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1.
Am J Surg ; : 115793, 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38879355

ABSTRACT

BACKGROUND: Radiofrequency ablation (RFA) effectively reduces volume and improves symptoms of benign, non-functioning thyroid nodules (NFTNs). Given RFA's unclear impact on thyroid function, we examined post-RFA trends in thyroid hormones and antibodies. METHODS: A retrospective cross-sectional analysis was conducted of patients treated at Columbia University with RFA for benign NFTNs between August 2019 and July 2023. Thyroid function tests were recorded pre-RFA and repeated 3, 6, and 12 months post-RFA. RESULTS: We analyzed 185 patients with 243 benign NFTNs who underwent RFA. Volume reduction ratio increased post-RFA. Mean TSH increased to 2.4 mlU/L (p â€‹= â€‹0.005) at 3 months post-RFA and decreased to 1.8 mlU/L (p â€‹= â€‹0.551) by 12 months post-RFA. Tg and TPO antibody levels peaked at 6 months post-RFA (103.1 IU/mL, p â€‹= â€‹0.868 and 66.6 IU/mL, p â€‹= â€‹0.523, respectively). CONCLUSIONS: With expected volume reduction post-RFA, we observed transient relative hypothyroidism as well as transient increases in thyroid antibodies, with normalization of these changes within 12 months.

2.
Thyroid ; 34(4): 460-466, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38468547

ABSTRACT

Background: Molecular testing (MT) has become standard practice to more accurately rule out malignancy in indeterminate Bethesda III (BIII) thyroid lesions. We sought to assess the adoption of this technology and its impact on cytology reporting, malignancy yield, and rates of surgery across community and academic sites affiliated with a tertiary medical center. Methods: We performed a retrospective cross-sectional study including all fine-needle aspirations (FNAs) analyzed at our institution from 2017 to 2021. We analyzed trends in MT utilization by platform and by community or academic site. We compared BIII call rates, MT utilization rates, rates of subsequent surgery, and malignancy yield on final pathology before and after MT became readily available using chi-square analysis and linear regression. Results: A total of 8960 FNAs were analyzed at our institution from 2017 to 2021. There was broad adoption of MT across both community and academic sites. There was a significant increase in both the BIII rate and the utilization of MT between the pre- and post-MT periods (p < 0.001 and p < 0.001). There was no significant change in the the malignancy yield on final pathology (57.1% vs. 50.0%, p = 0.347), while the positive predictive value of MT decreased from 85% to 50% (p = 0.008 [confidence interval 9.5-52.5% decrease]). Conclusions: The use of MT increased across the institution over the study period, with the largest increase seen after a dedicated pass for MT was routinely collected. This increased availability of MT may have led to an unintended increase in the rates of BIII lesions, MT utilization, and surgery for benign nodules. Physicians who use MT should be aware of potential consequences of its adoption to appropriately counsel patients.


Subject(s)
Thyroid Neoplasms , Thyroid Nodule , Humans , Thyroid Nodule/diagnosis , Thyroid Nodule/surgery , Thyroid Nodule/pathology , Thyroid Neoplasms/diagnosis , Thyroid Neoplasms/surgery , Thyroid Neoplasms/pathology , Retrospective Studies , Cross-Sectional Studies , Molecular Diagnostic Techniques
3.
Thyroid ; 34(3): 388-398, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38251649

ABSTRACT

Background: Over the last decade, the utilization of molecular testing (MT) for the evaluation of thyroid nodules has increased. Rates and patterns of adoption of MT and its effect on thyroidectomy rates nationally are unknown. Varying rates of MT adoption at the state level provide an opportunity to study the effects of MT on thyroidectomy rates using a quasiexperimental study design. Methods: We performed a retrospective analysis of American adult patients in the Merative™ MarketScan® Research Databases who underwent thyroid fine-needle aspiration (FNA) from 2011 to 2021. MT included commercially available DNA and RNA platforms and traditional targeted mutational analysis. Interrupted time series analysis was used to evaluate the inflection of MT adoption and thyroidectomy rates after 2015. Difference-in-differences (DID) analysis was used to causally analyze the effect of MT adoption on thyroidectomy rates in high-adoption (at least a 10% increase in MT utilization) versus low-adoption states (no more than 5% increase in MT utilization) from 2015 to 2021. Results: We identified 471,364 patients who underwent thyroid FNA. The utilization of MT increased over the study period from 0.01% [confidence interval, CI: 0.00% to 0.02%] to 10.1% [CI: 9.7% to 10.5%], in 2021, with an immediate (ß2 = 1.61, p = 0.002) and deeper (ß3 = 0.6, p < 0.001) increase in MT adoption after 2015. Utilization of MT was lower in black patients, the elderly, rural areas, and patients with Medicaid (p < 0.05). Thyroidectomy rates were inversely correlated with MT utilization (r = -0.98, p < 0.0001). From 2015 to 2021, the average MT utilization rate increased from 2.4% to 15.3% in high-adoption states and 1.6% to 5.6% in low-adoption states. In low-adoption states, thyroidectomy rates decreased more but to similar levels (18.5-13.2%) compared with high-adoption states (15.9-13.4%) with an adjusted DID rate of -3.3% [CI -5.6% to -0.8%]. Conclusions: The acceleration in adoption of MT after 2015 likely coincides with the publication of American Thyroid Association guidelines. Black, elderly, and rural patients are less likely to receive MT. Although thyroidectomy rates were inversely correlated with MT utilization, our study suggests that this correlation is not causal. The effect of MT on thyroidectomy rates may be overshadowed by decreasing aggressiveness of thyroid nodule evaluation.


