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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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INTRODUCTION: The incidence of thyroid nodules has increased as diagnostic imaging has become more prevalent, but the management in transplant candidates, a high-risk population because of the need for chronic immunosuppression, has not been described. We sought to review our institution's approach to thyroid nodules incidentally found during pretransplant workup. METHODS: A multisite retrospective review was performed of pretransplant patients with incidental thyroid nodules diagnosed between 2011 and 2021. Demographics, nodule characteristics, treatment timeline, and oncologic outcomes were collected. Patients diagnosed before and after 2017 were compared to evaluate how adoption of Thyroid Imaging Reporting and Data System and expansion of a dedicated transplant center were correlated with changes in patient management. RESULTS: A total of 10,340 patients underwent abdominal transplant, 236 had incidental thyroid nodules. After 2017, radiology recommendations for biopsy decreased from 39% to 29% (P = 0.174) and fewer biopsies were performed, 45%-33% (P = 0.055). Time between imaging and biopsy was significantly shorter after 2017, from 14 mo to 4 (P = 0.038). Overall time from imaging to transplant was also significantly reduced, from 31 mo to 11 (P < 0.001). Thirty-one (13.1%) patients underwent thyroid surgery before transplant and four (1.7%) patients after. CONCLUSIONS: In the recent years, thyroid biopsy rates for thyroid incidentalomas found during pretransplant workup have decreased and more closely match imaging-based guideline recommendations. Patients who required biopsy obtained them sooner and underwent transplant surgery sooner. Guideline-driven thyroid incidentaloma workup for the pretransplant population allows for timely and appropriate cancer care while avoiding unnecessary delays in transplant.
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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.
Subject(s)
Hospitals , Humans , United States/epidemiology , Hospital Mortality , Logistic ModelsABSTRACT
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.
Subject(s)
Breast Neoplasms , Mammaplasty , Humans , Female , Mastectomy/methods , Quality of Life , Breast Neoplasms/surgery , Patient Discharge , Patient Satisfaction , Mammaplasty/methodsABSTRACT
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.
Subject(s)
Breast Neoplasms , Neoadjuvant Therapy , Breast/pathology , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/drug therapy , Breast Neoplasms/surgery , Female , Humans , Magnetic Resonance Imaging/methods , Mammography/methods , Neoplasm, Residual/diagnostic imaging , Neoplasm, Residual/pathologyABSTRACT
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.
Subject(s)
Breast Neoplasms , Ketorolac , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Breast Neoplasms/complications , Breast Neoplasms/surgery , Female , Hematoma/epidemiology , Hematoma/etiology , Humans , Ketorolac/adverse effects , Mastectomy/adverse effects , Outpatients , Pain, Postoperative/drug therapy , Pain, Postoperative/etiology , Retrospective StudiesABSTRACT
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.
Subject(s)
Breast Neoplasms/diagnostic imaging , Contrast Media , Mammaplasty , Mammography/methods , Carcinoma in Situ/diagnostic imaging , Carcinoma, Ductal, Breast/diagnostic imaging , Carcinoma, Lobular/diagnostic imaging , Contraindications, Procedure , Female , Humans , Magnetic Resonance Imaging/adverse effects , Retrospective StudiesABSTRACT
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.
Subject(s)
Breast Implants , Breast Neoplasms , Mammaplasty , Breast Implants/adverse effects , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , Female , Follow-Up Studies , Humans , Mammaplasty/adverse effects , Mastectomy , Postoperative Complications , Radiotherapy, Adjuvant , Treatment OutcomeABSTRACT
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.
Subject(s)
Breast Neoplasms , Mammaplasty , Breast Neoplasms/surgery , Female , Humans , Mastectomy , Patient Discharge , Postoperative Complications/epidemiology , Retrospective StudiesABSTRACT
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.
Subject(s)
Breast Implants , Breast Neoplasms , Mammaplasty , Breast Implants/adverse effects , Breast Neoplasms/surgery , Follow-Up Studies , Humans , Mammaplasty/adverse effects , Mastectomy , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Reoperation , Retrospective Studies , Treatment OutcomeABSTRACT
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.
