Over-The-Counter Aspirin Use In Patients Diagnosed With Multiple Myeloma

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1961-1961
Author(s):  
Susan A Oliveria ◽  
Nancy Brandenburg ◽  
Syd Phillips ◽  
Kimberley J Woodcroft ◽  
Karen Wells ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Care Delivery ◽  
The United States ◽  
Low Risk ◽  
High Dose ◽  
Related Factors ◽  
Over The Counter ◽  
Vte Prophylaxis ◽  
Increased Risk ◽  
Daily Aspirin

Abstract Patients with multiple myeloma (MM) are at increased risk for venous thromboembolism (VTE) due to patient, disease, and treatment-related factors. Current National Comprehensive Cancer Network (NCCN) guidelines for VTE suggest that patients with MM receiving thalidomide or lenalidomide in combination with high-dose dexamethasone (480 mg per month) receive VTE prophylaxis. For MM patients at high risk for VTE (≥2 risk factors), low molecular weight heparin or full-dose warfarin is recommended. For MM patients at low risk for VTE (0-1 risk factor), aspirin 81-325 mg once daily is recommended for VTE prophylaxis. Eighty-five percent of patients diagnosed with MM are aged ≥55 and many of them are prescribed aspirin for primary or secondary prevention of cardiovascular or cerebrovascular disease, independent of their MM diagnosis. According to the 2010 National Health Interview survey, the prevalence of regular aspirin use among persons in the United States ≥50 years of age is 35.9%. Because aspirin use may provide effective prophylaxis of venous events in MM patients at low risk for VTE, it is important to understand the prevalence of aspirin use among MM patients. As part of a larger study examining the risk of VTE among patients diagnosed with MM and treated with thalidomide or lenalidomide, the objective of this study was to estimate the prevalence of over-the-counter (OTC) aspirin use among MM patients. Patients ≥18 years of age diagnosed with MM between January 1, 2005 and September 30, 2012 were identified from the tumor registry at the Henry Ford Health System (HFHS), a large integrated health care delivery system located in southeastern Michigan; whose data are included in the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute. We developed a telephone survey, and then contacted all eligible patients (i.e. they were alive and/or not documented as deceased) to quantify OTC aspirin use. Data analyses included descriptive statistics to assess the demographic, clinical, and aspirin use characteristics. We identified 381 patients diagnosed with MM; of those, 177 were eligible for the survey. We contacted these patients and achieved a 67% (n=119) response rate. The median age of survey respondents was 64 years (range 41-93) and 93 (78%) were aged ≥55. Sixty-two (52%) of the survey responders were female, 82 (69%) were African American, and 36 (30%) were white. Of the respondents, 46 (39%) reported weekly aspirin use and 43 of the 46 (94%) reported daily aspirin use. The average daily dose was 114 mg/day (standard deviation 93) and most patients (n=39 of 46; 85%) reported taking an 81 mg dose. The reason for daily aspirin use was cited as “Other reason for prophylaxis” by 36 (of 43; 84%) of the patients. In this case, patients indicated that they were taking aspirin for prophylaxis, but did not provide enough information to determine the reason for daily aspirin use. Only 5 patients (12%) reported taking aspirin for heart disease prophylaxis. Roughly one-quarter of the MM patients (n=31 of 119; 26%) indicated that they had a health problem that made aspirin use unsafe. Twenty-seven (23%) reported that they had a parent or sibling who had a heart attack before the age of 60; fourteen patients (12%) reported that they had a parent or sibling who has or ever had a VTE. Seventeen patients (14%) reported a history of ever having a VTE event themselves. Our data indicate that over one-third of patients diagnosed with MM use OTC aspirin daily. When treating patients diagnosed with MM, assessing risk for VTE and determining an appropriate VTE prophylaxis therapy is of the utmost importance. Disclosures: Brandenburg: Celgene Corporation: Employment, Equity Ownership.

scholarly journals Risk of acute myeloid leukemia and myelodysplastic syndromes after multiple myeloma and its precursor disease (MGUS)

Blood ◽  
2011 ◽  
Vol 118 (15) ◽  
pp. 4086-4092 ◽  
Author(s):  
Sham Mailankody ◽  
Ruth M. Pfeiffer ◽  
Sigurdur Y. Kristinsson ◽  
Neha Korde ◽  
Magnus Bjorkholm ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Acute Myeloid Leukemia ◽  
Myelodysplastic Syndromes ◽  
Myeloid Leukemia ◽  
Excess Risk ◽  
M Protein ◽  
High Dose ◽  
Related Factors ◽  
Increased Risk ◽  
Acute Myeloid