Subject(s)
Thyroid Neoplasms , Thyroid Nodule , Adult , Humans , Aged , Thyroidectomy , Thyroid Neoplasms/genetics , Thyroid Neoplasms/surgery , Retrospective Studies , Thyroid Nodule/surgery , Thyroid Nodule/genetics , Molecular Diagnostic Techniques
4.
Surgery ; 175(4): 1029-1033, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38097483

ABSTRACT

BACKGROUND: The American Thyroid Association updated guidelines in 2015 to allow lobectomy for low-risk thyroid cancers. The objectives of this study were (1) to determine thyroid hormone supplementation rates after lobectomy and (2) to evaluate the effect of the American Thyroid Association guideline change on lobectomy and hormone supplementation rates among thyroid cancer patients. METHODS: The Merative MarketScan Databases was used to identify adult (≥age 18) patients who underwent thyroidectomy for benign nodules or thyroid cancer. The association between indication for surgery and postoperative thyroid hormone supplementation was examined using χ2 analyses and multivariable logistic regression models. Among patients with thyroid cancer, lobectomy and hormone supplementation rates were compared in the periods before (2008-2015) and after the guideline change (2016-2019). RESULTS: Of the 81,926 patients identified, 33,756 (41.2%) underwent thyroid lobectomy, 45,104 (55.1%) underwent total thyroidectomy, and 3,066 (3.7%) underwent completion thyroidectomy. Patients who underwent lobectomy for malignancy were significantly more likely to require hormone supplementation (59.3% vs 39.4% [P < .001], adjusted odds ratio 2.34 [95% confidence interval 2.20-2.48]) compared to those with benign disease. Compared to the 2008 to 2015 period, the proportion of patients who underwent lobectomy for thyroid cancer was higher in the 2016 to 2019 period (34.3% vs 30.3%, P < .001), with fewer patients requiring completion thyroidectomy (25.6% vs 29.8%, P < .001) and thyroid hormone supplementation (56.9% vs 60.1%, P = .04). CONCLUSION: The postoperative thyroid hormone supplementation rate was significantly higher in patients who had thyroid cancers compared to benign diseases. After the American Thyroid Association guidelines changed, lobectomy rates increased significantly without a concomitant increase in the completion of thyroidectomy.


Subject(s)
Thyroid Neoplasms , Thyroidectomy , Adult , Humans , Adolescent , Thyroidectomy/adverse effects , Retrospective Studies , Thyroid Neoplasms/surgery , Thyroid Neoplasms/pathology , Thyroid Hormones , Dietary Supplements
5.
Surgery ; 175(1): 57-64, 2024 01.
Article in English | MEDLINE | ID: mdl-37872045

