Publications by authors named "Roland Bassett"

207 Publications

Eltrombopag for Post-Transplantation Thrombocytopenia: Results of Phase II Randomized, Double-Blind, Placebo-Controlled Trial.

Transplant Cell Ther 2021 May 6;27(5):430.e1-430.e7. Epub 2021 Feb 6.

Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address:

Prolonged thrombocytopenia occurs in up to 37% of patients after hematopoietic stem cell transplantation (HSCT) and is associated with adverse prognosis and increased risk of bleeding. Eltrombopag, a thrombopoietin receptor agonist, can increase platelet counts in thrombocytopenic patients. We conducted a phase II study, adaptively randomizing patients at ≥35 days post-HSCT to receive placebo or eltrombopag at a platelet count ≤20,000/µL for 7 days or platelet transfusion-dependent and a neutrophil count ≥1500/µL. Sixty patients were randomized to eltrombopag (n = 42) or placebo (n = 18) and received at least 1 dose. Fifteen patients (36%) in the eltrombopag arm achieved a platelet count of ≥30,000/µL, compared with 5 patients (28%) in the placebo arm, with a posterior probability of 0.75. (The protocol required this probability to be >0.975 to declare a winner; thus, the results are inconclusive.) However, 9 patients (21%) in the eltrombopag arm achieved a platelet count of ≥50,000/µL, compared with no patients in the placebo arm (P = .046). The overall survival, progression-free survival, relapse rate, and nonrelapse mortality were similar in the 2 arms. In conclusion, compared with placebo, treatment with eltrombopag led to a higher percentage of patients achieving a platelet count of ≥50,000/µL in patients with persistent thrombocytopenia after HSCT.
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http://dx.doi.org/10.1016/j.jtct.2021.02.004DOI Listing
May 2021

Adequacy of small biopsy and cytology specimens for comprehensive genomic profiling of patients with non-small-cell lung cancer to determine eligibility for immune checkpoint inhibitor and targeted therapy.

J Clin Pathol 2021 May 5. Epub 2021 May 5.

Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

Aims: In advanced-stage non-small-cell lung cancer (NSCLC), incomplete genotyping for guideline-recommended genomic biomarkers poses a significant challenge to making informed and timely clinical decisions. We report our institution's experience in assessing the adequacy of small specimens for comprehensive genomic profiling for guideline-recommended lung cancer biomarker testing.

Methods: We performed a retrospective evaluation of all image-guided procedures for NSCLC performed in our institution between October 2016 and July 2018, including core needle biopsy (CNB) and fine-needle aspiration (FNA) in patients who had undergone genomic profiling for lung cancer. Lung cancer biomarker adequacy, defined as successful testing of guideline-recommended biomarkers including, epidermal growth factor receptor (); serine/threonine protein kinase B-Raf (); anaplastic lymphoma kinase (); proto-oncogene tyrosine protein kinase ROS (); Rearranged during Transfection (); Tyrosine protein kinase Met (); and programmed cell death ligand 1 (PD-L1), was evaluated.

Results: A total of 865 cases were evaluated in this study, 785 of which included testing of all lung cancer biomarkers. Lung tissue was adequate for biomarker testing in 84% of cases; this rate increased to 87% when biomarker testing was combined with concurrently acquired FNA or CNB specimens. Biomarker testing success correlated strongly with DNA concentration (p<0.0001) and the use of 22G needles in endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) procedures (p=0.0035). Biomarker testing of CNB specimens showed a significantly higher success rate than did biomarker testing of cytology FNA specimens (p=0.0005). The adequacy of EBUS-TBNA samples was not significantly different from that of the transthoracic needle aspiration samples (p=0.40). Variables such as age, gender, lesion size, site, diagnosis and number of needle passes showed no significant correlation with success rates in lung cancer biomarker testing.

Conclusion: The growing numbers of therapeutic biomarkers in NSCLC requires judicious triage of limited-volume tissue from small specimens. Our study showed that thoracic small tissue specimens can be used successfully to provide prognostic and predictive information for the current guideline-recommended biomarkers for NSCLC in most cases.
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http://dx.doi.org/10.1136/jclinpath-2021-207597DOI Listing
May 2021

Immune checkpoint inhibitor related hypophysitis: diagnostic criteria and recovery patterns.

Endocr Relat Cancer 2021 Apr 1. Epub 2021 Apr 1.

R Dadu, Department of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, University of Texas MD Anderson Cancer Center, Houston, United States.

Data on the diagnosis, natural course and management of immune checkpoint inhibitor (ICI) related hypophysitis (irH) are limited. We propose this study to validate the diagnostic criteria, describe characteristics and hormonal recovery and investigate factors associated with occurrence and recovery of irH. A retrospective study including patients with suspected irH at the University of Texas MD Anderson Cancer Center from 5/2003 to 8/2017 was conducted. IrH was defined as: (1) ACTH or TSH deficiency plus MRI changes or (2) ACTH and TSH deficiencies plus headache/fatigue in the absence of MRI findings. We found that of 83 patients followed for a median of 1.75 years (range 0.6-3), the proposed criteria used at initial evaluation accurately identified 61/62 (98%) irH cases. In the irH group (n=62), the most common presentation were headache (60%), fatigue (66%), central hypothyroidism (94%), central adrenal insufficiency (69%) and MRI changes (77%). Compared with non-Ipilimumab (Ipi) regimens, Ipi has a stronger association with irH occurrence (p=0.004) and a shorter time to irH development (p<0.01). Thyroid, gonadal and adrenal axis recovery occurred in 24%, 58% and 0% patients, respectively. High dose steroids (HDS) or ICI discontinuation were not associated with hormonal recovery. In the non-irH group (n=19), one patient had isolated central hypothyroidism and 6 had isolated central adrenal insufficiency. All remained on hormone therapy at last follow up. We propose a strict definition of irH that identifies the vast majority of patients. HDS and ICI discontinuation is not always beneficial. Long term follow up to assess recovery is needed.
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http://dx.doi.org/10.1530/ERC-20-0513DOI Listing
April 2021

HER2 testing in breast cancers: comparison of assays and interpretation using ASCO/CAP 2013 and 2018 guidelines.

Breast Cancer Res Treat 2021 May 3;187(1):95-104. Epub 2021 Apr 3.

Department of Pathology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 085, G1.3617B, Houston, TX, 77030, USA.

Purpose: HER2 overexpression and gene amplification are routinely tested by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), respectively. In addition, HER2 mRNA expression is also tested by the Oncotype DX assay. Discordance between laboratories among the different assays remains a problem. To improve the routine HER2 reporting, the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) updated their guidelines in 2018. Our study will compare concordance of HER2 status by IHC and FISH using ASCO/CAP 2013 and 2018 guidelines with Oncotype DX.

Methods: We retrospectively reviewed 657 estrogen receptor positive primary breast cancer cases with available Oncotype DX tests between 2011 and 2018. Medical records were reviewed for HER2 results by IHC, FISH, and Oncotype DX. The HER2 results by different assays and between 2013 and 2018 guidelines were compared.

