Erythropoiesis-stimulating agents for cancer patients: Increasingly restrictive guidelines and policies in the United States and Europe

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20725-e20725
Author(s):  
A. T. Samaras ◽  
S. Y. Lai ◽  
B. Kim ◽  
D. P. West ◽  
J. M. McKoy ◽  
...  

e20725 Background: Erythropoiesis stimulating agents (ESAs) have transformed the treatment of cancer-associated anemia worldwide. However, recent reports of venous thromboembolism (VTE), tumor progression, and mortality risks associated with ESA administration to cancer patients have resulted in reassessments of the safety and appropriate usage of these agents. The present study investigated the disparate factors that contributed to the transformation of ESA policies. Methods: We reviewed meta-analyses, advisory committee recommendations, manufacturer label revisions, clinical guidelines, reimbursement policies from the Centers for Medicare and Medicaid Services (CMS), updated clinical guidelines, and ESA usage trends. Results: See Table . Conclusions: The risks and benefits of ESAs for cancer patients have been reassessed, resulting in increasingly restrictive guidelines and labels in the U.S. and Europe. In response to the 2008 ESA labeling change mandated by the U.S. Food and Drug Administration (FDA), the European advisory committee, Committee for Medicinal Products for Human Use (CHMP), convened to reassess the risk-benefit profile of ESAs and determined that for patients with reasonably long life expectancies, the benefits of ESAs do not outweigh the risks. Additionally, the U.S. National Comprehensive Cancer Network (NCCN) revised clinical guidelines in accordance with the FDA labeling change. Therefore, FDA actions combined with the CMS reimbursement policy have provided the impetus for increasingly restrictive use of ESAs. [Table: see text] [Table: see text]

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4753-4753
Author(s):  
Leann Norris ◽  
Donald Mattison ◽  
Zaina Parvez Qureshi ◽  
Charles Bennett

Abstract Abstract 4753 Background: Erythropoiesis stimulating agents (ESAs) are approved for preventing transfusions (United States (US)) or treating symptomatic anemia (Canada/Europe) among chemotherapy or chronic kidney disease (CKD) patients. Extensive reassessments of safety, efficacy, dosing, and target hemoglobin levels have occurred. Methods: Regulatory agencies', ESA manufacturer notifications, clinical guidelines, phase III trials and meta-analyses cited in clinical guidelines were reviewed (2007 to 2011). Results: CKD and Cancer: Quality of life benefits are reported in Europe and Canada. In the US, product labels report exercise capacity improvements for CKD patients. CKD: Clinical trials reported cardiovascular, cerebrovascular, and mortality risks with ESAs targeting high versus low hemoglobin levels or cardiovascular and mortality risks with ESAs versus placebo. 2011 US' advisories recommend ESA doses sufficient to prevent transfusions among dialysis patients and caution with ESA administration to non-dialysis patients. Canadian and European recommendations target hemoglobin levels between 10 and 12 g/dl and 11 to 12 g/dl, respectively. Following these recommendations among non-dialysis US patients, ESA use decreased 16%. Most US dialysis CKD patients receive ESAs, with lower achieved hemoglobin levels, and 30% decreased ESA usage since 2008. In Europe and Canada, which initially had substantially lower ESA use, there has been a gradual increase. Cancer: Trials identified mortality, tumor progression, and venous thromboembolism risks with ESAs targeting higher versus lower hemoglobin levels. US labels warn against administering ESAs with potentially curative chemotherapy. European guidelines recommend ESAs for symptomatic patients at hemoglobin levels of 9 to 11 g/dL and consider for asymptomatic patients at levels of 11 to 11.9 g/dL. Canadian advisories report cost-utility ratios exceeding accepted standards. ESA use decreased by 70% in the US. Current ESA utilization rates for cancer are higher in Europe and lower in Canada. Conclusions: International differences in interpreting efficacy and safety data and ESA utilization exist. The changes have been most apparent in the US. Disclosures: No relevant conflicts of interest to declare.


