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1.
J Surg Oncol ; 2024 Aug 19.
Article in English | MEDLINE | ID: mdl-39155668

ABSTRACT

BACKGROUND AND OBJECTIVES: The American Joint Committee on Cancer (AJCC) TNM staging system defines atypical parathyroid neoplasia (APN) as tumor in situ (Tis) and reserves the definition of parathyroid carcinoma (PC) to parathyroid tumor with invasion into surrounding structures. Because the parathyroid gland has no true capsule, "extension" with APN versus microscopic "invasion" of surrounding soft tissue can be difficult and confusing for clinicians. We aimed to determine the clinical course of atypical parathyroid neoplasm with and without soft tissue extension and parathyroid carcinoma with only soft tissue invasion (pT1) and to report the outcomes. METHODS: Following an IRB-approved protocol, we identified all patients treated for parathyroid neoplasm or cancer at our single tertiary care cancer center from 1990 to 2021. We excluded all patients with evidence of clinical or pathologic gross invasion into surrounding structures (pT2 or higher), lymph node involvement, or metastatic disease. By definition, this excluded all cases where the distinction was clinically evident to the surgeon at the time of the operation based on finding a hard, firm, sticky, or discolored parathyroid gland. Only patients with pathologic T1 (pT1) parathyroid carcinoma or APN were included. All pathologic examinations were independently re-reviewed by a single designated expert senior endocrine pathologist. The definition of APN strictly followed the WHO definition of a clinically worrisome lesion having features including fibrous bands or increased mitotic rate, necrosis, or trabecular growth that did not meet robust criteria for frank invasion. Pathologic T1 disease was defined as invasion limited to soft tissue. Analyses were performed using R version 4.0.2 and Jamovi. RESULTS: Of all PC patients at our institution, only 71 met the strict inclusion criteria of APN or pT1. Forty-four patients had pT1 disease and 27 had APN: 12 of the APN had soft tissue extension, and 15 had no soft tissue extension. The groups were similar with regard to age at diagnosis (p = 0.328). The average follow-up duration was 84 months from initial surgical intervention. Of the 12 with APN, one patient (1/12; 8%) with soft tissue extension recurred, developed distant metastases, and subsequently died during follow up. Of the 44 patients with pT1 PC, six developed distant metastases and 13 (13/44; 30%) died during the follow-up period. One patient with APN and soft tissue extension recurred and died and no patient with APN and no soft tissue extension died. CONCLUSIONS: Patients with APN and extension into soft tissue have a clinical course similar to that of APN without soft tissue extension. APN with soft tissue extension is a different disease from pT1 disease with invasion of soft tissue. The pTis classification appears justified for APN with and without soft tissue extension.

2.
Thyroid ; 34(9): 1117-1125, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38984944

ABSTRACT

Background: Large population-based registries, such as the Surveillance, Epidemiology and End Results (SEER) Registry, help in the study of rare tumors, including medullary thyroid cancer (MTC), but lack data to understand the natural history of the disease. The Medullary Thyroid Cancer Collaborative Registry (MTCCoRe) is an exhaustive multi-institutional collection of demographic, clinical, and pathological data. To determine the extent to which MTCCoRe represents the real-world MTC population, we compared the characteristics of patients enrolled in MTCCoRe with patients enrolled in population-based cancer registries. Methods: Comparison of demographic and clinical characteristics of MTC patients who were enrolled in MTCCoRe, Texas Cancer Registry (TCR), California Cancer Registry (CCR), and SEER between 1995 and 2018. Results: A total of 1416 patients were identified in MTCCoRe, 329 in TCR, 2105 in CCR, and 3820 in SEER. Percentages of patients 20-54 years in MTCCoRe were 58.0%, 50.2% in TCR, 47.2% in CCR, and 44.8% in SEER (p < 0.0001). About half of the patients were female (55.9% in MTCCoRe, 61.4% in TCR, 59% in CCR, and 57.5% in SEER (p = 0.3). Percentages of Hispanic and Black patients differed among cohorts (10.1% and 3.8% for MTCCoRe, 23.7% and 8.2% for TCR, 24.8% and 4.9% in CCR, and 15.9% and 8.2% for SEER, respectively; p < 0.001). MTCCoRe patients presented with more advanced T and N classifications than patients in the other registries (MTCCoRe, 28.6% T3-4 and 49.4% N1; TCR, 12.7% and 32.2%; CCR, 18.6% and 32.4%; and SEER, 24% and 37.8%; p < 0.0001). Prevalence of M1 disease was 10% in MTCCoRe, 11.9% in TCR, 14.1% in CCR, and 9.5% in SEER (p < 0.0001). In the MTCCoRe, 11.4% underwent systemic therapy (compared with 0.3% in TCR and 5.6% in CCR). Conclusions: The clinicodemographic profile of patients with MTC enrolled in a multi-institutional registry differs from those enrolled in population-based databases, with lower proportions of Hispanic and Black patients but additive data on treatment modalities. Moving forward, MTCCoRe and other registry and clinical trial enrollment efforts should intentionally include underrepresented groups via community engagement techniques, patient stakeholder involvement, and inclusion of languages other than English in study materials to yield more generalizable results and conclusions.