Results: Of the 657 cases, 280 were tested by IHC, FISH, and Oncotype DX. HER2-equivocal cases by IHC 2013 guidelines were all negative (67/67, 100%) by FISH 2018 guidelines and by Oncotype DX. HER2-equivocal cases by FISH 2013 guidelines were all negative (16/16, 100%) by FISH 2018 guidelines, while 15/16 (93.8%) negative and 1/16 (6.2%) equivocal by Oncotype DX. The HER2-equivocal and HER2-negative groups were similar in age, gender, histology, grade, and Ki67 score.

Conclusions: HER2 concordance was highest between Oncotype DX (99.6%) and FISH per 2018 guidelines. This suggests that the ASCO/CAP 2018 guidelines improved the accurate stratification of HER2-equivocal cases.
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http://dx.doi.org/10.1007/s10549-021-06208-5DOI Listing
May 2021

Randomized phase II trial of extracorporeal phototherapy and steroids vs. steroids alone for newly diagnosed acute GVHD.

Bone Marrow Transplant 2021 Jan 4. Epub 2021 Jan 4.

Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas Cancer Center, Houston, TX, USA.

Steroids remain the initial therapy for acute graft-vs.-host disease (AGVHD). Strategies to improve response and minimize steroid exposure are needed. We report results of a randomized, adaptive, Bayesian-designed, phase II trial of prednisone with or without extracorporeal photopheresis (ECP) as an initial therapy for patients with newly diagnosed AGVHD. The primary endpoint was success at day 56 defined as: alive, in remission, achieving AGVHD response without additional therapy, and on <1 mg/kg at day 28 and <0.5 mg/kg on day 56 of steroids. Eighty-one patients were randomized to the ECP arm (n = 51) or steroids alone (n = 30). Median age was 54 years (range: 17-75); 90% had grade II AGVHD and 10% had grades III and IV AGVHD, with skin (85%), upper (22%)/lower (22%) gastrointestinal, and liver (10%) involvement. The ECP arm had a higher probability of success (0.815) and exceeded the predefined threshold for determining the investigational arm promising. ECP was potentially more beneficial than steroids-alone in skin-only AGVHD (response rate: 72% vs. 57%, respectively) than for visceral-organ AGVHD (47% vs. 43%, respectively). The addition of ECP to steroids may result in higher GVHD response as initial therapy for AGVHD, especially for patients with skin-only involvement.
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http://dx.doi.org/10.1038/s41409-020-01188-4DOI Listing
January 2021

MRI features of pseudoangiomatous stromal hyperplasia with histopathological correlation.

Breast J 2021 Mar 4;27(3):242-247. Epub 2021 Jan 4.

Department of Breast Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Pseudoangiomatous stromal hyperplasia (PASH), a rare, noncancerous lesion, is often an incidental finding on magnetic resonance imaging (MRI)-guided biopsy analysis of other breast lesions. We sought to describe the characteristics of PASH on MRI and identify the extent to which these characteristics are correlated with the amount of PASH in the pathology specimens. We identified 69 patients who underwent MRI-guided biopsies yielding a final pathological diagnosis of PASH between 2008 and 2015. We analyzed pre-biopsy MRI scans to document the appearance of the lesions of interest. All biopsy samples were classified as having ≤50% PASH or ≥51% PASH present on the pathological specimen. On MRI, 9 lesions (13%) appeared as foci, 19 (28%) appeared as masses with either washout or persistent kinetics, and 41 (59%) appeared as regions of nonmass enhancement. Of this latter group, 33 lesions (80%) showed persistent kinetic features. Masses, foci, and regions of nonmass enhancement did not significantly correlate with the percentage of PASH present in the biopsy specimens (P ≥ .05). Our findings suggest that PASH has a wide-ranging appearance on MRI but most commonly appears as a region of nonmass enhancement with persistent kinetic features. Our finding that most specimens had ≤50% PASH supports the notion that PASH is usually an incidental finding. We did not identify a definitive imaging characteristic that reliably identifies PASH.
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http://dx.doi.org/10.1111/tbj.14154DOI Listing
March 2021

Distant Metastases From Childhood Differentiated Thyroid Carcinoma: Clinical Course and Mutational Landscape.

J Clin Endocrinol Metab 2021 Mar;106(4):e1683-e1697

Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Context: Distant metastases (DM) from childhood differentiated thyroid carcinoma (DTC) are uncommon and published studies are limited.

Objective: This work aimed to describe the outcomes of patients with DM from childhood DTC and to evaluate the molecular landscape of these tumors.

Methods: A retrospective study was conducted at a tertiary cancer center including patients with pediatric DTC (diagnosed at age ≤ 18 years from 1946 to 2019) and DM.

Results: We identified 148 patients; 144 (97%) had papillary thyroid carcinoma (PTC) and 104 (70%) were female. Median age at DTC diagnosis was 13.4 years (interquartile range [IQR], 9.9-15.9 years). Evaluable individuals received a median of 2 (IQR, 1-3) radioactive iodine (RAI) treatments at a median cumulative administered activity of 238.0 mCi (IQR, 147.5-351.0 mCi). The oncogenic driver was determined in 64 of 69 PTC samples: RET fusion (38/64; 59%), NTRK1/3 fusions (18/64; 28%), and the BRAF V600E mutation (8/64; 13%). At last evaluation, 93% had persistent disease. The median overall and disease-specific survival after DTC diagnosis were 50.7 and 52.8 years, respectively. Eight (5%) PTC patients died of disease after a median of 30.7 years (IQR, 20.6-37.6 years).

Conclusion: Childhood DTC with DM persists in most patients despite multiple courses of RAI, but disease-specific death is uncommon, typically occurring decades after diagnosis. Fusion genes are highly prevalent in PTC, and all identified molecular alterations have appropriate targeted therapies. Future studies should focus on expanding genotype-phenotype correlations, determining how to integrate molecularly targeted therapy into treatment paradigms, and relying less on repeated courses of RAI to achieve cure in patients with DM from childhood DTC.
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http://dx.doi.org/10.1210/clinem/dgaa935DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7993569PMC
March 2021

The Expression of CD74-Regulated Inflammatory Markers in Stage IV Melanoma: Risk of CNS Metastasis and Patient Survival.

Cancers (Basel) 2020 Dec 14;12(12). Epub 2020 Dec 14.

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.

Innate inflammatory features have been found in melanoma tumors from patients at all stages, and molecular analysis has identified definitive inflammatory proteins expressed by tumors cells in patients who presents the worst prognosis. We have previously observed weakened outcomes in patients with constitutive expression of inducible nitric oxide synthase (iNOS), macrophage migration inhibitory factor (MIF) and improved outcomes with CD74 expression in stage III melanoma. In our current study, we tested our hypothesis on CD74-regulated inflammatory markers' expression in stage IV melanoma tumors whether the signature is associated with survival outcome and/or risk of developing CNS metastasis. We retrospectively identified 315 patients with stage IV melanoma. In a tissue microarray (TMA), we examined the expression of cells with CD74, its receptor MIF, and downstream inflammatory markers iNOS, nitrotyrosine (NT), cyclooxygenase (COX)-2 and microsomal prostaglandin E synthase-1 (mPGES1). We analyzed the association of those inflammatory markers with overall survival time (OS) and time to CNS metastasis using Kaplan-Meier survival analyses. Our data validates CD74 as a useful prognostic tumor cell protein marker associated with favorable OS as in stage III melanomas, while the tumor NT expression strongly predicts an increased risk of developing CNS metastasis ( = 0.0008) in those patients.
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http://dx.doi.org/10.3390/cancers12123754DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7764866PMC
December 2020

Diagnostic Performance of MRI to Differentiate Uterine Leiomyosarcoma from Benign Leiomyoma: A Meta-Analysis.

