Assessment of bleeding incidences associated with rivaroxaban therapy in adults with solid tumors

2018 ◽  
Vol 25 (1) ◽  
pp. 192-197
Author(s):  
Kellie J Weddle ◽  
Patrick J Kiel ◽  
Parth J Patel
Keyword(s):  
Prostate Cancer ◽  
Solid Tumors ◽  
Major Bleeding ◽  
Solid Tumor ◽  
Renal Cell ◽  
Anticoagulation Therapy ◽  
University Hospital ◽  
Cancer Center ◽  
Minor Bleeding ◽  
Cancer Types

Purpose Report bleeding incidences associated with rivaroxaban in adult patients with solid tumor malignancies requiring anticoagulation therapy. Methods This retrospective review was conducted at Indiana University Health, University Hospital and the Simon Cancer Center in Indianapolis, IN from January 2013 – February 2016. Patients were included if they had a solid tumor malignancy and prescribed rivaroxaban. Data were collected on 144 patients. Major bleeding was defined as bleeding requiring treatment (local, systemic treatment, blood cell transfusions) or hospitalization and minor bleeding was defined as bleeding not requiring treatment or hospitalization. Results Sixty-four (44%) patients experienced bleeding while on rivaroxaban. There were six cancer types that had a higher incidence of bleeding: bladder, breast, melanoma, pancreas, prostate, and renal cell cancers; 40% (6/15) of patients with bladder cancer experienced bleeding; 54% (7/13) with breast cancer experienced bleeding; 40% (4/10) of patients with melanoma experienced bleeding; 58% (11/19) of patients with pancreatic cancer experienced bleeding; 45% (10/22) of patients with prostate cancer experienced bleeding; and 56% (5/9) of patients with renal cell carcinoma experienced bleeding. No other data collected identified increased incidence of bleeding. Conclusions Patients on rivaroxaban with a diagnosis of bladder, breast, melanoma, pancreas, prostate, or renal cell cancers had a higher incidence of bleeding compared to other solid tumors. Major bleeding was higher in bladder, breast, pancreas, and renal cell carcinomas, while minor bleeding was higher in patients with melanoma and prostate cancer.

Investigating the various predictive values of POLE/POLD1 mutations for response to immune checkpoint inhibitors (ICIs) in different solid tumors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2606-2606
Author(s):  
Yanling Niu ◽  
Tonghui Ma ◽  
Yanling Niu ◽  
Tao Li
Keyword(s):  
T Cells ◽  
Solid Tumors ◽  
Checkpoint Inhibitors ◽  
Tumor Infiltrating Lymphocytes ◽  
Cancer Center ◽  
Cancer Type ◽  
Cancer Dataset ◽  
Predictive Values ◽  
Esophagogastric Cancer ◽  
Cancer Types

2606 Background: Both POLE and POLD1 encode the catalytic subunit of polymerase enzyme complexes involved in DNA replication and repair. The mutations of POLE and POLD1 have been shown to be oncogenic and lead to DNA repair defects and elevated tumor mutation burden (TMB). And patients with POLE/POLD1 mutations are more likely to benefit from ICIs therapy. Previous studies have shown that TMB has divergent predictive value for response to ICIs therapy in different cancer types. We hypothesized that the associations between POLE/POLD1 mutations and ICIs efficacy are also varied in different solid tumors. Therefore, we explored the prediction values of POLE/POLD1 mutations in some cancer types. Methods: The ICIs treatment cohort from Memorial Sloan Kettering Cancer Center (MSKCC) was selected to analyze the association of POLE/POLD1 mutations with ICIs efficacy. TCGA cohort was enrolled for characterizing tumor infiltrating lymphocytes (TILs) with CIBERSORT. The patients were classified into two groups: POLE/POLD1 mutations (Mut) and wildtype (WT). Overall survival (OS) after ICIs therapy was estimated with Kaplan-Meier method. Results: In MSKCC pan-cancer dataset, patients with POLE/ POLD1 mutations had significantly longer median OS after ICIs therapy (34.00 vs 19.00 months, P = 0.0143), indicating that POLE/POLD1 mutations were associated with better immunotherapy outcomes. Then we analyzed the predictive roles in each cancer type. Notably, we found the associations of POLE/POLD1 mutations with longer median OS in NSCLC (Undefined vs 12.00 months, P = 0.05) and esophagogastric cancer (27.00 vs 15.00 months, P = 0.05). However, the associations between POLE/POLD1 mutations and ICIs efficacy were not observed in bladder cancer, melanoma, glioma, head and neck cancer, renal cell carcinoma, and colorectal cancer. Furthermore, our data showed that the median TMB was significantly higher in the Mut group for NSCLC (20.2 vs 6.9 muts/Mb, P < 0.0001) and esophagogastric cancer (21.4 vs 5.6 muts/Mb, P < 0.0001). In TCGA esophagogastric cancer cohort, POLE/POLD1 mutations were correlated with decreased naive B cells (P = 0.0306) and increased activated memory CD4+ T cells (P = 0.0224). In TCGA NSCLC cohort, POLE/POLD1 mutations were correlated with elevated gamma delta T cells (P = 0.0219). These data suggested that POLE/POLD1 mutations were also involved in the infiltration of some immune cells. Conclusions: Although POLE/POLD1 mutations were associated with better ICIs efficacy for all the enrolled patients, the prolonged OS was only found in the Mut group for NSCLC and esophagogastric. These data suggested that POLE/POLD1 mutations may be a useful predictor for ICIs efficacy in these two types of cancer. Moreover, POLE/POLD1 mutations were correlated with the level of TILs in NSCLC and esophagogastric. The finding was consistent with the efficacy of immunotherapy.

