Safety and Effectiveness of Direct Oral Anticoagulants for the Treatment of Gastrointestinal Cancer-Associated Venous Thromboembolism.

BACKGROUND: Patients with gastrointestinal cancer (GICA) are at high risk for venous thromboembolism (VTE). Data from randomized clinical trials in cancer-associated VTE suggest that direct oral anticoagulants (DOACs) conferred similar or superior efficacy but a heterogeneous safety profile in patients with GICA. We compared the safety and effectiveness of DOACs in patients with GICA and VTE at MD Anderson Cancer Center. MATERIALS AND METHODS: This was a retrospective chart review of patients with GICA and VTE receiving treatment with DOACs for a minimum of 6 months. Primary outcomes were the proportion of patients experiencing major bleeding (MB), clinically relevant non-major bleeding (CRNMB), and recurrent VTE. Secondary outcomes were time to bleeding and recurrent VTE. RESULTS: A cohort of 433 patients with GICA who were prescribed apixaban (n = 300), or rivaroxaban (n = 133) were included. MB occurred in 3.7% (95% confidence interval [CI] 2.1-5.9), CRNMB in 5.3% (95% CI 3.4-7.9), and recurrent VTE in 7.4% (95% CI 5.1-10.3). The cumulative incidence rates of CRNMB and recurrent VTE were not significantly different when comparing apixaban to rivaroxaban. CONCLUSION: Apixaban and rivaroxaban had a similar risk of recurrent VTE and bleeding and could be considered as anticoagulant options in selected patients with GICA and VTE.

Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update.

PURPOSE: To update the ASCO guideline on the management of cancer-related fatigue (CRF) in adult survivors of cancer. METHODS: A multidisciplinary panel of medical oncology, geriatric oncology, internal medicine, psychology, psychiatry, exercise oncology, integrative medicine, behavioral oncology, nursing, and advocacy experts was convened. Guideline development involved a systematic literature review of randomized controlled trials (RCTs) published in 2013-2023. RESULTS: The evidence base consisted of 113 RCTs. Exercise, cognitive behavioral therapy (CBT), and mindfulness-based programs led to improvements in CRF both during and after the completion of cancer treatment. Tai chi, qigong, and American ginseng showed benefits during treatment, whereas yoga, acupressure, and moxibustion helped to manage CRF after completion of treatment. Use of other dietary supplements did not improve CRF during or after cancer treatment. In patients at the end of life, CBT and corticosteroids showed benefits. Certainty and quality of evidence were low to moderate for CRF management interventions. RECOMMENDATIONS: Clinicians should recommend exercise, CBT, mindfulness-based programs, and tai chi or qigong to reduce the severity of fatigue during cancer treatment. Psychoeducation and American ginseng may be recommended in adults undergoing cancer treatment. For survivors after completion of treatment, clinicians should recommend exercise, CBT, and mindfulness-based programs; in particular, CBT and mindfulness-based programs have shown efficacy for managing moderate to severe fatigue after treatment. Yoga, acupressure, and moxibustion may also be recommended. Patients at the end of life may be offered CBT and corticosteroids. Clinicians should not recommend L-carnitine, antidepressants, wakefulness agents, or routinely recommend psychostimulants to manage symptoms of CRF. There is insufficient evidence to make recommendations for or against other psychosocial, integrative, or pharmacological interventions for the management of fatigue.Additional information is available at www.asco.org/survivorship-guidelines.

Literature Review of Fatigue Scales and Association with Clinically Meaningful Improvements in Outcomes Among Patients With and Without Paroxysmal Nocturnal Hemoglobinuria.

INTRODUCTION: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disorder characterized by anemia and debilitating fatigue. Limited evidence characterizes the association between hemoglobin, an indicator of anemia and disease activity, and patient-reported fatigue scales. This review identifies benchmarks for clinically meaningful improvements in patients with and without PNH. METHODS: MEDLINE, Embase, Cochrane, and PsycINFO databases were searched along with Google Scholar to identify publications for patients with and without PNH. Full-text articles and conference abstracts of clinical trials or observational studies that examined patient-reported fatigue or associations between fatigue and hemoglobin were included. RESULTS: Fourteen publications were included in this study. Four clinical trials conducted in patients with PNH reported that patients achieved and sustained clinically meaningful improvements in fatigue. However, these studies did not examine the association between fatigue and hemoglobin. Ten studies conducted in patients with cancer and anemia (with or without chemotherapy) demonstrated an association between increased hemoglobin and improvements in fatigue (P < 0.05). The greatest incremental gain in fatigue improvement was observed when hemoglobin increased from 11 to 12 g/dL. CONCLUSION: Evidence among patients with cancer without PNH demonstrates that increased hemoglobin levels are associated with clinically significant improvements in fatigue. Future studies should validate this relationship among patients with PNH.

