Publications by authors named "Erin Moshier"

138 Publications

Quality Care in Survivorship: Lessons Learned From the ASCO Quality Oncology Practice Initiative.

JCO Oncol Pract 2021 Jul 20:OP2100290. Epub 2021 Jul 20.

National Cancer Institute, Division of Cancer Control and Population Sciences, Bethesda, MD.

Purpose: The ASCO Quality Oncology Practice Initiative (QOPI) project was established to evaluate the influence of guideline recommendations on routine clinical practice.

Methods: QOPI provided summary data from 839 unique practices in which data were collected every six months from the Fall of 2015 to the Spring of 2019. From these data, six items were chosen based on their relationship to domains of survivorship. A zero-inflated negative binomial regression model was used to test for trends in QOPI measures adherence rates over time. The models were adjusted for the time period, region, practice-ownership, multispecialty site, fellowship program, and hospital type.

Results: Smoking cessation counseling recommended and smoking cessation counseling administered or referred both increased over time, 50%-61% (adjusted incidence rate ratios (IRR), 1.028; 95% CI, 1.016 to 1.040; < .001) and 34%-49% (adjusted IRR, 1.052; 95% CI, 1.035 to 1.070; < .001), respectively. Infertility risks discussed before chemotherapy increased from 36% to 53% (adjusted IRR, 1.056; 95% CI, 1.035 to 1.078; < .001) and fertility options discussed or referred to specialists increased from 23% to 38% (adjusted IRR, 1.074; 95% CI, 1.046 to 1.102; < .001). Twenty-nine percent documented a positron emission tomography, computed tomography, or bone scan within the first 12 months for women diagnosed with early breast cancer treated for curative intent (adjusted IRR, 1.000; 95% CI, 0.977 to 1.024; = .971). Tumor marker surveillance within 12 months increased from 78% to 87% (adjusted IRR, 1.018; 95% CI, 1.002 to 1.033; = .023).

Conclusion: As scientific evidence to guide cancer survivorship care grows, the role of guideline recommendations permeating clinical practice using quality metrics will become increasingly important.
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http://dx.doi.org/10.1200/OP.21.00290DOI Listing
July 2021

Effect of Advanced Glycation End Products on Cognition in Older Adults with Type 2 Diabetes: Results from a Pilot Clinical Trial.

J Alzheimers Dis 2021 Jul 5. Epub 2021 Jul 5.

The Joseph Sagol Neuroscience Center, Sheba Medical Center, Tel-Hashomer, Israel.

Background: Dietary advanced glycation end-products (AGEs) are linked to cognitive decline. However, clinical trials have not tested the effect of AGEs on cognition in older adults.

Objective: The aim of the current pilot trial was to examine the feasibility of an intervention to reduce dietary AGEs on cognition and on cerebral blood flow (CBF).

Methods: The design is a pilot randomized controlled trial of dietary AGEs reduction in older adults with type 2 diabetes. Seventy-five participants were randomized to two arms. The control arm received standard of care (SOC) guidelines for good glycemic control; the intervention arm, in addition to SOC guidelines, were instructed to reduce their dietary AGEs intake. Global cognition and CBF were assessed at baseline and after 6 months of intervention.

Results: At baseline, we found a reverse association between AGEs and cognitive functioning, possibly reflecting the long-term toxicity of AGEs on the brain. There was a significant improvement in global cognition at 6 months in both the intervention and SOC groups which was more prominent in participants with mild cognitive impairment. We also found that at baseline, higher AGEs were associated with increased CBF in the left inferior parietal cortex; however, 6 months of the AGEs lowering intervention did not affect CBF levels, despite lowering AGEs exposure in blood.

Conclusion: The current pilot trial focused on the feasibility and methodology of intervening through diet to reduce AGEs in older adults with type 2 diabetes. Our results suggest that participants with mild cognitive impairment may benefit from an intensive dietary intervention.
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http://dx.doi.org/10.3233/JAD-210131DOI Listing
July 2021

Ruxolitinib discontinuation in polycythemia vera: Patient characteristics, outcomes, and salvage strategies from a large multi-institutional database.

Leuk Res 2021 May 27;109:106629. Epub 2021 May 27.

Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, United States. Electronic address:

Ruxolitinib is approved for the treatment of patients with polycythemia vera (PV) who are intolerant or resistant to hydroxyurea. While ruxolitinib discontinuation in myelofibrosis is associated with dismal outcomes, the analogous experience in PV has not been reported. Using a large, multi-institutional database of PV patients, we identified 93 patients with PV who were treated with ruxolitinib, of whom 22 discontinued therapy. Adverse events were the primary reason for discontinuation. After a median follow-up of 18.2 months following ruxolitinib discontinuation, no patients experienced a thrombotic event. One patient died 20.8 months after discontinuation. As compared with the 71 patients who were still receiving treatment with ruxolitinib at last follow up, patients who discontinued ruxolitinib were older at time of treatment initiation (67.5 versus 64.8 years, p = 0.0058), but had similar patient and disease characteristics. After discontinuation, only 4 patients (18 %) received subsequent cytoreductive therapy, including hydroxyurea in one patient and pegylated interferon α-2a in three patients. In stark contrast to the experience in myelofibrosis, discontinuation of ruxolitinib in PV was associated with generally favorable outcomes. However, there is a lack of available salvage therapies, highlighting the need for further therapeutic development in PV.
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http://dx.doi.org/10.1016/j.leukres.2021.106629DOI Listing
May 2021

Prognostic Factors and Survival Outcomes among Patients with Breast Cancer and Brain Metastases at Diagnosis: A National Cancer Database Analysis.

Oncology 2021 2;99(5):280-291. Epub 2021 Mar 2.

Hematology/Oncology Department, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Introduction: The aim of this study was to assess for clinicopathologic and socioeconomic features that predict improved survival for patients with advanced breast cancer with synchronous brain metastases at diagnosis.

Methods: We utilized the National Cancer Database (NCDB) to identify all patients with brain metastases present at diagnosis, with adequate information on receptor status (ER, PR, Her2), clinical T stage of cT1-4, clinical M1, with 3,943 patients available for analysis. The association between brain metastases patterns and patient/disease variables was examined by robust Poisson regression model. Cox proportional hazards model was used to quantify the associations between overall survival (OS) and these variables.

