Projecting the number of patients with colorectal carcinoma by phases of care in the US: 2000–2020

2006 ◽  
Vol 17 (10) ◽  
pp. 1215-1226 ◽  
Author(s):  
Angela B. Mariotto ◽  
K. Robin Yabroff ◽  
Eric J. Feuer ◽  
Roberta De Angelis ◽  
Martin Brown
2007 ◽  
Vol 41 (10) ◽  
pp. 1740-1743 ◽  
Author(s):  
Michelle M Bottenberg ◽  
Geoffrey C Wall ◽  
Roger L Harvey ◽  
Shahid Habib

Objective: To report a case of possible oral aloe vera-induced hepatitis. Case Summary: A 73-year-old female was admitted to the hospital for acute hepatitis. Extensive laboratory testing did not reveal the cause of the patient's disease. She was asked multiple times whether she was taking any home medications, which she initially denied. It was only after an extensive medication history done by a clinical pharmacist that the patient admitted to using oral aloe vera capsules for constipation. Upon discontinuation of the oral aloe vera, liver markers of hepatotoxicity returned to normal levels. Discussion: Herbal medications pose an increasing problem in patient safety, as the different types of these products and the number of patients who use them continue to grow. In the US, these products are not subject to the same regulatory scrutiny as prescription medications; thus, safety information can be difficult to obtain. In particular, hepatic toxicity due to herbal agents is poorly described in the medical literature. Aloe vera, often used topically for minor burns, can also be used orally as a laxative or an “anti-aging” agent. According to the Naranjo probability scale, the hepatotoxicity in this case was possibly related to ingestion of oral aloe vera. Additionally, using the Roussel Uclaf Causality Assessment Method for determining drug hepatotoxicity, the patient's symptoms were scored as probably caused by oral aloe vera. The more conservative designation was used in our report. Conclusions: With the widespread use of oral aloe vera and other herbal products, clinicians faced with a case of acute hepatitis that is not readily diagnosed should question patients about herbal use.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4253-4253 ◽  
Author(s):  
Maneesha Mehra ◽  
Nicole Cossrow ◽  
Robert A Stellhorn ◽  
Jessica Vermeulen ◽  
Avinash Desai ◽  
...  