Author(s):  
Jessica Y. Islam ◽  
Veeral Saraiya ◽  
Rebecca A. Previs ◽  
Tomi Akinyemiju

Palliative care improves quality-of-life and extends survival, however, is underutilized among gynecological cancer patients in the United States (U.S.). Our objective was to evaluate associations between healthcare access (HCA) measures and palliative care utilization among U.S. gynecological cancer patients overall and by race/ethnicity. We used 2004–2016 data from the U.S. National Cancer Database and included patients with metastatic (stage III–IV at-diagnosis) ovarian, cervical, and uterine cancer (n = 176,899). Palliative care was defined as non-curative treatment and could include surgery, radiation, chemotherapy, and pain management, or any combination. HCA measures included insurance type, area-level socioeconomic measures, distance-to-care, and cancer treatment facility type. We evaluated associations of HCA measures with palliative care use overall and by race/ethnicity using multivariable logistic regression. Our population was mostly non-Hispanic White (72%), had ovarian cancer (72%), and 24% survived <6 months. Five percent of metastatic gynecological cancer patients utilized palliative care. Compared to those with private insurance, uninsured patients with ovarian (aOR: 1.80,95% CI: 1.53–2.12), and cervical (aOR: 1.45,95% CI: 1.26–1.67) cancer were more likely to use palliative care. Patients with ovarian (aOR: 0.58,95% CI: 0.48–0.70) or cervical cancer (aOR: 0.74,95% CI: 0.60–0.88) who reside >45 miles from their provider were less likely to utilize palliative care than those within <2 miles. Ovarian cancer patients treated at academic/research programs were less likely to utilize palliative care compared to those treated at community cancer programs (aOR: 0.70, 95%CI: 0.58–0.84). Associations between HCA measures and palliative care utilization were largely consistent across U.S. racial-ethnic groups. Insurance type, cancer treatment facility type, and distance-to-care may influence palliative care use among metastatic gynecological cancer patients in the U.S.


1979 ◽  
Vol 12 (03) ◽  
pp. 330-333 ◽  

The 22nd annual meeting of the Advisory Committee on Historical Documentation met in Washington on November 3, 1978, with the officers and staff of the Historical Office of the U.S. Department of State, and with other officials in the Bureau of Public Affairs, the Department and the government who are concerned with the release and publication of historical documentation on American foreign relations. The Committee, formerly called the Advisory Committee onForeign Relations of the United States, continues to be concerned chiefly with theForeign Relationsseries as the major form of the Department's historical documentation.The leitmotiv of the meeting—continuing from last year—was the problem of the appropriate adaptation of the series to fiscal constraint. The problem is the more acute because theForeign Relationsseries is now dealing with the 1950s, where it confronts a veritable explosion of documentation involving other agencies of government as well as the Department of State. This expansion of the relevant historical record comes at a time when increases in the budget have barely been able to keep up with the pace of inflation, thus holding practically constant the real resources available for publication.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6041-6041
Author(s):  
J. A. Lee ◽  
M. A. Mathiason ◽  
C. A. Czeczok ◽  
J. K. Keller ◽  
R. S. Go