scholarly journals A modified microchip-based flow chamber system for evaluating thrombogenicity in patients with thrombocytopenia

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Bengo Atari ◽  
Takashi Ito ◽  
Tomoka Nagasato ◽  
Tomoko Ohnishi ◽  
Kazuya Hosokawa ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Platelet Transfusion ◽  
Thrombus Formation ◽  
Flow Chamber ◽  
University Hospital ◽  
Minor Bleeding ◽  
Chamber System ◽  
Occlusion Time ◽  
Function Tests ◽  
Thrombogenic Potential

Abstract Background In the intensive care unit (ICU), patients with thrombocytopenia are at high risk for bleeding and should be assessed for their thrombogenic potential. However, the analytical conditions of conventional hemostatic tests are unsuitable for the evaluation of low-platelet samples. Here we aimed to establish suitable analytical conditions with the Total Thrombus-formation Analysis System (T-TAS) for quantitative assessment of thrombogenic potential in patients with thrombocytopenia and to investigate how T-TAS values relate to bleeding symptoms and the effects of platelet transfusion. Methods Modified chips with a different chamber depth were developed for the analysis of low-platelet samples in the T-TAS. We included 10 adult patients admitted to the ICU of Kagoshima University Hospital who required platelet transfusion. Patients were divided into major and minor bleeding groups according to their bleeding scale before platelet transfusion. The thrombogenic potential of these patients before and after platelet transfusion was assessed with hemostatic function tests, including rotational thromboelastometry, multiplate aggregometry, and the T-TAS. Results Analysis of low-platelet samples revealed that, compared with the conventional chip (80-μm-deep chamber), the modified chip (50-μm-deep chamber) achieved higher sensitivity in detecting elevation of flow pressure caused by growth of an occlusive thrombus in the T-TAS analytical chamber. All patients in the minor bleeding group retained thrombogenic potential that occluded the modified chip (occlusion time 16.3 ± 3.3 min), whereas most patients in the major bleeding group were unable to occlude the modified chip during the 30-min measurement (P <  0.01). The recovery of thrombogenic potential after platelet transfusion was confirmed with the T-TAS and correlated with the function, rather than the count, of transfused platelets. Among all evaluated parameters in hemostatic function tests, only the T-TAS showed significant differences in occlusion time and area under the curve both between the minor and major bleeding groups and between pre- and post-platelet transfusion. Conclusions We developed a modified microchip-based flow chamber system that reflects the hemostatic function of patients with thrombocytopenia.

Evaluation of Rivaroxaban and Dalteparin in Cancer Associated Thrombosis

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 432-432
Author(s):  
Ateefa Chaudhury ◽  
Asha Balakrishnan ◽  
Christy Thai ◽  
Bjorn Holmstrom ◽  
Michael V. Jaglal
Keyword(s):  
Cancer Patients ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Cancer Center ◽  
Minor Bleeding ◽  
Efficacy And Safety ◽  
Recurrent Vte ◽  
Chi Square Analysis ◽  
Cancer Associated Thrombosis ◽  
Active Cancer