Abstract Using population-based data from Sweden, we identified all multiple myeloma (MM) patients (n = 8740) and 5652 monoclonal gammopathy of undetermined significance (MGUS) patients diagnosed between 1986 and 2005. We calculated standardized incidence rates (SIRs) for all subsequent hematologic and nonhematologic malignancies for MM patients diagnosed before/after 1995 (introduction of high-dose melphalan/autologous stem cell transplantation [HDM-ASCT]) and 2000 (introduction of immunomodulatory drugs [IMiDs]), respectively. MM patients had an 11.51-fold (95% confidence interval: 8.19-15.74) increased risk of acute myeloid leukemia (AML)/myelodysplastic syndromes (MDS); risk was very similar before/after 1995 and 2000, respectively. MGUS patients had an 8.01-fold (5.40-11.43) increased risk of AML/MDS. Risk was confined to IgG/IgA, while no IgM MGUS patients developed AML/MDS; patients with monoclonal-protein (M-protein) concentrations > 1.5 g/dL (SIR = 11.12; 3.61-25.96) had higher risk than those < 1.5 g/dL (SIR = 4.67; 1.71-10.16). An excess risk of nonmelanoma skin cancer was observed subsequent to both MM (SIR = 2.22; 1.74-2.80) and MGUS (SIR = 3.30; 2.76-3.90). Our novel observations of an excess risk for AML/MDS following IgG/IgA (but not IgM) MGUS, and the highest risk associated with M-protein concentrations > 1.5 g/dL, support a role for nontreatment-related factors in plasma cell dyscrasias. AML/MDS risk following MM was the same before/after the introduction of HDM-ASCT. Longer follow-up is needed to characterize second tumor risks in the IMiD era.

scholarly journals Bortezomib administration is a risk factor associated with the development of tumor lysis syndrome in male patients with multiple myeloma: A retrospective study

2020 ◽  
Author(s):  
Masahiro Kondo ◽  
Yuji Hotta ◽  
Karen Yamauchi ◽  
Akimasa Sanagawa ◽  
Hirokazu Komatsu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multiple Myeloma ◽  
Odds Ratio ◽  
Tumor Lysis Syndrome ◽  
Low Risk ◽  
Novel Therapies ◽  
Tumor Lysis ◽  
Factors Associated ◽  
Increased Risk ◽  
Male Patients

Abstract Background: Novel agents such as proteasome inhibitors have been developed for several years to treat multiple myeloma. Although multiple myeloma is a low-risk disease for developing tumor lysis syndrome (TLS), treatment with these novel therapies might increase TLS risk. Previous studies, mostly case reports or case series, have reported bortezomib-induced TLS in patients with multiple myeloma. This study aimed to investigate risk factors associated with TLS development in multiple myeloma patients.Methods: We retrospectively investigated incidences of laboratory and clinical TLS (LTLS and CTLS, respectively) in patients who received primary therapy for treatment-naive, symptomatic multiple myeloma between May 2007 and January 2018. We used multivariate logistic regression analyses to evaluate the associations between TLS and several parameters previously reported to be associated with increased risk.Results: This study included 210 patients with multiple myeloma, of which ten (4.8%) had LTLS and seven (3.3%) had CTLS. The characteristics of the administered anticancer or prophylactic antihyperuricemic agents were similar between patients with and without TLS. Multivariate analyses revealed that TLS was most strongly associated with bortezomib-containing therapy (odds ratio = 3.40, P = 0.069), followed by male sex (odds ratio = 2.29, P = 0.153). In a subgroup analysis focused on men, treatment with bortezomib-containing therapy was significantly associated with increased risk of TLS (odds ratio = 8.51, P = 0.046).Conclusion: In the present study, we investigated the risk factors associated with TLS development in 210 multiple myeloma patients, which, to the best of our knowledge, is the largest number of patients reported to date. Furthermore, this study is the first to evaluate TLS risk factors in MM by adjusting for the effects of potential confounding factors in patients’ backgrounds. Consequently, we found that bortezomib-containing therapy increases the risk of TLS in male patients with multiple myeloma. TLS risk should be evaluated further in low-risk diseases such as multiple myeloma, since a significant number of novel therapies can achieve high antitumor responses.

scholarly journals VTE Rates and Safety Analysis of Newly Diagnosed Multiple Myeloma Patients Receiving Carfilzomib-Lenalidomide-Dexamethasone (KRD) with or without Rivaroxaban Prophylaxis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1835-1835 ◽  
Author(s):  
Katrina M Piedra ◽  
Hani Hassoun ◽  
Larry W. Buie ◽  
Sean M. Devlin ◽  
Jessica Flynn ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Venous Thromboembolism ◽  
Board Of Directors ◽  
Research Funding ◽  
High Dose ◽  
Newly Diagnosed ◽  
Advisory Committees ◽  
Cancer Trial ◽  
Oncology Research ◽  
Increased Risk