6041 Background: Most cancer patients are diagnosed and treated in the community but clinical trial accrual rate is low. Published data on trial accrual from community-based cancer centers throughout the U.S. are limited. The Association of Community Cancer Centers (ACCC) is a national multidisciplinary education and advocacy organization that maintains a membership caring for over 60% of all patients with cancer in the U.S. In order to determine the clinical trial accrual patterns in the community across various geographic regions in the U.S., we performed a retrospective study utilizing the data from ACCC membership maintained at their web site. Methods: Data available from the most recent year (2003–2005) were obtained from 621 centers throughout the U.S., representing 49 states (no data for WY) and the DC. We investigated the number of patients (new and old) accrued into trials per year relative to the number of new analytical patients seen in the same year, a value we termed accrual ratio (AR). In addition, we studied the effects of geographic location, size of the cancer program, number of affiliations with National Cancer Institute sponsored cancer cooperative groups, and the number of medical/support/data management staffs on trial accrual. Results: A total of 670,215 new patients were seen across the ACCC membership with 43,743 patients accrued into trials for a median AR of 6.5% (range, 0.3–16.9). The top and bottom 5 accruing states were VT, MD, SD, LA, ID and KS, ND, VA, NH, AR, respectively. Regionally, the AR for Midwest, Middle Atlantic, West, South, Southwest, and New England were as follows: 7.4%, 7.0%, 6.2%, 6.0%, 5.7%, and 5.4% (p < 0.001). One hundred (16.1%) centers representing 11.8% of all new patients were not affiliated with any of the cooperative groups. This group had the lowest AR (3.1%). AR increased when centers were affiliated with more cooperative groups (p < 0.001) or cared for more new patients (p < 0.001). The number of medical, support, and data management staffs did not influence accrual. Conclusions: Overall, clinical trial accrual in the U.S. community cancer centers is low. Accrual patterns differed significantly among various geographic locations. Better access to trials is needed in order to improve participation of cancer patients. No significant financial relationships to disclose.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19113-e19113
Author(s):  
Nosayaba Osazuwa-Peters ◽  
Matthew C Simpson ◽  
Eric Y Du ◽  
Scott A Hong ◽  
Aleksandr R Bukatko ◽  
...  

e19113 Background: The risk of suicide among cancer survivors more than double that of the general population, highlighting the need to mitigating risk factors for suicide. While several studies have described marital status, a surrogate for social support, as associated with cancer mortality, it is inconclusive whether marital status impacts suicide as a competing cause of cancer mortality. We tested this hypothesis by describing the association of marital status and suicide among survivors of four cancer sites with the highest suicide mortality rates in the United States. Methods: Adult cancer patients were identified from the Surveillance, Epidemiology and End Results database from 2004 to 2016 for four index cancer sites previously identified with highest suicide mortality rates: pancreas, head and neck, lung/bronchus and stomach ( n = 800,798). Cumulative incidence curves stratified by marital status (divorced/separated, widowed, never unmarried, and married/partnered) estimated unadjusted probability of suicide (outcome of interest). A multivariable competing risk proportional hazards model yielded sub-distribution hazard ratios (sdHRs) and 95% confidence intervals (CI) to estimate the association of marital status with suicide for each cancer site, while controlling for clinical and nonclinical factors. Results: Half (50.7%) of the cohort were married/partnered, males (56.8%), and non-Hispanic whites (71.0%). Mean age at diagnosis was 67.3 years. Most patients (60.9%) had cancer in the lung/bronchus, 17.9% head and neck, 13.8% pancreas, and 8.3% stomach. Unadjusted probability of suicide was highest among head and neck cancer survivors (0.3%). In the fully adjusted model, mortality by suicide was more likely among divorced/separated patients vs. married/partnered patients across cancer sites (sdHRhead and neck = 1.81; 95% CI 1.38, 2.37; sdHRlung/bronchus = 1.68; 95% CI 1.28, 2.19; sdHRpancreas = 2.19; 95% CI 1.27, 3.78; and sdHRstomach = 2.38; 95% CI 1.17, 4.58). Additionally, for lung/bronchus cancer, patients who were never married patients were more likely to die by suicide than those married/partnered (sdHRlung/bronchus = 1.47; 95% CI 1.09, 1.98). Conclusions: Marital status is associated with suicide mortality among cancer survivors, and divorced/separated survivors may have greater suicide mortality risks, independent of cancer site. As overall probability of suicide remains low, these findings might help identify cancer survivors who may be candidates for ongoing surveillance and psychosocial support to mitigate suicide mortality risks.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4782-4782
Author(s):  
Alfonso Enrique Bencomo ◽  
Andres J Rubio ◽  
Mayra Alejandra Gonzalez ◽  
Idaly Maria Olivas ◽  
Joshua Lara ◽  
...  