J Belg Soc Radiol 2020 Nov 24;104(1):69. Epub 2020 Nov 24.

Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas, US.

Purpose: To perform a meta-analysis comparing the diagnostic performance of increased signal intensity on T1- and T2-weighted magnetic resonance images and apparent diffusion coefficient (ADC) values in differentiating uterine leiomyosarcoma (LMS) from benign leiomyoma (LM).

Methods: A systematic literature search for original studies was performed using PubMed/MEDLINE, the Cochrane Library, Embase, and Web of Science. Data necessary for the meta-analysis was extracted from the selected articles and analyzed.

Results: Eight studies with 795 patients met our predefined inclusion criteria and were included in the analysis. Increased signal on T1-weighted imaging had a pooled sensitivity of 56.8% (95% CI: 20%-87.4%) for LMS (n = 60) which was significantly higher than 7.6% (95% CI: 2.2%-22.7%) for LM (n = 1272) ( = 0.0094). Increased signal analysis on T2-weighted imaging had a pooled sensitivities of 93.2% and 93.2% (95% CI: 45.7%-99.6% and 42.9%-99.6%) for LMS (n = 90), which were not significantly different from the 54.5% and 53.9% (95% CI: 33.6%-74%, 32%-74%) for LM (n = 215) ( = 0.102 and 0.112). On ADC value analysis, LMS (n = 43) had a weighted mean and standard deviation of 0.896 ± 0.19 10 mm/s, 0.929 ± 0.182 10 mm/s, which were significantly lower from 1.258 ± 0.303 10 mm/s, 1.304 ± 0.303 10 mm/s for LM (n = 159) ( = < 0.0001, < 0.0001).

Conclusion: Our meta-analysis demonstrated that high signal intensity on T1-weighted images and low ADC values can accurately differentiate LMS from LM. Although, LMS had a higher pooled sensitivity for T2-weighted increased signal intensity compared to LM, there was no statistical significance.
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http://dx.doi.org/10.5334/jbsr.2275DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7693867PMC
November 2020

A Comparison of the Diagnostic Value of Positron Emission Tomography/Computed Tomography and Ultrasound for the Detection of Metastatic Axillary Nodal Disease in Treatment-Naive Breast Cancer.

Ultrasound Q 2020 Nov 13;37(1):28-33. Epub 2020 Nov 13.

Department of Biostatistics.

Abstract: The objective of this study was to describe the diagnostic value of positron emission tomography/computed tomography (PET/CT) and ultrasound (US) for identifying metastatic axillary disease in primary breast cancer. This is a retrospective review of 240 patients with treatment-naive unilateral primary breast cancer of at least stage T2. Eighty-five patients met our inclusion criteria. Initial whole-body PET/CT and axillary US examinations were reviewed and compared with the criterion standard of fine-needle aspiration cytology. Sensitivity, accuracy, and positive predictive value (PPV) for each modality were computed. Because of all positive US cases, specificity and negative predictive value of US were not determined. Sensitivity and accuracy between modalities were compared using McNemar test. The majority of the patients were White women with clinical inflammatory breast cancer and with histologically invasive ductal carcinoma. The most common tumor and nodal stage was T4N3. The tumors were predominantly estrogen receptor positive, progesterone receptor negative, and human epidermal growth factor receptor 2 negative. The sensitivities of PET/CT and US were 96.2% and 100%, respectively. The accuracies for PET/CT and US were 91.8% and 94.1%, respectively. The PPV for PET/CT was 95.1%, and for US, the PPV was 94.1%. No significant difference in sensitivity or accuracy was shown between PET/CT and US for the diagnosis of metastatic axillary nodal disease. Three of 85 cases showed discordance between negative PET/CT and positive US and fine-needle aspiration cytology.
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http://dx.doi.org/10.1097/RUQ.0000000000000535DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7933074PMC
November 2020

Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results From a Single-Arm Phase II Study.

J Clin Oncol 2021 Feb 30;39(6):599-607. Epub 2020 Oct 30.

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.

Purpose: Metastatic uveal melanoma has poor overall survival (OS) and no approved systemic therapy options. Studies of single-agent immunotherapy regimens have shown minimal benefit. There is the potential for improved responses with the use of combination immunotherapy.

Patients And Methods: We conducted a phase II study of nivolumab with ipilimumab in patients with metastatic uveal melanoma. Any number of prior treatments was permitted. Patients received nivolumab 1 mg/kg and ipilimumab 3 mg/kg for four cycles, followed by nivolumab maintenance therapy for up to 2 years. The primary outcome of the study was overall response rate (ORR) as determined by RECIST 1.1 criteria. Progression-free survival (PFS), OS, and adverse events were also assessed.

Results: Thirty-five patients were enrolled, and 33 patients were evaluable for efficacy. The ORR was 18%, including one confirmed complete response and five confirmed partial responses. The median PFS was 5.5 months (95% CI, 3.4 to 9.5 months), and the median OS was 19.1 months (95% CI, 9.6 months to NR). Forty percent of patients experienced a grade 3-4 treatment-related adverse event.

Conclusion: The combination regimen of nivolumab plus ipilimumab demonstrates activity in metastatic uveal melanoma, with deep and sustained confirmed responses.
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http://dx.doi.org/10.1200/JCO.20.00605DOI Listing
February 2021

Utilization of cytology smears improves success rates of RNA-based next-generation sequencing gene fusion assays for clinically relevant predictive biomarkers.

Cancer Cytopathol 2021 May 29;129(5):374-382. Epub 2020 Oct 29.

Department of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Background: The use of RNA-based next-generation sequencing (NGS) assays to detect gene fusions for targeted therapy has rapidly become an essential component of comprehensive molecular profiling. For cytology specimens, the cell block (CB) is most commonly used for fusion testing; however, insufficient cellularity and/or suboptimal RNA quality are often limiting factors. In the current study, the authors evaluated the factors affecting RNA fusion testing in cytology and the added value of smears in cases with a suboptimal or inadequate CB.

Methods: A 12-month retrospective review was performed to identify cytology cases that were evaluated by a targeted RNA-based NGS assay. Samples were sequenced by targeted amplicon-based NGS for 51 clinically relevant genes on a proprietary platform. Preanalytic factors and NGS quality parameters were correlated with the results of RNA fusion testing.