ABSTRACT

BACKGROUND: Whereas racial disparities in thyroid cancer care are well established, the role of social determinants of health is less clear. We aimed to assess the individual and cumulative impact of social determinants of health on mortality and time to treatment among patients with thyroid cancer. METHODS: We collected social determinants of health data from thyroid cancer patients registered in the National Cancer Database from 2004 to 2017. We created a count variable for patients in the lowest quartile of each social determinant of health (ie, low income, low education, and no insurance). We assessed the association of social determinants of health with mortality and time to treatment and the association between cumulative social determinants of health count and time to treatment using Cox regression. RESULTS: Of the 142,024 patients we identified, patients with longer time to treatment had greater mortality compared to patients treated within 90 days (90-180 days, adjusted hazard ratio 1.21 (95% confidence interval 1.13-1.29, P < .001); >180 days, adjusted hazard ratio 1.57 (95% confidence interval 1.41-1.76, (P < .001). Compared to patients with no adverse social determinants of health, patients with 1, 2, or 3 adverse social determinants of health had a 10%, 12%, and 34%, respectively, higher likelihood of longer time to treatment (1 social determinant of health, hazard ratio 0.90, 95% confidence interval 0.89-0.92, P < .001; 2 social determinants of health, hazard ratio 0.88, 95% confidence interval 0.87-0.90, P < .001; 3 social determinants of health, hazard ratio 0.66, 95% confidence interval 0.62-0.71, P < .001 for all). On subgroup analysis by race, each adverse social determinant of health was associated with an increased likelihood of a longer time to treatment for Black and Hispanic patients (P < .05). CONCLUSION: A greater number of adverse social determinants of health leads to a higher likelihood of a longer time to treatment for patients with thyroid cancer, which, in turn, is associated with an increased risk for mortality.


Subject(s)
Social Determinants of Health , Thyroid Neoplasms , Humans , Risk Factors , Thyroid Neoplasms/therapy , Time-to-Treatment
6.
Am Soc Clin Oncol Educ Book ; 43: e390018, 2023 May.
Article in English | MEDLINE | ID: mdl-37155946

ABSTRACT

Over the past decade, our understanding of AML pathogenesis and pathophysiology has improved significantly with mutational profiling. This has led to translational advances in therapeutic options, as there have been 10 new US Food and Drug Administration (FDA) approvals for AML therapies since 2017, half of which target specific driver mutations in FLT3, IDH1, or IDH2. These new agents have expanded the therapeutic armamentarium for AML, particularly for patients who are considered ineligible for intensive chemotherapy with anthracycline- and cytarabine-containing regimens. These new treatment options are relevant because the median age at diagnosis is 68 years, and outcomes for patients older than 60 years have historically been dismal. However, the optimal approach to incorporating novel agents into frontline regimens remains a clinical challenge, particularly with regard to sequencing of therapies, considering the role of allogeneic hematopoietic stem cell transplantation and managing toxicities.


Subject(s)
Leukemia, Myeloid, Acute , Humans , Aged , Leukemia, Myeloid, Acute/diagnosis , Leukemia, Myeloid, Acute/genetics , Leukemia, Myeloid, Acute/therapy , Anthracyclines/therapeutic use , Cytarabine/therapeutic use
7.
Surgery ; 173(1): 201-206, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36334980

ABSTRACT

BACKGROUND: Radiofrequency ablation is an emerging technology in the United States to treat benign thyroid nodules. The cost-effectiveness of radiofrequency ablation in comparison with traditional thyroidectomy is unknown. METHODS: A patient-level state transition microsimulation decision model was constructed comparing radiofrequency ablation with lobectomy in the management of benign thyroid nodules. Our base case was a 45-year-old woman with a solitary 30-cm3 nodule. Estimates of health utilities, complications, and mortality were obtained from the literature, and costs were estimated using Medicare reimbursement data. The primary outcomes of interest included total cost, quality-adjusted life years, and incremental cost-effectiveness ratios. All model estimates were subjected to 1-way sensitivity analyses to identify factors that strongly influence cost-effectiveness. A probabilistic sensitivity analysis was run across 1 million simulations to gauge outcome confidence with a willingness-to-pay threshold set at $100,000/quality-adjusted life year. RESULTS: Radiofrequency ablation was assumed to cost $5,000, with an initial success rate of 78%. Patients with volume reduction ratio <50% underwent a second treatment of radiofrequency ablation. Radiofrequency ablation represented the dominant strategy, yielding 21.31 quality-adjusted life years for a total cost of $16,563 in comparison to lobectomy, which yielded 21.13 quality-adjusted life years for a total cost of $19,262. In a 1-way sensitivity analysis varying the cost of radiofrequency ablation across of range of values, the radiofrequency ablation strategy remained cost-effective until the cost of radiofrequency ablation exceeded $12,330 at willingness-to-pay $50,000 or $17,950 at willingness-to-pay $100,000. CONCLUSION: Radiofrequency ablation is a cost-effective strategy in the treatment of benign thyroid nodules but is most sensitive to the cost of radiofrequency ablation.