Introduction Immunomodulatory agents (IMiD's) are associated with an increased risk of venous thromboembolism (VTE), particularly when combined with high dose steroids. Studies evaluating the use of lenalidomide-bortezomib-dexamethasone (RVD) and carfilzomib-lenalidomide-dexamethasone (KRD) in the frontline setting for multiple myeloma (MM) have reported a 6% and 24% incidence of thrombosis, respectively, despite primary thrombotic prophylaxis with aspirin (ASA) (Richardson, et al. Blood. 2010; Korde, et al. JAMA Oncol 2015). Recent data, including the Hokusai VTE Cancer Trial, have suggested that safety and efficacy of direct oral anticoagulants (DOACs) are preserved in the setting of treatment of solid malignancy-associated thrombosis (Raskob, et al. N Engl J Med. 2018; Mantha, et al. J Thromb Thrombolysis. 2017). Despite this data, there is limited experience and use of DOACs in prevention of thromboses in the setting of hematologic malignancies, specifically MM. After careful review of literature, since early 2018, we changed our clinical practice and routinely placed newly diagnosed MM (NDMM) patients receiving KRD at Memorial Sloan Kettering Cancer Center (MSKCC) on concomitant rivaroxaban 10 mg once daily, regardless of VTE risk stratification. In the following abstract, we present VTE rates and safety data for newly diagnosed MM patients receiving RVD with ASA vs. KRD with ASA vs. KRD with rivaroxaban prophylaxis. Methods This was an IRB-approved, single-center, retrospective chart review study. All untreated patients with newly diagnosed MM, receiving at least one cycle of RVD or KRD between January 2015 and October 2018 were included. The period of observation included the time between the first day of therapy until 90 days after completion of induction therapy. Patients were identified by querying the pharmacy database for carfilzomib or bortezomib administration and outpatient medication review of thromboprophylaxis with rivaroxaban or ASA. VTE diagnoses were confirmed by ICD-10 codes and appropriate imaging studies (computed tomography and ultrasound). Descriptive statistics were performed. Results During the observation period, 241 patients were identified to have received RVD or KRD in the frontline (99 RVD with ASA; 97 KRD with ASA; 45 KRD with rivaroxaban). Baseline characteristics were well distributed among the three arms, with a median age of 60 (30-94) in the RVD ASA arm, 62 (33-77) in the KRD ASA arm, and 60 (24-79) in the KRD rivaroxaban arm. Patients had International Staging System (ISS) stage 3 disease in 13% (N=13), 9.3% (N=9), and 11% (N=5) of the RVD ASA, KRD ASA, and KRD rivaroxaban arms, respectively. Median weekly doses of dexamethasone were higher in both KRD arms, 40 mg (20-40) vs. 20 mg (10-40) in the RVD ASA arm. The average initial doses of lenalidomide were 22 mg in the RVD ASA arm compared to 25 mg in both the KRD ASA and KRD rivaroxaban arms. After querying the pharmacy database, no patients were identified to have a history or concomitant use of erythropoietin stimulating agent (ESA) use. Treatment-related VTE's occurred in 4 patients (4.0%) in the RVD ASA arm, 16 patients (16.5%) in the KRD ASA arm, and in 1 patient (2.2%) in the KRD rivaroxaban arm. Average time to VTE was 6.15 months (Range 5.42, 9.73) after treatment initiation in the RVD ASA group, while it was 2.61 months (Range 0.43, 5.06) in the KRD ASA group and 1.35 months in the KRD rivaroxaban group. Minor, grade 1 bleeding events per the Common Terminology Criteria for Adverse Events (CTCAE) were identified in 1 (1.1%) patient in the RVD ASA arm, 5 (5.2%) patients in the KRD ASA arm, and 1 (2.2%) patient in the KRD rivaroxaban arm. Conclusion More efficacious MM combination therapies have been found to increase the risk of VTE when using ASA prophylaxis, indicating better thromboprophylaxis is needed. We found patients receiving ASA prophylaxis with KRD were more likely to experience a VTE and these events occurred earlier compared to patients receiving ASA prophylaxis with RVD. Importantly, the rate of VTE was reduced to the same level as ASA prophylaxis with RVD when low-dose rivaroxaban 10 mg daily was used with KRD, and without necessarily increasing bleeding risk. Our retrospective data support the development of prospective clinical trials further investigating DOAC use in thromboprophylaxis for NDMM patients receiving carfilzomib-based treatments. Figure Disclosures Hassoun: Novartis: Consultancy; Janssen: Research Funding; Celgene: Research Funding. Lesokhin:BMS: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Janssen: Research Funding; GenMab: Consultancy, Honoraria; Serametrix Inc.: Patents & Royalties; Genentech: Research Funding; Juno: Consultancy, Honoraria. Mailankody:Juno: Research Funding; Celgene: Research Funding; Janssen: Research Funding; Takeda Oncology: Research Funding; CME activity by Physician Education Resource: Honoraria. Smith:Celgene: Consultancy, Patents & Royalties, Research Funding; Fate Therapeutics and Precision Biosciences: Consultancy. Landgren:Theradex: Other: IDMC; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Abbvie: Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Other: IDMC; Sanofi: Membership on an entity's Board of Directors or advisory committees; Adaptive: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. OffLabel Disclosure: Off-label use of rivaroxaban for outpatient prophylaxis of venous thromboembolism (VTE) will be explicitly disclosed to the audience.