Subject(s)
Carcinoma, Neuroendocrine , Registries , SEER Program , Thyroid Neoplasms , Humans , Thyroid Neoplasms/epidemiology , Thyroid Neoplasms/pathology , Thyroid Neoplasms/therapy , Female , Male , Middle Aged , Adult , Carcinoma, Neuroendocrine/epidemiology , Carcinoma, Neuroendocrine/pathology , Young Adult , Aged , Adolescent , California/epidemiology , Child , Texas/epidemiology , Aged, 80 and over
3.
Am J Hematol ; 99(7): 1230-1239, 2024 07.
Article in English | MEDLINE | ID: mdl-38654461

ABSTRACT

Venous thromboembolism (VTE) poses a significant risk to cancer patients receiving systemic therapy. The generalizability of pan-cancer models to lymphomas is limited. Currently, there are no reliable risk prediction models for thrombosis in patients with lymphoma. Our objective was to create a risk assessment model (RAM) specifically for lymphomas. We performed a retrospective cohort study to develop Fine and Gray sub-distribution hazard model for VTE and pulmonary embolism (PE)/ lower extremity deep vein thrombosis (LE-DVT) respectively in adult lymphoma patients from the Veterans Affairs national healthcare system (VA). External validations were performed at the Harris Health System (HHS) and the MD Anderson Cancer Center (MDACC). Time-dependent c-statistic and calibration curves were used to assess discrimination and fit. There were 10,313 (VA), 854 (HHS), and 1858 (MDACC) patients in the derivation and validation cohorts with diverse baseline. At 6 months, the VTE incidence was 5.8% (VA), 8.2% (HHS), and 8.8% (MDACC), respectively. The corresponding estimates for PE/LE-DVT were 3.9% (VA), 4.5% (HHS), and 3.7% (MDACC), respectively. The variables in the final RAM included lymphoma histology, body mass index, therapy type, recent hospitalization, history of VTE, history of paralysis/immobilization, and time to treatment initiation. The RAM had c-statistics of 0.68 in the derivation and 0.69 and 0.72 in the two external validation cohorts. The two models achieved a clear differentiation in risk stratification in each cohort. Our findings suggest that easy-to-implement, clinical-based model could be used to predict personalized VTE risk for lymphoma patients.


Subject(s)
Lymphoma , Venous Thromboembolism , Humans , Retrospective Studies , Lymphoma/complications , Lymphoma/epidemiology , Middle Aged , Female , Male , Aged , Risk Assessment , Venous Thromboembolism/etiology , Venous Thromboembolism/epidemiology , Adult , Pulmonary Embolism/etiology , Pulmonary Embolism/epidemiology , Venous Thrombosis/etiology , Venous Thrombosis/epidemiology , Risk Factors , Incidence , Aged, 80 and over
4.
Cancer Med ; 13(5): e7069, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38466021

ABSTRACT

BACKGROUND: Personal history of cancer is an independent risk factor for lung cancer but is omitted from existing lung cancer screening eligibility criteria. In this study, we assess the lung cancer risk among cancer survivors and discuss potential implications for screening. METHODS: This was a retrospective, secondary analysis of data from the Surveillance, Epidemiology and End Results (SEER) registry and the MD Anderson Cancer Center (MDACC). We estimated the standardized incidence ratios (SIRs) for lung cancer by site of first primary cancer using data from SEER. We assessed the lung cancer risk among head and neck cancer survivors from MDACC using cumulative incidence and compared the risk ratios (RR) by individuals' screening eligibility status. RESULTS: Other than first primary lung cancer (SIR: 5.10, 95% CI: 5.01-5.18), cancer survivors in SEER with personal history of head and neck cancer (SIR: 3.71, 95% CI: 3.63-3.80) had the highest risk of developing second primary lung cancer, followed by bladder (SIR: 1.86, 95% CI: 1.81-1.90) and esophageal cancers (SIR: 1.78, 95% CI: 1.61-1.96). Head and neck cancer survivors had higher risk to develop lung cancer compared to the National Lung Screening Trial's subjects, (781 vs. 572 per 100,000 person-years, respectively). Head and neck cancer survivors ineligible for lung cancer screening seen at MDACC had significantly higher lung cancer risk than head and neck cancer survivors from SEER (RR: 1.9, p < 0.001). CONCLUSION: Personal history of cancer, primarily head and neck cancer, is an independent risk factor for lung cancer and may be considered as an eligibility criterion in future lung cancer screening recommendations.