Results: In univariable analysis, OS was significantly associated with the number of sites of metastases (p < 0.0001). Patients with 2 or more additional extracranial sites of metastases had significantly worse OS (median 8.8 months, 95% confidence interval [CI] 7.8, 9.9) than patients with brain metastases only (median OS 10.6 months, 95% CI 9.4, 12.9) or brain metastases plus one other extracranial site of metastases (median OS 13.1 months, 95% CI 11.8, 14.4). Risk factors which predicted poor prognosis included triple-negative disease, high comorbidity score, poorly differentiated tumors, invasive lobular histology, multi-organ involvement of metastases, and government or lack of insurance. Factors which improve survival include younger age and Hispanic race.

Discussion/conclusion: Using a large NCDB, we identified various factors associated with prognosis for patients with brain metastases at the time of breast cancer diagnosis. Insurance status and related socioeconomic challenges provide potential areas for improvement in care for these patients. This information may help stratify patients into prognostic categories at the time of diagnosis to improve treatment plans.
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http://dx.doi.org/10.1159/000512212DOI Listing
May 2021

Neoadjuvant therapy for gastrointestinal stromal tumors: A propensity score-weighted analysis.

Int J Cancer 2021 Jul 19;149(1):177-185. Epub 2021 Mar 19.

Department of Medicine, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Retrospective and single-arm prospective studies have reported clinical benefit with neoadjuvant imatinib for GISTs. In the absence of randomized Phase III data, the impact of neoadjuvant systemic therapy (NAT) on survival compared to upfront resection (UR) remains unknown. We identified N = 16 308 patients within the National Cancer Database (2004-2016) who underwent resection of localized GIST of the stomach, esophagus, small bowel and colorectum, with or without ≥3 months of NAT. Inverse probability of treatment weighting adjusted for covariable imbalance among treatment groups. We estimated the effect of NAT on overall survival with a weighted time-dependent Cox proportional hazards model, and on 90-day postoperative mortality and R0 resection with weighted logistic regressions. Eight hundred sixty-five (5.3%) patients received NAT compared to 15 443 (94.7%) who underwent UR. Median NAT duration was 6.3 months. 53.7% of NAT patients were male vs 48.6% of UR patients, 67.3% vs 65.1% had primary gastric GIST and 72.8% vs 49.7% were at high risk. NAT patients had larger tumors and higher mitotic index. >3 months of NAT was associated with a significant survival benefit (weighted HR 0.85 [0.80-0.91]). 90-day postoperative mortality rate was 4/865 (0.5%) among NAT patients vs 346/15443 (2.2%). NAT was associated with lower odds of 90-day postoperative mortality. R0 resection rate was not significantly different between groups. In conclusion, despite higher risk features among NAT patients, this analysis suggests that NAT for localized GIST is associated with a modest survival benefit and lower risk of 90-day postoperative mortality, with no difference in likelihood of achieving an R0 resection.
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http://dx.doi.org/10.1002/ijc.33536DOI Listing
July 2021

Trends in neoadjuvant chemotherapy versus surgery-first in stage I HER2-positive breast cancer patients in the National Cancer DataBase (NCDB).

Breast Cancer Res Treat 2021 May 4;187(1):177-185. Epub 2021 Jan 4.

Dubin Breast Center of the Tisch Cancer Institute, Mount Sinai Hospital, New York, NY, USA.

Background: Neoadjuvant chemotherapy (NAC) is the standard of care for locally advanced HER2 + breast cancer (BC). Optimal sequencing of treatment (NAC vs. surgery first) is less clear cut in stage I (T1N0) HER2 + BC, where information from surgical pathology could impact adjuvant treatment decisions. Utilizing the NCDB, we evaluated the trend of NAC use compared to upfront surgery in patients with small HER2 + BC.

Methods: We identified NCDB female patients diagnosed with T1 N0 HER2 + BC from 2010 through 2015. Prevalence ratios (PR) using multivariable robust Poisson regression models were calculated to measure the association between baseline characteristics and the receipt of NAC. Analysis of trends over time was denoted by annual percent change (APC) of NAC versus surgery upfront.

Results: Of the 14,949 that received chemotherapy and anti-HER2 therapy during the study period, overall 1281 (8.6%) received NAC and 13,668 (91.4%) received adjuvant treatment. Patients receiving NAC increased annually from 4.2% in 2010 to 17.3% in 2015, with the most rapid increase occurring between years 2013 (8.5%) and 2014 (14.2%). The greatest increase was seen in patients with cT1c tumors with an APC of 37.8% over the study period (95% CI 29.0, 47.3%, p < 0.01), although a significant trend was likewise seen in patients with cT1a (APC = 26.1%,95% CI 1.59, 56.6%), and cT1b (APC = 27.4%, 95% CI 18.0, 37.7%) tumors. Predictors of neoadjuvant therapy receipt were age younger than 50 (PR = 1.69, 95% CI 1.52, 1.89), Mountain/Pacific area (PR = 1.24, 95% CI 1.05, 1.46), and estrogen receptor negativity (ER- PR + : PR = 2.01, 95% CI 1.51, 2.68; ER- PR- : PR = 1.49, 95% CI 1.32, 1.69).

Conclusions: Neoadjuvant therapy for T1 N0 HER2 + BC increased over the study period and was mostly due increased use in clinical T1c tumors. This may be consistent with secular change in Pertuzumab treatment following FDA approval in 2013.
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http://dx.doi.org/10.1007/s10549-020-06041-2DOI Listing
May 2021

The impact of a rectal hydrogel spacer on dosimetric and toxicity outcomes among patients undergoing combination therapy with external beam radiotherapy and low-dose-rate brachytherapy.

Brachytherapy 2021 Mar-Apr;20(2):296-301. Epub 2020 Nov 13.

Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York, NY.

Purpose: Rectal hydrogel spacers have been shown to decrease rectal radiation dose and toxicity. In this study, we compared prostate and rectal dosimetry and acute toxicity outcomes in patients who had and had not received a rectal hydrogel spacer prior to combination therapy with external beam radiotherapy and low-dose-rate brachytherapy.

Materials And Methods: All patients with intermediate-risk and high-risk prostate cancer who received combination therapy at our institution were identified between 2014 and 2019. Dosimetric outcomes of brachytherapy implants and quality of life (QOL) outcomes were compared between patients who had and had not received a hydrogel spacer.