Subject(s)
Catheter Ablation , Thyroid Nodule , Female , Humans , Aged , United States , Middle Aged , Thyroid Nodule/surgery , Cost-Benefit Analysis , Medicare , Thyroidectomy , Quality-Adjusted Life Years , Treatment Outcome
10.
Surgery ; 173(1): 19-25, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36167697

ABSTRACT

BACKGROUND: Phenoxybenzamine has been the standard agent for blockade before adrenalectomy for pheochromocytoma. However, high cost and limited availability have hampered its use. This study investigated whether other agents have supplanted the use of phenoxybenzamine as the first-line agent for alpha blockade in pheochromocytoma. METHODS: We performed a retrospective analysis of patients in the IBM MarketScan Database who underwent adrenalectomy for pheochromocytoma (2008-2019). Patients were categorized as having been blocked with phenoxybenzamine, selective alpha blockers, calcium channel blockers and/or beta blockers, or none of the above. The outcomes included prescription costs, perioperative costs, and length of stay. RESULTS: A total of 552 patients were identified; 58.7% were female, and the median age was 49 (interquartile range 40-57) years. In total, 291 (52.7%) patients were blocked with phenoxybenzamine, 114 (20.7%) with selective alpha blockers, 42 (7.6%) with only calcium channel blockers and/or beta blockers, and 76 (13.8%) with none. The proportion of patients blocked with phenoxybenzamine decreased from 71.0% in 2008 to 21.2% in 2019. The proportion of patients blocked with selective alpha blockers increased from 6.5% in 2008 to 42.4% and in 2019. The median cost of phenoxybenzamine increased from $722 (interquartile range $441-$1,514) in 2008 to $9,616 (interquartile range $5,049-$16,373) in 2019 (P < .001). Length of stay (2 [interquartile range 1-4] days vs 2 [interquartile range 0-3] days) and total perioperative costs ($24,250 [interquartile range $17,462-$33,849] vs $22,098 [interquartile range $16,341-$29,178] between phenoxybenzamine and selective alpha blocker groups were similar. CONCLUSION: There has been a significant shift away from phenoxybenzamine for preoperative blockade before resection of pheochromocytoma. Selective alpha blockers and calcium channel blockers are increasingly used, likely due to reduced costs, without compromised length of stay or intensive care unit admission.


Subject(s)
Adrenal Gland Neoplasms , Pheochromocytoma , Humans , Female , Adult , Middle Aged , Male , Phenoxybenzamine/therapeutic use , Retrospective Studies , Calcium Channel Blockers/therapeutic use , Pheochromocytoma/surgery , Adrenal Gland Neoplasms/surgery , Adrenal Gland Neoplasms/drug therapy , Adrenalectomy , Adrenergic alpha-Antagonists/therapeutic use
11.
Endocr Pract ; 28(9): 889-896, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35809774

ABSTRACT

OBJECTIVE: Phenoxybenzamine (nonselective, noncompetitive alpha-blocker) is the preferred drug for preoperative treatment of pheochromocytoma, but doxazosin (selective, competitive alpha-blocker) may be equally effective. We compared the efficacy of doxazosin vs phenoxybenzamine. METHODS: We conducted a prospective study of patients undergoing pheochromocytoma or paraganglioma resection by randomizing pretreatment with phenoxybenzamine or doxazosin at a single tertiary referral center. The high cost of phenoxybenzamine led to high crossover to doxazosin. Randomization was halted, and a consecutive historical cohort of phenoxybenzamine patients was included for a case-control study design. The efficacy of alpha-blockade was assessed with preinduction infusion of incremental doses of phenylephrine. The primary outcomes were mortality, cardiovascular complications, and intensive care unit admission. The secondary outcomes were hemodynamic instability index (proportion of operation outside of hemodynamic goals), adequacy of blockade by the phenylephrine titration test, and drug costs. RESULTS: Twenty-four patients were prospectively enrolled (doxazosin, n = 20; phenoxybenzamine, n = 4), and 15 historical patients treated with phenoxybenzamine were added (total phenoxybenzamine, n = 19). No major cardiovascular complications occurred in either group. The phenylephrine dose-response curves showed less blood pressure rise in the phenoxybenzamine than in the doxazosin group (linear regression coefficient = 0.008 vs 0.018, P = .01), suggesting better alpha-blockade in the phenoxybenzamine group. The median hemodynamic instability index was 14% vs 13% in the phenoxybenzamine and doxazosin groups, respectively (P = .56). The median highest daily cost of phenoxybenzamine was $442.20 compared to $5.06 for doxazosin. CONCLUSION: Phenoxybenzamine may blunt intraoperative hypertension better than doxazosin, but this difference did not translate to fewer cardiovascular complications and is offset by a considerably increased cost.