Results: The overall success rate of RNA fusion testing was 92%. Of the 146 cases successfully sequenced, 14% had a clinically relevant fusion detected. NGS testing success positively correlated with RNA yield (P = .03) but was independent of the tumor fraction, the tumor size, or the number of slides used for extraction. CB preparations were adequate for testing in 45% cases, but the inclusion of direct smears increased the adequacy rate to 92%. There was no significant difference in testing success rates between smears and CB preparations.

Conclusions: The success of RNA-based NGS fusion testing depends on the quality and quantity of RNA extracted. The use of direct smears significantly improves the adequacy of cytologic samples for RNA fusion testing for predictive biomarkers.
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http://dx.doi.org/10.1002/cncy.22381DOI Listing
May 2021

Dermatofibrosarcoma Protuberans Found Within Procedural Scars: A Retrospective Review at a Tertiary Referral Cancer Center.

Cureus 2020 Sep 7;12(9):e10286. Epub 2020 Sep 7.

Dermatology, MD Anderson Cancer Center, Houston, USA.

Background: Surgical scars are not a well-known risk factor for the development of dermatofibrosarcoma protuberans (DFSP). However, DFSP can arise within a surgical scar.

Objective: This study determined the number of DFSP found within scars from prior surgical procedures at a tertiary academic cancer center.

Methods: A retrospective data analysis was performed of all patients with biopsy-proven DFSP from January 2000 to April 2018 at MD Anderson Cancer Center (MDACC), a tertiary referral cancer center. Chart review was performed, and data were recorded for gender, race, and age of patients. We also recorded the site, location, and size of the DFSP and whether the patients had a history of prior surgery at the DFSP site. All patients had a pathologic diagnosis of DFSP at MDACC. Patients were selected from the pathology database at MDACC using the keywords "DFSP" or "dermatofibrosarcoma protuberans". A total of 458 patients were identified; however, 94 patients were excluded from the study because they were only referred to MDACC with a confirmed diagnosis of DFSP and were not seen as patients by a MDACC physician.

Results: Of the remaining 364 patients, 37 patients (10.1%) had either a history of a benign neoplasm or an inflammatory disease that had been evaluated or treated by either punch biopsy, shave biopsy, or minor excision at the site of DFSP (8.5%, 31 patients) or a DFSP arising within a major surgical procedural scar (1.6%, six patients). The surgical sites identified were the abdomen (four patients) and the groin (two patients). Three of the patients with a major surgical scar DFSP had prior laparoscopic surgery at the site.

Conclusions: DFSPs occur at surgical scars. The development of surgical scar DFSP in 10% of our patients prompts us to postulate that the neoplasm may be associated with the malignant transformation of these scars.
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http://dx.doi.org/10.7759/cureus.10286DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7540178PMC
September 2020

A phase II study of the insulin-like growth factor type I receptor inhibitor IMC-A12 in patients with metastatic uveal melanoma.

Melanoma Res 2020 12;30(6):574-579

Department of Melanoma Medical Oncology.

Uveal melanoma is a rare and aggressive malignancy and up to half of all patients will develop metastatic disease despite the effective treatment of the primary tumor. Insulin-like growth factors I/II play a fundamental role in the cell migration, proliferation, and apoptosis. IMC-A12, a mAb specifically targets insulin-like growth factor type I receptor, has shown promise in preclinical studies. We performed a multicenter phase II study for patients with metastatic uveal melanoma administered IMC-A12 10 mg/kg IV every two weeks until disease progression or unacceptable toxicity. The primary endpoint was objective response (proportion of patients with complete or partial response), and secondary endpoints were disease control rate, progression-free survival, and overall survival. A total of 18 patients enrolled in this study (10 males and eight females) with a median age. Ten patients (55%) had stable disease, seven patients (38%) had progression as best overall response. No partial response or complete response was observed; however, the disease control rate, defined as complete response + partial response + stable disease ≥3 months, was 50%. Median progression-free survival was 3.1 months, and median overall survival was 13.8 months. Adverse events of any grade occurred in 13 patients (72.2%). Treatment-related grade 3 adverse events were rare, and there were no grade 4 or 5 related adverse events. IMC-A12 was very well tolerated, however, showed limited clinical activity in uveal melanoma as a single agent. Due to its low toxicity profile it could be studied in combination with other pathway-specific agents.
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http://dx.doi.org/10.1097/CMR.0000000000000694DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643799PMC
December 2020

The survival impact of CKS1B gains or amplification is dependent on the background karyotype and TP53 deletion status in patients with myeloma.

Mod Pathol 2021 02 9;34(2):327-335. Epub 2020 Sep 9.

Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Gains or amplification (amp) of chromosome 1q21/CKS1B are reported to be a high-risk factor in myeloma. In this retrospective study, we analyzed the impact of CKS1B gain/amp on overall survival in the context of other genetic aberrations, such as TP53 deletion, FGFR3-IGH, IGH-MAF, MYEOV/CCND1-IGH, and RB1, as well as karyotype. The cohort included 132 myeloma patients with CKS1B gain/amp detected by fluorescence in-situ hybridization. There were 72 men and 60 women with a median age of 65 years (range 39-88 years). A normal, simple, or complex karyotype was observed in 39.5%, 5.4%, and 55% of patients, respectively. "Double hit," defined as CKS1B gain/amp coexisting with TP53 deletion, or "triple hit," defined as double hit plus t(4;14)FGFR3-IGH or t(14;16)IGH-MAF, were identified in 25 patients (18.9%) and five patients (3.8%), respectively. Double and triple hit were highly associated with a complex karyotype (p = 0.02). Ninety-nine patients (99/128, 77.3%) received stem cell transplantation. The median follow-up time was 48.2 months (range 2-104 months); 68 patients (51.5%) died, with a median overall survival of 58.8 months. Multivariate analysis (Cox model) showed that double hit with TP53 deletion (p = 0.0031), triple hit (p = 0.01), and complex karyotype (p = 0.0009) were each independently associated with poorer overall survival. Stem cell transplantation was associated with better overall survival, mainly in patients with a double or triple hit and complex karyotype (p = 0.003). These findings indicate that the inferior outcome of myeloma patients with CKS1B gain/amp is attributable to the high number of high-risk patients in this group. The prognostic impact of CKS1B gain/amp depends on the background karyotype and TP53 status.
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http://dx.doi.org/10.1038/s41379-020-00669-7DOI Listing
February 2021

Endothelial-to-mesenchymal transition compromises vascular integrity to induce Myc-mediated metabolic reprogramming in kidney fibrosis.

Sci Signal 2020 06 9;13(635). Epub 2020 Jun 9.

Department of Cancer Biology, Metastasis Research Center, University of Texas MD Anderson Cancer Center, Houston, TX 77054, USA.

