Development of a prediction model for emergency medical service witnessed traumatic out-of-hospital cardiac arrest: A multicenter cohort study.

BACKGROUND/PURPOSE: To develop a prediction model for emergency medical technicians (EMTs) to identify trauma patients at high risk of deterioration to emergency medical service (EMS)-witnessed traumatic cardiac arrest (TCA) on the scene or en route. METHODS: We developed a prediction model using the classical cross-validation method from the Pan-Asia Trauma Outcomes Study (PATOS) database from 1 January 2015 to 31 December 2020. Eligible patients aged ≥18 years were transported to the hospital by the EMS. The primary outcome (EMS-witnessed TCA) was defined based on changes in vital signs measured on the scene or en route. We included variables that were immediately measurable as potential predictors when EMTs arrived. An integer point value system was built using multivariable logistic regression. The area under the receiver operating characteristic (AUROC) curve and Hosmer-Lemeshow (HL) test were used to examine discrimination and calibration in the derivation and validation cohorts. RESULTS: In total, 74,844 patients were eligible for database review. The model comprised five prehospital predictors: age <40 years, systolic blood pressure <100 mmHg, respiration rate >20/minute, pulse oximetry <94%, and levels of consciousness to pain or unresponsiveness. The AUROC in the derivation and validation cohorts was 0.767 and 0.782, respectively. The HL test revealed good calibration of the model (p = 0.906). CONCLUSION: We established a prediction model using variables from the PATOS database and measured them immediately after EMS personnel arrived to predict EMS-witnessed TCA. The model allows prehospital medical personnel to focus on high-risk patients and promptly administer optimal treatment.

Daylily (Hemerocallis fulva Linn.) flowers improve sleep quality in human and reduce nitric oxide and interleukin-6 production in macrophages.

The flowers of daylily (Hemerocallis fulva Linn.) have been used as vegetable and medicinal herb for thousands of years in Taiwan and eastern Asia. Daylily flowers have been demonstrated to exert several biomedical properties. In this study, we provided the evidences show that daylily flowers exert anti-inflammatory activity in vitro and improved the sleep quality in vivo. We demonstrated that adult volunteers received water extract of daylily flowers improved sleep quality, sleep efficiency and daytime functioning, while sleep latency was reduced, compared to the adult volunteers received water. In addition, we demonstrated that aqueous and ethanol extracts of daylily flowers inhibited nitric oxide and interleukin-6 production in lipopolysaccharide-activated macrophages. Furthermore, the quantitative high performance liquid chromatography-based analysis showed the rutin content of the aqueous extract, ethanolic extract, ethyl acetate fractions of ethanolic extract, and water fractions of ethanolic extract were 7.27, 23.30, 14.71, and 57.43 ppm, respectively. These results indicate that daylily flowers have the potential to be a nutraceutical for improving inflammatory-related diseases and sleep quality in the future.

Characteristics of non-accidental injuries in children and adolescents in Asia: a cross-national, multicenter cohort study.

Children and adolescents are vulnerable to non-accidental injury. Early identification and prevention rely on detailed epidemiological studies, which are limited in Asia. This retrospective study used the registry data of Pan-Asian Trauma Outcome Study (PATOS) from October 1, 2015 to December, 31, 2020. Pediatric patients (aged < 20 years) with non-accidental injuries were enrolled, which were divided by age into preschool (0-6 years), child (7-12 years), and adolescent (13-19 years) groups. Baseline characteristics, injury epidemiology, and excess mortality ratio-adjusted injury severity score (EMR-ISS) were collected. Major trauma was defined as an EMR-ISS score > 24. The study enrolled 451 patients with non-accidental injuries, accounting for 2.81% of pediatric trauma events presented to an emergency department in the PATOS registry. The overall mortality rate was 0.9%, similar to those in Western countries. Mortality rate was high in preschool children (8.7%, p = 0.017) than in other age groups. The sex-specific incidence was higher in boys (3.10% vs. 2.13%, p = 0.001). In adolescents, more events occurred on the street (25.9%), whereas home remained the most common locale in girls of all ages. In the multivariable regression analysis, abdominal and multiple injuries were risk factors for major trauma.