Abstract Abstract 4253 Background: Castleman's Disease (CD), first described in 1956 by Benjamin Castleman and also known as angiofollicular or giant lymph node hyperplasia, is characterized by lymphadenopathy resulting from abnormal proliferation of B lymphocytes and plasma cells. The clinical manifestations of the disease range from asymptomatic discrete lymphadenopathy, Unicentric Castleman's Disease (UCD), to a more severe form with recurrent episodes of diffuse lymphadenopathy and multi-organ involvement, Multicentric Castleman's Disease (MCD). In a discrete subpopulation, MCD is associated with HIV and Human herpesvirus-8 (HHV-8) infection. Incidence and prevalence of this rare disease is generally unknown but the hypothesized prevalence of CD ranges between 30,000 and 100,000 in the US. There are no codes to accurately identify CD, UCD or MCD in national databases. Objective: The objective of this effort is to propose an algorithm identifying and characterizing potential CD patients to estimate related incidences based on available information and patient characteristics from a national claims database. Methods: The diagnostic and procedure codes that are used in diagnosing lymphadenopathy patients in a longitudinal commercial claims database were used to define and characterize a cohort of likely CD patients. Included patients were required to be continuously enrolled in the database for at least three years. Patients with a history of rheumatoid arthritis (RA), Lupus, Hodgkin's disease (HD), Non-Hodgkin's Lymphoma (NHL) or other malignancies were excluded. Patients must have a diagnosis code of ICD-9 = 785.6 indicating lymphadenopathy followed by a lymph node biopsy (procedure code = 38505) on or within two years after the initial ICD-9 diagnosis date. Patients who had a diagnosis, within 1 year after the initial ICD-9 diagnosis date, of RA, Lupus, HD, NHL or other malignancies were excluded. Once the pool of potential CD patients was identified, it was further characterized according to age, gender, prescription medication use and comorbidities, particularly the development of NHL. To estimate incidence of the disease in the US, the number of patients identified in the pool adjusted for the total patient-time in the database was applied to US census population. Results: In a claims database of nearly 27 million patients (N=26,982,399), 16,967 patients were identified with an ICD-9 diagnosis of 785.6 and a biopsy code of 38505. After the additional exclusion criteria based on a three year continuous enrollment and a biopsy code on of within two years after the index diagnosis date and excluding patients with prior RA, Lupus, HD, NHL or other malignancies, there were 2,094 patients. After further excluding patients who developed RA, Lupus, HD, NHL other malignancies or HIV within one year after the diagnosis date, 1,153 patients remained with potential diagnosis of CD. These patients were mostly female (64.4%, N=742) and the mean and median age of this cohort were 43 and 45 years, respectively. The most common comorbid conditions were swelling in head/neck, followed by malaise and fatigue and pain in limb. Among these patients, only a quarter were taking a steroid or chemotherapy. Steroid use (dexamethasone and prednisone) was the more common treatment; rituxan usage was documented for less than 1% of the cohort. Based on this sample the incidence rate of CD is 21 cases per million person-years. Applying this rate to the 25 years and older US population, assumed to be 207,301,600 in 2011, the incidence of CD in the US is 4,353 patients. Discussion: To date, a thorough investigation of the incidence of CD in the US has not been done. Within the limitations of this effort, a plausible strategy using a US claims database to identify and characterize patients with CD was developed and confirms the very low incidence of CD. Furthermore this effort characterizes potential CD patients as young adults, and only very few of them receive treatment with steroids or chemotherapy. The low chemotherapy usage may suggest that there are very few MCD patients in this cohort. The value of this effort is to demonstrate a relatively quick and cost-effective strategy to characterize the epidemiology and medical need for a rare disorder. Disclosures: Mehra: Janssen Global Services, LLC: Employment. Cossrow:Janssen Global Services, LLC: Employment. Stellhorn:Janssen Global Services, LLC: Employment. Vermeulen:Janssen Biologics Europe: Employment. Desai:Janssen Global Services, LLC: Employment. Munshi:Janssen Global Services, LLC: Consultancy.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13000-13000 ◽  
Author(s):  
A. L. Ervin-Haynes ◽  
R. M. Schinagl ◽  
M. R. Dalesandro ◽  
J. Roecker ◽  
H. Youssoufian ◽  
...  

13000 Background: EGFR expression, as determined by IHC, is currently used to select patients for cetuximab therapy. Based on prior studies in colorectal cancer patients, approximately 60 to 75% of patients express EGFR. There is increasing evidence that EGFR expression is not predictive of response to cetuximab therapy, and does not properly select patients who might benefit from such therapy (Chung et al 2005, Saltz et al 2005, Scartozi et al 2004, NCCN 2005). Such selection limits access to a considerable number of patients who might otherwise benefit. Methods: A clinical trial of cetuximab (Erbitux®) monotherapy is being conducted in 60 EGFR-undetectable patients with metastatic colorectal cancer at 14 sites in the US and Canada to explore the relationship between EGFR expression and cetuximab activity. Results: As of January 5, 2006, 112 patients have been screened. Of these patients, 33 (29%) were EGFR-undetectable and continued screening for study enrollment; 52 (46%) tested positive for EGFR expression; and 2 (2%) did not have enough tissue to evaluate EGFR status and were not enrolled onto the trial. The remaining 25 pts (22%), were initially found to be EGFR-undetectable by IHC testing at local labs, but were subsequently identified as EGFR-positive after reevaluation at a highly experienced, centralized laboratory. Conclusion: The majority of patients tested for EGFR expression are tested using the EGFR pharmDx™ IHC assay. Results of the IHC-based assay for EGFR expression are highly dependent upon sample preparation and the methods used in conducting the assay. Variability in methods among labs may result in poor identification of pts expressing EGFR. This finding, together with the growing evidence that EGFR expression is not predictive of response to cetuximab therapy, indicate that the current routine practice of tumor IHC EGFR testing for the purpose of selecting cetuximab therapy may be inappropriate and pts who could potentially benefit from cetuximab therapy are being excluded from a treatment option. [Table: see text]


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6564-6564 ◽  
Author(s):  
Lola A. Fashoyin-Aje ◽  
Laura L. Fernandes ◽  
Steven Lemery ◽  
Patricia Keegan ◽  
Rajeshwari Sridhara ◽  
...  