Results: A Total of 168 patients meeting our inclusion criteria were identified. Twenty-two patients had received a rectal hydrogel spacer, among whom the mean separation between the rectum and prostate was 7.5 mm, and the V100 was reduced by 47% (0.09 cc vs. 0.17 cc, p = 0.04). There was no difference in the percentage of patients achieving a D90 of ≥100 Gy between those who had and had not received a spacer. The mean rate of change in I-PSS and SHIM scores did not differ between the two groups at 2 months after PID.

Conclusion: LDR brachytherapy appears feasible after the placement of a rectal hydrogel spacer. While there was a significantly reduced V100 among patients who had received a hydrogel spacer, there was no statistically significant difference in patients achieving a D90 of ≥100 Gy. Although there was no difference appreciated in QOL scores, the length of follow-up was limited in the rectal-spacer group.
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http://dx.doi.org/10.1016/j.brachy.2020.09.018DOI Listing
November 2020

Patient Perception of Telehealth Services for Breast and Gynecologic Oncology Care during the COVID-19 Pandemic: A Single Center Survey-based Study.

J Breast Cancer 2020 Oct 19;23(5):542-552. Epub 2020 Oct 19.

Department of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Prior to the coronavirus disease 2019 (COVID-19) pandemic, telehealth was rarely utilized for oncologic care in metropolitan areas. Our large New York City based outpatient breast/gynecologic cancer clinic administered an 18-question survey to patients from March to June 2020, to assess the perceptions of the utility of telehealth medicine. Of the 622 patients, 215 (35%) completed the survey, and of the 215 respondents, 74 (35%) had participated in a telehealth visit. We evaluated the use of telehealth services using the validated Service User Technology Acceptability Questionnaire. Sixty-eight patients (92%) reported that telehealth services saved them time, 54 (73%) reported telehealth increased access to care, and 58 (82%) reported telehealth improved their health. Overall, 67 (92%) of patients expressed satisfaction with the use of telehealth services for oncologic care during the COVID-19 pandemic. Telehealth services should be carefully adopted as an addition to in-person clinical care of patients with cancer.
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http://dx.doi.org/10.4048/jbc.2020.23.e56DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7604367PMC
October 2020

Safety, Efficacy, and Long-Term Outcomes of Anticoagulation in Cirrhotic Portal Vein Thrombosis.

Dig Dis Sci 2020 Nov 5. Epub 2020 Nov 5.

Division of Liver Diseases, Recanati/Miller Transplantation Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Background: The role of anticoagulation (AC) in the management of cirrhotic patients with portal vein thrombosis (PVT) remains unclear.

Aims: We conducted a retrospective study of cirrhotic patients diagnosed with PVT from 1/1/2000 through 2/1/2019, comparing those who received AC to those who did not.

Methods: Outcomes included rate of complete radiographic resolution (CRR) of PVT, recanalization of occlusive PVT (RCO), PVT extension, major bleeding, and overall survival (OS). The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox-proportional-hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals.

Results: A total of 214 patients were followed for a median 27 months (IQR 12-48). Eighty-six patients (39%) received AC. AC was associated with significantly greater CRR (48% vs. 27%, p = 0.0007), (multivariable HR for CRR with AC; 2.49 (1.54-4.04, p = 0.0002)). AC was also associated with significantly greater RCO (69% vs. 28%, p = 0.0013), (multivariable HR for RCO with AC; 4.86 (1.91-12.37, p = 0.0009)). Rates of major bleeding were similar with and without AC (20% vs. 17%, p = 0.5207), multivariable HR for major bleeding with AC; 1.29 (0.68-2.46, p = 0.4423)). OS rates in the AC and no-AC groups were 83% and 70%, respectively (p = 0.1362), (HR for death with AC; 0.69 (0.38-1.28, p = 0.2441)). Among 75 patients who had CRR, 10 (13%) experienced recurrent PVT during follow-up (none were receiving AC at the time of recurrence).

Conclusions: AC appears safe and effective for the treatment of cirrhotic PVT; however, prospective studies to confirm these findings and evaluate additional outcomes are needed.
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http://dx.doi.org/10.1007/s10620-020-06695-4DOI Listing
November 2020

Durable disease control with local treatment for oligoprogression of metastatic solid tumors treated with immune checkpoint blockade.

Cancer Treat Res Commun 2020 8;25:100216. Epub 2020 Oct 8.

Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Background: While the concept of oligometastatic disease is increasingly recognized as a distinct clinical disease state, the concept of oligoprogression is less well-characterized. Oligoprogression may be particularly relevant in the context of immune checkpoint inhibitors (CPI) given the underlying mechanism of action and insights regarding acquired resistance. In this study, we sought to characterize the incidence of oligoprogression in patients on CPI and explore the impact of local therapy.

Materials And Methods: We performed a retrospective analysis of all patients with advanced solid tumors (excluding glioblastoma multiforme) who received a PD-1, PD-L1, or CTLA-4 inhibitor at a single institution between 2011 and 2017. Oligoprogression was defined as progression at ≤3 metastatic lesions outside of the brain after achieving at least stable disease on CPI for 3 months. Progression-free survival (PFS) was calculated using the Kaplan-Meier method.

Results: Among 425 patients treated with CPI, 390 had advanced primary solid tumors outside of the central nervous system. 321 of these patients were evaluable for response, among whom 102 achieved at least stable disease. Oligoprogression was observed in 4.1% of the entire cohort and 15.7% of patients achieving at least stable disease on CPI. Among 16 patients experiencing oligoprogression, 15 received local therapy to the oligoprogressive lesions, many of whom continued CPI. At a median follow-up of 25.8 months, the median PFS for patients with oligoprogression after local therapy was 15.4 months.

Conclusions: Oligoprogression occurs in a subset of patients after an initial response to CPI. However, patients receiving local therapy to oligoprogressive sites may experience durable disease control. Further study is warranted.

Microabstract: Oligoprogression was observed in 4.1% of the entire cohort of patients on immune checkpoint inhibitors in this study and 15.7% of patients achieving at least stable disease. Among 16 patients experiencing oligoprogression, 15 received local therapy. At a median follow-up of 25.8 months, the median progression-free survival for patients with oligoprogression after local therapy was 15.4 months and zero patients had died. Oligoprogression occurs in a subset of patients after an initial response to CPI and local therapy to oligoprogressive sites may result in durable disease control.
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http://dx.doi.org/10.1016/j.ctarc.2020.100216DOI Listing
October 2020

Transperineal Versus Transrectal Targeted Biopsy With Use of Electromagnetically-tracked MR/US Fusion Guidance Platform for the Detection of Clinically Significant Prostate Cancer.