Epidemiology and Prehospital Care of Pediatric Unintentional Injuries Among Countries with Different Economic Status in Asia: A Cross-National, Multi-Center Observational Study.

OBJECTIVE: Injury is a major cause of morbidity and mortality in children. However, the epidemiology and prehospital care for pediatric unintentional injuries in Asia are still unclear. METHODS: A total of 9,737 pediatric patients aged <18 years with unintentional injuries cared for at participating centers of the Pan-Asian Trauma Outcome Study (PATOS) from October 2015 to December 2020 were reviewed retrospectively. Patients were divided into two groups: those <8 and those ≥8 years of age. Variables such as patient demographics, injury epidemiology, Injury Severity Score (ISS), and prehospital care were collected. Injury severity and administered prehospital care stratified by gross national income were also analyzed. RESULTS: Pediatric unintentional injuries accounted for 9.4% of EMS-transported trauma cases in the participating Asian centers, and the mortality rate was 0.88%. The leading cause of injury was traffic injuries in older children aged ≥8 years (56.5%), while falls at home were common among young children aged <8 years (43.9%). Compared with younger children, older children with similar ISS tended to receive more prehospital interventions. Uneven disease severity was found in that older children in lower-middle and upper-middle-income countries had higher ISS compared with those in high-income countries. The performance of prehospital interventions also differed among countries with different gross national incomes. Immobilizations were the most performed prehospital intervention followed by oxygen administration, airway management, and pain control; only one patient received prehospital thoracentesis. Procedures were performed more frequently in high-income countries than in upper-middle-income and lower-middle-income countries. CONCLUSIONS: The major cause of injury was road traffic injuries in older children, while falls at home were common among young children. Prehospital care in pediatric unintentional injuries in Asian countries was not standardized and might be insufficient, and the economic status of countries may affect the implementation of prehospital care.

Joint Effect of Heavy Vehicles and Diminished Light Conditions on Paediatric Pedestrian Injuries in Backover Crashes: A UK Population-Based Study.

Backover crashes cause considerable injuries especially among young children. Prior research on backover crashes has not assessed the joint effect of heavy vehicles and diminished light conditions on injuries. By analysing the United Kingdom STATS19 crash dataset from 1991 to 2020, this study focused on backover crashes involving paediatric cyclists or pedestrians aged ≤17 years and other motorised vehicles. By estimating the adjusted odds ratio (AOR) of multiple logistic regression models, pedestrians appeared to have 82.3% (95% CI: 1.78-1.85) higher risks of sustaining killed or serious injuries (KSIs) than cyclists. In addition, casualties involved in backover crashes with heavy vehicles were 39.3% (95% CI: 1.35-1.42) more likely to sustain KSIs than those involved in crashes with personal cars. The joint effect of heavy vehicles and diminished light conditions was associated with a 71% increased probability of sustaining KSIs (AOR = 1.71; 95% CI: 1.60-1.83). Other significant joint effects included young children (aged 0 to 5 years) as pedestrian (AOR = 1.92; 95% CI: 1.87-1.97), in diminished light conditions (AOR = 1.23; 95% CI: 1.15-1.31), and with heavy vehicle (AOR = 1.37; 95% CI: 1.28-1.47).

Injury in Children with Developmental Disorders: A 1:1 Nested Case-Control Study Using Multiple Datasets in Taiwan.