Subject(s)
Ambulatory Surgical Procedures , Breast Neoplasms , Enhanced Recovery After Surgery , Mastectomy , Adult , Aged , Breast Neoplasms/surgery , Feasibility Studies , Female , Humans , Length of Stay , Mastectomy/methods , Middle Aged , Patient Discharge , Retrospective Studies , Treatment OutcomeABSTRACT
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.
Subject(s)
Analgesics, Non-Narcotic/adverse effects , Analgesics, Opioid/therapeutic use , Pain, Postoperative/drug therapy , Parathyroidectomy/adverse effects , Practice Patterns, Physicians'/standards , Adult , Aged , Aged, 80 and over , Drug Prescriptions/standards , Female , Humans , Male , Middle Aged , Opioid Epidemic/etiology , Opioid Epidemic/prevention & control , Pain Measurement , Pain, Postoperative/diagnosis , Pain, Postoperative/etiology , Practice Guidelines as Topic , Prescription Drug Misuse/prevention & control , Program Evaluation , Prospective Studies , Retrospective Studies , Thyroidectomy/adverse effectsABSTRACT
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.
Subject(s)
Breast Neoplasms, Male/therapy , Neoplasms, Second Primary/epidemiology , Adult , Age Factors , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Body Mass Index , Breast Neoplasms, Male/metabolism , Breast Neoplasms, Male/pathology , Humans , Incidence , Kaplan-Meier Estimate , Lymphatic Metastasis , Male , Middle Aged , Receptor, ErbB-2/metabolism , Receptors, Estrogen/metabolism , Survival Rate , Young AdultABSTRACT
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.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Anti-Infective Agents/therapeutic use , Metronidazole/therapeutic use , Neoplasms/complications , Odorants , Wounds and Injuries/drug therapy , Double-Blind Method , Humans , Prospective Studies , Soft Tissue Injuries/drug therapy , Soft Tissue Injuries/etiology , Wounds and Injuries/etiologyABSTRACT
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.
Subject(s)
Breast Neoplasms/epidemiology , Carcinoma, Ductal, Breast/epidemiology , Carcinoma, Intraductal, Noninfiltrating/epidemiology , Neoplasm Recurrence, Local/epidemiology , Adult , Age Factors , Aged , Aged, 80 and over , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma, Intraductal, Noninfiltrating/secondary , Carcinoma, Intraductal, Noninfiltrating/surgery , Female , Humans , Kaplan-Meier Estimate , Mastectomy, Segmental , Middle Aged , Risk Factors , Time Factors , Young AdultABSTRACT
Background: The 2015 American Thyroid Association (ATA) guidelines added thyroid lobectomy (TL) as the appropriate treatment for low-risk differentiated thyroid cancer (DTC). We aimed to investigate the population-level factors that influence the utilization of TL. Methods: The Surveillance, Epidemiology and End Results (SEER) database was queried for all DTC patients fitting low-risk criteria as defined by the ATA. Trends in total thyroidectomy (TT) and TL were identified using a Cochrane-Armitage test. Multivariable logistic regression identified patient and socioeconomic characteristics associated with TL, and difference-in-difference analysis was used to control for secular trends over time. Results: A total of 43,526 patients with low-risk DTC were identified in the SEER database; 39,411 pre-2015 and 4115 post-2015. After 2015, TT continued to outnumber TL (76.2% vs 23.8%), although the rate of TL increased significantly (11.6% to 23.8%, P < 0.001). However, difference-in-difference analysis found that age > 55 (OR 1.11, 95% CI 1.01-1.19, P < 0.001) and rurality (OR 1.16, 95% CI 1.05-1.28, P < 0.001) were independently associated with TT. TL was associated with T1 disease (OR 1.11, 95% CI 1.04-1.19, P = 0.001). Conclusion: Although the 2015 ATA guideline update led to an increase in TL for low-risk DTC, most patients still underwent TT. Age and neighborhood significantly impact the odds of receiving guideline-appropriate TL for low-risk DTC, especially for T2 disease.