Urology 2020 Dec 18;146:278-286. Epub 2020 Sep 18.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY; Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address:

Objective: To compare transperineal (TP-TBx) and transrectal (TR-TBx) targeted prostate biopsy in a prospective non randomized single surgeon series of MR/US fusion-guided targeted biopsy performed using an electromagnetic tracking platform (NCT04026763).

Materials And Methods: In this single-institution prospective study, 168 patients who underwent transperineal systematic 12-core biopsy and TP-TBx with electromagnetic tracking (UroNav, Invivo, Gainesville, FL) were compared to 211 patients who underwent a similar procedure by a transrectal approach. Univariate and multivariate analyses were used to assess if biopsy technique impacted all cancer detection rates or clinically significant (Gleason score >3+4) cancer detection rates.

Results: Patients who underwent TP-TBx were older (68 vs 65 y, P = .014), with a slightly higher rate of PI-RADSv2.0 score (39% vs 28%, P = .039) and higher lesion volume on mpMRI (0.54 vs 0.41 cc, P = .039). The rates of CS disease detection by TP-TBx and TR-TBx were 59% and 54%, respectively. In a multivariate analysis adjusting for PSA, previous biopsy status, prostate volume, PI-RADS score, lesion volume, and lesion location, there was no statistically significant difference in likelihood to detect any PCa (OR, 0.98; 95% CI, 0.56-1.71; P = .940) or CS PCa (OR, 0.94, 95% CI, 0.58-1.51; P = .791).

Conclusion: Transperineal targeted biopsy with electromagnetic-tracking is comparable to the transrectal fusion-guided approach in the detection of any PCa and csPCa cancer.
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http://dx.doi.org/10.1016/j.urology.2020.07.072DOI Listing
December 2020

Admission D-dimer levels, D-dimer trends, and outcomes in COVID-19.

Thromb Res 2020 12 20;196:99-105. Epub 2020 Aug 20.

Division of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, United States of America.

Observational data suggest an acquired prothrombotic state may contribute to the pathophysiology of COVID-19. These data include elevated D-dimers observed among many COVID-19 patients. We present a retrospective analysis of admission D-dimer, and D-dimer trends, among 1065 adult hospitalized COVID-19 patients, across 6 New York Hospitals. The primary outcome was all-cause mortality. Secondary outcomes were intubation and venous thromboembolism (VTE). Three-hundred-thirteen patients (29.4%) died, 319 (30.0%) required intubation, and 30 (2.8%) had diagnosed VTE. Using Cox proportional-hazard modeling, each 1 μg/ml increase in admission D-dimer level was associated with a hazard ratio (HR) of 1.06 (95%CI 1.04-1.08, p < 0.0001) for death, 1.08 (95%CI 1.06-1.10, p < 0.0001) for intubation, and 1.08 (95%CI 1.03-1.13, p = 0.0087) for VTE. Time-dependent receiver-operator-curves for admission D-dimer as a predictor of death, intubation, and VTE yielded areas-under-the-curve of 0.694, 0.621, and 0.565 respectively. Joint-latent-class-modeling identified distinct groups of patients with respect to D-dimer trend. Patients with stable D-dimer trajectories had HRs of 0.29 (95%CI 0.17-0.49, p < 0.0001) and 0.22 (95%CI 0.10-0.45, p = 0.0001) relative to those with increasing D-dimer trajectories, for the outcomes death and intubation respectively. Patients with low-increasing D-dimer trajectories had a multivariable HR for VTE of 0.18 (95%CI 0.05-0.68, p = 0.0117) relative to those with high-decreasing D-dimer trajectories. Time-dependent receiver-operator-curves for D-dimer trend as a predictor of death, intubation, and VTE yielded areas-under-the-curve of 0.678, 0.699, and 0.722 respectively. Although admission D-dimer levels, and D-dimer trends, are associated with outcomes in COVID-19, they have limited performance characteristics as prognostic tests.
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http://dx.doi.org/10.1016/j.thromres.2020.08.032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7439969PMC
December 2020

Use of neoadjuvant versus adjuvant chemotherapy for hormone receptor-positive breast cancer: a National Cancer Database (NCDB) study.

Breast Cancer Res Treat 2020 Nov 1;184(1):203-212. Epub 2020 Aug 1.

Mount Sinai Health System, New York, USA.

Introduction: Neoadjuvant chemotherapy (NAC) is a well-established therapeutic option for patients with locally advanced disease often allowing downstaging and facilitation of breast conserving therapy. With evolution of better targeted treatment regimens and awareness of improved outcomes for significant responders, use of NAC has expanded particularly for triple negative and HER2-positive (HER2+) breast cancer. In this study, we explore utility of neoadjuvant chemotherapy for hormone receptor-positive HER2-negative (HR+ HER2-) patients.

Methods: Patients with HR+ HER2- breast cancer treated with chemotherapy before or after surgery were identified from 2010 to 2015 in the NCDB. Multivariable regression models adjusted for covariates were used to determine associations within these groups.

Results: Among 134,574 patients (clinical stage 2A, 64%; 2B, 21%; 3, 15%), 105,324 (78%) had adjuvant chemotherapy (AC) and 29,250 (22%) received NAC. Use of NAC increased over time (2010-2015; 13.2-19.4% and PR = 1.34 for 2015; p < 0.0001). Patients were more likely to receive NAC with cT3, cT4, and cN+ disease. Patients less likely to receive NAC were age ≥ 50, lobular carcinoma, increased Charlson-Deyo score, and government insurance. Complete response (pCR) was noted in 8.3% of NAC patients. Axillary downstaging occurred in 21% of patients, and predictors included age < 50 years, black race, poorly differentiated grade, invasive ductal histology, and either ER or PR negativity.