6564 Background: In the US, statistics for Asians are often aggregated with other racial groups. This poses challenges in estimating the cancer burden and in defining cancer clinical trial enrollment targets in this demographic subgroup. ‘Asian‘ refers to persons with origins in the Far East, Southeast Asia, or the Indian sub-continent. Asians comprise 6% of the US population and the largest Asian subgroups in the US are of Chinese (22%), Filipino (19%), Asian Indian (19%), Vietnamese (10%), Korean (9%), and Japanese (7%) descent. The representation of Asian patients in global clinical trials may not be reflective of the Asian subgroups in the US. FDA conducted an analysis to describe patients categorized as ‘Asian’ in clinical trials supporting the approval of new drugs. Methods: We reviewed the marketing applications of 33 new molecular entities approved for the treatment of solid tumor malignancies between 2011- 2016 to identify trials that provided the primary evidence of safety and efficacy. Results: A total of 29,941 patients were enrolled; 17 % were Asian. Most Asian patients were enrolled in Korea (20%), Taiwan (20%), mainland China (20%), Japan (16%), and US (5%). Few patients were enrolled in India (3%); the Philippines (1%); Vietnam (0). In the US, Asian patients comprised 3% of the total number of patients enrolled. Conclusions: Asian patients represented a heterogeneous mix. A large proportion was enrolled in Taiwan (20%) and Korea (20%), whereas the largest proportion of US Asians have origins in mainland China (22%), the Philippines (19%), India (19%), and Vietnam (10%). Nevertheless, although Asians share a common ancestry, it is not clear whether data from global clinical trials are generalizable to Asian patients in the US. Therefore, strategies to improve the enrollment of US Asian patients in clinical trials are needed. Among patients enrolled in the US, 3% were Asians, a proportion that is below US Asian population estimates (6%). While most site-specific cancer incidence and death rates are lower in US Asians compared to Whites, the rates of some cancers (e. g., stomach and liver) are higher in this group. Therefore, studies are needed to determine adequate enrollment targets in this demographic subgroup.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4137-4137
Author(s):  
Ravi Kumar Paluri ◽  
Paul Cockrum ◽  
Ashley Ann Laursen ◽  
Joseph Louis Gaeta ◽  
Shu Wang ◽  
...  

4137 Background: The coronavirus disease 2019 (COVID-19) pandemic has caused abrupt changes to the US health system and disruption in cancer care delivery. Little has been reported on the impact of COVID-19 on patients with mPDAC and the care delivery. Our study aimed to characterize the impact of COVID-19 on healthcare utilization and outcomes for patients with mPDAC in the US in the community oncology setting. Methods: We performed a retrospective cohort study of adult patients diagnosed with mPDAC between March – September 2019 and March – September 2020 using the nationwide Flatiron Health EHR database, comprising data from over 280 (largely community based) cancer clinics. Patients were stratified into two cohorts based on the year of diagnosis (2019 vs. 2020). Clinical characteristics were summarized including age at metastatic diagnosis, stage at initial diagnosis, and ECOG performance score (PS). Overall survival (OS) from metastatic diagnosis was estimated using Kaplan-Meier methods. A sensitivity analysis limiting the follow-up time to November of each year was conducted. Results: Overall, 1,719 patients were included in the study (2019: n = 923, 2020: n = 796); both cohorts had similar demographic compositions in terms of age and sex (2019: median age = 70 (IQR: 62 – 76), 52.2% male; 2020: median age = 70 [IQR: 62 – 76], 53.5% male). In 2020, the number of newly diagnosed mPDAC patients decreased by 13.8% compared to 2019. A slightly higher proportion of patients were initially diagnosed with stage IV disease in 2020 (69.7%) vs 2019 (62.3%). A similar proportion of patients with ECOG PS 0-1 was observed between the two cohorts (2019: 48.5%; 2020: 47.9%). The number of visits recorded within the first 90 days after metastatic diagnosis was similar between the two cohorts (2019: median 8 [IQR: 3 – 14]; 2020: median 9 [IQR: 4 – 14]). For both cohorts, the proportion of patients who received 1L treatment was similar (2019: 75.8%; 2020: 76.5%), and the most common 1L treatment regimen was gemcitabine plus nab-paclitaxel (2019: 37.6%; 2020: 40.9%). Of the 1L treated populations, 37.6% of patients diagnosed in 2019 received second line (2L) compared to 17.9% of the 2020 cohort; 16.9% of 1L treated patients in 2019 received 2L in the sensitivity analysis. Patients diagnosed in 2020 had a significantly lower median OS of 6.1 months (95% CI: 5.4 – 6.9) compared to patients diagnosed in 2019: 8.4 months (7.5 – 9.0) (p < 0.001). Conclusions: During the COVID-19 pandemic era, the diagnoses of de novo mPDAC appears to have been impacted, with a higher number of patients diagnosed with advanced stage at presentation. Our analysis suggests that while patients diagnosed in 2020 received a similar level of care as those in 2019, their survival outcomes were adversely affected. Further research is necessary to characterize the impact of the COVID-19 pandemic on cancer care and outcomes.