Subject(s)
Esophageal Neoplasms , Lung Neoplasms , Neoplasms, Second Primary , Humans , Early Detection of Cancer , Lung Neoplasms/diagnosis , Lung Neoplasms/epidemiology , Retrospective Studies , Neoplasms, Second Primary/diagnosis , Neoplasms, Second Primary/epidemiology , Risk Factors , Lung
5.
J Cancer Educ ; 39(4): 368-373, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38468110

ABSTRACT

Providing safe and informed healthcare for sexual and gender minority (SGM) individuals with cancer is stymied by the lack of sexual orientation and gender identity (SOGI) data reliably available in health records and by insufficient training for staff. Approaches that support institutional learning, especially around sensitive topics, are essential for hospitals seeking to improve practices impacting patient safety and research. We engineered annual institutional retreats to identify and unify stakeholders, promote awareness of gaps and needs, identify initiatives, minimize redundant projects, and coordinate efforts that promote improvements in SGM cancer care, education, and research. The 2022 and 2023 retreats employed a 4-h hybrid format allowing virtual and in-person engagement. Retreat organizers facilitated small-group discussions for brainstorming among participants. We performed descriptive statistics from retreat evaluations. The retreats engaged 104 attendees from distinct departments and roles. Participants expressed robust satisfaction, commending the retreat organization and content quality. Notably, the first retreat yielded leadership endorsement and funding for a Quality Improvement pilot to standardize SOGI data collection and clinical staff training. The second retreat provided a platform for updates on focused efforts across the institution and for receiving direction regarding national best practices for SGM care and research. We report the processes and outcomes of institution-wide retreats, which served as a platform for identifying gaps in organizational healthcare practices and research for SGM individuals with cancer. The strategies described herein may be readily scaled at other cancer hospitals seeking to learn and enact system-wide practice changes that support the needs of SGM patients and families.


Subject(s)
Cancer Care Facilities , Humans , Cancer Care Facilities/organization & administration , Sexual and Gender Minorities , Neoplasms , Quality Improvement , Female , Leadership , Male , Learning
6.
Endocr Pract ; 30(1): 25-30, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37858722

ABSTRACT

OBJECTIVE: Adrenocortical carcinoma (ACC) is a rare malignancy without established association with environmental risk factors. ACC incidence is stable based on large surgical databases while referral centers data reported increasing number of cases seen. We studied ACC incidence and distribution at a county level to find potential ACC "hot spots" that could be linked to environmental exposures. METHODS: A retrospective analysis of Texas Cancer Registry that included ACC patients diagnosed between 2000 and 2018. County-level heatmaps were created and compared with breast, prostate, and lung cancer. RESULTS: We identified 448 ACC cases during the study period. Cases were registered in 110 of the 254 counties (43.3%) in Texas, representing 92.74% of the total population. The median incidence was 23 new cases/y (range 14-33). The mean population-adjusted ACC incidence rate was 0.104 per 100 000 per year (standard deviation 0.005; 95% CI, 0.092-0.116). Seven counties (6.3%) accounted for 215 (48.0%) cases, with more than 10 cases each and median standardized incidence ratio (SIR) of 0.1 (range, 0.0-0.9). One hundred three counties (93.7%) accounted for the remaining 233 cases (52%), with fewer than 10 cases per county. The highest standardized incidence ratios were found in counties with a median population of fewer than 14 000 residents and with only one reported case. CONCLUSION: Our analysis is the first report to create ACC heatmap and could not detect any geographic clustering of ACC in Texas. The incidence of ACC remained stable and consistent with data from other large databases.