Conclusions: NAC use among HR+ HER2- breast cancer patients has expanded over time and offers downstaging of disease for some patients, with pCR seen in only a small subset, but downstaging of the axilla in 21%. Further analysis is warranted to determine the subgroup of patients with HR+ HER2- disease who benefit from this approach.
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http://dx.doi.org/10.1007/s10549-020-05809-wDOI Listing
November 2020

Timing of Autologous Stem Cell Transplantation for Multiple Myeloma in the Era of Current Therapies.

Clin Lymphoma Myeloma Leuk 2020 10 7;20(10):e734-e751. Epub 2020 Jun 7.

Department of Medicine, Icahn School of Medicine at Mount Sinai, York, NY.

Background: Autologous stem cell transplantation (SCT) during the initial treatment of multiple myeloma has been shown to improve progression-free survival (PFS) but not overall survival (OS). While awaiting further prospective data, we retrospectively analyzed the outcomes of patients at our program.

Patients And Methods: We included consecutive patients with newly diagnosed myeloma who had undergone stem cell harvest (SCH) from 2005 to 2014 and separated them into early (SCT within 12 months of diagnosis) and delayed (all others, including SCT not yet) groups. The outcomes were OS, PFS to first relapse, and PFS to second relapse.

Results: Of the 514 patients who had undergone SCH, 227 were in the early and 287 in the delayed groups. Patients in the delayed group who had undergone SCT had received more therapy before SCT (55% had received ≥ 2 lines vs. 6% in the early group; P < .001), had had more progressive disease at SCT (34% vs. 4%; P < .001), had received melphalan doses < 200 mg/m (22% vs. 10%; P = .001), and had had lower rates of very good partial response or better after SCT (58% vs. 79%; P = .001). On multivariable analysis, no differences were found in median OS (90 vs. 84 months; P = .093), PFS to first relapse (40 vs. 37 months; P = .552), or PFS to second relapse (54 vs. 52 months; P = .488) between the early and delayed groups.

Conclusion: Delaying SCT did not affect OS or even PFS to second relapse in our cohort of patients with newly diagnosed myeloma who had received current era induction therapy.
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http://dx.doi.org/10.1016/j.clml.2020.05.027DOI Listing
October 2020

Real-World Outcomes of Ruxolitinib Treatment for Polycythemia Vera.

Clin Lymphoma Myeloma Leuk 2020 10 29;20(10):697-703.e1. Epub 2020 May 29.

Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address:

Introduction: Ruxolitinib is approved for the treatment of polycythemia vera (PV) with hydroxyurea resistance or intolerance. Approval was based on the phase III RESPONSE trial, which demonstrated efficacy in a highly selected patient population.

Materials And Methods: To characterize the tolerability and outcomes of ruxolitinib outside of a clinical trial, we performed a multi-center retrospective analysis of patients with PV treated with ruxolitinib at 11 participating sites across the United States. Outcomes of interest included change in phlebotomy requirements after starting ruxolitinib and spleen response, as these were included in the primary composite outcome in the RESPONSE trial.

Results: One hundred twenty-six patients met eligibility criteria, and the median duration of follow-up was 22.4 months (range, 0-63.0 months). At 32 weeks after starting ruxolitinib, the percentage of patients who received at least 1 phlebotomy was significantly decreased compared with before ruxolitinib (37% vs. 56%; relative risk [RR], 0.66; 95% confidence interval [CI], 0.52-0.84; P < .001). Phlebotomy requirements were similarly decreased in patients who had received at least 3 phlebotomies prior to ruxolitinib initiation (28% vs. 17%; RR, 1.65; 95% CI, 1.13-2.40; P < .01). Resolution of palpable splenomegaly was also documented (48% vs. 20%; RR, 2.45; 95% CI, 1.70-3.53; P < .0001). A total of 9.5% of patients discontinued ruxolitinib owing to treatment-emergent adverse events, and 81.7% of patients were receiving ruxolitinib at last known follow-up.

Conclusion: These real-world results are similar to those reported from the RESPONSE trial, although additional follow-up is necessary to assess long-term outcomes and potential for late-onset toxicity.
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http://dx.doi.org/10.1016/j.clml.2020.05.019DOI Listing
October 2020

Practicing Antimicrobial Stewardship: De-Escalating Antibiotics in Patients With Acute Myeloid Leukemia and Neutropenic Fever.

Open Forum Infect Dis 2020 May 21;7(5):ofaa138. Epub 2020 Apr 21.

Division of Infectious Disease, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

We compared risk of recurrent fever in patients with acute myeloid leukemia undergoing induction chemotherapy with febrile neutropenia without an infectious source in which antibacterials were de-escalated before neutrophil recovery versus continued. There was less recurrent fever when antibacterials were de-escalated early with no increased adverse events.
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http://dx.doi.org/10.1093/ofid/ofaa138DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7216765PMC
May 2020

Factors associated with the receipt and completion of whole brain radiation therapy among older adults in the United States from 2010-2013.

J Geriatr Oncol 2020 09 31;11(7):1096-1102. Epub 2020 Mar 31.

Department of Radiation Oncology, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, 1184 Fifth Avenue, New York, NY 10029, USA; Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, 1470 Madison Avenue, New York, NY 10029, USA. Electronic address:

Introduction: Whole brain radiation therapy (WBRT) is widely used to treat patients with brain metastases. However, there is debate regarding its utility in patients with poor prognoses. In this study, we sought to characterize the use of WBRT in the United States, especially in adults aged 55 and above.

Material And Methods: Patients with brain metastases were identified using the National Cancer Database between 2010 and 2013. The receipt and completion of WBRT with various patient factors were correlated using multivariable logistic regression.

Results: 28,422 patients with brain metastases were identified, 23,362 of whom were aged 55 or above. 14,845 patients received WBRT and 12,310 patients completed treatment. Among adults aged 55 and above, 11,945 patients received WBRT, and 9812 patients completed treatment. Patients aged 60 and above were less likely to receive WBRT, while those aged 65 and above were less likely to complete WBRT.

Discussion: These results suggest that WBRT may be over-utilized in the United States, especially among older adults. Better interventions to improve pre-WBRT decision-making in this population are needed to select patients who might derive benefit.
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http://dx.doi.org/10.1016/j.jgo.2020.03.010DOI Listing
September 2020

The Natural History, Treatments, and Outcomes of Portal Vein Thrombosis in Patients With Inflammatory Bowel Disease.