HSR19-088: Severe Obesity Does Not Worsen Transplantation Outcome in Multiple Myeloma

2019 ◽  
Vol 17 (3.5) ◽  
pp. HSR19-088
Author(s):  
Zhubin J. Gahvari ◽  
Michael Lasarev ◽  
Jens C. Eickhoff ◽  
Aric C. Hall ◽  
Peiman Hematti ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Linear Models ◽  
Severe Obesity ◽  
Health Hazard ◽  
The United States ◽  
Hospital Length Of Stay ◽  
Nccn Guidelines ◽  
Post Transplant ◽  
Risk Of Death ◽  
Increased Risk

Background: Obesity, and in particular severe obesity, is increasingly prevalent in the United States. Epidemiological studies have shown an association in multiple myeloma (MM) between obesity and mortality (Teras et al, Br J Haematol 2014). Autologous peripheral blood stem cell transplantation (autoPBSCT) remains a crucial aspect of treating MM, and the NCCN Guidelines recommend all eligible patients be evaluated for transplant. There is limited data analyzing the relationship between severe obesity and transplant outcomes in MM patients in the era of modern therapy, routine post-transplant maintenance, and genetic-based risk stratification. Methods: We retrospectively reviewed consecutive patients undergoing autoPBSCT for MM at our institution from 2010–2017. Patients were categorized by body mass index (BMI) and Revised International Staging System (R-ISS) score. Patients were followed from time of first transplant until death. Surviving patients and those lost to follow-up were censored at last point of contact. Cox proportional hazard regression models and associated log-rank tests were used to assess whether age, BMI, lag time between diagnosis and transplant, and R-ISS score were associated with risk of death. Post-transplant hospital length of stay (LOS) was evaluated using generalized linear models with response following a gamma distribution. Results: 314 patients (59.2% male) were included. BMI was categorized as nonobese ([16, 30) kg/m2; n=178, 56.7%), obese ([30, 35) kg/m2; n=72, 22.9%) or severely obese ([35, 55) kg/m2; n=64, 20.4%) and was not found to be associated with risk of death following transplant, either independently (P=.17) or when adjusting for age, sex, lag, and R-ISS (P=.26). As expected, R-ISS score was associated (P=.006) with risk of death after transplant. No association was found between mean LOS and BMI (P=.875). Kaplan-Meier mortality estimates are shown in Figure 1. Conclusions: Obesity and severe obesity were not associated with an increased risk of mortality for MM patients receiving autoPBSCT. Although severe obesity is a health hazard, this should not be used to exclude patients from transplant.

Racial and Ethnic Differences in Incidence and Disease Specific Survival of Multiple Myeloma- New Mexico Tumor Registry Based Study

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 46-47
Author(s):  
Shashank R Cingam ◽  
Martha Mapalo ◽  
Meisner L Angela ◽  
Charles Wiggins ◽  
Leslie A. Andritsos
Keyword(s):  
Multiple Myeloma ◽  
New Mexico ◽  
Native Americans ◽  
The United States ◽  
Disease Specific Survival ◽  
Related Factors ◽  
Tumor Registry ◽  
Hispanic Females ◽  
Racial Ethnic ◽  
Disease Specific

