scholarly journals Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Senri Yamamoto ◽  
Hirotoshi Iihara ◽  
Ryuji Uozumi ◽  
Hitoshi Kawazoe ◽  
Kazuki Tanaka ◽  
...  

Abstract Background The efficacy of olanzapine as an antiemetic agent in cancer chemotherapy has been demonstrated. However, few high-quality reports are available on the evaluation of olanzapine’s efficacy and safety at a low dose of 5 mg among patients treated with carboplatin regimens. Therefore, in this study, we investigated the efficacy and safety of 5 mg olanzapine for managing nausea and vomiting in cancer patients receiving carboplatin regimens and identified patient-related risk factors for carboplatin regimen-induced nausea and vomiting treated with 5 mg olanzapine. Methods Data were pooled for 140 patients from three multicenter, prospective, single-arm, open-label phase II studies evaluating the efficacy and safety of olanzapine for managing nausea and vomiting induced by carboplatin-based chemotherapy. Multivariable logistic regression analyses were performed to determine the patient-related risk factors. Results Regarding the endpoints of carboplatin regimen-induced nausea and vomiting control, the complete response, complete control, and total control rates during the overall study period were 87.9, 86.4, and 72.9%, respectively. No treatment-related adverse events of grade 3 or higher were observed. The multivariable logistic regression models revealed that only younger age was significantly associated with an increased risk of non-total control. Surprisingly, there was no significant difference in CINV control between the patients treated with or without neurokinin-1 receptor antagonist. Conclusions The findings suggest that antiemetic regimens containing low-dose (5 mg) olanzapine could be effective and safe for patients receiving carboplatin-based chemotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18101-e18101
Author(s):  
Achuta Kumar Guddati ◽  
Gagan Kumar ◽  
Iuliana Shapira ◽  
Parijat Saurav Joy

e18101 Background: Chemotherapy induced cardiomyopathy is an important complication of some chemotherapeutic agents. The stress of a cancer diagnosis and ongoing chemotherapy may contribute to cardiac morbidity in these patients. The burden of Takotsubo Cardiomyopathy (TCP) in cancer patients is unknown. The incidence of TCP and related outcomes in cancer patients was investigated in this study. Methods: The 2007-2013 National Inpatient Sample (NIS) was analyzed for patients with a prior and new diagnosis of TCP with and without malignancy. Risk factors for mortality were adjusted for associated conditions by multivariable logistic regression analysis. Results: From 2007 through 2013, an estimated 122,750 adults were admitted with a diagnosis of TCP. In 2013, the incidence of admissions in US of patients with coexisting TCP and malignancy was 1.13%. Admissions in 34,957 patients were for a primary diagnosis of TCP with 91.7% females; overall, 665 (2.1%) had solid organ cancer, 237 (0.74%) had hematological malignancy and 354 (1.11%) had metastatic cancer. Patients admitted for TCP with coexisting malignancy had a significantly higher mortality (13.8% vs. 2.9%, p < 0.0001), length of stay (7 vs. 4 days, p < 0.0001) and total charges ($29291 vs. $ 36231, p < 0.0001), compared to those with no malignancy. In patients with a primary diagnosis of TCP and without any underlying malignancy, males had a higher mortality (4.02% vs. 1.03%, p < 0.0001) whereas there was no gender difference in mortality in those with coexisting malignancy (6.25% vs 6.45%, p = 0.965). On multivariable logistic regression analysis, risk factors associated with mortality were solid cancer (OR 3.43, p = 0.008), stroke (OR 18.33, p < 0.0001), venous thromboembolic disease (OR 4.52, p = 0.004), malnutrition (OR 2.41, p = 0.006) and heart failure (OR 1.918, p = 0.004). Conclusions: Outcomes are significantly worse in patients with TCP and solid malignancy. Hence, this patient population must be regarded as high-risk and early diagnostic consideration for TCP is warranted. Early intervention may help lower mortality, decrease resource utilization and reduce the health care costs in these patients.


PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248845
Author(s):  
Syahrul Sazliyana Shaharir ◽  
Siew Huoy Chua ◽  
Rozita Mohd ◽  
Ruslinda Mustafar ◽  
Malehah Mohd Noh ◽  
...  