Although past studies have identified predictors related to child injuries with developmental disorders, national-level research in Asia is limited. The objective of this study was to explore the risk factors for child injuries with developmental disorders in Taiwan using a national-level integrated database for the period between 2004-2015 (The Maternal and Child Health Database, National Health Insurance Research Database, Census Registry, and Indigenous Household Registration). Children younger than 12 years old who had records of visiting the ER or being hospitalized due to injury or without injury were included in this study. A 1:1 nested case-control study (injury vs. noninjury) to examine the risk factors for child injury with developmental disorder was performed. A total of 2,167,930 children were enrolled. The risk factors were associated with repeated ER visits or hospitalization: being indigenous (adjusted odds ratio [AOR]: 1.51; CI: 1.45-1.57); having a developmental disorder (AOR: 1.74; CI: 1.70-1.78); and having parents with illicit drug use (AOR: 1.48; CI: 1.32-1.66), alcohol abuse (AOR: 1.21; CI: 1.07-1.37), or a history of mental illness (AOR: 1.43; CI: 1.41-1.46). Being indigenous, having developmental disorders, and having parents with history of illicit drug use, alcohol abuse, or mental illness were predictors related to injuries in children.

Association between prehospital fluid resuscitation with crystalloids and outcome of trauma patients in Asia by a cross-national multicenter cohort study.

Prehospital fluid resuscitation with crystalloids in patients following trauma remain controversial. This study aimed to investigate the association between prehospital fluid resuscitation and outcomes of trauma patients in Asia. We conducted a retrospective cohort study of trauma patients between 2016 and 2018 using data from the Pan-Asia Trauma Outcomes Study (PATOS) database. Prehospital fluid resuscitation was defined as any administration of intravenous crystalloid fluid on the ambulance before arrival to hospitals. The outcomes were in-hospital mortality and poor functional outcomes, defined as Modified Rankin Scale ≥ 4. Propensity score matching (PSM) was used to equalize potential prognostic factors in both groups. This study included 31,735 patients from six countries in Asia, and 4318 (13.6%) patients had ever received prehospital fluid resuscitation. The patients receiving prehospital fluid resuscitation had a higher risk of in-hospital mortality, with an adjusted odds ratio (aOR) of 2.02, 95% confidence interval (CI) 1.32-3.10, p = 0.001 in PSM analysis. Prehospital fluid resuscitation was also associated with poor functional outcomes, with an OR 1.73, 95% CI: 1.48-2.03, p < 0.001 in PSM analysis. Prehospital fluid resuscitation in patients with major trauma (injury severity score ≥ 16) presented a higher risk of poor functional outcomes (aOR = 2.65, 95% CI: 1.89-3.73 in PSM analysis, pinteraction = 0.006) via subgroup analysis. Prehospital fluid resuscitation of trauma patients is associated with higher in-hospital mortality and poor functional outcomes in the subgroup in countries studied.

Pediatric Traffic Injuries on Halloween in the United Kingdom: Prevalence and Injury Severity.

The study results serve as a reminder for parents, children, and drivers to be alert to the danger of traffic crashes on Halloween. The aim of this study was to examine whether Halloween is associated with a higher incidence of traffic injuries and whether traffic injuries sustained on Halloween are more severe than those sustained on other days. The U.K. STATS19 database, including the data of all road traffic crashes occurring from 1990 to 2017, was employed. A total of 73,587 pediatric traffic casualties (involving pedestrians, cyclists, and moped riders) were included. Between 17:00 and 19:00 (17:00~18:59) on Halloween, the number of casualties was higher than that on other public holidays and usual days. The logistic regression model revealed that, between 17:00 and 18:00 (17:00~17:59), the risk of being killed or seriously injured on Halloween was 34.2% higher (odds ratio = 1.342; 95% CI = 1.065-1.692) than that on other days. Pediatric crashes occurring on Halloween are associated with a higher number of injuries and increased injury severity.

Prognostic Model for De Novo and Recurrent Metastatic Breast Cancer.