Background: Multiple Myeloma is a plasma cell neoplasm which is characterized by an increase in monoclonal proteins or light chains and end-organ damage. Multiple Myeloma accounts for 1.8% of all new cancer cases in the United States, with an estimated 32,110 new cases annually. In population-based studies, African Americans have a higher incidence of Myeloma and inferior outcomes when compared to Caucasians. Disparities in the incidence of Myeloma for other races in the United States also exist but are not well studied.(1). Analyses of Surveillance, Epidemiology, and End Results program (SEER) data showed that Hispanics had poor or delayed access to novel agents and transplant, and poor overall survival.(2). Data for Native Americans was not reported due to small or insignificant numbers. New Mexico is a majority minority state, with approximately 1 million Hispanics residing in the state, constituting 49.1% of the total population and the largest statewide percentage of Hispanic residents nationally. (3) New Mexico also has a sizable population of 219,237 Native Americans, who make-up nearly 10.5% of the state's entire population. (3) Hence, the significant minority population in New Mexico allows the comparison of incidence between racial and ethnic subgroups as well as disease specific survival of Myeloma in New Mexico residents using the New Mexico Tumor Registry. Methods: We utilized data from the New Mexico Tumor Registry to study patients with a documented diagnosis of Myeloma. Descriptive statistics including the incidence rates of myeloma and Kaplan-Meier product-limit methods to assess cause-specific survival for incident myeloma cases diagnosed among New Mexico residents during the time period 2008-2017. Other variables including transplantation rates were also studied but are not reported in this abstract. Results: Men had higher incidence of Myeloma compared to females (p<0.01) and Hispanic females had a higher incidence compared to Non-Hispanic white females (p<0.05). The incidence of Myeloma (for both sexes) was slightly increased in Hispanics (5.6 /per 100,000, CI- 5.1,6.2) and Native Americans (6.3/per 100,000, CI- 5.1,7.7) compared to Non- Hispanic Caucasians (5.1/per 100,000, CI- 4.7,5.5). (Fig. 1) However, these differences were not statistically significant. The incidence of multiple myeloma has been stable for all racial-ethnic group examined during 1981-2017. (Fig. 2) Modest differences in survival among Non-Hispanic whites, Hispanics, and American Indians were not statistically significant (log-rank test, p=0.3907). (Fig.3) Conclusion: Racial-ethnic differences in incidence and disease specific survival of Multiple Myeloma were evident but were not statistically significant in New Mexico, except incidence of Multiple Myeloma among Hispanic females compared to Non-Hispanic white females. Further study of disease-related factors (high risk disease, mutational profiles, stage at diagnosis) and patient-related factors (access to standard treatments, transplantation or clinical trials) may be needed to understand these differences and better care for the patients. Disclosures Andritsos: Innate Pharma: Consultancy, Honoraria.

Thalidomide (thal), Lenalidomide (len), and Dexamethasone (dex)-Associated Venous Thromboembolism (VTE) and Reported VTE Rates Pre- and Post-FDA Approval: Optimal Prophylaxis Strategies Are Still Unclear

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2403-2403
Author(s):  
Monica Boen ◽  
June McKoy ◽  
Dennis West ◽  
Beatrice Edwards ◽  
Jayesh Mehta ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Randomized Trial ◽  
Randomized Trials ◽  
Low Dose ◽  
Adverse Drug Events ◽  
Safety Concern ◽  
Attorney General ◽  
High Dose ◽  
Vte Prophylaxis ◽  
Fda Approval

Abstract Background: We previously reported that thal and len administration was associated with high VTE rates, particularly for multiple myeloma (JAMA 2006). The Connecticut Attorney General filed a Citizen’s Petition in 2005 with the FDA highlighting this safety concern. In 2006, when the FDA granted approval to thal and len to treat multiple myeloma patients, the FDA upheld much of the Petition and the sponsor included a Black Box warning to package inserts for both drugs when administered to MM patients, and encouraged consideration of VTE prophylaxis (although optimal strategies were not known). Herein, to compare the len/thal/dex-associated VTE rates pre- and post-FDA approval, the Research on Adverse Drug Events and Reports (RADAR) project performed a literary search through Pubmed and Ovid, with the search terms: “VTE,” “thrombosis,” “thromboembolism,” “DVT,” “multiple myeloma,” “thalidomide,” and “lenalidomide.” Methods: Reports of VTE with thal or len treatment of MM were reviewed and ordered by thal and dex dosages (table below). High dose thal was defined as higher than 200mg/d, low dose thal as 200mg/d or lower, and high dose dex as higher than 20mg/d and low dose dex as 20mg/d and lower. Data sources included: Pubmed and Ovid with randomized trials from 2006 to 2008. Results: A total of 56 randomized trials were included, with 35 previously reported trials (JAMA 2006) from 1998 to July 2006 (2423 patients) and 21 new trials from August 2006 to 2008 (2261 patients). In the recent trials, lower doses of both thal and dex were used, which are leading to lower VTE rates. The dosage/use of dex has a direct impact on VTE rates, with recent randomized trials of low dose thal and low dose dex reporting VTE rates as low as 0% (0–5) regardless of the use of anticoagulant prophylaxis. When high thal and no dex were used without prophylaxis, VTE rates were 2%. The benefit of prophylaxis is still unclear because when low dose thal and low dose dex are administered, the effects of prophylaxis are negligible. Len and high dose dex associated VTE rates in MM patients have reached a high of 15% (3–15), which is lower than the 29% maximum VTE rates found in our previous report (JAMA 2006). The lower len and dex-associated VTE rates in recent trials with MM patients is confounded by exclusion of VTE risk MM patients prior to treatment. Both the pre- and post-FDA approval trials do not demonstrate significantly reduced len and high dose dex-associated VTE rates with prophylaxis. As with thal, cogent VTE prophylaxis strategies for MM patients who receive len are unclear. Conclusion: After FDA approval of thal and len in 2006, low thal and low dex dosages were used treat MM patients and have shown to be an effective way to decrease VTE risk. Optimal VTE prophylaxis strategies for MM patients who receive len or thal with dex continue to be uncertain. A formal randomized trial of alternative VTE strategies is needed. Randomized Trial VTE Results Bold: new results 8/06–08/08, Regular: previous results in JAMA 2006 Thal (n=1713) Len (n=548) None ASA LWMH Coumadin None ASA LWMH Coumadin DVT prophylaxis (n=905) (n=961) (n=154) (n=402) (n=252) (n=83) (n=211) (n=846) (n=160) (n=133) (n=177) Dosage Low Thal/Low Dex 2% (0–5) [3/122] n/a n/a n/a 5% [2/38] n/a n/a n/a Len + Dex + DVT screening n/a n/a 9% (3–10) [10/106] n/a n/a n/a n/a n/a n/a n/a Low Thal/No Dex 0% [0/30] 18% [9/49] 8% [4/37] n/a 0% [0/30] n/a 1% [2/202] n/a Len + dex + no DVT screening 10% (6–11) [22/211] 14% (4–28) [86/624] n/a 11% (3–19) [10/88] n/a n/a n/a n/a 15% [26/177] n/a Low Thal/High Dex 16% (6–18) [52/328] 17% (15–20) [35/202] 8% [9/117] 7% [3/45] n/a n/a 14% [7/50] n/a Len + no Dex + no DVT screening n/a 2% [4/222] 6% [3/54] 7% [3/45] n/a n/a n/a n/a n/a n/a High Thal/High Dex 12% [15/124] 7% (0–13%) [7/106] n/a n/a 29% [98/334] n/a n/a 6% [2/33] High Thal/Low Dex n/a 11% (7–26) [21/193] n/a n/a n/a n/a n/a 16% (8–25) [8/50] High Thal/No Dex 2% [6/301] 9% (0–16) n/a n/a n/a n/a n/a n/a