Handoff Tool Enabling Standardized Transitions Between the Emergency Department and the Hospitalist Inpatient Service at a Major Cancer Center.

Communication failures during patient handoff can lead to serious errors. A quality improvement team created a standardized handoff tool/process (DE-PASS: Decisive problem requiring admission, Evaluation time, Patient summary, Acute issues/action list, Situation unfinished/awareness, Signed out to) for admitting patients from the emergency department (ED) to the hospitalist inpatient service of a tertiary cancer center. DE-PASS mirrors the institution's ED workflow, stratifies patients as stable/urgent/emergent, and establishes requirements for verbal and email communications between providers. Comparison of preintervention and postintervention results from the 1-month pilot revealed that within a 24-hour period, DE-PASS reduced the number of intensive care unit transfers by 58% ( P = .393), the number of rapid-response team calls by 39% ( P = .637), and time to inpatient order by 31% ( P = .004). ED physicians' and hospitalists' satisfaction with DE-PASS increased. Reduction in intensive care unit transfers was sustained after the pilot ( P = .029). DE-PASS feasibility was evidenced by 100% uptake. By stratifying patients by risk level, DE-PASS reduced admission-to-evaluation times for unstable patients, potentially improving patient safety.

Ibandronate for the prevention of bone loss after allogeneic stem cell transplantation for hematologic malignancies: a randomized-controlled trial.

The purpose of this study was to evaluate the effects of ibandronate on bone loss following allogeneic stem cell transplantation (allo-SCT). A single-centered, open-label prospective randomized-controlled study following allo-SCT. The treatment group received 3 mg of intravenous ibandronate quarterly starting within 45 days of allo-SCT. All patients received daily calcium and vitamin D supplements. We compared the changes in bone mineral density (BMD) in the lumbar spine, femoral neck and total hip at 6 and 12 months following allo-SCT between the control and treatment groups. We also assessed relationships between bone loss and cumulative glucocorticoid dose, cumulative tacrolimus dose and acute and chronic graft-versus-host disease (GVHD) by linear regression. In all, 78 patients were enrolled. The treatment group had significantly less BMD loss in the lumbar spine at 6 months (mean percent change 0.06±4.03 (treatment group) versus -2.61±4.2 (control group)) and 12 months (mean percent change 1.27±5.29 (treatment group) versus -1.81±4.49 (control group)) than the control group (P=0.03). Both groups lost more BMD in the femoral neck and total hip than in the lumbar spine at 6 and 12 months. The changes in BMD in the femoral neck and total hip did not differ significantly between groups. Both glucocorticoids and tacrolimus reduced BMD in the lumbar spine, but ibandronate prevented this loss. Ibandronate may reduce bone loss in the lumbar spine in patients who undergo allo-SCT, particularly those who have received high doses of glucocorticoids and/or tacrolimus.

Diagnostic evaluation of patients with a high suspicion of malignancy: comorbidities and clinical predictors of cancer.

BACKGROUND: The diagnosis of cancer is based on the demonstration of malignant cells obtained via biopsy or needle aspiration. For some patients, diagnostic options may be limited either because of tumor location, underlying comorbid conditions, or lack of access to care. METHODS: 275 of 282 consecutive patients presenting to the University of Texas M.D. Anderson Cancer Center with a suspicion of cancer between April 1, 2000 and January 23, 2003 were evaluated retrospectively. We analyzed differences in means of diagnosis, complication rates, clinical characteristics, and comorbid medical conditions between patients with and without a cancer diagnosis. Logistic regression analysis was used to determine the independent predictors of a diagnosis of cancer. RESULTS: 179 (65%) patients had a cancer diagnosis. Endoscopic ultrasonography with fine needle aspiration (EUS/FNA) and image-guided percutaneous biopsy (IGPB) were the most commonly used diagnostic techniques. Complications occurred in 6% of all cases. Independent predictors of a cancer diagnosis included age of 50 years or older, jaundice, weight loss, percentage of monocytes greater than 7, and platelet count greater than 440x10/L; the ROC statistic was 0.796 (CI, 0.738-0.854; P<0.001). Controlling for age, there was no difference in comorbidity between patients with and without a cancer diagnosis. CONCLUSIONS: EUS/FNA and IGPB play an important role in the diagnosis of certain types of malignancy and are associated with a low risk for complications. Advanced age, prior history of malignancy, weight loss, abnormally high percentage of monocytes, and thrombocytosis may be predictive of a cancer diagnosis in patients with suspected malignancy. Comorbid medical conditions are common among patients and occur at rates similar to the general population. Further study is necessary to determine organ-specific predictors of malignancy and to better understand the relationship between cancer and coexisting medical conditions.