Inflamm Bowel Dis 2021 Jan;27(2):215-223

Division of Liver Diseases, Recanati/Miller Transplantation Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Background: Portal vein thrombosis (PVT) is a poorly described complication of inflammatory bowel disease (IBD). We sought to better characterize presentations, compare treatments, and assess outcomes in IBD-related PVT.

Methods: We conducted a retrospective investigation of IBD-related PVT at our institution. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios across treatments.

Results: Sixty-three patients with IBD-related PVT (26 with Crohn disease, 37 with ulcerative colitis) were followed for a median 21 months (interquartile ratio [IQR] = 9-52). Major risk factors included intra-abdominal surgery (60%), IBD flare (33%), and intra-abdominal infection (13%). Primary hematologic thrombophilias were rare and did not impact management. Presentations were generally nonspecific, and diagnosis was incidental. Ninety-two percent of patients (58/63) received anticoagulation (AC), including 23 who received direct oral anticoagulants (DOACs), 22 who received warfarin, and 13 who received enoxaparin. All anticoagulated patients started AC within 3 days of diagnosis. Complete radiographic resolution (CRR) of PVT occurred in 71% of patients. We found that DOACs were associated with higher CRR rates (22/23; 96%) relative to warfarin (12/22; 55%): the hazard ratio of DOACs to warfarin was 4.04 (1.83-8.93; P = 0.0006)). Patients receiving DOACs required shorter courses of AC (median 3.9 months; IQR = 2.7-6.1) than those receiving warfarin (median 8.5 months; IQR = 3.9-NA; P = 0.0190). Incidence of gut ischemia (n = 3), symptomatic portal hypertension (n = 3), major bleeding (n = 4), and death (n = 2) were rare, and no patients receiving DOACs experienced these adverse outcomes.

Conclusions: We show that early and aggressive use of AC can lead to excellent outcomes in IBD-associated PVT and that DOACs are associated with particularly favorable outcomes in this setting.
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http://dx.doi.org/10.1093/ibd/izaa053DOI Listing
January 2021

Clinical Benefit Derived from Decitabine Therapy for Advanced Phases of Myeloproliferative Neoplasms.

Acta Haematol 2021 11;144(1):48-57. Epub 2020 Mar 11.

Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA,

Treatment options are limited for patients with advanced forms of myeloproliferative neoplasms (MPN) including blast-phase disease (MPN-BP). Decitabine has frequently been deployed but its efficacy and safety profile are not well described in this population. We retrospectively reviewed 42 patients treated with decitabine either alone or in combination with ruxolitinib at our institution: 16 with MPN-BP, 14 with MPN accelerated-phase (MPN-AP), and 12 with myelofibrosis with high-risk features (MF-HR). The median overall survival (OS) for the MPN-BP patients was 2.6 months, and for those who received ≥2 cycles of decitabine therapy, it was 6.7 months (3.8-29.8). MPN-BP patients with a poor performance status and who required hospitalization at the time of the initiation of decitabine had a dismal prognosis. After a median follow-up of 12.4 months for MPN-AP patients, and 38.7 months for MF-HR patients, the median OS was not reached for either cohort, with 1 and 2 patients alive at 60 months, respectively. The probability of spleen length reduction and transfusion independence within 12 months of initiating decitabine was 28.6 and 23.5%, respectively. The combination of decitabine and ruxolitinib appeared to improve overall survival versus single-agent decitabine (21 and 12.9 months, respectively). Decitabine, alone or in combination with ruxolitinib, appears to have clinical benefit for patients with advanced phases of MPN when initiated early in the disease course prior to the development of MPN-BP.
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http://dx.doi.org/10.1159/000506146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7773003PMC
March 2021

Persistent leukocytosis in polycythemia vera is associated with disease evolution but not thrombosis.

Blood 2020 05;135(19):1696-1703

Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY; and.

There are unresolved questions regarding the association between persistent leukocytosis and risk of thrombosis and disease evolution in polycythemia vera (PV), as much of the published literature on the topic does not appropriately use repeated-measures data or time-dependent modeling to answer these questions. To address this knowledge gap, we analyzed a retrospective database of 520 PV patients seen at 10 academic institutions across the United States. Taking hematologic laboratory data at ∼3-month intervals (or as available) for all patients for duration of follow-up, we used group-based trajectory modeling to identify latent clusters of patients who follow distinct trajectories with regard to their leukocyte, hematocrit, and platelet counts over time. We then tested the association between trajectory membership and hazard of 2 major outcomes: thrombosis and disease evolution to myelofibrosis, myelodysplastic syndrome, or acute myeloid leukemia. Controlling for relevant covariates, we found that persistently elevated leukocyte trajectories were not associated with the hazard of a thrombotic event (P = .4163), but were significantly associated with increased hazard of disease evolution in an ascending stepwise manner (overall P = .0002). In addition, we found that neither hematocrit nor platelet count was significantly associated with the hazard of thrombosis or disease evolution.
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http://dx.doi.org/10.1182/blood.2019003347DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7205813PMC
May 2020

The efficacy and safety of direct oral anticoagulants in noncirrhotic portal vein thrombosis.

Blood Adv 2020 02;4(4):655-666

Tisch Cancer Institute.

Guidelines currently favor vitamin K antagonists or low-molecular-weight heparins for treatment of noncirrhotic portal vein thrombosis (ncPVT). Use of direct oral anticoagulants (DOACs) in PVT has been met with concern because of the lack of data. We conducted a retrospective study to investigate the efficacy and safety of DOACs for the treatment of ncPVT, and to compare them with standard therapies: 330 patients with ncPVT, followed-up for a mean 41.6 months, received warfarin (n = 108), enoxaparin (n = 70), rivaroxaban (n = 65), apixaban (n = 20), dabigatran (n = 8), fondaparinux (n = 2), or no anticoagulation (n = 57). The primary outcome was complete radiographic resolution (CRR) of PVT. Secondary outcomes included recanalization of occlusive PVT, cavernous transformation of the PV, development of chronic portal hypertensive symptoms (cPHS), and major bleeding. DOACs were associated with the highest CRR rates (dabigatran, 6/8 [75%]; apixaban, 13/20 [65%]; rivaroxaban, 42/65 [65%]). Enoxaparin was associated with a CRR rate similar to that of the DOACs (40/70 = 57%). Warfarin was associated with worse outcomes in this regard (CRR rate, 31% [33/108]; hazard ratio [HR] DOACs:warfarin, 2.91; 95% confidence interval [CI], 1.87-4.52; P < .0001). DOACs were associated with recanalization rates similar to enoxaparin and greater than warfarin (HR DOACs:warfarin, 3.45; 95% CI, 1.93-6.18; P < .0001). DOACs were associated with lower rates of cPHS, although this did not attain significance (DOACs, 8/93 [9%]; enoxaparin, 13/70 [19%]; warfarin, 31/108 [29%]). DOACs were associated with less major bleeding relative to warfarin (HR DOACs:warfarin, 0.20; 95% CI, 0.05-0.86; P = .0307). Patients harboring JAK2V617F, those with no evident predisposing factor for PVT, and those with occlusive thrombus demonstrated worse outcomes. DOACs appear effective and safe for the treatment of ncPVT.
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http://dx.doi.org/10.1182/bloodadvances.2019001310DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042983PMC
February 2020