Improving VTE prophylaxis in hospitalized oncologic patients: Institutional impact VTE mentored QI project.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 148-148
Author(s):  
Josiah Halm
Keyword(s):  
United States ◽  
Risk Assessment ◽  
Pulmonary Embolism ◽  
Cancer Patients ◽  
Care Delivery ◽  
The United States ◽  
Vte Prophylaxis ◽  
Oncologic Patients ◽  
Order Sets ◽  
Order Set

148 Background: Venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism affects hundreds of thousand Americans each year. Pulmonary embolism(PE), is the 3rd leading cause of hospital related death and the most common preventable cause of death in the United States. Cancer is associated with 6-fold increase in the risk of VTE. For those undergoing surgery, the risks of post-operative DVT and fatal PE are 2-3 times greater, respectively, for cancer patients than non-cancer patients. VTE prophylaxis is widely available and effective, but frequently underused. VTE prevention is of particular concern to oncologists. Evidence based oncology-specific guidelines are available from several organizations including American Society of Clinical Oncology (ASCO) to highlight the importance of prophylaxis in oncology patients. An Interdisciplinary team of pharmacists and hospitalists received an educational grant to implement a VTE mentored project in a large Comprehensive Academic Cancer Center in the Southern United States. There was anecdotal evidence and data to suggest adherence to thrombo-prophylaxis was suboptimal, with multiple departments and physicians having their "own" order sets of varying complexities. Performance data on VTE was not routinely being collected and data on hospital-acquired VTE events was not consistently collected and reported. To meet increasing financial, regulatory and the clinical challenge of harmonizing VTE prophylaxis in the institution, a multi-disciplinary team was formed to implement this VTE initiative. Methods: The QI methodology used was the Plan, Do, Study and Act (PDSA). Step 1. Draft a single VTE protocol using best evidence with input from all stakeholders that will be acceptable to most users. Step 2. Analyze the care delivery throughout the hospital Step 3. Set up performance tracking with IT support Step 4. Staggered introduction/education of the VTE protocol across departments/physicians Step 5. Implement and track through cycles of PDSA. Results: The institution went from having about 10 different VTE order sets to a single VTE order set that was a single page and was utilized by medical, surgical and emergency room and ICU physicians. This was embed in all admission, transfer and post op orders. Use of VTE prophylaxis order set went from an aggregate of 40.7 to 76.1%, 3 months after implementation of initiative. 26% percent of patient with no prophylaxis ordered had no contraindications checked. 60.9% and 16% of admitted patients were risk stratified as moderate or high risk respectively. Conclusions: 4 key findings from the implementation project led to improved rates of thrombo-prophylaxis. Prescribers are in the best position to understand all components of the VTE risk as well as contraindications and should be responsible for VTE risk assessment, as hitherto nurses were doing risk assessment and physicians were prescribing prophylaxis. New VTE order set provided a linked menu of appropriate prophylaxis options for each level of risk which the older sets did not do. Embedding VTE order set in admission/transfer and post op orders sets led to increase use. Efforts to raise VTE awareness should be ongoing, routinely monitored and included with other safety indicators such as falls etc and reported back to providers and appropriate medical staff and executive committees.