PURPOSE: Metastatic breast cancer (MBC) has a heterogeneous clinical course. We sought to develop a prognostic model for overall survival (OS) that incorporated contemporary tumor and clinical factors for estimating individual prognosis. METHODS: We identified patients with MBC from our institution diagnosed between 1998 and 2017. We developed OS prognostic models by Cox regression using demographic, tumor, and treatment variables. We assessed model predictive accuracy and estimated annual OS probabilities. We evaluated model discrimination and prediction calibration using an external validation data set from the National Comprehensive Cancer Network. RESULTS: We identified 10,655 patients. A model using age at diagnosis, race or ethnicity, hormone receptor and human epidermal growth factor receptor 2 subtype, de novo versus recurrent MBC categorized by metastasis-free interval, Karnofsky performance status, organ involvement, frontline biotherapy, frontline hormone therapy, and the interaction between variables significantly improved predictive accuracy (C-index, 0.731; 95% CI, 0.724 to 0.739) compared with a model with only hormone receptor and human epidermal growth factor receptor 2 status (C-index, 0.617; 95% CI, 0.609 to 0.626). The extended Cox regression model consisting of six independent models, for < 3, 3-14, 14-20, 20-33, 33-61, and ≥ 61 months, estimated up to 5 years of annual OS probabilities. The selected multifactor model had good discriminative ability but suboptimal calibration in the group of 2,334 National Comprehensive Cancer Network patients. A recalibration model that replaced the baseline survival function with the average of those from the training and validation data improved predictions across both data sets. CONCLUSION: We have generated and validated a robust prognostic OS model for MBC. This model can be used in clinical decision making and stratification in clinical trials.

Effects of systemic therapy and local therapy on outcomes of 873 breast cancer patients with metastatic breast cancer to brain: MD Anderson Cancer Center experience.

Outcomes of treatments for patients with breast cancer brain metastasis (BCBM) remain suboptimal, especially for systemic therapy. To evaluate the effectiveness of systemic and local therapy (surgery [S], stereotactic radiosurgery [SRS] and whole brain radiotherapy [WBRT]) in BCBM patients, we analyzed the data of 873 BCBM patients from 1999 to 2012. The median overall survival (OS) and time to progression in the brain (TTP-b) after diagnosis of brain metastases (BM) were 9.1 and 7.1 months, respectively. WBRT prolonged OS in patients with multiple BM (hazard ratio [HR], 0.68; 95% CI, 0.52-0.88; P = .004). SRS alone, and surgery or SRS followed by WBRT (S/SRS + WBRT), were equivalent in OS and TTP-b (median OS, 14.9 vs 17.2 months; median TTP-b, 8.2 vs 8.6 months). Continued chemotherapy prolonged OS (HR, 0.35; 95% CI, 0.30-0.41; P < .001) and TTP-b (HR, 0.48; 95% CI, 0.33-0.70; P < .001), however, with no advantage of capecitabine over other chemotherapy agents used (median OS, 11.8 vs 12.4 months; median TTP-b, 7.2 vs 7.4 months). Patients receiving trastuzumab at diagnosis of BM, continuation of anti-HER2 therapy increased OS (HR, 0.53; 95% CI, 0.34-0.83; P = .005) and TTP-b (HR, 0.41; 95% CI, 0.23-0.74; P = .003); no additional benefit was seen with switching over between trastuzumab and lapatinib (median OS, 18.4 vs 22.7 months; median TTP-b: 7.4 vs 8.7 months). In conclusion, SRS or S/SRS + WBRT were equivalent for patients' OS and local control. Continuation systemic chemotherapy including anti-HER2 therapy improved OS and TTP-b with no demonstrable advantage of capecitabine and lapatinib over other agents of physicians' choice was observed.

Incorporation of clinical and biological factors improves prognostication and reflects contemporary clinical practice.