Subject(s)
Adrenal Cortex Neoplasms , Adrenocortical Carcinoma , Male , Humans , Adrenocortical Carcinoma/epidemiology , Adrenocortical Carcinoma/pathology , Retrospective Studies , Incidence , Registries , Adrenal Cortex Neoplasms/epidemiology , Adrenal Cortex Neoplasms/pathology
8.
Am J Hematol ; 98(7): 1052-1057, 2023 07.
Article in English | MEDLINE | ID: mdl-37067102

ABSTRACT

Venous thromboembolism (VTE) is a significant complication for cancer patients undergoing systemic therapy. We performed an independent external validation for a recently derived and validated a novel electronic health record (EHR) VTE risk score in a comprehensive cancer center. Adult patients with incident cancer diagnoses were identified from MD Anderson Cancer Center Tumor Registry 1/2017-1/2021. Baseline covariates extracted at the time of first-line systemic therapy included demographics, cancer site/histology, stage, treatment, complete blood count, body mass index, recent prolonged hospitalization, and history of VTE or paralysis. VTE was ascertained using an institution-specific natural language processing radiology algorithm (positive predictive value of 94.8%). The median follow-up for 21 142 cancer patients was 8.1 months. There were 1067 (5.7%) VTE within 6 months after systemic therapy. The distribution of the novel score for 0-, 1, 2, 3, 4, 5+ was 5661, 3558, 3462, 3489, 2918, and 2054; while the corresponding 6-month VTE incidence was 1.3%, 3.1%, 5.4%, 7.3%, 9.3%, and 13.8%, respectively (c statistic 0.71 [95% CI 0.69-0.72] with excellent calibration). In comparison, the Khorana score had a c statistic of 0.64 [95% CI 0.62-0.65]. The two risk scores had 80% concordance; the novel score reclassified 20% of Khorana score (3530 low-to-high with 9.0% VTE; 734 high-to-low with 3.4% VTE) and led to a 25% increment in VTEs captured in the high-risk group. In conclusion, the novel score demonstrated consistent discrimination and calibration across cohorts with heterogenous demographics. It could become a new standard to select high-risk populations for clinical trials and VTE monitoring.


Subject(s)
Neoplasms , Thrombosis , Venous Thromboembolism , Adult , Humans , Venous Thromboembolism/etiology , Retrospective Studies , Neoplasms/epidemiology , Risk Factors , Thrombosis/complications , Risk Assessment
9.
JNCI Cancer Spectr ; 2022 Aug 09.
Article in English | MEDLINE | ID: mdl-35944228

ABSTRACT

The U.S. Centers for Disease Control and Prevention (CDC), the U.S. Preventive Services Task Force (USPSTF) and the National Comprehensive Cancer Network (NCCN) recommend offering HIV testing for patients presenting for cancer care. Not recognizing and treating HIV infection adversely impacts both cancer treatment and HIV outcomes. Acceptance rates of oncology patients for HIV screening are not known. Our tertiary cancer center inserted language requesting permission to screen for HIV infection into the consent forms for initial presentation for cancer care. Willingness to undergo testing was examined in 29,549 consecutive new patients. These were analyzed by gender and age. Overall, 80.9% of patients agreed to HIV screening. Incorporation of language requesting permission for HIV screening into the consent form provided at presentation for cancer care, relieves clinicians from adding this task.

10.
JCO Clin Cancer Inform ; 5: 272-278, 2021 03.
Article in English | MEDLINE | ID: mdl-33739855

ABSTRACT

The cancer registrar reports accurate, complete, and timely abstracted cancer data to various healthcare agencies. The data are used for understanding the incidence of cancer, evaluating the effectiveness of public health efforts in the prevention of new cases and improving patient care outcomes and survival. There are increasing demands placed on registrars for additional data points with real-time submission to reporting agencies. To that end, registrars are increasing the use of informatics to meet the demand. The purpose of this article is the role of the registrar in the collection and reporting of critical cancer data and how registrars are currently using informatics to enhance their work. This article describes how informatics can be leveraged in the future and how registrars play a vital role in meeting the increasing demands placed on them to provide timely, meaningful, and accurate data for the cancer community.


Subject(s)
Delivery of Health Care , Neoplasms , Humans , Informatics , Neoplasms/epidemiology , Neoplasms/therapy
11.
Cancers (Basel) ; 12(12)2020 Dec 14.
Article in English | MEDLINE | ID: mdl-33327406

ABSTRACT

Although genetic changes may be pivotal in the origin of cancer, cellular context is paramount. This is particularly relevant in a progenitor germ cell tumor and its differentiated mature teratoma counterpart when it concerns tumor heterogeneity and cancer dormancy in subsequent second malignancies (subsequent malignant neoplasms (SMNs)). From our tumor registry database, we identified 655 testicular germ cell tumor (TGCT) patients who developed SMNs between January 1990 and September 2018. Of the 113 solid organ SMNs, 42 had sufficient tumor tissue available for fluorescence in situ hybridization (FISH) analysis of isochromosome 12p [i(12p)]. We identified seven additional patients for targeted DNA and RNA sequencing of teratomas and adjacent somatic transformation. Finally, we established cell lines from freshly resected post-chemotherapy teratomas and evaluated the cells for stemness expression by flow cytometry and by the formation of teratomas in a xenograft model. In our cohort, SMNs comprising non-germ cell tumors occurred about 18 years after a diagnosis of TGCT. Of the 42 SMNs examined, 5 (12%) contained i(12p) and 16 (38%) had 12p gain. When comparing a teratoma and adjacent somatic transformation, targeted DNA and RNA sequencing demonstrated high concordance. Studies of post-chemotherapy teratoma-derived cell lines revealed cancer-initiating cells expressing multipotency as well as early differentiation markers. For the first time, we demonstrated the prevalence of i(12p) in SMNs and the presence of progenitor cells embedded within mature teratomas after chemotherapy. Our findings suggest a progenitor stem-like cell of origin in SMN and TGCT and highlight the importance of cellular context in this disease.