Endothelial-to-mesenchymal transition (EndMT) is a cellular transdifferentiation program in which endothelial cells partially lose their endothelial identity and acquire mesenchymal-like features. Renal capillary endothelial cells can undergo EndMT in association with persistent damage of the renal parenchyma. The functional consequence(s) of EndMT in kidney fibrosis remains unexplored. Here, we studied the effect of Twist or Snail deficiency in endothelial cells on EndMT in kidney fibrosis. Conditional deletion of (which encodes Twist) or (which encodes Snail) in VE-cadherin or Tie1 endothelial cells inhibited the emergence of EndMT and improved kidney fibrosis in two different kidney injury/fibrosis mouse models. Suppression of EndMT limited peritubular vascular leakage, reduced tissue hypoxia, and preserved tubular epithelial health and function. Hypoxia, which was exacerbated by EndMT, resulted in increased Myc abundance in tubular epithelial cells, enhanced glycolysis, and suppression of fatty acid oxidation. Pharmacological suppression or epithelial-specific genetic ablation of Myc in tubular epithelial cells ameliorated fibrosis and restored renal parenchymal function and metabolic homeostasis. Together, these findings demonstrate a functional role for EndMT in the response to kidney capillary endothelial injury and highlight the contribution of endothelial-epithelial cross-talk in the development of kidney fibrosis with a potential for therapeutic intervention.
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http://dx.doi.org/10.1126/scisignal.aaz2597DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7790440PMC
June 2020

Clinical outcome and toxicity from taxanes in breast cancer patients with BRCA1 and BRCA2 pathogenic germline mutations.

Breast J 2020 08 4;26(8):1572-1582. Epub 2020 Jun 4.

Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.

Germline variations in genes coding for proteins involved in the oxidative stress and DNA repair greatly influence drug response and toxicity. Because BRCA1 and BRCA2 proteins play a role in DNA damage repair, we postulated that taxane-related toxicity is potentially higher and clinical outcome in different in patients with BRCA pathogenic variants (PV). Seven hundred nineteen women who underwent BRCA genetic testing and were treated with taxane-containing chemotherapy for early-stage breast cancer between 1997 and 2018 were included in the study. Patients with BRCA variants of uncertain significance were excluded. The Kaplan-Meier product-limit method was used to estimate recurrence-free survival (RFS) and overall survival (OS) rates. Logistic regression models were used to assess the association between chemotherapy toxicity and factors of interest. Cox regression models were used to assess the association between RFS and OS and factors of interest. Ninety-four (13%) and 54 (7%) patients had BRCA1 and BRCA2-PVs, respectively. While anemia (P = .0025) and leukopenia (P = .001) were more frequently seen in BRCA noncarriers, there was no difference in regards to peripheral neuropathy or other toxicities between the groups. Increasing doses of taxane were associated with increased risk of neutropenia, stomatitis, nausea, vomiting, acne/rash, and peripheral neuropathy across all groups. In a multivariate logistic regression model, BRCA2 status remained as an independent significant predictor for decreased hematologic toxicity (HR: 0.36; 95% CI: 0.20-0.67; P = .001) and increased gastrointestinal toxicity (HR: 1.93; 95% CI: 1.02-3.67; P = .04). Being overweight, obese and African-American race were significant predictors for peripheral neuropathy (P = .04; P = .03; P = .06, respectively). Total taxane dose received did not have any impact on survival outcomes. Our study demonstrates that taxane-containing chemotherapy regimens do not increase risk of peripheral neuropathy or hematologic toxicity in patients with BRCA PVs. The mechanisms for this finding need to be further investigated as it may provide an opportunity to combine taxanes with other agents, such as platinum salts or PARP inhibitors, with less anticipated toxicity.
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http://dx.doi.org/10.1111/tbj.13922DOI Listing
August 2020

Optimizing the Conditioning Regimen for Hematopoietic Cell Transplant in Myelofibrosis: Long-Term Results of a Prospective Phase II Clinical Trial.

Biol Blood Marrow Transplant 2020 08 11;26(8):1439-1445. Epub 2020 May 11.

Department of Stem Cell Transplantation and Cellular Therapy, University of Texas M.D. Anderson Cancer Center, Houston, Texas.

Optimal conditioning regimens for older patients with myelofibrosis undergoing allogeneic hematopoietic cell transplant are not known. Likewise, the role of dose intensity is not clear. We conducted a nonrandomized, prospective, phase II trial using low-dose, later escalated to high-dose (myeloablative conditioning), busulfan with fludarabine (Bu-Flu) in myelofibrosis patients up to age 74 years. The first 15 patients received i.v. busulfan 130 mg/m/day on days -3 and -2 ("low dose"); 31 patients received high-dose conditioning, either 100 mg/m/day (days -5 to -2; n = 4) or pharmacokinetic-guided area under the curve of 4000 μmol/min (days -5 to -2; n = 27). The primary endpoint was day 100 nonrelapse mortality (NRM). Median age was 58 years (interquartile range [IQR], 53-63). Dynamic international prognostic scoring system-plus was intermediate (n = 28) or high (n = 18). Donors were related (n = 19) or unrelated (n = 27). Cumulative incidence of NRM was 9.7% (95% confidence interval [CI], 0-20.3) at day 100 and at 3 years in the high-dose group and 0% in the low-dose group at day 100, which increased to 20% (95% CI, 0-41.9) at 3 years. With a median follow-up of 5.1 years (IQR, 3.8-6), 3-year relapse was 32.3% (95% CI, 15.4-49.1) in high dose versus 53.3% (95% CI, 26.6-80.1) in low dose. Event-free survival was 58% (95% CI, 43-78) versus 27% (95% CI, 12-62), and overall survival was 74% (95% CI, 60-91) versus 60% (95% CI, 40-91). In multivariate analysis, high-dose busulfan had a trend toward lower relapse (hazard ratio, .44; 95% CI, .18-1.07; P = .07), with no impact on NRM. Intensifying the Bu-Flu regimen using pharmacokinetic-monitoring appears to be promising in reducing relapse without increasing NRM.
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http://dx.doi.org/10.1016/j.bbmt.2020.03.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7547798PMC
August 2020

Concordance among hematopathologists in classifying blasts plus promonocytes: A bone marrow pathology group study.

Int J Lab Hematol 2020 Aug 16;42(4):418-422. Epub 2020 Apr 16.

Department of Hematopathology, University of Texas MD Anderson Cancer Center, Houston, Texas.

Enumeration of blasts and promonocytes is essential for World Health Organization (WHO) classification of myelomonocytic neoplasms. The accuracy of distinguishing blasts, promonocytes and monocytes, including normal vs abnormal monocytes, remains controversial. The objective of this analysis is to assess concordances between experienced hematopathologists in classifying cells as blasts, promonocytes, and monocytes according to WHO criteria. Each of 11 hematopathologists assessed glass slides from 20 patients [12 with chronic myelomonocytic leukemia (CMML) and 8 with acute myeloid leukemia (AML)] including blood and BM aspirate smears, and limited nonspecific esterase (NSE) stains. All cases were blindly reviewed. Fleiss' extension of Cohen's kappa for multiple raters was used on these variables, separately for peripheral blood (PB) and bone marrow (BM). Spearman's rank correlation was used to assess correlations between each pair of hematopathologists for each measurement. For the classification based on the sum of blasts and promonocytes in the BM, Fleiss' kappa was estimated as 0.744. For PB, categorizing patients according to the sum of blasts and promonocytes, Fleiss' kappa was estimated as 0.949. Distinction of abnormal monocytes from normal monocytes in PB did not achieve a good concordance and showed strong evidence of differences between hematopathologists (P < .0001). The hematopathologists achieved a good concordance rate of 74% in CMML vs AML classification and a high k rate, confirming that criteria for defining the blasts equivalents (blasts plus promonocytes) could be applied consistently. Identification of monocyte subtypes (abnormal vs normal) was not concordant. Our results support the practice of combining blasts/promonocytes into a single category.
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http://dx.doi.org/10.1111/ijlh.13212DOI Listing
August 2020

Clinico-pathologic characteristics and outcomes of the World Health Organization (WHO) provisional entity de novo acute myeloid leukemia with mutated RUNX1.