High-dose chemotherapy as salvage treatment in germ cell tumors: a multivariate analysis of prognostic variables.

1996 ◽  
Vol 14 (10) ◽  
pp. 2638-2645 ◽  
Author(s):  
J Beyer ◽  
A Kramar ◽  
R Mandanas ◽  
W Linkesch ◽  
A Greinix ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Germ Cell ◽  
Germ Cell Tumors ◽  
The United States ◽  
High Dose Chemotherapy ◽  
Hematopoietic Progenitor Cell ◽  
Risk Category ◽  
High Dose ◽  
Prognostic Variables ◽  
Increased Risk

PURPOSE To identify prognostic variables for response and survival in male patients with relapsed or refractory germ cell tumors treated with high-dose chemotherapy (HDCT) and hematopoietic progenitor cell support. PATIENTS AND METHODS Three hundred ten patients treated with HDCT at four centers in the United States and Europe were retrospectively evaluated. Univariate and multivariate analysis of patient, disease, and treatment characteristics were used for comparisons of response rates and failure-free survival (FFS). RESULTS The actuarial FFS rate was 32% at 1, 30% at 2, and 29% at 3 years. Multivariate analysis identified progressive disease before HDCT, mediastinal nonseminomatous primary tumor, refractory or absolute refractory disease to conventional-dose cisplatin, and human chorionic gonadotropin (HCG) levels greater than 1,000 U/L before HDCT as independent adverse prognostic variables for FFS after HDCT. These variables were used to identify patients with good, intermediate, and poor prognoses. In the good-risk category, the predicted FFS rate at 2 years was 51%, compared with 27% and 5% in the intermediate-risk and poor-risk categories (P < .001). The increased risk for treatment failure was due to both a significantly lower rate of favorable responses and a significantly higher rate of relapses. Within the prognostic categories, the particular HDCT regimen or higher dosages of carboplatin or etoposide did not have a significant influence on treatment outcome. CONCLUSION Prognostic variables for treatment response after HDCT can be identified. The proposed prognostic model might help to optimize the use of HDCT in germ cell tumors and warrants validation in future trials.

scholarly journals Risk of monoclonal gammopathy of undetermined significance (MGUS) and subsequent multiple myeloma among African American and white veterans in the United States

Blood ◽  
2006 ◽  
Vol 107 (3) ◽  
pp. 904-906 ◽  
Author(s):  
Ola Landgren ◽  
Gloria Gridley ◽  
Ingemar Turesson ◽  
Neil E. Caporaso ◽  
Lynn R. Goldin ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
African American ◽  
African Americans ◽  
Monoclonal Gammopathy ◽  
White Male ◽  
Cumulative Risk ◽  
Prevalence Ratio ◽  
The United States ◽  
Increased Risk ◽  
Undetermined Significance

Abstract The age-adjusted incidence of multiple myeloma (MM) is 2-fold higher in African Americans than in whites. A few small studies have reported a higher prevalence of monoclonal gammopathy of undetermined significance (MGUS) in African Americans versus whites. Etiologic factors for MGUS and determinants for transformation of MGUS to MM are unknown. We quantified the prevalence of MGUS and subsequent risk of MM among 4 million African American and white male veterans admitted to Veterans Affairs (VA) hospitals. The age-adjusted prevalence ratio of MGUS in African Americans compared with whites was 3.0 (2.7-3.3 95% confidence interval). Among 2046 MGUS cases, the estimated cumulative risk of MM during the first 10 years of follow-up was similar (P = .37) for African Americans (17%) and whites (15%). In the largest study to date, we suggest that the excess risk of MM in African Americans results from an increase in risk of MGUS rather than an increased risk of progression from MGUS to MM.

scholarly journals Impact of Daratumumab-Containing Induction on Stem Cell Mobilization and Collection, Engraftment and Hospitalization Parameters Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3886-3886
Author(s):  
Evangelos Eleutherakis Papaiakovou ◽  
Evangelos Terpos ◽  
Nikolaos Kanellias ◽  
Magdalini Migkou ◽  
Maria Gavriatopoulou ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Research Funding ◽  
Treated Group ◽  
High Dose ◽  
On Demand ◽  
Increased Risk