12.
Cancer ; 126(16): 3708-3718, 2020 08 15.
Article in English | MEDLINE | ID: mdl-32484922

ABSTRACT

BACKGROUND: Although there are a growing number of survivors of adolescent and young adult (AYA) cancer, to the authors' knowledge the long-term overall survival (OS) patterns for AYA cancer survivors are underreported. The objective of the current study was to assess the long-term survival of AYA cancer survivors and identify factors associated with diminished long-term survival. METHODS: The authors used The University of Texas MD Anderson Cancer Center's tumor registry to identify 5-year survivors of cancer diagnosed as AYAs (ages 15-39 years) between the years 1970 and 2005, and who were alive 5 years after diagnosis. Kaplan-Meier curves were used to estimate OS rates over time, and Cox proportional hazards models were fitted to evaluate the association of covariates with OS. RESULTS: The authors identified 16,728 individuals who were 5-year survivors of cancer and were diagnosed as AYAs with a median follow-up of 20.0 years. The 10-year, 20-year, and 25-year OS rates were 86% (95% confidence interval [95% CI], 85%-86%), 74% (95% CI, 73%-75%), and 68% (95% CI, 67%-68%), respectively, all of which were lower than the age-adjusted estimated survival rates of the general population. Long-term OS improved for AYAs diagnosed between 2000 and 2005 compared with those diagnosed in the prior decades (P < .001). Older age at the time of diagnosis, receipt of radiation, and diagnoses including central nervous system tumors and breast cancer each were associated with diminished long-term survival. CONCLUSIONS: AYA cancer survivors have inferior long-term survival compared with the general population. Studies investigating the prevalence and types of late treatment effects and causes of death among AYA survivors are needed to more accurately identify AYAs who are at highest risk of early or late mortality.


Subject(s)
Age Factors , Cancer Survivors , Neoplasms/epidemiology , Adult , Disease-Free Survival , Female , Humans , Kaplan-Meier Estimate , Male , Neoplasms/pathology , Proportional Hazards Models , Risk Factors , Survival Rate , Young Adult
13.
Br J Clin Pharmacol ; 84(12): 2802-2810, 2018 12.
Article in English | MEDLINE | ID: mdl-30187509

ABSTRACT

AIMS: The aims of the current study were: (i) to examine the prescribing of preventative medication in a cohort of people with advanced lung cancer on hospital admission and discharge across different healthcare systems; and (ii) to explore the factors that influence preventative medication prescribing at hospital discharge. METHODS: A retrospective cohort study was conducted across two centres in the UK and the US. The prescribing of preventative medication was examined at hospital admission and discharge for patients who died of lung cancer. A zero-inflated negative binomial regression model was used to examine the association between preventative medications at discharge and patient- and hospital-based factors. The classes of preventative medication prescribed included were: vitamins and minerals, and antidiabetic, antihypertensive, antihyperlipidaemic and antiplatelet medications. RESULTS: In the UK site (n = 125), the mean number of preventative medications prescribed was 1.9 [standard deviation (SD) 1.7) on admission, and 1.7 (SD 1.7) on discharge, and in the US site (n = 191) the mean was 2.6 (SD 2.2) on admission and 1.9 (SD 2.2) on discharge. The model found a significant association between the number of preventative drugs prescribed on admission and the number on discharge; it also found a significant association between the total number of drugs prescribed on discharge and the number of preventative medications on discharge. Other indicators related to patient and hospital factors were not significantly associated with the number of preventative medications supplied on discharge. CONCLUSIONS: The use of preventative medication was common in lung cancer patients, despite undergoing discharge. Patient- and hospital-based factors did not influence the prescribing of preventative medication.