Vitamin E Intake Is Associated with Lower Brain Volume in Haptoglobin 1-1 Elderly with Type 2 Diabetes.

J Alzheimers Dis 2020 ;74(2):649-658

The Joseph Sagol Neuroscience Center, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.

Backgrounds: The efficacy of vitamin E in prevention of diabetes-related complications differs by Haptoglobin (Hp) genotype.

Objective: To examine the role of Hp genotype in the relationship of vitamin E intake with brain volume in cognitively normal elderly patients with type 2 diabetes.

Methods: Brain volumes for the superior, middle, and inferior frontal gyri and for the middle temporal gyrus were generated from structural T1 MRI in 181 study participants (Hp 1-1: n = 24, Hp 2-1: n = 77, Hp 2-2: n = 80). Daily vitamin E intake was assessed using the Food Frequency Questionnaire. Analyses of covariance, controlling for demographic and cardiovascular variables was used to evaluate whether the association of daily vitamin E intake with brain volume was modified by Hp genotype.

Results: Average age was 70.8 (SD = 4.2) with 40% females, and mean Mini-Mental State Examination score of 28.17 (SD = 1.90). A significant interaction was found between vitamin E intake and Hp genotype in inferior frontal gyrus' volume; p = 0.0108. For every 1 microgram increase in vitamin E intake, the volume of the inferior frontal gyrus decreased by 0.955% for Hp 1-1 (p = 0.0348), increased by 0.429% for Hp 2-1 (p = 0.0457), and by 0.077% for Hp 2-2 (p = 0.6318). There were no significant interactions between vitamin E intake and Hp genotype for the middle (p = 0.6011) and superior (p = 0.2025) frontal gyri or for the middle temporal gyrus (p = 0.503).

Conclusions: The effect of dietary vitamin E on the brain may differ by Hp genotype. Studies examining the impact of vitamin E on brain-related outcomes should consider Hp genotype.
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http://dx.doi.org/10.3233/JAD-191294DOI Listing
January 2020

Portal vein thrombosis patients harboring JAK2V617F have poor long-term outcomes despite anticoagulation.

J Thromb Thrombolysis 2020 Oct;50(3):652-660

Tisch Cancer Institute, Icahn School of Medicine At Mount Sinai, One Gustave L. Levy Place, Box 1079, New York, NY, 10029, USA.

Non-cirrhotic portal vein thrombosis (ncPVT) most often occurs in the setting of intraabdominal proinflammatory processes. Less often, ncPVT may result from primary hematologic thrombophilia (most commonly JAK2V617F). Although these etiologic categories are pathophysiologically distinct, they are treated similarly using anticoagulation. We conducted a retrospective assessment of outcomes among ncPVT patients harboring JAK2V617F, and compared them to outcomes among patients with other etiologies for ncPVT, to determine whether anticoagulation alone is adequate therapy for JAK2V617F associated PVT. Outcomes were complete radiographic resolution (CRR) of PVT, recanalization (RC) of occlusive PVT, and development of significant portal hypertension (SPH). Three-hundred-thirty ncPVT patients seen between 1/2000 and 1/2019, including 37 harboring JAK2V617F (JAK2), 203 with other evident etiology (OE) for PVT, and 90 with no evident etiology (NE) for PVT followed for a median 29 months (53, 21, and 32 months respectively). Outcomes among the JAK2 cohort were dismal relative to the other groups. CRR rates were 8%, 31%, and 55% for the JAK2, NE, and OE cohorts respectively (multivariable HR JAK2:OE = 0.15 (0.05, 0.49), p = 0.0016). RC rates were 16%, 33%, and 49% for the JAK2, NE, and OE cohorts respectively (multivariable HR for RC JAK2:OE = 0.24 (0.09, 0.63), p = 0.0036). SPH rates were 49%, 32%, and 17% for the JAK2, NE, and OE cohorts respectively (multivariable HR for SPH JAK2:OE = 1.23 (0.62, 2.42), p = 0.5492). Given the strikingly poor outcomes among patients harboring JAK2V617F, anticoagulation alone does not appear to be adequate therapy for this cohort. Further investigation into thrombolysis and/or thrombectomy as an adjunct to anticoagulation is merited in this high-risk group.
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http://dx.doi.org/10.1007/s11239-020-02052-4DOI Listing
October 2020

Risk factors for infections and secondary malignancies in patients with a myeloproliferative neoplasm treated with ruxolitinib: a dual-center, propensity score-matched analysis.

Leuk Lymphoma 2020 03 12;61(3):660-667. Epub 2019 Nov 12.

Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Ruxolitinib is a JAK1/2 inhibitor approved for the treatment of myelofibrosis (MF) and polycythemia vera (PV). Recent data have suggested the possibility of increased infectious and secondary malignancy rates in patients treated with ruxolitinib. We conducted a dual-center, retrospective study of 202 myeloproliferative neoplasm (MPN) patients receiving ruxolitinib and a control cohort of 73 ruxolitinib-naïve MPN patients. We utilized propensity score matching to analyze the primary outcome of development of any grade infection. Infections occurred in 38.4% of ruxolitinib-naïve patients and 42.6% of ruxolitinib-treated patients and were primarily grade 1/2. After propensity score weighting, there was no difference in risk of infection between ruxolitinib-treated and -naïve patients with MF (HR 1.15 [95% CI 0.80-1.65],  = .466) and non-MF MPNs (HR = 0.52 [95% CI 0.21-1.28,  = .152). These results suggest that there is not an increased risk of infection with ruxolitinib therapy.
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http://dx.doi.org/10.1080/10428194.2019.1688323DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7771191PMC
March 2020

The Effect of Glucose Levels Prior to Hematopoietic Cell Transplantation on Post-Transplant Complications and Health Resource Utilization.