Avascular necrosis of bone (AVN) is increasingly being recognized as a complication of SLE and causes significant disability due to pain and mobility limitations. We studied the prevalence and factors associated with avascular necrosis (AVN) in a multiethnic SLE cohort. SLE patients who visited the outpatient clinic from October 2017 to April 2019 were considered eligible. Their medical records were reviewed to identify patients who developed symptomatic AVN, as confirmed by either magnetic resonance imaging or plain radiography. Subsequently, their SLE disease characteristics and treatment were compared with the characteristics of patients who did not have AVN. Multivariable logistic regression analyses were performed to determine the independent factors associated with AVN among the multiethnic SLE cohort. A total of 390 patients were recruited, and the majority of them were females (92.6%); the patients were predominantly of Malay ethnicity (59.5%), followed by Chinese (35.9%) and Indian (4.6%). The prevalence of symptomatic AVN was 14.1%, and the mean age of AVN diagnosis was 37.6 ± 14.4 years. Both univariate and multivariable logistic regression analyses revealed that a longer disease duration, high LDL-C (low density lipoprotein cholesterol), positive anti-cardiolipin (aCL) IgG and anti-dsDNA results, a history of an oral prednisolone dose of more than 30 mg daily for at least 4 weeks and osteoporotic fractures were significantly associated with AVN. On the other hand, hydroxychloroquin (HCQ), mycophenolate mofetil (MMF) and bisphosphonate use were associated with a lower risk of AVN. No associations with ethnicity were found. In conclusion, several modifiable risk factors were found to be associated with AVN, and these factors may be used to identify patients who are at high risk of developing such complications. The potential protective effects of HCQ, MMF and bisphosphonates warrant additional studies.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2418-2418
Author(s):  
Xiaomeng Yue ◽  
David Hallett ◽  
Yangyang Liu ◽  
Reethi Iyengar ◽  
Elisa Basa ◽  
...  

Abstract Introduction COVID-19 poses a serious concern for mB-cell NHL patients given their advanced age, high burden of comorbidities, and immune dysfunction. Limited by smaller sample sizes during the early period of the COVID-19 pandemic, previous studies were unable to thoroughly evaluate the impact of COVID-19 on patients with mB-cell NHL 1,2. We aim to describe demographics and clinical characteristics, outcomes, and risk factors associated with death and other severe outcomes among COVID-19 patients with mB-cell NHL in a large US nationwide database. Methods This retrospective cohort study was conducted using the Optum EHR database, comprising data from an integrated network of ambulatory and hospital care providers across the US. Patients with COVID-19 (diagnosis code of U07.1, U07.2, or a positive result of SARS-Cov-2 virus PCR or antigen tests) between Feb. 1, 2020 and Jan 7, 2021 (index date) and mB-cell NHL diagnosis prior to the COVID-19 diagnosis were included. Patients were excluded if they were under 18 years of age, had missing age or sex, or had &lt;1year continuous eligibility prior to their index date (pre-index period). All baseline characteristics, including demographics and comorbidities, were determined during the one-year pre-index period. Severe outcomes, including death, hospitalization, ICU admission, and acute respiratory insufficiency (ARI), were evaluated within 30 days post-index date. Multivariable logistic regression was conducted to identify variables independently associated with severe outcomes. Results Among 2,767 patients with mB-cell NHL who were infected with SARS-CoV-2 between Feb. 1, 2020 and Jan. 7, 2021 (mean age±SD: 67.9 years±14.7, 53.9% male), majority were white (73.9%), followed by African American (10.9%), Hispanic (6.9%), and Asian (1.2%). The most common subtypes of mB-cell NHL were chronic lymphocytic leukemia/small lymphocytic lymphoma (26.9%), multiple myeloma (22.4%), diffuse large B-cell lymphoma (13.2%), and follicular lymphoma (7.3%). Of these patients, 93.4% have at least one comorbidity. The most common comorbidities were hypertension (58.5%), neurological disease (49.4%), diabetes (28.2%), ischemic heart disease (25.5%), cardiac arrhythmia/conduction disorders (24.4%), chronic kidney disease (CKD, 19.2%), heart failure/cardiomyopathy (18.1%), and COPD (12.3%). Overall, 960 patients (34.7%) developed severe outcomes, among which, 847 patients (30.6%) were hospitalized, 214 patients (7.7%) were admitted to the ICU, 201 patients (7.3%) experienced ARI, and 220 patients (8.0%) died. Multivariable logistic regression showed that increased odds of severe outcomes were independently associated with older age (85+ years vs. &lt;65 years; adjusted odds ratio [OR], 2.0; 95% CI, 1.4-2.7), male gender (OR, 1.4; 95% CI, 1.1-1.6), insurance coverage with Medicaid (OR, 1.8; 95% CI, 1.1-2.9) and/or Medicare (vs. commercial only; OR, 1.9; 95% CI, 1.5-2.5), infected during the first quarter (OR, 5.6; 95% CI, 3.4-9.4) or second quarter of 2020 (vs. fourth quarter of 2020; OR, 1.7; 95% CI, 1.4-2.1), having CKD (OR, 1.3; 95% CI, 1.0-1.6), COPD (OR, 1.4; 95% CI, 1.0-1.8), diabetes (OR, 1.3; 95% CI, 1.1-1.6), and receiving active treatment for NHL (OR, 1.4; 95% CI, 1.0-2.0) within 30 days prior to COVID-19 diagnosis (Figure). Conclusions This study demonstrated key demographic and clinical characteristics associated with severe outcomes among COVID-19 patients with mB-cell NHL using one of the largest nationwide databases. Risk factors for severe outcomes identified in the general population, such as older age, male gender, and having certain underlying medical conditions were also identified in this study. In addition, COVID-19 infection occurring earlier in the pandemic and receiving active NHL treatments were associated with severe outcomes. These latter two observations might reflect the improvement in patient management during the latter period of the pandemic and that active mB-cell NHL disease and treatment rendered an increased risk of severe outcomes in COVID-19 patients with mB-cell NHL. These insights highlight the importance of utilizing demographic, clinical and treatment information to estimate the risk for severe outcomes, whereas prospective studies focusing on optimal COVID-19 management are required to identify specific actions that can be taken to improve outcomes of COVID-19 in patients with mB-cell NHL. Figure 1 Figure 1. Disclosures Yue: Joule: Current Employment. Hallett: AbbVie: Current Employment. Liu: AbbVie: Current Employment. Iyengar: AbbVie: Current Employment. Basa: AbbVie: Current Employment. Yang: AbbVie: Current Employment.