Subject(s)
Inappropriate Prescribing , Lung Neoplasms/drug therapy , Polypharmacy , Adult , Aged , Aged, 80 and over , Continuity of Patient Care , Female , Humans , Male , Middle Aged , Patient Discharge , Preventive Medicine , Retrospective Studies
14.
J Oncol Pract ; 12(5): e554-63, 2016 05.
Article in English | MEDLINE | ID: mdl-27072570

ABSTRACT

PURPOSE: The identification of patients at high risk for poor outcomes may allow for earlier palliative care and prevent futile interventions. We examined the association of presenting symptoms on risk of intensive care unit (ICU) admission and hospital death among patients with cancer admitted through an emergency department (ED). METHODS: We queried MD Anderson Cancer Center databases for all patients who visited the ED in 2010. Presenting symptoms, ICU admissions, and hospital deaths were reviewed; patient data analyzed; and risk factors for ICU admission and hospital mortality identified. RESULTS: The main presenting symptoms were pain, fever, and respiratory distress. Of the patients with cancer who visited the ED, 5,362 (58%) were admitted to the hospital at least once (range, 1 to 13 admissions), 697 (13%) were admitted to the ICU at least once, and 587 (11%) died during hospitalization (31% of 233 patients with hematologic malignancies and 27% of 354 patients with solid tumors died in the ICU; P < .001). In multivariable logistic regression, presenting symptoms of respiratory distress or altered mental status; lung cancer, leukemia, or lymphoma; and nonwhite race were independent predictors of hospital death. Patients who died had a longer median length of hospital stay than patients discharged alive (14 v 6 days for hematologic malignancies and 7 v 5 days for solid tumors; P < .001). CONCLUSION: Patients with cancer admitted through an ED experience high ICU admission and hospital mortality rates. Patients with advanced cancer and respiratory distress or altered mental status may benefit from palliative care that avoids unnecessary interventions.


Subject(s)
Cancer Care Facilities/statistics & numerical data , Emergency Service, Hospital/statistics & numerical data , Hospital Mortality , Hospitalization/statistics & numerical data , Intensive Care Units/statistics & numerical data , Neoplasms/mortality , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Young Adult
15.
Clin Cancer Res ; 22(3): 533-9, 2016 Feb 01.
Article in English | MEDLINE | ID: mdl-26832744

ABSTRACT

In 2013, the U.S. Department of Health and Human Services modified the Health Insurance Portability and Accountability Act Privacy Rule to "strengthen privacy and security protections" while "improving workability and effectiveness to increase flexibility for and decrease burden on regulated entities." In this article, we attempt to translate these generalized goals into the real-world implications of these changes. Under the new rules, researchers can obtain participants' permission to use their protected health information for more research activities with a single, upfront authorization (thereby reducing paperwork for participants, researchers, and institutional review boards) while providing potential participants with more information upon which to base their decisions about participation. The combined authorizations can be used in clinical trials and their optional substudies and in stand-alone biospecimen-banking research that includes authorization to permit future research use. We also suggest best practices for taking advantage of the flexibility offered by the new rules while maintaining strong privacy protections for human subjects.


Subject(s)
Academic Medical Centers , Cancer Care Facilities , Health Insurance Portability and Accountability Act/legislation & jurisprudence , Research Personnel , Biomedical Research/legislation & jurisprudence , Humans , United States
16.
PLoS One ; 10(3): e0122047, 2015.
Article in English | MEDLINE | ID: mdl-25822612

ABSTRACT

BACKGROUND: Docetaxel, a lipophilic drug, is indicated for castration-resistant metastatic prostate cancer. Most men with such disease would have had androgen-deprivation therapy, which decreases muscle and increases body fat. Obesity and body composition changes may influence the outcomes of docetaxel therapy. METHODS: We conducted a retrospective review of 333 patients with metastatic prostate cancer treated with docetaxel at a comprehensive cancer center between October 7, 2004 and December 31, 2012. Body composition parameters were measured based on the areas of muscle and adipose tissues in the visceral and subcutaneous compartments on CT images at L3-4 levels. Dose calculations, toxicity and adverse reaction profiles, and overall survival were analyzed. RESULTS: Obese patients were younger at the diagnosis of prostate cancer and had a shorter duration from diagnosis to docetaxel therapy. Analysis of body composition found that a high visceral fat-to-subcutaneous fat area ratio (VSR) was associated with poor prognosis but a high visceral fat-to-muscle area ratio (VMR) and high body mass index were associated with increased duration from starting docetaxel to death, allowing such men to catch up with patients with normal body mass index in overall survival from cancer diagnosis to death. Cox proportional hazard regression showed that age ≥65 years, high VSR, abnormal serum alkaline phosphatase, and >10% reduction of initial dosage were significant predictors of shorter time between starting docetaxel and death, and that high VMR, obesity, and weekly regimens were significant predictors of longer survival after docetaxel. CONCLUSION: Obese and overweight patients may benefit more from weekly docetaxel regimens using the reference dosage of 35 mg/m2 without empirical dosage reduction.