Subject(s)
Adrenal Gland Neoplasms , Pheochromocytoma , Adrenal Gland Neoplasms/drug therapy , Adrenal Gland Neoplasms/surgery , Adrenergic alpha-Antagonists/therapeutic use , Case-Control Studies , Doxazosin/pharmacology , Doxazosin/therapeutic use , Humans , Phenoxybenzamine/pharmacology , Phenoxybenzamine/therapeutic use , Phenylephrine/therapeutic use , Pheochromocytoma/drug therapy , Pheochromocytoma/surgery , Prospective Studies
12.
Am J Surg ; 224(3): 834-835, 2022 09.
Article in English | MEDLINE | ID: mdl-35623947
13.
Blood Adv ; 5(16): 3147-3151, 2021 08 24.
Article in English | MEDLINE | ID: mdl-34424318

ABSTRACT

Monitoring of measurable residual disease (MRD) is essential to the management of acute lymphoblastic leukemia (ALL) and is typically performed through repeated bone marrow (BM) assessments. Using a next-generation sequencing (NGS) MRD platform, we performed a prospective observational study evaluating the correlation between peripheral blood (PB) and BM MRD in adults with ALL receiving cellular therapies (hematopoietic cell transplantation [HCT] and chimeric antigen receptor T-cell [CAR-T] therapies). Among the study cohort (N = 69 patients; 126 paired PB/BM samples), we found strong correlation between PB and BM MRD (r = 0.87; P < .001), with a sensitivity and specificity of MRD detection in the PB of 87% and 90%, respectively, relative to MRD in the BM. MRD became detectable in the PB in 100% of patients who subsequently relapsed following HCT, with median time from MRD+ to clinical relapse of 90 days, and in 85% of patients who relapsed following CAR T, with median time from MRD+ to clinical relapse of 60 days. In adult patients with ALL undergoing cellular therapies, we demonstrate strong concordance between NGS-based MRD detected in the PB and BM. Monitoring of ALL MRD in the PB appears to be an adequate alternative to frequent invasive BM evaluations in this clinical setting.


Subject(s)
Hematopoietic Stem Cell Transplantation , Precursor Cell Lymphoblastic Leukemia-Lymphoma , Adult , Bone Marrow , Bone Marrow Examination , Humans , Neoplasm, Residual , Precursor Cell Lymphoblastic Leukemia-Lymphoma/diagnosis , Precursor Cell Lymphoblastic Leukemia-Lymphoma/therapy , Prospective Studies
14.
J Exp Psychol Appl ; 27(2): 307-323, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33764121

ABSTRACT

One standard pedagogical approach in physical science courses engages students in making predictions about physical phenomena that elicit non-normative expectations, then make observations intended to provide counterevidence that sparks conceptual change. This article presents five experiments investigating conditions where observation and recall are impacted by incorrect expectations and how these theory-laden observational errors might be mitigated. Using the context of balancing, Experiments 1-3 examine how the ambiguity of the stimuli may allow observers to selectively attend to information that is consistent with prior beliefs, while discounting incongruent information. As ambiguity is removed, the biasing effects of conceptual expectations are reduced. Experiments 4 and 5 extend the findings to investigate whether the effect of conceptual expectations also applies to memory of one's own bodily experiences of balancing. The results suggest that the ambiguity-driven, theory-laden observation effects found for visual observation, do not necessarily translate to recall for an embodied action, even though the experience of balancing contained perceptuo-motor ambiguity. Taken altogether, these five experiments show how conceptual knowledge can impinge on accurate recall of observations or embodied experiences and that instruction engaging students with demonstrations or embodied experiences may not necessarily provide intended counterevidence that contradicts prior expectations. (PsycInfo Database Record (c) 2021 APA, all rights reserved).