Author(s):  
Tanya Ralli ◽  
Vivekanandan Kalaiselvan ◽  
Ritu Tiwari ◽  
Shatrunajay Shukla ◽  
Kanchan Kholi

Introduction: Silymarin is a mixture of 9 different active flavanolignans extracted from the seeds of the milk thistle (Silybum marianum) plant. It has been extensively used by local people and medicinal practitioners in European countries from around 2,000 years for the treatment of liver and biliary-related disorders. Aims of this review: This review article documents and critically assesses, for the first time, up to date the regulatory status of the silymarin extract for the treatment of hepatic and other diseases. Methods: Information was collected systematically from electronic scientific databases including Google Scholar, Science Direct, PubMed, Web of Science, ACS Publications, Elsevier, SciFinder, and Wiley Online Library, as well as other literature sources (e.g., books). Additionally, various regulatory authority websites have been searched for exploring the data. Key findings: Silymarin has been approved in different doses for the treatment or adjuvant therapy for liver disorders by the regulatory authorities of different countries. But, silymarin has still been used as a dietary supplement in the US, despite its high sales. The potential of silymarin to be approved for various other indications has been proved by assessing its efficacy in human patients. In addition to efficacy, it is found to be safe and well-tolerated. Conclusion: Phytochemical and pharmacological studies have demonstrated that silymarin is an important medicinal herb with prominent bioactivities. Thus, there is a need to conduct clinical trials in a larger number of patients to get approval for use in diseases like metabolic syndrome, diabetes mellitus, cancer, and many more.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 229-229
Author(s):  
Sejal S. Kuthiala ◽  
Gary H. Lyman ◽  
Oscar F. Ballester

Introduction: Evidence-based medicine defines standard therapies primarily from Phase III randomized controlled trials (RCT), when available. In this report we examined trends in ther number and characteristics of phase III RCT addressing the management of adult patients with hematological malignancies, comparing the patterns of activity in the US and Europe. Materials and Methods: We attempted to identify all phase III RCT published in the English medical literature from 1/1992 to 12/2003. A systematic search of Medline and published references was conducted using multiple keywords for each malignancy as well as for hematopoeitic stem cell transplant (HSCT). We cross-referenced the data by searching individual journals, as well as the ASH education books from 1998–2003. Studies published in abstract form only were not included. Results: We identified 306 published RCT that accrued a total of 4899 patients. Eighty-three of these studies included HSCT with a total accrual of 2081 patients. Country of origin included: US (n= 25), Europe (n=54), other (n=4). Four European countries (France, Italy, Germany and UK: FIGU) with a combined population similar to that of the US produced 32 studies. This figure for FIGU does not include their contributions to 12 separate European cooperative trials. There were no significant trends in the number of trials published per year during the study period. However, significant differences emerged when the focus of the studies and the accrual numbers were analyzed. RCTs comparing HSCT to standard dose therapy represented 34.9% of the 83 trials and 59.4% of FIGU trials, but only 4% (1 out of 25) of US studies (p <.001). US trials accrued a mean of 110.2 patients per study, as compared to 205.3 in other countries and 222.6 in FIGU studies (p= .006). In multivariate analysis, only focus of study was independently related to greater study size (p<.001). Among the remaining 223 trials not involving HSCT (US produced 68 and FIGU 77), a significant trend for increasing numbers of trials published per year during the study period was documented (p=.015). No significant differences in the mean number of patients accrued per trial (US= 279.5, other countries= 302.8 and FIGU= 347.8), or in the focus of the studies were observed in univariate or multivariate analysis. Conclusions: While there has been an increase in the number of Phase III RTCs in patients with hematological malignancies published during 1992–2003, the activity for HSCT trials has remained stationary. US HSCT trials have focused on issues other than the comparison of HSCT to standard therapies, such as graft manipulation, growth factors and graft versus host disease. US HSCT have accrued significantly fewer patients per study. The reasons for these differences are not apparent from our data, and may include patient and/or physician attitudes/biases toward phase III trials, issues of financial coverage for the HSCT procedure and/or health care delivery policies. There is a serious paucity of US trials defining the role of HSCT in the management of hematological malignancies.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3531-3531 ◽  
Author(s):  
Therese M. Conner ◽  
QuynhChau D. Doan ◽  
Annette L. LeBlanc ◽  
Ian B. Walters ◽  
Roy A. Beveridge