Abstract Introduction: Advances in induction regimens have significantly improved depth of response and duration of remission in multiple myeloma (MM) patients who are eligible for high-dose therapy and autologous stem cell transplantation (ASCT). Proteasome inhibitor-based induction regimens are standard as part of induction and it has been shown not to have any detrimental effect on stem cell (SC) collection and engraftment. Daratumumab (DARA) is an IgG1k monoclonal antibody directed against CD38 with potent antimyeloma activity. Based on the results of prospective studies DARA is now approved as part of induction therapy. Available data indicate a potential impact of DARA on SC collection but there is limited data on engraftment, duration of hospitalization and infection risk. In this retrospective analysis we evaluated the effect of DARA-based induction on ASCT parameters. Methods: The analysis included consecutive newly diagnosed MM patients that received ASCT between 2016 and 2020, as part of their upfront treatment regimen in our institution (Department of Clinical Therapeutics, Athens, Greece). Per institutional protocol, after 4-6 cycles of induction, pts received low dose cyclophosphamide (2.5 g/m2) followed by G-CSF (10 mcg/Kg/day) to mobilize and collect SCs. Plerixafor was administered on-demand in case of poor mobilization and insufficient first day collection. Large volume leukapheresis was performed in pts with low CD34+ counts in order to increase CD34+ yield. Pts received G-CSF 480 μcg once daily from day +4 after SC reinfusion to ANC &gt;1500/mm3. All pts received antiviral and antifungal but no anti-bacterial prophylaxis. Results: 200 eligible pts were included in the analysis; 40 (20%) pts received DARA as part of PI-based upfront treatment and 160 (80%) pts received PI-based upfront treatment without DARA. Baseline demographics (age, gender, performance status) and disease characteristics (ISS and R-ISS stage, cytopenias, eGFR, lytic bone disease etc) were not different between the two groups. Response after induction was also similar (CR+VGPR rate was 93% vs 95% for non-DARA and DARA-containing regimens respectively). Use of DARA at induction was associated with lower total mean number of collected CD 34+ SCs (10.48 x 10^6/kg vs 16.58 x 10^6/kg, p&lt;0.0001), or SC collection on day 1 (7.99 x 10^6/kg vs 16.27 x 10^6/kg, p&lt;0.0001). Fewer pts in the DARA-treated group achieved the planned yield of at least 5 X 10^6 CD34+/kg, compared to DARA-untreated group (87.5 % vs 96.2%, p=0.047). DARA-treated pts required more often additional SC mobilization with on demand administration of plerixafor (42.5% vs 7.6%, p&lt;0.0001). In order to compensate for a poorer mobilization and lower quality graft (CD34% 0.66% vs 1.26% in apheresis product, p&lt;0.0001) DARA-treated group underwent more often &gt;1 day of SC collection (37.5% vs 6.3%, P &lt;0.0001), resulting in longer duration of collections (689 vs 452 min, p&lt;0.0001) and larger total apheresis volumes (723 vs 557 ml, p&lt;0.0001). However, 97% and 98% of pts in the two groups respectively were able to move to at least a single ASCT. Following ASCT, DARA-treated pts had a slightly delayed hematopoietic recovery (11 vs 10 days to PMN&gt;500/mm3, p&lt;0.001 and 12 vs 11 days for PLT counts&gt; 25x10^9/mm3, p&lt;0.001) and required more transfusions (2 vs 1 for RBCs, p=0.031 and 4 vs 2 for platelets, p&lt;0.001). Rates of neutropenic fever were higher (80% vs 67%, p=0.182), required antibiotics for longer duration (10 vs 8 days, p=0.042) and more often 2 or more lines of antibiotic therapy (53% vs 39%, p=0.003), experienced more often septic shock (12.5% vs 1.3%, p=0.003) and as a results DARA-treated pts had a slightly prolonged hospitalization (21 vs 19 days, p=0.02). However, D100 mortality was not statistically different (&lt;2% in both groups). Conclusion: DARA-containing induction before ASCT is associated with poorer mobilization and frequent need for use of plerixafor. However, similar percentage of patients can move to at least a single ASCT. The use of DARA-containing induction was also associated with slightly increased risk of infectious complications, antibiotics use and blood product transfusions but no increase in the risk of D100 mortality. These data point to the need for certain modifications to ASCT protocol for patients treated with DARA-containing regimens at induction, such as preemptive use of plerixafor, and perhaps prophylactic antibiotics. Disclosures Terpos: Amgen: Consultancy, Honoraria, Research Funding; BMS: Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Genesis: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Novartis: Honoraria; Takeda: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria, Research Funding; GSK: Honoraria, Research Funding. Gavriatopoulou: Takeda: Honoraria; Karyopharm: Honoraria; Sanofi: Honoraria; GSK: Honoraria; Genesis: Honoraria; Janssen: Honoraria; Amgen: Honoraria. Dimopoulos: Amgen: Honoraria; BMS: Honoraria; Janssen: Honoraria; Takeda: Honoraria; BeiGene: Honoraria. Kastritis: Takeda: Honoraria; Pfizer: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Genesis Pharma: Honoraria; Janssen: Consultancy, Honoraria, Research Funding.

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