Subject(s)
Knowledge , Mental Recall , Humans
15.
Cancer ; 127(7): 1039-1048, 2021 04 01.
Article in English | MEDLINE | ID: mdl-33259056

ABSTRACT

BACKGROUND: The availability of novel agents (NAs), including blinatumomab and inotuzumab ozogamicin (InO), has improved the outcomes of patients with relapsed/refractory (RR) B-cell acute lymphoblastic leukemia (ALL). Because of the relative effectiveness, it is often a challenge for clinicians to determine how to best sequence these NAs with respect to efficacy and toxicity. METHODS: In this multicenter, retrospective study of patients with RR ALL treated with blinatumomab, InO, or both, their efficacy as a first or second NA was compared. RESULTS: Among 276 patients, 221 and 55 received blinatumomab and InO, respectively, as a first NA therapy. The complete remission (CR)/complete remission with incomplete count recovery (CRi) rate was 65% and 67% for the blinatumomab and InO groups, respectively (P = .73). The rate of treatment discontinuation due to adverse events was 4% and 7% in the blinatumomab and InO groups, respectively. Ninety-two patients (43%) in the blinatumomab group and 13 patients (29%) in the InO group proceeded with allogeneic hematopoietic stem cell transplantation. The median overall survival (OS) was 15 and 11.6 months in the blinatumomab and InO groups, respectively. A subset analysis was performed for 61 patients who received both NAs (blinatumomab and then InO [n = 40] or InO and then blinatumomab [n = 21]). The CR/CRi rate was 58% for patients who received InO as the second NA and 52% for patients who received blinatumomab as the second NA. The median OS was 10.5 for patients who received InO as the second NA and 5.9 months for patients who received blinatumomab as the second NA (P = .09). CONCLUSIONS: Although the limited power of this study to detect a significant difference between subgroups is acknowledged, the data suggest that blinatumomab and InO may have comparable efficacy as a first or second NA therapy in RR ALL.


Subject(s)
Antibodies, Bispecific/administration & dosage , Antineoplastic Agents, Immunological/administration & dosage , Inotuzumab Ozogamicin/administration & dosage , Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Bispecific/adverse effects , Antineoplastic Agents, Immunological/adverse effects , Drug Administration Schedule , Drug Resistance, Neoplasm , Female , Hematopoietic Stem Cell Transplantation/statistics & numerical data , Humans , Inotuzumab Ozogamicin/adverse effects , Male , Middle Aged , Precursor Cell Lymphoblastic Leukemia-Lymphoma/mortality , Remission Induction , Retrospective Studies , Treatment Outcome , Withholding Treatment/statistics & numerical data , Young Adult
16.
JAMA Oncol ; 7(1): 70-77, 2021 Jan 01.
Article in English | MEDLINE | ID: mdl-33300952

ABSTRACT

IMPORTANCE: Approximately 20% of thyroid nodules display indeterminate cytology. Molecular testing can refine the risk of malignancy and reduce the need for diagnostic hemithyroidectomy. OBJECTIVE: To compare the diagnostic performance between an RNA test (Afirma genomic sequencing classifier) and DNA-RNA test (ThyroSeq v3 multigene genomic classifier). DESIGN, SETTING, AND PARTICIPANTS: This parallel randomized clinical trial of monthly block randomization included patients in the UCLA Health system who underwent thyroid biopsy from August 2017 to January 2020 with indeterminate cytology (Bethesda System for Reporting Thyroid Cytopathology category III or IV). INTERVENTIONS: Molecular testing with the RNA test or DNA-RNA test. MAIN OUTCOMES AND MEASURES: Diagnostic test performance of the RNA test compared with the DNA-RNA test. The secondary outcome was comparison of test performance with prior versions of the molecular tests. RESULTS: Of 2368 patients, 397 were eligible for inclusion based on indeterminate cytology, and 346 (median [interquartile range] age, 55 [44-67] years; 266 [76.9%] women) were randomized to 1 of the 2 tests. In the total cohort assessed for eligibility, 3140 thyroid nodules were assessed, and 427 (13.6%) nodules were cytologically indeterminate. The prevalence of malignancy was 20% among indeterminate nodules. The benign call rate was 53% (95% CI, 47%-61%) for the RNA test and 61% (95% CI, 53%-68%) for the DNA-RNA test. The specificities of the RNA test and DNA-RNA test were 80% (95% CI, 72%-86%) and 85% (95% CI, 77%-91%), respectively (P = .33); the positive predictive values (PPV) of the RNA test and DNA-RNA test were 53% (95% CI, 40%-67%) and 63% (95% CI, 48%-77%), respectively (P = .33). The RNA test exhibited a higher PPV compared with the prior test version (Afirma gene expression classifier) (54% [95% CI, 40%-67%] vs 38% [95% CI, 27%-48%]; P = .01). The DNA-RNA test had no statistically significant difference in PPV compared with its prior version (ThyroSeq v2 next-generation sequencing) (63% [95% CI, 48%-77%] vs 58% [95% CI, 43%-73%]; P = .75). Diagnostic thyroidectomy was avoided in 87 (51%) patients tested with the RNA test and 83 (49%) patients tested with the DNA-RNA test. Surveillance ultrasonography was available for 90 nodules, of which 85 (94%) remained stable over a median of 12 months follow-up. CONCLUSIONS AND RELEVANCE: Both the RNA test and DNA-RNA test displayed high specificity and allowed 49% of patients with indeterminate nodules to avoid diagnostic surgery. Although previous trials demonstrated that the prior version of the DNA-RNA test was more specific than the prior version of the RNA test, the current molecular test techniques have no statistically significant difference in performance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02681328.