Abstract Introduction: Venous thromboembolism (VTE) in the form of deep venous thrombosis (DVT) or pulmonary embolism (PE) is a complication of malignancy. Several studies have demonstrated the superiority of dalteparin (Fragmin®), a low molecular weight heparin (LMWH), in comparison to oral vitamin K antagonists in preventing VTE recurrence in the setting of active cancer. LMWH is the preferred treatment of cancer associated thrombosis. However, the cost of LMWH can be prohibitive and the need for daily subcutaneous injections can decrease patients' quality of life. While rivaroxaban (Xarelto®), a Factor Xa inhibitor, has been approved for the treatment and secondary prevention of DVT and PE, there is limited data regarding its use in cancer patients. The objective of our study is to determine the efficacy and safety of rivaroxaban compared to dalteparin in cancer associated thrombosis. Methods: This is a retrospective chart review of cancer patients greater than age 18 treated at H. Lee Moffitt Cancer Center between May 3, 2010 and June 30, 2015 on anticoagulation with rivaroxaban or dalteparin. Patients were excluded if the length of anticoagulant therapy was < 30 days, anticoagulant therapy was initiated > 6 months after VTE diagnosis, the indication for treatment was not DVT/PE, if patients had contraindications to either LMWH or rivaroxaban, or patients were not on treatment doses of therapy. Out of 459 patients identified, 226 patients (107 in the rivaroxaban group, and 119 in the dalteparin group) were eligible for analysis based on our exclusion criteria. Efficacy was determined by the incidence of recurrent VTE, such as recurrent DVT, new fatal or non-fatal PE within 30 days. The secondary endpoint of the study was to determine the safety of rivaroxaban compared to dalteparin in cancer patients for the treatment of VTE. Safety was determined by the incidence and severity of bleeding. Major bleeding was defined as clinically overt if it was associated with a fall in hemoglobin of 2 g/dL or more, required transfusions of ≥ 2 units of packed red blood cells, involved retroperitoneal, intracranial, or critical site bleeding, or if it contributed to death. Minor bleeding was defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact with a physician, interruption or discontinuation of anticoagulation treatment, or associated with any other discomfort such as pain or impairment of activities of daily life. Descriptive statistical analyses were utilized. Chi square analysis and t- test were performed to compare categorical and continuous variables. All data was analyzed using SPSS version 21.0 statistical software. Results: Rivaroxaban had a similar rate of DVT and PE failure with 1 event versus 2 with dalteparin (p = 0.625). The rivaroxaban group had 0 major and 8 minor bleeds compared to 3 major and 8 minor bleeds in the dalteparin group with p values of 0.09 and 0.86 respectively. Comorbidities and risk factors for thrombosis were similar in both groups as summarized in Table 1. Table. Rivaroxaban vs. Dalteparin: No Significant Differences in the Efficacy and Safety Profile in Cancer Associated Thrombosis RivaroxabanN = 107 DalteparinN =119 P value DVT Failure within 30 days 1 (0.93%) 2 (1.68%) 0.625 PE Failure within 30 days 1 (0.93%) 1 (0.84%) 0.94 Major Bleeding 0 (0 %) 3 (2.5%) 0.09 Minor Bleeding 8 (7.5%) 8 (6.7%) 0.864 Median Age (Yrs) 61 65 0.93 MaleFemale 58 (54.2%) 49 (45.8%) 60 (50.4%) 59 (49.6%) 0.596 Active Cancer 96 (86.5%) 111 (93.2%) 0.350 Surgery within 30 Days 14 (13.1%) 13 (10.9%) 0.684 Hypertension 58 (54.2%) 61 (51.3%) 0.69 Diabetes 14 (13.1%) 14 (11.8%) 0.84 Coronary Artery Disease 6 (5.61%) 11 (9.2%) 0.326 History of Previous DVT 12 (11.2%) 5 (4.2%) 0.074 BMI >30 39 (36.4%) 48 (40.3%) 0.585 Creatinine Clearance (Cr Cl) 30 - 50 Cr Cl 50 - 70 7 (6.5%) 100 (93.3%) 7 (5.9%) 112 (94.1%) 0.837 Conclusions: Our study evaluated the safety and efficacy of rivaroxaban compared to dalteparin in patients with predominantly active cancer treated at a large comprehensive cancer center and found rivaroxaban to be comparable to dalteparin in this cohort. There were no significant differences in regards to recurrent VTE or major/minor bleeding with patients on rivaroxaban or dalteparin in our cohort of patients. Large randomized trials evaluating the efficacy and safety of rivaroxaban in the oncology population are needed to further validate our findings. Disclosures No relevant conflicts of interest to declare.