Outcomes and cost of deep venous thrombosis among patients with cancer.

BACKGROUND: Although deep venous thrombosis (DVT) often complicates the clinical course in patients with cancer, few studies of the outcomes of DVT in this population have been published. Furthermore, the cost of DVT is largely undescribed. We herein report the largest study of DVT in this population to date. METHODS: We reviewed the medical records of 529 consecutive cancer patients in whom DVT developed from January 1, 1994, through December 31, 1997, and followed up these patients through December 31, 2000, for outcomes. The cost of hospitalization was obtained from our hospital's cost-accounting system and inflated to 2002 US dollars using the Consumer Price Index for Medical Care. Logistic regression was used to identify factors that were associated with a high risk of poor outcomes. RESULTS: The most common complication of DVT was bleeding, which occurred in 13% of patients. Pulmonary embolus occurred in 4%. Five patients (1%) died of complications of DVT and 5 (1%) of complications of anticoagulation. Recurrence of DVT was common (17% overall), particularly among those who had inferior vena cava filters (32%; P<.001) or a previous episode of DVT (P =.03). All but 4 patients were hospitalized for initial anticoagulation therapy, for a mean of 11 days. The mean cost of hospitalization was 2002 US $20 065. CONCLUSIONS: Among patients with cancer, DVT frequently is associated with serious clinical outcomes. Its treatment is resource intensive and costly. More effective agents and less costly management strategies could have a significant impact on the outcomes and cost of DVT in this population.

Chronic conditions and health status in older cancer survivors.

BACKGROUND: With the aging population and improved cancer care, the number of cancer survivors is steadily increasing. Planning for their care requires an understanding of the impact of cancer and chronic conditions on quality of life. We sought to determine chronic conditions and health status in older cancer survivors compared to controls. METHODS: In this retrospective cross-sectional study, we used survey data from 18,133 cancer survivors and 94,407 controls age 65 and older who participated in the Behavioral Risk Factor Surveillance System 2009 telephonic survey. Our main measures were chronic conditions (cardiovascular disease, hypertension, diabetes mellitus, high cholesterol, and arthritis) and poor health status (poor or fair self-rated health). RESULTS: Cancer survivors were older, more likely white, had higher education, and slightly more likely to have a healthcare provider and higher levels of emotional support. More survivors reported having 2 or more chronic conditions compared to controls (67.5% vs. 64.5%, respectively). Health status was lower for survivors, and was significantly different by racial/ethnic group. In a multivariable model for health status, having 2 or more chronic conditions was more strongly associated with poorer health status than cancer survivorship. CONCLUSIONS: Cancer survivors had slightly higher numbers of chronic conditions and poorer health status than controls. However, chronic conditions were more strongly associated with poor health status than cancer. Monitoring for recurrence and second cancers is important in cancer survivors, but chronic conditions also need to be given priority due to their substantial impact on health status.

Screening, assessment, and management of fatigue in adult survivors of cancer: an American Society of Clinical oncology clinical practice guideline adaptation.

PURPOSE: This guideline presents screening, assessment, and treatment approaches for the management of adult cancer survivors who are experiencing symptoms of fatigue after completion of primary treatment. METHODS: A systematic search of clinical practice guideline databases, guideline developer Web sites, and published health literature identified the pan-Canadian guideline on screening, assessment, and care of cancer-related fatigue in adults with cancer, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Cancer-Related Fatigue and the NCCN Guidelines for Survivorship. These three guidelines were appraised and selected for adaptation. RESULTS: It is recommended that all patients with cancer be evaluated for the presence of fatigue after completion of primary treatment and be offered specific information and strategies for fatigue management. For those who report moderate to severe fatigue, comprehensive assessment should be conducted, and medical and treatable contributing factors should be addressed. In terms of treatment strategies, evidence indicates that physical activity interventions, psychosocial interventions, and mind-body interventions may reduce cancer-related fatigue in post-treatment patients. There is limited evidence for use of psychostimulants in the management of fatigue in patients who are disease free after active treatment. CONCLUSION: Fatigue is prevalent in cancer survivors and often causes significant disruption in functioning and quality of life. Regular screening, assessment, and education and appropriate treatment of fatigue are important in managing this distressing symptom. Given the multiple factors contributing to post-treatment fatigue, interventions should be tailored to each patient's specific needs. In particular, a number of nonpharmacologic treatment approaches have demonstrated efficacy in cancer survivors.