Circulation ◽  
2016 ◽  
Vol 133 (suppl_1) ◽  
Author(s):  
Harsha V Ganga ◽  
Jennifer Jantz ◽  
Gaurav Choudhary ◽  
Wen-Chih Wu

Background: Short duration of outpatient Phase II cardiac rehabilitation (CR) program is not sufficient to sustain benefits of CR. Participation in long-term Phase III CR improves exercise capacity and lipoprotein profile. Hypothesis: We examined the factors predicting Phase III CR enrollment in those who have successfully completed Phase II CR in a large urban CR center. Methods: 4714 participants who completed structured 36-session Phase II CR program from the year 2000 to 2014 were included in this retrospective study. Multivariable logistic regression model was used to identify demographic, socio-economic factors predicting Phase III CR enrollment. The Cochran-Armitage test was used to assess temporal trends in Phase III CR enrollment. Results: A total of 901, out of 4714 participants completing Phase II CR, enrolled into Phase III CR. Mean age was 65 years and 31% were females. Univariate predictors include age, race, education, occupation, income, return to work obligation, insurance status, weight loss, depression and anxiety, exercise duration, and metabolic equivalents (METs). On multivariable logistic regression, those with at least college education (Odds Ratio [OR] 1.5,95% confidence interval [CI], 1.07-2), depression (OR,1.5, 95% CI, 1.07-1.96), weight loss (OR, 1.03, 95% CI, 1.01-1.05) and attending more Phase II sessions (OR,1.06, 95% CI, 1.02-1.10) were more likely to enroll whereas those living > 30 minutes from CR center (OR, 0.40, 95% CI, 0.20-0.75), with higher METs (OR,0.93, 95% CI, 0.87-0.99) and exercising longer (OR, 0.96, 95% CI, 0.93-0.99) were less likely to enroll. There is significantly increased temporal trend for Phase III CR enrollment (Z=11.34, P<0.0001). Conclusion: In participants completing Phase II CR, higher education, depression and weight loss predict increased Phase III CR enrollment whereas increased distance from CR center or better exercise capacity predict decreased Phase III CR enrollment.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S448-S448
Author(s):  
Alison L Blackman ◽  
Sabeen Ali ◽  
Xin Gao ◽  
Rosina Mesumbe ◽  
Carly Cheng ◽  
...  