We developed prognostic models for breast cancer-specific survival (BCSS) that consider anatomic stage and other important determinants of prognosis and survival in breast cancer, such as age, grade, and receptor-based subtypes with the intention to demonstrate that these factors, conditional on stage, improve prediction of BCSS. A total of 20,928 patients with stage I-III invasive primary breast cancer treated at The University of Texas MD Anderson Cancer Center between 1990 and 2016, who received surgery as an initial treatment were identified to generate prognostic models by Fine-Gray competing risk regression model. Model predictive accuracy was assessed using Harrell's C-index. The Aalen-Johansen estimator and a selected Fine-Gray model were used to estimate the 5-year and 10-year BCSS probabilities. The performance of the selected model was evaluated by assessing discrimination and prediction calibration in an external validation dataset of 29,727 patients from the National Comprehensive Cancer Network (NCCN). The inclusion of age, grade, and receptor-based subtype in addition to stage significantly improved the model predictive accuracy (C-index: 0.774 (95% CI 0.755-0.794) vs. 0.692 for stage alone, p < 0.0001). Young age (<40), higher grade, and TNBC subtype were significantly associated with worse BCSS. The selected model showed good discriminative ability but poor calibration when applied to the validation data. After recalibration, the predictions showed good calibration in the training and validation data. More refined BCSS prediction is possible through a model that has been externally validated and includes clinical and biological factors.

Comparison of trauma systems in Asian countries: a cross-sectional study.

OBJECTIVE: This study aimed to compare the demographic characteristics and trauma service structures and processes of hospitals in 15 countries across the Asia Pacific, and to provide baseline data for the integrated trauma database: the Pan-Asian Trauma Outcomes Study (PATOS). METHODS: Medical directors and emergency physicians at PATOS-participating hospitals in countries across the Asia Pacific were surveyed through a standardized questionnaire. General information, trauma care system data, and trauma emergency department (ED) outcomes at each hospital were collected by email and analyzed using descriptive statistics. RESULTS: Survey data from 35 hospitals across 15 countries were collected from archived data between June 2014 and July 2015. Designated trauma centers were identified as the highest hospital level for trauma patients in 70% of surveyed countries. Half of the hospitals surveyed had special teams for trauma care, and almost all prepared activation protocol documents for these teams. Most hospitals offered specialized trauma education programs, and 72.7% of hospitals had a hospital-based trauma registry. The total number of trauma patients visiting the ED across 25 of the hospitals was 300,376. The overall survival-to-discharge rate was 97.2%; however, it varied greatly between 85.1% and 99.7%. The difference between survival-to-discharge rates of moderate and severe injury groups was highest in Taiwan (41.8%) and lowest in Thailand (18.6%). CONCLUSION: Trauma care systems and ED outcomes vary widely among surveyed hospitals and countries. This information is useful to build further detailed, systematic platforms for trauma surveillance and evidence-based trauma care policies.

Outcomes in patients with early-stage breast cancer who underwent a 21-gene expression assay.

BACKGROUND: Invasive disease-free survival (IDFS) rates are excellent in patients with breast cancer (BC) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), axillary lymph node-negative (LN-) tumors with a 21-gene expression assay recurrence score (RS) of 0 to 10. However, to the authors' knowledge, the outcomes among patients with an RS of 11 to 25 who are treated with endocrine therapy alone are unknown. METHODS: In this retrospective single-institution study, the authors described the characteristics of patients with HR+, HER2-, LN- BC who underwent a 21-gene expression assay. In addition, among those individuals diagnosed between 2005 and 2011, we measured IDFS, recurrence-free survival, distant recurrence-free survival, and overall survival rates, focusing on patients with an RS of 11 to 25 by receipt of chemotherapy. The Kaplan-Meier method was used to estimate survival rates and multivariable Cox proportional hazards models were used to calculate hazard ratios and 95% confidence intervals (95% CIs). RESULTS: Among 1424 patients, the RS distribution was 0 to 10 in 297 patients (21%), 11 to 25 in 894 patients (63%), and >25 in 233 patients (16%); of these, 1.7%, 15%, and 73.4% of patients, respectively, received chemotherapy. With a median follow-up of 58 months, those patients with an RS of 11 to 25 had an IDFS rate at 5 years of 92.6% (95% CI, 89.6%-94.7%), which was comparable between those who received chemotherapy and those who did not. The hazard ratios of the effect of chemotherapy were 1.64 for IDFS (95% CI, 0.73-3.71), 1.46 for recurrence-free survival (95% CI, 0.41-5.23), 1.25 for distant recurrence-free survival (95% CI, 0.32-4.92), and 2.19 for overall survival (95% CI, 0.44-11.0). CONCLUSIONS: The results of the current study demonstrate similar outcomes with or without chemotherapy in patients with HR+, HER2-, LN- BC who have an RS of 11 to 25, but a benefit from chemotherapy in this group cannot be ruled out. Cancer 2017;123:2422-31. © 2017 American Cancer Society.