Subject(s)
Antineoplastic Agents/administration & dosage , Body Composition , Prostatic Neoplasms, Castration-Resistant/drug therapy , Prostatic Neoplasms, Castration-Resistant/pathology , Taxoids/administration & dosage , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/adverse effects , Antineoplastic Agents/therapeutic use , Body Mass Index , Docetaxel , Dose-Response Relationship, Drug , Humans , Male , Middle Aged , Proportional Hazards Models , Retrospective Studies , Survival Analysis , Taxoids/adverse effects , Taxoids/therapeutic use , Treatment Outcome
17.
J Pain ; 15(10): 1015-22, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25043982

ABSTRACT

UNLABELLED: Survival outcomes in patients with squamous cell carcinoma of the head and neck (HNSCC) vary by extent of disease, behavioral factors, and socioeconomic factors. We assessed the extent to which pretreatment pain influences survival in 2,340 newly diagnosed patients with HNSCC, adjusting for disease stage, symptoms, pain medications, comorbidities, smoking, alcohol consumption, age, sex, and race/ethnicity. Patients rated their pain at presentation to the cancer center (0 = "no pain" and 10 = "pain as bad as you can imagine"). Survival time was calculated from the date of diagnosis to the date of death of any cause or last follow-up. Five-year overall survival was calculated for all the variables assessed in the study. Severe pain (≥7) was most prevalent among those with oral cancer (20.4%; pharynx = 18.8%; larynx = 16.1%) and significantly varied by tumor stage, fatigue severity, smoking status, comorbid lung disease, and race (all P < .05) across cancer diagnoses. Overall 5-year survival varied by pain for oral (severe pain = 31% vs nonsevere pain = 52%; P < .001) and pharyngeal cancer (severe pain = 33% vs nonsevere pain = 53%; P < .001). Multivariable analyses showed that pain persisted as an independent prognostic factor for survival. Pain reported prior to treatment should be considered in understanding survival outcomes in HNSCC patients. PERSPECTIVE: Pretreatment pain was an independent predictor of survival in a large sample of HNSCC patients even after accounting for tumor node metastasis stage, fatigue, age, race/ethnicity, smoking, and alcohol intake. Therefore, symptoms at presentation and before cancer treatment are important factors to be considered in understanding survival outcomes in HNSCC patients.


Subject(s)
Carcinoma, Squamous Cell/epidemiology , Carcinoma, Squamous Cell/physiopathology , Head and Neck Neoplasms/epidemiology , Head and Neck Neoplasms/physiopathology , Pain/physiopathology , Carcinoma, Squamous Cell/diagnosis , Carcinoma, Squamous Cell/therapy , Comorbidity , Female , Head and Neck Neoplasms/diagnosis , Head and Neck Neoplasms/therapy , Humans , Kaplan-Meier Estimate , Laryngeal Neoplasms/diagnosis , Laryngeal Neoplasms/epidemiology , Laryngeal Neoplasms/physiopathology , Laryngeal Neoplasms/therapy , Male , Middle Aged , Mouth Neoplasms/diagnosis , Mouth Neoplasms/epidemiology , Mouth Neoplasms/physiopathology , Mouth Neoplasms/therapy , Multivariate Analysis , Pain/epidemiology , Pain Measurement , Pharyngeal Neoplasms/diagnosis , Pharyngeal Neoplasms/epidemiology , Pharyngeal Neoplasms/physiopathology , Pharyngeal Neoplasms/therapy , Prognosis , Squamous Cell Carcinoma of Head and Neck
18.
J Crit Care ; 29(5): 775-9, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24973103

ABSTRACT

PURPOSE: Timely recognition of critical patients by emergency center triage is an ongoing challenge. Peripheral tissue oxygen saturation (StO2) measurement has been used to monitor shock patients' responses to resuscitation. Interest has developed in evaluating StO2 as a triage tool, but limited studies have addressed critically ill patients. MATERIAL AND METHODS: This is a single-center, retrospective study of 158 emergent cancer patients with hypotension and/or modified systemic inflammatory response syndrome who underwent StO2 spot measurement at triage. RESULTS: Of the 57 patients with StO2 less than 70%, 17 went to the intensive care unit (ICU), whereas only 14 of the 101 patients with StO2 of 70% to 89% (P = .01) went to the ICU. There was no significant difference in non-ICU hospital admission or mortality between the 2 groups. The odds ratio of ICU admission for patients with StO2 less than 70% relative to those with StO2 of 70% to 89% was 2.64 (95% confidence interval, 1.18-5.87) and 2.87 (95% confidence interval, 1.23-6.66) when adjusted for mean arterial pressure, pulse, and temperature. CONCLUSIONS: In this patient population, an StO2 less than 70% significantly increased the risk of ICU admission. Tissue oxygen saturation at triage identifies critical patients who may not be recognized by vital signs alone. Tissue oxygen saturation measurement could help providers make earlier decisions regarding hospital resource allocation.