Mod Pathol 2020 09 1;33(9):1678-1689. Epub 2020 Apr 1.

Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, USA.

We studied the characteristics of the provisional category de novo acute myeloid leukemia (AML) with mutated RUNX1 (AML-RUNX1) proposed by the World Health Organization (WHO). Until now, most published studies have combined de novo and secondary AML-RUNX1. We compared the clinicopathologic characteristics and outcomes of WHO-defined de novo AML-RUNX1 with de novo AML without RUNX1 alterations (AML-RUNX1). We performed sequential NGS to assess RUNX1 mutation stability over disease course. We identified 46 de novo AML-RUNX1 patients [32 (70%) men, 14 (30%) women; median age, 66.5 years] with 54 RUNX1 mutations [median VAF, 32% (2-97%)]. Point mutations clustered within the runt-homology-domain and frame-shift mutations within the transactivation domain. Compared with AML-RUNX1, AML-RUNX1 showed male predominance (p = 0.02), higher frequency of SRSF2 (p = 0.02), and ASXL1 (p = 0.0004) mutations and normal karyotype (p = 0.01), and absent NPM1 mutations (p = 0.0002). De novo AML-RUNX1 showed no significant difference in overall survival (OS) compared with AML-RUNX1 (median: 26 vs. 32 months) (p = 0.71). AML-RUNX1 with clonal RUNX1 mutation (≥20% VAF) had shorter OS than subclonal <20% VAF (23 months vs. undefined; p = 0.04). However, the difference was not significant when compared with AML-RUNX1 (23 vs. 32 months; p = 0.23). No significant OS difference was noted between de novo AML-RUNX1 and AML-NOS-RUNX1. By sequential multigene mutation profiling, RUNX1 mutation disappeared at relapse in one of ten patients. Overall, the findings support separate categorization of this entity. However, there is no significant outcome difference compared with AML-RUNX1.
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http://dx.doi.org/10.1038/s41379-020-0531-2DOI Listing
September 2020

Comparison of Real-Time Fluorescence Confocal Digital Microscopy With Hematoxylin-Eosin-Stained Sections of Core-Needle Biopsy Specimens.

JAMA Netw Open 2020 03 2;3(3):e200476. Epub 2020 Mar 2.

Department of Interventional Radiology, The University of Texas MD Anderson Cancer Center, Houston.

Importance: Strategies to procure high-quality core-needle biopsy (CNB) specimens are critical for making basic tissue diagnoses and for ancillary testing.

Objectives: To investigate acquisition of fluorescence confocal microscopy (FCM) images of interventional radiology (IR)-guided CNB in real time in the radiology suite and to compare the accuracy of FCM diagnoses with those of hematoxylin-eosin (H&E)-stained CNB sections.

Design, Setting, And Participants: In this diagnostic study, FCM imaging of IR-guided CNBs was performed in the radiology suite at a major cancer center for patients with an imaging abnormality from August 1, 2016, to April 30, 2019. The time taken to acquire FCM images and the quality of FCM images based on percentage of interpretable tissue with optimal resolution was recorded. The FCM images were read by 2 pathologists and categorized as nondiagnostic, benign/atypical, or suspicious/malignant; these diagnoses were compared with those made using H&E-stained tissue sections. Cases with discrepant diagnosis were reassessed by the pathologists together for a consensus diagnosis. Data were analyzed from June 3 to July 19, 2019.

Interventions: Each IR-guided CNB was stained with 0.6mM acridine orange, subjected to FCM imaging, and then processed to generate H&E-stained sections.

Main Outcomes And Measures: Mean time taken for acquisition of FCM images, quality of FCM images based on interpretable percentage of the image, and accuracy of diagnostic categorization based on FCM images compared with H&E-stained sections.

Results: A total of 105 patients (57 male [54.3%]; mean [SD] age, 63 [13] years) underwent IR-guided CNBs in a mean (SD) of 7 (2) minutes each. The FCM images showed at least 20% of the tissue with optimal quality in 101 CNB specimens (96.2%). The FCM images were accurately interpreted by the 2 pathologists in 100 of 105 cases (95.2%) (2 false-positive and 3 false-negative) and 90 of 105 cases (85.7%) (6 false-positive and 9 false-negative). A reassessment of 14 discordant diagnoses resulted in consensus diagnoses that were accurate in 101 of 105 cases (96.2%) (1 false-positive and 3 false-negative).

Conclusions And Relevance: The ease of acquisition of FCM images of acceptable quality and the high accuracy of the diagnoses suggest that FCM may be useful for rapid evaluation of IR-guided CNBs. This approach warrants further investigation.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.0476DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059022PMC
March 2020

Burnout in Academic Radiologists in the United States.

Acad Radiol 2020 09 7;27(9):1274-1281. Epub 2020 Feb 7.

Department of Breast Imaging, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Rationale And Objectives: To assess the prevalence and associated factors of burnout among U.S. academic radiologists.

Materials And Methods: An online survey was sent to the radiologists who were full members of the Association of University Radiologists in December 2018. Burnout was measured using the abbreviated Maslach Burnout Inventory Human Services Survey. Survey respondents were also requested to complete questions on demographics, potential professional stressors, sense of calling, and career satisfaction. Associations between survey participants' characteristics and burnout were tested using logistic regression model.

Results: The survey response rate was 27% (228/831). Twenty-nine percent met all three criteria for high burnout, including high emotional exhaustion, high depersonalization, and low personal accomplishment. Seventy-nine percent had one or more symptoms of burnout. Numerous factors including work overload, inability to balance personal and professional life, lack of autonomy, lack of appreciation from patients and other medical staff were significantly associated (p < 0.05) with high burnout. Older age (OR, 0.95; 95%CI 0.92-0.98; p < 0.05), higher number of years of experience practicing as radiologists (OR, 0.95; 95%CI 0.92-0.98; p < 0.05), and holding academic rank of professor (OR, 0.25; 95%CI 0.11-0.56; p < 0.05) were factors associated with lower odds of experiencing burnout. Radiologists with high burnout were more likely to be dissatisfied with their career (OR, 2.28; 95%CI 1.70-3.07; p < 0.0001) and less likely to identify medicine as a calling.