Molecular Profiling Using Breast Cancer Subtype to Plan for Breast Reconstruction.

BACKGROUND: Molecular profiling using breast cancer subtype has an increasing role in the multidisciplinary care of the breast cancer patient. The authors sought to determine the role of breast cancer subtyping in breast reconstruction and specifically whether breast cancer subtyping can determine the need for postmastectomy radiation therapy and predict recurrence-free survival to plan for the timing and technique of breast reconstruction. METHODS: The authors reviewed prospectively collected data from 1931 reconstructed breasts in breast cancer patients who underwent mastectomy between November of 1999 and December of 2012. Reconstructed breasts were grouped by breast cancer subtype and examined for covariates predictive of recurrence-free survival and need for postmastectomy radiation therapy. RESULTS: Of the reconstructed breasts, 753 (39 percent) were luminal A, 538 (27.9 percent) were luminal B, 224 (11.6 percent) were luminal HER2, 143 (7.4 percent) were HER2-enriched, and 267 (13.8 percent) were triple-negative breast cancer. Postmastectomy radiation therapy was delivered in 69 HER2-enriched patients (48.3 percent), 94 luminal HER2 patients (42 percent), 200 luminal B patients (37.2 percent), 99 triple-negative breast cancer patients (37.1 percent), and 222 luminal A patients (29.5 percent) (p < 0.0001). Luminal A cases had better recurrence-free survival than HER2-enriched cases, and triple-negative breast cancer cases had worse recurrence-free survival than HER2-enriched cases. Luminal B and luminal HER2 cases had recurrence-free survival similar to that for HER2-enriched cases. Luminal A subtype was associated with the best recurrence-free survival. Subtyping may have improved the breast surgery planning for 33.1 percent of delayed reconstructions that did not require postmastectomy radiation therapy and 37 percent of immediate reconstructions that did require postmastectomy radiation therapy. CONCLUSION: This study is the first publication in the literature to evaluate breast cancer subtype to stratify risk for decision making in breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Mammographic breast density is associated with the development of contralateral breast cancer.

BACKGROUND: Women with dense mammographic breast density (BD) have a 2-fold increased risk of developing primary breast cancer (BC). The authors hypothesized that dense mammographic BD also is associated with an increased risk of developing contralateral breast cancer (CBC). METHODS: Among female patients treated at The University of Texas MD Anderson Cancer Center for sporadic, AJCC stage I to stage III BC between January 1997 and December 2012, the authors identified patients who had developed metachronous CBC (cases) and selected 1:2 matched controls who did not develop CBC using incidence density sampling, matched on attainted age, year of diagnosis, and hormone receptor status of the first BC. Mammographic BD, assessed at the time of first BC diagnosis, was categorized as "nondense" (American College of Radiology breast categories of fatty or scattered density) or "dense" (American College of Radiology categories of heterogeneously dense or extremely dense). Multivariable conditional logistic regression models were used for statistical analysis. RESULTS: A total of 229 cases and 451 controls were evaluated. Among the cases, approximately 39.3% had nondense breast tissue and 60.7% had dense breast tissue. Among controls, approximately 48.3% had nondense breast tissue and 51.7% had dense breast tissue. After adjustment for potential prognostic risk factors for BC, the odds of developing CBC were found to be significantly higher for patients with dense breasts (odds ratio, 1.80; 95% confidence interval, 1.22-2.64 [P<.01]) than for those with nondense breasts. Patients who received chemotherapy or endocrine therapy were less likely to develop CBC. CONCLUSIONS: In women with primary BC, mammographic BD appears to be a risk factor for the development of CBC. Cancer 2017;123:1935-1940. © 2017 American Cancer Society.