Abstract BACKGROUND: The efficacy and safety of single agent bortezomib (btz) in relapsed MM is well established. In that setting, typically 8 cycles of therapy (6 months) are given and treatment stops. However, no therapy is curative and upon relapse, patients are more refractory to subsequent therapies. Until recently, there has been little information on the feasibility and benefits of retreatment with btz. This study was designed to assess the safety and efficacy of btz used as retreatment either as a single agent or in combination with other agents in community oncology practices. METHODS: MM pts who received at least two btz-based therapies between May 2003 and November 2005 and who had a ≥60-day gap between each treatment were identified from 22 sites using the US Oncology electronic claims warehouse. Data were transcribed from the patient records to a prespecified case report form for analysis. Best response was determined using M-protein values when available: partial response (PR), 50–89% decrease; very good PR (VGPR) or better, ≥90% decrease. In some cases, physician assessments were available without laboratory confirmation in the chart. RESULTS: Ninety-four patients with relapsed MM met the eligibility requirements. Mean age was 65.9 years, 43% were female, median time from diagnosis to initial btz treatment was 3 years, and median number of therapies prior to first btz treatment was three. Patients received a median of 16 btz doses during the first treatment and a median of 12 doses in the second treatment; the median time between first and second btz treatment was 5 months (range 2–17). Notably, two patients in each treatment period received over 60 btz doses. The majority (55%) of patients received single agent btz without intervening therapies between first and second btz treatment. Of patients evaluable for response, a PR or better was achieved in 44 of 78 (56%) patients in response to initial therapy (26% achieved a VGPR or better) and in 17 of 85 (20%) in response to retreatment. Of patients with a ≥PR, 12 of 39 (31%) responded upon retreatment. Nine percent of patients who did not respond initially achieved a PR when retreated. Of those who achieved a VGPR or better on initial treatment, 18% achieved at least a VGPR on retreatment. The number of patients who stopped treatment due to toxicity was lower with retreatment (27%) compared with initial treatment (39%). Neuropathy and thrombocytopenia were the most common toxicities leading to discontinuation; treatment discontinuation due to neuropathy decreased from 17% on initial treatment to 5% on retreatment. Nine patients received ≥2 btz retreatments. CONCLUSIONS: Data from the US Oncology claims database for 94 patients retreated with btz (more than two retreatments in some) suggest that retreatment is safe and effective and not associated with new or cumulative toxicities. Btz is an option for repeated therapy in relapsed patients.