Conclusion: Multiple factors contribute to high burnout in academic radiologists. Familiarity with these factors may help academic radiology departments to develop strategies to promote health and wellness of their faculty.
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http://dx.doi.org/10.1016/j.acra.2019.12.029DOI Listing
September 2020

Percutaneous Cordotomy for Pain Palliation in Advanced Cancer: A Randomized Clinical Trial Study Protocol.

Neurosurgery 2020 08;87(2):394-402

Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Background: Cancer pain, one of the most common symptoms for patients with advanced cancer, is often refractory to maximal medical therapy. A controlled clinical trial is needed to provide definitive evidence to support the use of ablative procedures such as cordotomy for patients with medically refractory cancer pain.

Objective: To assess the efficacy of cordotomy for patients with unilateral advanced cancer pain using a controlled clinical trial study design. The secondary objectives are to define the patient experience of cordotomy for medically refractory cancer pain as well as to determine the utility of magnetic resonance imaging as a non-invasive biomarker for successful cordotomy.

Methods: We will undertake a single-institution, double-blind, sham-controlled clinical trial of cordotomy in patients with refractory cancer pain. Patients in the cordotomy arm will undergo a percutaneous computed tomography-guided cordotomy at C1-C2, while patients in the control arm will undergo a similar procedure where the needle will not penetrate the thecal sac. The primary endpoint will be the reduction in pain intensity, as measured by the Edmonton Symptoms Assessment Scale.

Expected Outcomes: We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention.

Discussion: This randomized clinical trial comparing cordotomy with a control intervention will provide the level of evidence necessary to determine whether cordotomy should be the standard of care intervention for patients with advanced cancer pain.
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http://dx.doi.org/10.1093/neuros/nyz527DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7360878PMC
August 2020

Simplified molecular classification of lung adenocarcinomas based on EGFR, KRAS, and TP53 mutations.

BMC Cancer 2020 Jan 31;20(1):83. Epub 2020 Jan 31.

Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Background: Gene expression profiling has consistently identified three molecular subtypes of lung adenocarcinoma that have prognostic implications. To facilitate stratification of patients with this disease into similar molecular subtypes, we developed and validated a simple, mutually exclusive classification.

Methods: Mutational status of EGFR, KRAS, and TP53 was used to define seven mutually exclusive molecular subtypes. A development cohort of 283 cytology specimens of lung adenocarcinoma was used to evaluate the associations between the proposed classification and clinicopathologic variables including demographic characteristics, smoking history, fluorescence in situ hybridization and molecular results. For validation and prognostic assessment, 63 of the 283 cytology specimens with available survival data were combined with a separate cohort of 428 surgical pathology specimens of lung adenocarcinoma.

Results: The proposed classification yielded significant associations between these molecular subtypes and clinical and prognostic features. We found better overall survival in patients who underwent surgery and had tumors enriched for EGFR mutations. Worse overall survival was associated with older age, stage IV disease, and tumors with co-mutations in KRAS and TP53. Interestingly, neither chemotherapy nor radiation therapy showed benefit to overall survival.

Conclusions: The mutational status of EGFR, KRAS, and TP53 can be used to easily classify lung adenocarcinoma patients into seven subtypes that show a relationship with prognosis, especially in patients who underwent surgery, and these subtypes are similar to classifications based on more complex genomic methods reported previously.
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http://dx.doi.org/10.1186/s12885-020-6579-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6995064PMC
January 2020

Update on Diagnostic Performance of PET/MRI in Gynecological Malignancies: A Systematic Review and Meta-Analysis.

J Belg Soc Radiol 2020 Jan 23;104(1). Epub 2020 Jan 23.

Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas, US.

Objective: The aim of this study was to assess the diagnostic performance of F-fluorodeoxyglucose (FDG) positron emission tomography/magnetic resonance imaging (PET/MRI) for gynecological cancers of the pelvis based on a systematic review and meta-analysis of published data.

Patients And Methods: A systematic literature search for original diagnostic studies was performed using PubMed/MEDLINE, the Cochrane Library, Embase and Web of Science. The methodological quality of each study was evaluated using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Data necessary for entry in 2 × 2 contingency tables were obtained, and patients, study, and imaging characteristics were extracted from the selected articles. Statistical analysis included data pooling, heterogeneity testing, sensitivity analyses, forest plotting, and summary receiver operating characteristic curve construction.

Result: Twelve studies met our predefined inclusion criteria and were included in this study. Patient-based analysis, the pooled sensitivity rate, specificity rate, diagnostic odds ratio, and area under the receiver operating characteristic curve for F-FDG PET/MRI in diagnosis of gynecological malignancies were 74.2% (95% confidence interval, 66.2-80.8%), 89.8% (95% CI, 82.2-94.3%), 26 (95% CI, 10-67), and 0.834, respectively. On lesion-based analysis, the pooled sensitivity rate, specificity rate, diagnostic odds ratio, and area under the curve were 87.5% (95% CI, 75.8-94.0%), 88.2% (95% CI, 84.2-91.3%), 50 (95% CI, 23-111), and 0.922, respectively.

Conclusions: Our meta-analysis demonstrated that F-FDG PET/MRI is a promising diagnostic method for primary tumors, nodal staging, and recurrence in patients with gynecological malignancies of the pelvis.
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http://dx.doi.org/10.5334/jbsr.1981DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6978989PMC
January 2020

A randomized trial of nurse-administered behavioral interventions to manage anticipatory nausea and vomiting in chemotherapy.

Cancer Med 2020 03 19;9(5):1733-1740. Epub 2020 Jan 19.

Department of General Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Purpose: Chemotherapy side effects diminish quality of life and can lead to treatment delay. Nausea and vomiting can occur prior to chemotherapy because of classical conditioning. We studied the effects of 20-minute behavioral interventions, administered by oncology nurses, of higher intensity (mindfulness relaxation-MR) or lower intensity (relaxing music-RM), on anticipatory nausea and vomiting (ANV).

Patients And Methods: Patients undergoing chemotherapy for solid tumors were randomized to MR (N = 160), RM (N = 159), or standard care SC (N = 155). Subjects were mostly female (91.8%) and white (86.1%) with breast cancer (85%). Most patients had early stage disease (Stage I: 26%; II: 52.9%; III: 19%; IV: 0.1%). Anticipatory nausea and vomiting were assessed at the midpoint and end of the chemotherapy course using the Morrow Assessment of Nausea and Emesis (MANE).

Results: Compared to SC, there was reduced anticipatory nausea at the midpoint of chemotherapy in those receiving MR (OR 0.44, 95% CI 0.20-0.93) and RM (OR 0.40, 95% CI 0.20-0.93), controlling for age, sex, cancer stage, and emetogenic level of chemotherapy. There was no difference between treatment groups in anticipatory nausea at the end of chemotherapy or in anticipatory vomiting and postchemotherapy nausea and vomiting at either time point.

Conclusion: A brief nurse-delivered behavioral intervention can reduce midpoint ANV associated with chemotherapy.
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http://dx.doi.org/10.1002/cam4.2863DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7050098PMC
March 2020

Harnessing Behavioral Economics Principles to Promote Better Surgeon Accountability for Operating Room Cost: A Prospective Study.