Subject(s)
Thyroid Neoplasms , Thyroid Nodule , Biopsy, Fine-Needle , Female , Gene Expression Profiling , Humans , Middle Aged , Molecular Diagnostic Techniques , Retrospective Studies , Thyroid Neoplasms/diagnosis , Thyroid Neoplasms/genetics , Thyroid Neoplasms/surgery , Thyroid Nodule/diagnosis , Thyroid Nodule/genetics , Thyroid Nodule/pathology , Thyroidectomy
17.
Clin Lymphoma Myeloma Leuk ; 20(8): 556-560.e2, 2020 08.
Article in English | MEDLINE | ID: mdl-32291234

ABSTRACT

BACKGROUND: Inotuzumab ozogamicin (InO) is an anti-CD22 monoclonal antibody-drug (calicheamicin) conjugate that has shown superior efficacy compared to conventional chemotherapy in relapsed/refractory (RR) B-cell acute lymphocytic leukemia (ALL) patients. We sought to find the safety and efficacy of InO in a real-world setting. PATIENTS AND METHODS: A multicenter cohort analysis on 84 RR ALL patients who received InO outside of clinical trials was conducted to evaluate response and toxicity. RESULTS: The median (range) age of patients at InO initiation was 50 (20-87) years. Forty patients (48%) had ≥ 3 therapies and 23 patients (27%) underwent allogeneic hematopoietic stem-cell transplantation (allo-HCT) before InO. The median (range) number of cycles of InO provided was 2 (1-6), and cumulative dose was 3.3 (1.8-9.3) mg/m2. Overall response rate (complete remission/complete remission with incomplete count recovery) was 63%; 44% had complete remission with minimal residual disease negativity. Twenty-three patients (27%) with response received allo-HCT. The median duration of response was 11.5 months and when censored at allo-HCT was not reached (51% in remission at 2 years). The median overall survival after InO was 11.6 months and when censored at time of allo-HCT was 13.6 months. The most common grade 3 or higher adverse events observed were transaminitis (16%), hyperbilirubinemia (5%), bleeding (4%), veno-occlusive disease (2%), and hyperglycemia (2%). In multivariate analysis, allo-HCT after InO did not retain favorable significance for duration of response (hazard ratio = 1.27; 95% confidence interval, 0.89-1.61; P = .2) or overall survival (hazard ratio = 1.10; 95% confidence interval, 0.37-3.25; P = .85). CONCLUSION: InO was well tolerated and had significant efficacy in RR B-cell ALL patients.


Subject(s)
Antineoplastic Agents, Immunological/therapeutic use , Inotuzumab Ozogamicin/therapeutic use , Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy , Adult , Aged , Aged, 80 and over , Antineoplastic Agents, Immunological/pharmacology , Female , Humans , Inotuzumab Ozogamicin/pharmacology , Male , Middle Aged , Precursor Cell Lymphoblastic Leukemia-Lymphoma/pathology , Retrospective Studies , Treatment Outcome , Young Adult
18.
J Vasc Surg Cases Innov Tech ; 5(3): 283-288, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31309169

ABSTRACT

Mortality after gunshot wounds to the thoracic aorta ranges from 92% to 100%. Survival is almost always in patients with injury from low-caliber, low-velocity bullets with hemorrhage contained by the wall of the aorta. Bullet embolization, even rarer with a reported incidence of 0.3% of vascular injuries, is most commonly found during autopsy. We report the successful treatment and survival of a patient who presented with a large-caliber gunshot wound to the aortic arch with contained rupture and bullet embolization from the aortic arch to the superficial femoral artery. The patient remained functionally independent and was discharged without complication.