2007 ◽  
Vol 41 (10) ◽  
pp. 1632-1637 ◽  
Author(s):  
Keith R McCain ◽  
Tama S Sawyer ◽  
Henry A Spiller

Background: There are 4 centrally acting cholinesterase inhibitors (CA-ChEI) available in the US: tacrine, galantamina, rivastigmine, and donepezil. Documented clinical experience involving exposure to these agents is limited. The lack of information makes decisions involving excessive or unintended CA-ChEI exposure difficult. Objective: TO assess the effects, demographics, and outcomes of CA-ChEI exposures reported to US poison centers. Methods: A retrospective review of the Toxic Exposure Surveillance System of the American Association of Poison Control Centers data of acute and acute-on-chrontc exposures involving only a CA-ChEI in patients 19 years of age or older with documented medical outcomes from 2000–2005 was performed. Results: There were 1026 records that met criteria for this study. Patients aged 70–89 years made up 73% of reports; 69% of the patients were female. Moderate (197) and major outcomes (20) accounted for 21% of exposures. There were no deaths. Clinical effects that occurred in 5% or more of patients included vomiting (34%), nausea (28%), diarrhea (12%), dizziness/vertigo (9.9%), drowsiness/lethargy (7.7%), diaphoresis (7.4%), tremor (5.2%), and bradycardia (5%). Patients were admitted to the hospital in 19% of all exposures. Of those patients, 42% were admitted to a critical care unit. The majority (65%) of exposures were attributed to unintentional therapeutic error. Patients received at least one form of therapy In 47% of exposures, including intravenous fluid (111), antiemetic (46), atropine (17), benzodiazepine (15), oxygen (14), antihypertensive (4), pralidoxime (4), intubation (3), antihistamine (2), antiarrhythmic (1), anticonvulsant (1), and pacemaker (1). Conclusions: The majority of patients evaluated in this retrospective study experienced no or mild effect; however, significant or life-threatening effects were observed in a small group of patients and an appreciable number of patients were admitted to a healthcare facility.


2014 ◽  
Vol 44 (5) ◽  
pp. 407-413
Author(s):  
Charles C. Broz ◽  
Rhonda K. Hammond

Purpose – The purpose of this study was to survey current culinary, hospitality and nutrition students to determine their level of knowledge about dysphagia, or swallowing impairment, and the dysphagia diet. In addition, the study provided a means by which to gauge current students’ awareness of health-care foodservice as a career option. Design/methodology/approach – A pilot study conducted in 2009 indicated that health-care foodservice workers were unaware of many of the risks associated with the dysphagia diet. A second study was conducted in 2012 to obtain an idea of the perceptions and knowledge levels of culinary, hospitality and nutrition students about dysphagia. Subjects included students across the three disciplines at two large universities in the Midwestern USA, and a private culinary school on the east coast of the USA. The instrument consisted of a traditional paper survey containing 18 questions. A total sample size of n = 139 surveys was collected and analyzed. Findings – Results of the survey suggests that current university students are lacking in some areas of knowledge concerning dysphagia patients and their dietary needs. Education and training are indicated, as the number of patients suffering from some degree of dysphagia is only going to increase as the US population ages. Findings also indicate that many introductory-level students are unaware of health-care foodservice as a viable career choice in industry. Research limitations/implications – The primary limitations to this research were the relatively small sample size, and the fact that most students surveyed were not interested or aware of health-care foodservice as a viable industry career choice. This study would be greatly enhanced by contacting professors/instructors at several universities representing the Northeast, Midwest, and east and west coasts of the USA. Educating future foodservice professionals at the introductory level would allow industry leaders to make students aware of this large and necessary sector of the foodservice industry. Likewise, there is no doubt that food preparers, food deliverers and foodservice managers in health care will come in contact with a patient with some level of dysphagia as our population ages. More research to strengthen this body of data is indicated, as are similar studies across broader ranges of the population. Practical implications – The occurrence of dysphagia is growing as the US population ages. That fairly little research has been done is somewhat alarming. There is a need for standardization of recipe formulas, benchmarking viscosities of dietary liquids and solids and training of food preparers. The symptom is found in very large populations in the USA, as well as in Europe. Also, the fact that dysphagia has so many potential causes makes the symptom that much more of a health issue. More research is certainly called for to better prepare potential institutional foodservice employees for the next 20 years. Originality/value – Millions of Americans currently suffer from at least some degree of dysphagia. This number is expected to increase as the Baby Boomer generation reaches retirement age. The USA will be populated by more elderly people than ever before, and will thus host more individuals suffering from swallowing impairment. Health-care foodservice, including hospital and long-term care foodservice will certainly become a viable career choice for current students of culinary arts, nutrition and hospitality.


Sign in / Sign up

Export Citation Format

Share Document