years of age and younger had better OS (P = 0.003) but not BCSS (P = 0.8). The 5-year cumulative incidence of SPC was 8.4% (95% CI 3.4-13.4%). The prior SPC rate was higher for men older than 65 years (n = 20, 31%) than for those age 65 years or younger (n = 7, 11%) (P = 0.008). This did not account for differences in life years at risk. No difference was observed in SPC cumulative incidence stratified by age (P = 0.3). CONCLUSIONS: Men 65 years of age or younger received more chemotherapy and had improved OS, but not BCSS, compared with men older than 65 years. For all BCM, SPC is a risk, and appropriate screening may be warranted.
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Neoplasias da Mama Masculina/terapia , Segunda Neoplasia Primária/epidemiologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Índice de Massa Corporal , Neoplasias da Mama Masculina/metabolismo , Neoplasias da Mama Masculina/patologia , Humanos , Incidência , Estimativa de Kaplan-Meier , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Receptor ErbB-2/metabolismo , Receptores de Estrogênio/metabolismo , Taxa de Sobrevida , Adulto JovemRESUMO
BACKGROUND: Malignant wounds are a devastating complication of cancer. They usually develop in the last six months of life, in the breast, chest wall or head and neck regions. They are very difficult to treat successfully, and the commonly associated symptoms of pain, exudate, malodour, and the risk of haemorrhage are extremely distressing for those with advanced cancer. Treatment and care of malignant wounds is primarily palliative, and focuses on alleviating pain, controlling infection and odour from the wound, managing exudate and protecting the surrounding skin from further deterioration. In malignant wounds, with tissue degradation and death, there is proliferation of both anaerobic and aerobic bacteria. The aim of antibiotic therapy is to successfully eliminate these bacteria, reduce associated symptoms, such as odour, and promote wound healing. OBJECTIVES: To assess the effects of systemic antibiotics for treating malignant wounds. SEARCH METHODS: We searched the following electronic databases on 8 March 2017: the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library, 2017, Issue 3), Ovid MEDLINE, Ovid Embase and EBSCO CINAHL Plus. We also searched the clinical trial registries of the World Health Organization (WHO) International Clinical Trials Registry Platform (apps.who.int/trialsearch) and ClinicalTrials.gov on 20 March 2017; and OpenSIGLE (to identify grey literature) and ProQuest Dissertations & Theses Global (to retrieve dissertation theses related to our topic of interest) on 13 March 2017. SELECTION CRITERIA: Randomised controlled trials that assessed the effects of any systemic antibiotics on malignant wounds were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently screened and selected trials for inclusion, assessed risk of bias and extracted study data. A third reviewer checked extracted data for accuracy prior to analysis. MAIN RESULTS: We identified only one study for inclusion in this review. This study was a prospective, double-blind cross-over trial that compared the effect of systemic metronidazole with a placebo on odour in malignant wounds. Nine participants with a fungating wound and for whom the smell was troublesome were recruited and six of these completed both the intervention and control (placebo) stages of the trial. Each stage lasted fourteen days, with a fourteen day gap (washout period) between administration of the metronidazole and the placebo.The study, in comparing metronidazole and placebo, reported on two of this review's pre-specified primary outcomes (malodour and adverse effects of the treatment) and on none of the review's pre-specified secondary outcomes.MalodourThe mean malodour (smell) scores for the metronidazole group was 1.17 (standard deviation (SD) 1.60) and the mean for the placebo group was 3.33 (SD 0.82). It is unclear if systemic antibiotics were associated with a difference in malodour (1 study with 6 participants; MD -2.16, 95% CI -3.6 to -0.72) as the quality of the evidence (GRADE) was very low for this outcome. The study was downgraded due to high risk of attrition bias (33% loss to follow-up) and very serious imprecision due to the small sample size.Adverse effectsNo adverse effects of the treatment were reported in either the intervention or control group by the trial authors. AUTHORS' CONCLUSIONS: It is uncertain whether systemic metronidazole leads to a reduction in malodour in patients with malignant wounds. This is because we were only able to include a single study at high risk of bias with a very small sample size, which focused only on patients with breast cancer. More research is needed to substantiate these findings and to investigate the effects of systemic metronidazole and other antibiotics on quality of life, pain relief, exudate and tumour containment in patients with malignant wounds.
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Antibacterianos/uso terapêutico , Anti-Infecciosos/uso terapêutico , Metronidazol/uso terapêutico , Neoplasias/complicações , Odorantes , Ferimentos e Lesões/tratamento farmacológico , Método Duplo-Cego , Humanos , Estudos Prospectivos , Lesões dos Tecidos Moles/tratamento farmacológico , Lesões dos Tecidos Moles/etiologia , Ferimentos e Lesões/etiologiaRESUMO
BACKGROUND: Age is a known risk factor for recurrence in women with ductal carcinoma in situ (DCIS) treated with breast-conserving surgery (BCS). We explored the relationship between age, other risk factors, and recurrence. METHODS: Using a prospectively maintained database of DCIS patients undergoing BCS from 1978 to 2010, the association of age and recurrence risk was analyzed using Kaplan-Meier estimates, multivariable analysis, and competing risk multivariable analysis. RESULTS: Overall, 2996 cases were identified. Median follow-up for those without recurrence was 75 months; 732 were followed for ≥10 years, and 363 (12 %) had recurrence [192 (53 %) DCIS, 160 (44 %) invasive, 11 (3 %) unknown]. Risk of recurrence decreased with age, even after adjustment for eight clinicopathologic variables on multivariable analysis [hazard ratios (HR), with <40 years of age as the reference: 40-49 years, 0.82 (p = 0.36), 50-59 years, 0.46 (p = 0.0005), 60-69 years, 0.50 (p = 0.003), 70-79 years, 0.56 (p = 0.02), ≥80 years, 0.21 (p = 0.0015)]. This association persisted for cohorts with and without radiation therapy. Using competing risk multivariable analysis, the effect of age on invasive recurrence was empirically stronger than for DCIS recurrence. Ten-year invasive recurrence was 16 and 6.5 % in women <40 years of age and women ≥40 years of age, respectively. Only 0.6 % of the population ultimately developed distant disease; those <40 years of age constituted 4.7 % (141/2996) of the population, but 21 % (4/19) of those developed distant disease. CONCLUSIONS: The risk of recurrence of DCIS decreases with age. This effect is particularly strong at the extremes of age and is independent of other clinicopathologic factors. The oldest women are at low risk of recurrence, while the youngest women have a higher overall, and especially invasive, recurrence rate, although mortality remains low. These findings should be incorporated into risk/benefit discussions of treatment options.