Subject(s)
Critical Illness , Hospitalization , Intensive Care Units , Oxygen Consumption/physiology , Sepsis/metabolism , Triage , Aged , Aged, 80 and over , Female , Fever/diagnosis , Humans , Hypotension/metabolism , Hypothermia/diagnosis , Male , Middle Aged , Oximetry , Regression Analysis , Retrospective Studies , Sepsis/diagnosis , Systemic Inflammatory Response Syndrome/metabolism , Tachycardia/diagnosis , Tachypnea/diagnosis
19.
Cancer Med ; 3(4): 962-70, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24802800

ABSTRACT

The prognostic accuracy of the CURB-65 criteria and pneumonia severity index (PSI) in immunocompromised cancer patients with pneumonia is unknown. We sought to determine whether CURB-65 and PSI predict 28-day mortality in cancer patients with pneumonia, and identify other factors that predispose cancer patients with pneumonia to a high mortality risk. We assessed sensitivities, specificities, predictive values, and areas under the receiver operating curve area under the curve (AUC) of the CURB-65 and PSI in predicting the 28-day mortality of cancer patients presenting to our institution's emergency department with pneumonia. We used the DeLong and Clarke-Pearson approach to determine whether the addition of other risk factors improved the scales' performances. The overall and pneumonia-related 28-day mortality rates were 20.2% (n = 44) and 17.4% (n = 38), respectively. In predicting 28-day mortality, the CURB-65 score had sensitivity of 45% and specificity of 81%, and the PSI score had sensitivity of 82% and specificity of 34%. The CURB-65 and PSI discriminated poorly between fatal and nonfatal pneumonia cases (AUCs, 0.664 and 0.658, respectively; 95% confidence interval [CI], 0.57-0.75 for each). The addition of radiation therapy (RT) within 4 weeks and stem cell transplant (SCT) significantly improved the AUCs of the CURB-65 (0.75; 95% CI, 0.67-0.83) and PSI (0.73; 95% CI, 0.65-0.82). Inadequate performances of CURB-65 and PSI demonstrate that a tool for predicting pneumonia-related mortality in cancer patients and other immunocompromised populations is needed. Pneumonia patients who have undergone recent RT or (SCT) are at a high risk of dying from pneumonia and require special consideration when assessing pneumonia-related mortality risk.


Subject(s)
Neoplasms/mortality , Pneumonia/mortality , Adult , Aged , Aged, 80 and over , Area Under Curve , Emergency Service, Hospital , Female , Humans , Male , Middle Aged , Mortality , Neoplasms/therapy , Oncology Service, Hospital , Pneumonia/pathology , ROC Curve , Retrospective Studies , Severity of Illness Index , Survival Analysis , Treatment Outcome , Young Adult
20.
SAGE Open Med Case Rep ; 2: 2050313X14533945, 2014.
Article in English | MEDLINE | ID: mdl-27489647

ABSTRACT

Most clinical studies of heparin-induced thrombocytopenia have not included cancer patients who have high risk of thromboembolism, frequent exposure to heparin, and many potential causes of thrombocytopenia other than heparin-induced thrombocytopenia. To estimate the incidence and prevalence of heparin-induced thrombocytopenia in cancer patients, we identified cases based on diagnostic codes, anti-heparin antibody testing, and clinical characteristics (4T score) at a comprehensive cancer center between 1 October 2008 and 31 December 2011. We estimated that the prevalence of heparin-induced thrombocytopenia to be 0.02% among all cancer patients and 0.24% among cancer patients exposed to heparin. The annual incidence of heparin-induced thrombocytopenia was 0.57 cases per 1000 cancer patients exposed to heparin. Of the 40 cancer patients with the International Classification of Diseases (Ninth Revision; ICD-9) code for heparin-induced thrombocytopenia, positive anti-heparin antibody, and 4T score ≥4, 5 (12.5%) died of related thromboembolic or hemorrhagic complications. In a multivariate logistic regression model, male gender was a significant (p = 0.035) factor, and non-hematological malignancy was a significant (p = 0.017) factor associated with anti-heparin antibody positivity. Future studies may further examine the risk factors associated with heparin-induced thrombocytopenia in larger cohorts.

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