Impact of clinical trial on survival outcomes.

The number of patients with breast cancer who participate in therapeutic clinical trials remains low. One reason is a lack of opportunity; another is health care providers who do not recommend trials because they fear poorer outcome from the use of new drugs. Thus, we compared survival outcome in patients with metastatic breast cancer (MBC) who participated in first-line therapeutic clinical trials with outcome in patients who had never enrolled in a clinical trial and received only standard care. We hypothesized that first-line therapeutic clinical trials does not have a negative survival outcome. We reviewed the records of patients with MBC who were treated at MD Anderson Cancer Center between January 2000, and December 2010. The medical records of 5501 patients with MBC were screened, and 652 patients-285 in the trial arm and 367 in the control arm-met our specific eligible criteria. The median follow-up of our cohort was 7.16 years (95 % confidence interval [CI] 6.53-7.64 years). Among the global population, no significant differences in progression-free survival (PFS) or overall survival (OS) were observed between the treatment arms: for the clinical trial cohort, median PFS was 7 months (95 % CI 5.72-8.71 months), and median OS was 28.48 months (95 % CI 22.70-34.60 months). For the control cohort, median PFS was 10.02 months (95 % CI 7.13-11.99 months), and median OS was 28.71 months (95 % CI 24.41-31.31 months) (P = .089 and .335, respectively). Enrollment in first-line MBC therapeutic clinical trials does not result in less favorable survival outcome than that in MBC patients who never enrolled in a clinical trial.

Lipofilling of the Breast Does Not Increase the Risk of Recurrence of Breast Cancer: A Matched Controlled Study.

BACKGROUND: Although many plastic surgeons perform autologous fat grafting (lipofilling) for breast reconstruction after oncologic surgery, it has not been established whether postoncologic lipofilling increases the risk of breast cancer recurrence. The authors assessed the risk of locoregional and systemic recurrence in patients who underwent lipofilling for breast reconstruction. METHODS: The authors identified all patients who underwent segmental or total mastectomy for breast cancer (719 breasts) (i.e., cases) or breast cancer risk reduction or benign disease (305 cancer-free breasts) followed by breast reconstruction with lipofilling as an adjunct or primary procedure between June of 1981 and February of 2014. They also then identified matched patients with breast cancer treated with segmental or total mastectomy followed by reconstruction without lipofilling (670 breasts) (i.e., controls). The probability of locoregional recurrence was estimated by the Kaplan-Meier method. RESULTS: Mean follow-up times after mastectomy were 60 months for cases, 44 months for controls, and 73 months for cancer-free breasts. Locoregional recurrence was observed in 1.3 percent of cases (nine of 719 breasts) and 2.4 percent of controls (16 of 670 breasts). Breast cancer did not develop in any cancer-free breast. The cumulative 5-year locoregional recurrence rates were 1.6 percent and 4.1 percent for cases and controls, respectively. Systemic recurrence occurred in 2.4 percent of cases and 3.6 percent of controls (p = 0.514). There was no primary breast cancer in healthy breasts reconstructed with lipofilling. CONCLUSIONS: The study results showed no increase in locoregional recurrence, systemic recurrence, or second breast cancer. These findings support the oncologic safety of lipofilling in breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Ten-Year Outcomes of Patients With Breast Cancer With Cytologically Confirmed Axillary Lymph Node Metastases and Pathologic Complete Response After Primary Systemic Chemotherapy.