Abstract Background The use of intraoperative topical vancomycin (VAN) is a strategy aimed to prevent surgical site infections (SSI). Although there is evidence to support its efficacy in SSI prevention following orthopedic spine surgeries, data describing its safety, specifically acute kidney injury (AKI) risk, is limited. The purpose of this study was to determine the AKI incidence associated with intraoperative topical VAN. Methods This is a retrospective cohort study reviewing patient encounters where intraoperative topical VAN was administered from February 2018 to July 2018. All adult patients ( ≥18 years) that received topical VAN in the form of powder, beads, rods, paste, cement spacers, or unspecified topical routes were included. Patient encounters were excluded for AKI or renal replacement therapy (RRT) at baseline, ≤ 2 serum creatinine values drawn after surgery, and/or if irrigation was the only topical formulation given. The primary outcome was the percentage of patients who developed AKI after intraoperative topical VAN administration. AKI was defined as an increase in serum creatinine (SCr) ≥50% from baseline, an increase in SCr >0.5 from baseline, or0 if RRT was initiated after topical VAN was given. Secondary outcomes included analysis of AKI risk factors and SSI incidence. AKI risk factors were analyzed using a multivariable logistic regression model. Results A total of 589 patient encounters met study criteria. VAN powder was the most common formulation (40.9%), followed by unspecified topical routes (30.7%) and beads (9.9%%). Nonspinal orthopedic surgeries were the most common procedure performed 46.7%. The incidence of AKI was 8.7%. In a multivariable logistic regression model, AKI was associated with concomitant systemic VAN (OR 3.39, [3.39–6.22]) and total topical VAN dose. Each doubling of the topical dose was associated with increased odds of developing AKI (OR = 1.42, [1.08–1.86]). The incidence of SSI was 5.3%. Conclusion AKI rates associated with intraoperative topical VAN are comparable to that of systemic VAN. Total topical vancomycin dose and concomitant systemic VAN was associated with an increased AKI risk. Additional analysis is warranted to compare these patients to a similar population that did not receive topical VAN. Disclosures All authors: No reported disclosures.


Heart ◽  
2020 ◽  
Vol 107 (2) ◽  
pp. 135-141 ◽  
Author(s):  
Jung Ho Kim ◽  
Hi Jae Lee ◽  
Nam Su Ku ◽  
Seung Hyun Lee ◽  
Sak Lee ◽  
...  

ObjectiveThe treatment of infective endocarditis (IE) has become more complex with the current myriad healthcare-associated factors and the regional differences in causative organisms. We aimed to investigate the overall trends, microbiological features, and outcomes of IE in South Korea.MethodsA 12-year retrospective cohort study was performed. Poisson regression was used to estimate the time trends of IE incidence and mortality rate. Risk factors for in-hospital mortality were identified with multivariable logistic regression, and model comparison was performed to evaluate the predictive performance of notable risk factors. Kaplan-Meier survival analysis and Cox regression were performed to assess long-term prognosis.ResultsWe included 419 patients with IE, the incidence of which showed an increasing trend (relative risk 1.06, p=0.005), whereas mortality demonstrated a decreasing trend (incidence rate ratio 0.93, p=0.020). The in-hospital mortality rate was 14.6%. On multivariable logistic regression analysis, aortic valve endocarditis (OR 3.18, p=0.001), IE caused by Staphylococcus aureus (OR 2.32, p=0.026), neurological complications (OR 1.98, p=0.031), high Sequential Organ Failure Assessment score (OR 1.22, p=0.023) and high Charlson Comorbidity Index (OR 1.11, p=0.019) were predictors of in-hospital mortality. Surgical intervention for IE was a protective factor against in-hospital mortality (OR 0.25, p<0.001) and was associated with improved long-term prognosis compared with medical treatment only (p<0.001).ConclusionsThe incidence of IE is increasing in South Korea. Although the mortality rate has slightly decreased, it remains high. Surgery has a protective effect with respect to both in-hospital mortality and long-term prognosis in patients with IE.


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