Characteristics and outcomes of cancer patients ≥80 years treated with chemotherapy at a comprehensive cancer center

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8548-8548
Author(s):  
P. Jiang ◽  
M. Choi ◽  
D. Smith ◽  
L. Heilbrun ◽  
S. M. Gadgeel
Keyword(s):  
Cancer Patients ◽  
Solid Tumors ◽  
Solid Tumor ◽  
Hematologic Malignancy ◽  
Survival Rates ◽  
The United States ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Tumor Patients ◽  
Hematologic Cancer

8548 Background: The percentage of cancer patients ≥ 80 years old is expected to rise in the United States. However data are limited on use of chemotherapy in this group of patients. Methods: Retrospective identification of patients who received systemic chemotherapy at our cancer center between 1/1/2000 to 12/31/2004 was performed using the computer generated pharmacy data and medical records. Patients who had diagnosis of cancer and ≥ 80 years were included in the study; patients receiving only supportive care, hormonal therapy, or oral chemotherapy were excluded. The protocol for this study was approved by the Wayne State University IRB. Results: A total of 133 patients ≥ 80 years who received chemotherapy was analyzed. The median age was 83 and 31% of the patients were ≥ 85 years. There were more females (61%) than males (39%). The gender distribution was more even (47% v. 53%) after excluding gender specific tumors. The racial distribution was diverse- Whites 65 (49%); Blacks 41 (31%); Other 18 (13%); Unknown 9 (7%). 16% of the patients had hematologic malignancy and 84% had solid tumors. Gynecological cancers (32%) followed by aerodigestive cancers (26%) were the most common solid tumors. Solid tumor patients primarily had regional (48%) or distant (45%) disease. During the first regimen, 512 cycles of chemotherapy was delivered with a median of 3 cycles per patient (range 1–24 cycles); 40% of patients received only 2 cycles of chemotherapy. 64% of patients were able to receive chemotherapy without 2nd cycle delay. The distribution of single or multidrug regimens was fairly similar; Solid tumors 52% v. 48%; Hematologic cancers 43% v. 57%. Carboplatin and paclitaxel (22%) was the most common regimen among solid tumor patients. 26% of all patients received a second regimen. The 1 year survival rates among hematologic cancer and solid tumor patients were 65% and 48%, respectively. Stage of disease was the only statistically significant factor predicting survival. Conclusions: In this diverse group of cancer patients ≥ 80 years old and selected for chemotherapy, the treatment was feasible. The survival outcomes in this elderly population were comparable to those of a younger patient population suggesting that the treatment is beneficial. No significant financial relationships to disclose.

In-hospital mortality of patients admitted through the emergency department of a comprehensive cancer center.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6125-6125 ◽  
Author(s):  
Ahmed F. Elsayem ◽  
Carmen E. Gonzalez ◽  
S. J. Yeung ◽  
Kelly W. Merriman ◽  
Knox H. Todd
Keyword(s):  
Mortality Rate ◽  
Hospital Mortality ◽  
Cancer Patients ◽  
Solid Tumors ◽  
Solid Tumor ◽  
Hematologic Malignancies ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Intractable Pain ◽  
Tumor Patients

6125 Background: Cancer is a common presenting condition for emergency departments (EDs); however, there is limited information on outcomes of ED cancer patients subsequently admitted to the hospital. The purpose of this study is to describe outcomes of patients with hematologic malignancies versus those with solid tumors admitted through the ED of a comprehensive cancer center. Methods: We queried the ED database of The University of Texas MD Anderson Cancer Center for calendar year 2010 and linked it to our institutional data warehouse, including tumor registry data. We classified all leukemia and related disorders, lymphoma, multiple myeloma, and bone marrow transplant patients as hematologic malignancies, and remaining cancers as solid tumors. Descriptive statistics, including chi-square, and t-tests were used in two-sided comparisons. All statistical analyses were performed using SPSS version 15. Results: 20,732 total ED visits were made by 9,320 unique cancer patients. Of these, 5,364 (58%) were admitted to the hospital at least once (range 1-13 admits). ED admissions constituted 39% of total unique patients admitted (N=13,753). The main admission indications for solid tumor patients were infectious complications (particularly pneumonia), intractable pain, or dehydration. For hematologic malignancies, the main indication was neutropenic fever. 211/1656 (13%) of liquid tumor patients were admitted to the Intensive Care Unit (ICU) compared to 484/3708 (13%) of solid tumor patients (P=NS). Of all patients admitted through the ED, 587/5364 (10.9%) died during hospitalization. The hematologic hospital mortality rate was 225/1653 (13.6%) versus 362/3708 (9.8%) for solid tumors (P<0.001). Only 242/8389 (3%) of patients admitted directly from outpatient clinics died during the hospitalization (p<0.001). Conclusions: Patients admitted through the ED, particularly those with hematologic malignancies, have a high hospital mortality rate. ED-based palliative care interventions may be justified to improve quality of life and prevent unnecessary costly interventions and ICU admission. Further research should define predictors of poor outcomes in cancer patients admitted through the ED.