Int J Hematol Oncol Stem Cell Res 2019 Jul;13(3):122-131

Department of Nursing, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Abnormal blood glucose (BG) levels during hematopoietic cell transplantation (HCT) are associated with increased infections, delayed engraftment, and prolonged hospitalization, though little is known about these associations. We retrospectively evaluated mean BG levels in the week prior to HCT and subsequent outcomes for 852 HCTs at our hospital from 1/2009 - 12/2013 pertaining to 745 patients. Outcomes included infections (pneumonia, , positive cultures, administration of antimicrobials, or neutropenic fever), time-to-engraftment (TTE), and quality indicators (30- and 90-day readmission rates [RR] and median length-of-stay [LOS]). 404 patients met the criteria for involvement in this study. The population was 55% male and was racially and ethnically mixed (White 38%, African American 23%, Hispanic 6%, Asian 7%, Other 21%). Mean age was 57+14 years. Significantly more patients in Group 2 were diagnosed with pneumonia (19%) compared with the Group 1 (7%) and Group 3 (10%) [p=.0054]. Patients in Group 2 also had significantly longer median LOS: Group 1-23 days, Group 2-26 days, Group 3-22 days [p = .0157]. No significant differences were noted in terms of the other infectious complications or in time-to-engraftment or readmissions. Pre-HCT BG trends may be a prognostic biomarker for adverse outcomes, and thus can help improve quality of care for HCT patients.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6801324PMC
July 2019

Response to meta-analysis of leukocytosis and thrombosis in essential thrombocythemia and polycythemia vera.

Blood Adv 2019 10;3(20):3010-3012

Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.

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http://dx.doi.org/10.1182/bloodadvances.2019000822DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6849951PMC
October 2019

Unexpected high-risk pathologic features following thyroidectomy in the chinese immigrant population.

Laryngoscope 2020 07 8;130(7):1844-1849. Epub 2019 Oct 8.

Department of Otolaryngology, Institute for Healthcare Delivery Science, Tisch Cancer Institute (TCI), Icahn School of Medicine at Mount Sinai, New York, New York.

Objective: To compare rates of unexpected high-risk pathologic features between Chinese and non-Asian patients who underwent thyroidectomy for papillary thyroid cancer.

Methods: This was a retrospective cohort study at a tertiary academic urban medical center. Patients who underwent thyroidectomy for papillary carcinoma from 2015 to 2017 were included. Patient demographics, tumor characteristics, and tumor histopathology were analyzed. Primary outcome was the presence of adverse histopathologic features such as lymphovascular invasion (LVI) or microscopic/minimal extrathyroidal extension (mETE). Differences between the groups were analyzed using multivariate logistical regression analysis and propensity score-weighted analysis.

Results: One hundred seventy-nine patients were included: 58 Chinese-born and 121 non-Asian. The median age of the cohort was 47 years old (36-58). Twenty-nine percent of patients were male, and 71% were female. There was no statistically significant difference between the two cohorts in rates of LVI, multifocality, extent of surgery, or presence of thyroiditis. Patients with mETE were more likely to have larger tumors (P = 0.00247). Both the multivariate and propensity-weighted models demonstrated that Chinese ancestry was independently associated with an increased rate of unexpected mETE (adjusted prevalence ratio, 2.52; 95% confidence interval, 1.82-3.48).

Conclusion: mETE is significantly higher in the immigrant Chinese compared to the non-Asian population. Given the high prevalence of unexpected mETE in the Chinese population, the added risk of this finding should be brought into the discussion during initial surgical planning.

Level Of Evidence: 3 Laryngoscope, 130:1844-1849, 2020.
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http://dx.doi.org/10.1002/lary.28319DOI Listing
July 2020

Safety and Efficacy of Liver Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma After Segmental Transarterial Radioembolization.

Int J Radiat Oncol Biol Phys 2019 12 16;105(5):968-976. Epub 2019 Sep 16.

Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address:

Purpose: With increasing use of radiation for hepatocellular carcinoma (HCC) through transarterial radioembolization (TARE) and stereotactic body radiation therapy (SBRT), there is concern for increased radiation-related complications when using SBRT after TARE. This study compares safety of SBRT after segmental TARE versus transarterial chemoembolization (TACE).

Methods And Materials: A retrospective review identified patients receiving SBRT after TACE or TARE for HCC from 2011 to 2017. TARE was delivered subselectively to individual segments using yttrium-90 with Theraspheres. Patients were assessed over time for Child-Turcott-Pugh (CTP)/albumin-bilirubin (ALBI) scores, and Common Terminology Criteria for Adverse Events version 4.0 grade ≥3 events. Linear mixed models were used to examine the trend of CTP and ALBI over time and compare groups. Secondary endpoints were objective response rate via modified Response Evaluation Criteria in Solid Tumors (RECIST), local control, and overall survival.

Results: Ninety-nine patients met criteria with median follow-up of 9.8 months (range, 0.9-47): 31 had SBRT after segmental TARE and 68 patients post-TACE. The groups were well balanced with regard to etiology of HCC, baseline CTP and ALBI scores, and SBRT dose, but there were significant differences in baseline Eastern Cooperative Oncology Group performance status, Barcelona Clinic Liver Cancer staging, and median follow-up. There was a significant increase in post-SBRT CTP and ALBI scores (P < .0001) for both groups. However, there was no significant difference in rise in CTP (P = .11) or ALBI score (P = .82) over time between SBRT post-TACE versus post-segmental TARE. There was no significant increase in ≥grade 3 toxicity postsegmental TARE. There was also no significant difference in local controls (P = 1.0) and overall survival (P = .26) between cohorts, but objective response rate was worse post-TARE.

Conclusions: SBRT after segmental TARE with Theraspheres appears to have acceptable tolerability and is effective compared with SBRT after TACE. Longer follow-up with larger numbers is needed to verify these data.
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http://dx.doi.org/10.1016/j.ijrobp.2019.09.006DOI Listing
December 2019