Assuntos
Neoplasias da Mama/epidemiologia , Carcinoma Ductal de Mama/epidemiologia , Carcinoma Intraductal não Infiltrante/epidemiologia , Recidiva Local de Neoplasia/epidemiologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Carcinoma Intraductal não Infiltrante/secundário , Carcinoma Intraductal não Infiltrante/cirurgia , Feminino , Humanos , Estimativa de Kaplan-Meier , Mastectomia Segmentar , Pessoa de Meia-Idade , Fatores de Risco , Fatores de Tempo , Adulto JovemRESUMO
PURPOSE: Contrast-enhanced mammography (CEM) and magnetic resonance imaging (MRI) have shown similar diagnostic performance in detection of breast cancer. Limited CEM data are available for high-risk breast cancer screening. The purpose of the study was to prospectively investigate the efficacy of supplemental screening CEM in elevated risk patients. MATERIALS AND METHODS: A prospective, single-institution, institutional review board-approved observational study was conducted in asymptomatic elevated risk women age 35 years or older who had a negative conventional two-dimensional digital breast tomosynthesis screening mammography (MG) and no additional supplemental screening within the prior 12 months. RESULTS: Four hundred sixty women were enrolled from February 2019 to April 2021. The median age was 56.8 (range, 35.0-79.2) years; 408 of 460 (88.7%) were mammographically dense. Biopsy revealed benign changes in 22 women (22/37, 59%), high-risk lesions in four women (4/37, 11%), and breast cancer in 11 women (11/37, 30%). Fourteen cancers (10 invasive, tumor size range 4-15 mm, median 9 mm) were diagnosed in 11 women. The overall supplemental cancer detection rate was 23.9 per 1,000 patients, 95% CI (12.0 to 42.4). All cancers were grade 1 or 2, ER+ ERBB2-, and node negative. CEM imaging screening offered high specificity (0.875 [95% CI, 0.844 to 0.906]), high NPV (0.998 [95% CI, 0.993 to 1.000), moderate PPV1 (0.164 [95% CI, 0.076 to 0.253), moderate PPV3 (0.275 [95% CI, 0.137 to 0.413]), and high sensitivity (0.917 [95% CI, 0.760 to 1.000]). At least 1 year of imaging follow-up was available on all patients, and one interval cancer was detected on breast MRI 4 months after negative screening CEM. CONCLUSION: A pilot trial demonstrates a supplemental cancer detection rate of 23.9 per 1,000 in women at an elevated risk for breast cancer. Larger, multi-institutional, multiyear CEM trials in patients at elevated risk are needed for validation.
RESUMO
PURPOSE: Our aim was to report physician- and patient-reported outcomes of patients with localized breast cancer treated with moderate versus ultrahypofractionated whole breast irradiation (WBI) after breast-conserving surgery (BCS). METHODS AND MATERIALS: Between February 2018 and February 2020, patients with localized breast cancer (pT0-3 pN0-1 M0) were offered participation in a phase 3 randomized clinical trial assessing adjuvant moderate hypofractionation (MHF) to 40 Gy in 15 fractions versus ultrahypofractionation (UHF) to 25 Gy in 5 fractions after BCS, with an optional simultaneously integrated boost. Toxicities, cosmesis, and quality of life were assessed at baseline, end of treatment (EOT), and 3 months, 1 year, 2 years, and 3 years from irradiation using validated metric tools. RESULTS: One hundred seven patients were randomized to MHF (n = 54) or UHF (n = 53) adjuvant WBI. The median follow-up was 42.8 months. Grade 2 radiation dermatitis was experienced by 4 patients (7.4%) in the MHF arm and 2 patients (3.7%) in the UHF arm at EOT (P = .726). No grade 3 or higher toxicities were observed. Deterioration of cosmesis by physician assessment was observed in 2 (6.7%) patients treated in the UHF arm and 1 (1.9%) patient treated in the MHF arm at EOT (P = .534), whereas at 3 months, only 1 (1.8%) patient treated in the MHF arm demonstrated deterioration of cosmesis (P = .315). At EOT, 91% and 94% of patients reported excellent/good cosmesis among those treated with MHF and UHF regimens, respectively (P = .550). At 3 months, more patients within the MHF arm reported excellent/good cosmesis compared with those in the UHF arm (100% vs 91%; P = .030). However, the difference in patient-reported cosmesis disappeared at the 1-, 2-, and 3-year time points. CONCLUSIONS: UHF WBI showed similar treatment-related late toxicities and similar provider-scored cosmesis compared with MHF radiation in patients treated adjuvantly after BCS.