J Am Coll Surg 2020 04 16;230(4):585-593. Epub 2020 Jan 16.

Department of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address:

Background: Operating room (OR) cost accounts for a significant portion of inpatient spending, but most surgeons are unaware of the costs of OR implants and supplies. We leveraged behavioral economics principles and a cost transparency tool to have an impact on discretionary OR spending (disposable supplies).

Study Design: We performed a single-institution, prospective study, from January to December 2018, across 3 departments: urology, thoracic, and endocrine. Two self-selected procedures per department were subjected to intraoperative supply cost (ISC) feedback via a custom dashboard and monthly email reports. Behavioral economics principles like choice overload, social ranking, and threshold effects were leveraged during study design. The primary outcome of percentage change in the department-level mean ISC, as determined via an interrupted time-series mixed effects model, was compared between the intervention year (2018) and "pre-baseline" (2016) and "baseline" (2017) years.

Results: A total of 2,853 procedures and 26 surgeons comprised our analytical sample. Costs decreased in 5 of the 6 procedures in 2018. On average, there was a significant monthly decrease in costs of approximately 0.5% over the study period (p = 0.0004). Post-intervention, there was a nonsignificant additional decrease of 0.6% in monthly cost (p = 0.0648). Overall cost significantly decreased by 20% due to the intervention (p < 0.0001). Similar results were noted on sensitivity analysis. There were no significant changes in the incidence of postoperative complication due to our intervention.

Conclusions: Deployment of a cost feedback tool using behavioral economics principles resulted in a significant decrease in OR spending without negatively affecting complication rate.
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http://dx.doi.org/10.1016/j.jamcollsurg.2019.12.013DOI Listing
April 2020

Confidence Calibration: An Introduction With Application to Quality Improvement.

J Am Coll Radiol 2020 May 10;17(5):620-628. Epub 2020 Jan 10.

Department of Radiology, University of Washington, Seattle, Washington.

A probabilistic forecast is one that assigns a probability (or likelihood) to the occurrence of an event. Radiologists commonly make probabilistic judgments in their reports, even if these predictions are not explicitly expressed as numbers. There are calls for radiologists to commit to their probabilistic predictions in a standardized fashion; however, without a mechanism for feedback, there is no opportunity for improvement. Analysis techniques familiar to radiologists (eg, calculation of sensitivity and specificity and construction of receiver operating characteristics curves) have a blind spot with regard to calibration of these probabilities to reality and are the main obstacle to improvement along this axis. We review statistical and graphical methods for calibration analysis in wider use outside the medical literature and present a framework for implementation of these techniques for quality improvement and radiologist self-assessment.
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http://dx.doi.org/10.1016/j.jacr.2019.12.009DOI Listing
May 2020

Diagnostic value of PET/CT versus PET/MRI in gynecological malignancies of the pelvis: A meta-analysis.

Clin Imaging 2020 Mar 6;60(1):53-61. Epub 2019 Dec 6.

Departmment of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America.

Purpose: To perform a meta-analysis of the literature to compare the diagnostic performance of 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) versus 18F-FDG positron emission tomography/magnetic resonance imaging (PET/MRI) for gynecological malignancies of the pelvis.

Materials And Methods: We searched for English-language studies, published through May 2019, on the diagnostic accuracy of PET/CT and PET/MRI for gynecological malignancies. To reduce inter-study heterogeneity, we focused primarily on studies in which both PET/CT and PET/MRI were performed on the entire study cohort. We pooled the sensitivity, specificity, diagnostic odds ratio, and area-under-the-receiver-operating-characteristic curve values for PET/CT and PET/MRI and determined the 95% confidence intervals (CIs).

Results: Out of 30 studies, nine met the inclusion criteria. On patient-based analysis, PET/CT had a pooled sensitivity and specificity of 62.6% (95% CI: 47.1%-76%) and 91.6% (95% CI: 81.9%-96.3%), respectively, compared with 73.3% (95% CI: 63.1%-81.6%) (P = 0.22) and 91.2% (95% CI: 81.8%-96%) (P = 94) for PET/MRI. On lesion-based analysis, PET/CT had a pooled sensitivity and specificity of 81.5% (95% CI: 59.3%-93.1%) and 86.6% (95% CI: 77.3%-92.5%), respectively, compared with 84.7% (95% CI: 66.8%-93.8%) (P = 0.77) and 89.3% (95% CI: 85.2%-92.3%) (P = 0.51) for PET/MRI. The diagnostic odds ratios for PET/CT compared with PET/MRI were not significantly different in the patient-based (P = 0.48) and lesion-based analyses (P = 0.4).

Conclusion: Compared with PET/CT, PET/MRI had slightly better diagnostic performance to that of 18F-FDG PET/CT in the gynecological malignancies on lesion level (44 vs 26) and patient level analysis (28 vs 17). However, the differences between results showed no statistical significance (P = 0.4 and 0.48, respectively).
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http://dx.doi.org/10.1016/j.clinimag.2019.11.018DOI Listing
March 2020

Methicillin-resistant Staphylococcus aureus (MRSA) is an important pathogen in erythrodermic cutaneous T-cell lymphoma (CTCL) patients.

Arch Dermatol Res 2020 May 27;312(4):283-288. Epub 2019 Nov 27.

Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.

Erythroderma can occur in cutaneous T-cell lymphoma (CTCL). Staphylococcus aureus (S. aureus) prevalence is increased in CTCL patients and contributes to CTCL disease flares. Our primary aim was to describe S. aureus infections, including resistance patterns and the antibiotic treatment regimens used, in erythrodermic CTCL patients. This was a retrospective chart review of erythrodermic CTCL patients who had S. aureus infection or colonization and were treated at the UT MD Anderson Cancer Center's Melanoma Skin Center between 2012 and 2016. Twenty-six erythrodermic CTCL patients had 50 documented S. aureus colonization or infection events. Patients had an improvement in body surface area (BSA) or modified Severity Weighted Assessment Tool (mSWAT) in 53% events treated for S. aureus. Seventeen of the 50 (34%) events were due to methicillin-resistant S. aureus (MRSA). One-third (33%) of MRSA events were initially treated with dicloxacillin. The MRSA isolates were sensitive to trimethoprim-sulfamethoxazole (92%) and doxycycline (88%). Patients treated in the outpatient setting (OR 0.073; 95% CI 0.008-0.627; p = 0.017) and patients with a previous history of topical anti-S. aureus decolonization treatments before S. aureus event as stand-alone (OR 0.125; 95% CI 0.018-0.887; p = 0.038) or in combination treatment with systemic antibiotics (OR 0.094; 95% CI 0.009-0.944; p = 0.045) were less likely to see improvement in BSA or mSWAT from S. aureus treatment. Treatment of S. aureus improved CTCL skin score in a high number of erythrodermic patients. The MRSA prevalence was high in erythrodermic CTCL patients. Clinicians should consider using empiric MRSA antibiotic coverage for these patients.
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http://dx.doi.org/10.1007/s00403-019-02015-7DOI Listing
May 2020