Outcomes of a cancer-related fatigue clinic in a comprehensive cancer center.

Cancer-related fatigue (CRF) is a significant issue for cancer patients and frequently precipitates increased stress and anxiety for patients and caregivers alike. CRF may present well after the initial phase of cancer diagnosis and treatment, regardless of whether the cancer is in remission, widely metastatic, or somewhere in between. Determining whether the etiology of fatigue is potentially reversible and whether it is an effect of treatment or another unrelated cause is often perplexing. Because of the significant impact of CRF on patients at our institution, we organized a CRF clinic and began evaluating patients for fatigue in 1998. Our goal has been to initiate a more focused and, at the same time, more comprehensive effort in educating, evaluating, and treating CRF. The purpose of this report was to present a retrospective review of patients treated in our CRF clinic between 1998 and 2005, to examine the outcomes of our patients, and to briefly describe some of the challenges encountered in treating these patients. This information may help reassess and improve approaches in addressing CRF and subsequently improve fatigue in these patients.

Outcomes and cost of outpatient or inpatient management of 712 patients with febrile neutropenia.

PURPOSE: We retrospectively compared the outcomes and costs of outpatient and inpatient management of low-risk outpatients who presented to an emergency department with febrile neutropenia (FN). PATIENTS AND METHODS: A single episode of FN was randomly chosen from each of 712 consecutive, low-risk solid tumor outpatients who had been treated prospectively on a clinical pathway (1997-2003). Their medical records were reviewed retrospectively for overall success (resolution of all signs and symptoms of infection without modification of antibiotics, major medical complications, or intensive care unit admission) and nine secondary outcomes. Outcomes were assessed by physician investigators who were blinded to management strategy. Outcomes and costs (payer's perspective) in 529 low-risk outpatients were compared with 123 low-risk patients who were psychosocially ineligible for outpatient management (no access to caregiver, telephone, or transportation; residence > 30 minutes from treating center; poor compliance with previous outpatient therapy) using univariate statistical tests. RESULTS: Overall success was 80% among low-risk outpatients and 79% among low-risk inpatients. Response to initial antibiotics was 81% among outpatients and 80% among inpatients (P = .94); 21% of those initially treated as outpatients subsequently required hospitalization. All patients ultimately responded to antibiotics; there were no deaths. Serious complications were rare (1%) and equally frequent between the groups. The mean cost of therapy among inpatients was double that of outpatients ($15,231 v $7,772; P < .001). CONCLUSION: Outpatient management of low-risk patients with FN is as safe and effective as inpatient management of low-risk patients and is significantly less costly.

Cost-minimization analysis of low-molecular-weight heparin (dalteparin) compared to unfractionated heparin for inpatient treatment of cancer patients with deep venous thrombosis.

GOALS: Low-molecular-weight heparin (LMWH) has shown to be as effective as unfractionated heparin (UFH) in the treatment of deep venous thrombosis (DVT). Although the acquisition cost of LMWH is significantly greater than that of UFH, we hypothesized that once-daily dalteparin, a LMWH, could reduce treatment costs of cancer patients with DVT by eliminating anticoagulation monitoring and shortening hospitalization. PATIENTS AND METHODS: We developed a cost-minimization model by using outcomes and resource utilization data from two retrospective matched cohorts of cancer patients who, between 1994 and 1999, were hospitalized at our comprehensive cancer center for treatment of DVT with either LMWH ( n=21) or UFH ( n=168). We assumed all LMWHs and UFH to be equally effective. The total costs for the dalteparin strategy and the UFH strategy were calculated in year 2003 U.S. dollars, from the provider's perspective, by multiplying the number of resources used for inpatient treatment of DVT by their unit costs. RESULTS: The mean total cost for inpatient care was $3,383 US dollars (95% CI= $2,683- $4,083) for dalteparin and $4,952 US dollars (95% CI=$4,718-$5,185) for UFH. Substantial savings resulted from shorter hospitalization among the dalteparin-treated patients (mean 3.19 versus 5.22 days). Sensitivity analysis did not change the conclusion that dalteparin is less expensive than UFH. CONCLUSIONS: Savings realized from less anticoagulant monitoring and shorter hospitalization offset the higher acquisition cost of dalteparin. The dalteparin strategy is less expensive than the UFH strategy for the inpatient treatment of DVT among cancer patients.