19.
J Vasc Surg ; 70(6): 1776-1781, 2019 12.
Article in English | MEDLINE | ID: mdl-31248760

ABSTRACT

OBJECTIVE: Treatment of type B aortic dissections with thoracic endovascular aortic repair (TEVAR) has been adopted in many centers with the goal of covering the proximal entry tear. Coverage of the left subclavian artery (LSCA) is commonly required to achieve a dissection-free proximal seal zone. A novel thoracic single side-branched (TSSB) endograft device offers a potential off-the-shelf option to achieve total endovascular incorporation of LSCA during zone 2 TEVAR. The aim of this study was to determine what percentage of patients with type B aortic dissection who require zone 2 TEVAR meet the anatomical requirements for this device. METHODS: All consecutive patients undergoing TEVAR for type B aortic dissections at a single institution from 2006 to 2016 were evaluated. Three-dimensional centerline reconstruction of preoperative computed tomography angiography was performed to identify the diameter of the aorta, distances between branch vessels, diameter of the target branch vessel, and location of the primary entry tear. Only patients who met criteria for zone 2 TEVAR were included in the analysis. The primary outcome was percentage of patients that meet all anatomical requirements for TSSB. Individual criteria were evaluated independently, and results were stratified by dissection chronicity. RESULTS: Eighty-seven patients who underwent TEVAR for Stanford type B aortic dissections were reviewed. Fifty-seven (66%) would have required zone 2 TEVAR. Indications for TEVAR were malperfusion (12), aneurysm (15), persistent pain (22), rupture (3), uncontrolled hypertension (5), and other (3). Mean follow-up was 19 months (range, 1-72 months). Only 16 of the 57 patients (28%) met all the requirements for anatomic suitability. The primary contributor was that only 49% of patients had sufficient length between arch branches to prevent coverage of a proximal branch. CONCLUSIONS: Although the new TSSB device can allow for a more proximal seal zone and eliminate the need for open aortic arch debranching, only 28% of patients with type B dissection who required zone 2 TEVAR met all the anatomic requirements for this device. Future devices will need to account for the short distance between the left carotid and LSCA to be more broadly applicable.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/surgery , Blood Vessel Prosthesis , Endovascular Procedures , Aged , Aortic Dissection/classification , Aorta, Thoracic/anatomy & histology , Aortic Aneurysm, Thoracic/classification , Female , Humans , Male , Middle Aged , Prosthesis Design , Retrospective Studies
20.
Endocr Pract ; 25(5): 470-476, 2019 May.
Article in English | MEDLINE | ID: mdl-30720335

ABSTRACT

Objective: The natural biochemical history of untreated primary hyperparathyroidism (PHPT) is poorly understood. The purpose of this study was to determine the extent of biochemical fluctuations in patients with PHPT. Methods: Retrospective cohort study from January 1, 1995, to December 31, 2014. Serum calcium and parathyroid hormone (PTH) levels in patients with classic (Ca >10.5 mg/dL, PTH >65 pg/mL) and nonclassic (Ca >10.5 mg/dL, PTH 40 to 65 pg/mL) PHPT were followed longitudinally at 1, 2, and 5 years. Biochemical profiles in follow-up were ranked in descending biochemical severity as classic PHPT, nonclassic PHPT, normal calcium with elevated PTH (Ca <10.5 mg/dL, PTH >65 pg/mL), possible PHPT (Ca >10.5 mg/dL, PTH 21 to 40 pg/mL), or absent PHPT (Ca >10.5 mg/dL, PTH <21 pg/mL or Ca <10.5 mg/dL, PTH <65 pg/mL). Results: Of 10,598 patients, 1,570 were treated with parathyroidectomy (n = 1,433) or medications (n = 137), and 4,367 were censored due to study closure, disenrollment, or death. In the remaining 4,661 untreated patients with 5 years of follow-up, 235 (5.0%) progressed to a state of increased biochemical severity, whereas 972 (20.8%) remained the same, and 3,454 (74.1%) regressed to milder biochemical states. In 2,522 untreated patients with classic PHPT, patients most frequently transitioned to the normal calcium with elevated PTH group (n = 1,257, 49.8%). In 2,139 untreated patients with nonclassic PHPT, patients most frequently transitioned to the absent PHPT group (n = 1,354, 63.3%). Conclusion: PHPT is a biochemically dynamic disease with significant numbers of patients exhibiting both increases and decreases in biochemical severity. Abbreviations: IQR = interquartile range; KPSC = Kaiser Permanente Southern California; PHPT = primary hyperparathyroidism; PTH = parathyroid hormone; PTx = parathyroidectomy.


Subject(s)
Hyperparathyroidism, Primary , Calcium , California , Humans , Parathyroid Hormone , Parathyroidectomy , Retrospective Studies
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