IMPORTANCE: The long-term effect of axillary pathologic complete response (pCR) on survival among women with breast cancer treated with primary systemic chemotherapy (PST) is unknown. OBJECTIVE: To assess the long-term effect of axillary pCR on relapse-free survival (RFS) and overall survival (OS) in women with breast cancer with cytologically confirmed axillary lymph node metastases treated with PST. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively analyzed the effect of axillary pCR on 10-year OS and RFS among all women who received a diagnosis of breast cancer stages II to III with cytologically confirmed axillary metastases between 1989 and 2007 who received PST at a large US comprehensive cancer center. Women were stratified by post-PST axillary status, and survival outcomes were estimated and compared according to response in the breast and axilla. MAIN OUTCOMES AND MEASURES: Outcomes of interest were RFS and OS. RESULTS: Of 1600 women treated, median (range) age at diagnisis was 49 (21-86) years. A total of 454 (28.4%) achieved axillary pCR. These patients were more likely to have human epidermal growth factor receptor 2 (HER2)-positive and triple-negative disease (P < .001), pCR in the breast (P < .001), high-grade tumors (P < .001), and lower clinical and pathologic T stage (P = .002). Ten-year OS rates were 84% (95% CI, 79%-88%) and 57% (95% CI, 54%-61%) (P < .001) and 10-year RFS rates 79% (95% CI, 74%-83%) and 50% (95% CI, 46%-53%) (P < .001) for patients with axillary pCR and residual axillary disease, respectively. For patients with axillary pCR, 10-year OS rates were 90% (95% CI, 84%-94%) for those with breast pCR and 72% (95% CI, 61%-80%) for those with residual breast disease (P < .001). For patients with residual axillary disease, 10-year OS rates were 66% (95% CI, 56%-74%) for patients with and 56% (95% CI, 52%-60%) for patients without breast pCR (P = .02). Of patients receiving HER2-targeted therapy for HER2-positive disease, 67.1% (100 of 149) achieved axillary pCR; 10-year OS rates were 92% (95% CI, 84%-96%) and 57% (95% CI, 20%-82%) (P = .003) and 10-year RFS rates 89% (95% CI, 81%-94%) and 44% (95% CI, 18%-68%) (P < .001) for those with axillary pCR and residual axillary disease, respectively. CONCLUSIONS AND RELEVANCE: Axillary pCR was associated with improved 10-year OS and RFS. Patients with axillary and breast pCR after PST had superior long-term survival outcomes. Patients undergoing HER2-targeted therapy for HER2-positive disease had high rates of axillary pCR, and those with axillary pCR had excellent 10-year OS.

Circulating tumor cells in newly diagnosed inflammatory breast cancer.

INTRODUCTION: Circulating tumor cells (CTCs) are an independent prognostic factor for progression-free survival (PFS) and overall survival (OS) in patients with metastatic breast cancer. Inflammatory breast cancer (IBC) is one of the most aggressive forms of breast cancer. The prognostic value of a CTC count in newly diagnosed IBC has not been established. The aim of this study was to assess the prognostic value of a baseline CTC count in patients with newly diagnosed IBC. METHODS: This retrospective study included 147 patients with newly diagnosed IBC (77 with locally advanced and 70 with metastatic IBC) treated with neoadjuvant therapy or first-line chemotherapy during the period from January 2004 through December 2012 at The University of Texas MD Anderson Cancer Center. CTCs were detected and enumerated by using the CellSearch system before patients were started with chemotherapy. RESULTS: The proportion of patients with ≥1 CTC was lower among patients with stage III than among patients with metastatic IBC (54.5% versus 84.3%; P=0.0002); the proportion of patients with ≥5 CTCs was also lower for stage III than for metastatic IBC (19.5% versus 47.1%; P=0.0004). Patients with fewer than five CTCs had significantly better progression-free survival (PFS) (hazard ratio (HR)=0.60; P=0.02) and overall survival (HR=0.59; P=0.03) than patients with five or more CTCs. Among patients with stage III IBC, there was a nonsignificant difference in PFS (HR=0.66; 95% confidence interval (CI), 0.31 to 1.39; P=0.29) and OS (HR=0.54; 95% CI, 0.24 to 1.26; P=0.48) in patients with no CTCs compared with patients with one or more CTCs. In multivariate analysis, CTC was prognostic for PFS and OS independent of clinical stage. CONCLUSIONS: CTCs can be detected in a large proportion of patients with newly diagnosed IBC and are a strong predictor of worse prognosis in patients with newly diagnosed IBC.