MD and RN ECOG-PS assessments prior to chemotherapy and concordance rates: A quality initiative at a comprehensive cancer center.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 228-228 ◽  
Author(s):  
Arvind Manohar Shinde ◽  
Azadeh Dashti ◽  
Eve Makoff ◽  
Navasard Ovasapians ◽  
Andrew Eugene Hendifar ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Solid Tumors ◽  
Solid Tumor ◽  
Performance Status ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Professional Societies ◽  
Stark Contrast ◽  
Ecog Ps

228 Background: ECOG-PS is a widely implemented scale in oncology to assess performance status (PS). Higher scores are associated with poorer tolerance to higher-intensity chemotherapy (Ct). While professional societies recommend limiting Ct in patients with solid tumors and poor PS, the practice remains pervasive. To reduce this practice, in 2014 the Cedars-Sinai (CS) cancer quality committee developed a quality initiative (QI) requiring oncologists to indicate ECOG-PS on IV chemotherapy orders, with a structured hard-stop to evaluate patients with ECOG-PS≥3. Previously ECOG-PS was not required. Ct nurses also scored ECOG-PS, though their evaluation was not reported back to oncologists, and did not affect Ct decisions. Earlier studies have suggested a bias for oncologists to rate the ECOG-PS more positively than nurses when evaluating the same patient. Methods: 1084 of the total 12,259 Ct orders activated from 3/1/14-2/28/15 in a CS infusion center were randomly audited for ECOG-PS scoring by MD and RN for quality assurance. Completion and concordance rates for ECOG-PS were determined. Results: 93% and 83% of charts documented MD and RN ECOG-PS, respectively. 827 charts had both MD and RN ECOG-PS scores. Concordance rates, and discordance directionality are described in the Table. Conclusions: This QI achieved high rates of ECOG-PS documentation by oncologists, and low rates of Ct administration to patients with ECOG-PS≥3. MD/RN concordance rates were similar to those described in the literature. Interestingly, and in stark contrast to previous studies, MDs were more likely to score ECOG-PS as poorer compared to RNs in solid tumor discordant cases. [Table: see text]

scholarly journals Prevention of Chemotherapy-induced Alopecia: Experience of a Cancer Center in Romania

2021 ◽  
Vol 1 (1) ◽  
pp. 1-13
Author(s):  
Andrea Onisim ◽  
Adina Sabău ◽  
Andrada Ciucă ◽  
Adrian Udrea
Keyword(s):  
Solid Tumors ◽  
Hair Loss ◽  
Cooling System ◽  
Gynecological Cancer ◽  
Cancer Center ◽  
Scalp Cooling ◽  
Serious Adverse Events ◽  
Cancer Types ◽  
Study Support ◽  
The Mean

"Background: Chemotherapy still represents the backbone of systemic treatment for many solid tumors. Alopecia remains one of its most distressing side effects. Scalp cooling is an effective strategy to reduce the risk of alopecia induced by chemotherapy, therefore this study aimed to assess the efficiency of DigniCap scalp-cooling system in our center. Material&Methods: 113 patients diagnosed with solid tumors, who underwent chemotherapy using the DigniCap scalp-cooling system in our center between January 2018 - December 2020, were included in the study. Alopecia was evaluated by the physician according to Dean’s scale at baseline and after the last cycle of chemotherapy. The primary endpoint was to evaluate scalp-cooling efficiency defined by a Dean's scale score of 0–2 (hair loss ≤50%). Results: 78 (72.3%) out of the 113 patients who used scalp cooling presented hair loss of 50% or less, the majority were females (91.2%) and had a diagnosis of breast cancer (49.6%) or gynecological cancer (27.4%). The mean number of chemotherapy cycles using DigniCap was 4.82 cycles. Hair loss greater than 50% of the scalp surface was observed in 27.7% of patients, the highest grade of alopecia being observed for anthracycline-based chemotherapy. No serious adverse events were reported. Conclusion: The results of this study support the evidence existing so far in the literature. Among patients who underwent chemotherapy for various cancer types, the DigniCap System significantly prevented hair loss and we consider that it should be integrated in the supportive care of patients."

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