Introduction: Hispanics represent the largest minority group in the United States (U.S.), with 57.5 million individuals (18% of the population). Most U.S. Hispanics are of Mexican origin (63.2%), followed by Puerto Rican (9.5%), Cuban (3.9%), Salvadoran (3.8%), and Dominican (3.3%), but distribution varies by state. The majority of Hispanics in the U.S. reside in the Southwest region, and >11 million live in the state of Texas. Cancer is the leading cause of death in the Hispanic population, accounting for 21% of deaths in people of all ages. Health disparities for Hispanic cancer patients have previously been linked to disproportionate poverty and other barriers to optimal healthcare, and in the case of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), Hispanics were found to be diagnosed younger and to have worse overall survival (OS) than Non-Hispanic whites (NHWs) (ACS. Cancer Facts & Figures for Hispanics/Latinos 2018-2020). However, little is known about incidence and survival for Hispanic blood cancer patients residing at the U.S./Mexico border. To understand the impact of Hispanic ethnicity on outcomes for blood cancer patients diagnosed in this area, we examined OS in adult patients with hematologic malignancies throughout the state of Texas compared to Texas Health Service Region (HSR) 10, encompassing El Paso County. Methods: We retrospectively reviewed data available from the Texas Cancer Registry for hematologic malignancies diagnosed in the state of Texas between 1995 and 2016, focusing our analysis on chronic and acute leukemias (both myeloid and lymphoid), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPNs). Survival for Hispanic and NHW groups was compared using the log-rank test, and Cox regression analyses adjusting for age and diagnosis. Differences in age at diagnosis were evaluated using t-tests and generalized linear models. Similar analyses compared Hispanic patients from HSR 10 versus Hispanic patients from the rest of Texas. Research was conducted according to a local Institutional Review Board-approved protocol in accordance with the Declaration of Helsinki. Results: Of the 69,941 cases of hematologic malignancies with available information throughout the state of Texas, 18.29% self-identified as Hispanic. Surprisingly, in unadjusted analyses, Hispanic patients had significantly better OS than NHWs diagnosed with AML (p<0.0001), MDS (p<0.0001), and chronic myeloid leukemia (CML, p<0.0001), with no significant differences in OS for patients with ALL, MPN, acute promyelocytic leukemia (APL), or chronic lymphocytic leukemia (CLL). However, Hispanic patients were diagnosed at a significantly younger age in all diseases analyzed (Table 1), possibly explaining the improved survival. After adjusting for age, ALL (HR 1.32, p<.0001), CLL (HR 1.11, p=0.002), and CML (HR 1.15, p=0.008) showed significantly worse outcomes for Hispanics, with better outcomes in MDS (HR 0.92, p=0.0004), and no significant differences for AML, APL or MPN. Running the same analyses for the entire El Paso population versus the rest of Texas, we found no significant interaction except for a suggestion of a greater ethnic disparity in CML patients from El Paso (p=0.06). We also compared Hispanic patients diagnosed in El Paso versus Hispanics from the rest of Texas. Hispanics in El Paso had a significant reduction in OS compared to Hispanics in other areas of Texas for patients with ALL (p=0.0164), AML (p<0.0001), and CML (p=0.0160), but not for patients with APL, CLL, MDS, or MPN. Again the negative effects become less marked after adjustment for age, as those diagnosed in El Paso tended to be 3 years older at diagnosis than elsewhere in Texas. In analyses adjusted for age and diagnosis, there was again a suggestion that differences between El Paso and the rest of Texas were greater in Hispanics than NHW (p=0.08). Conclusions: While Hispanic patients with AML, MDS, and CML had significantly better OS compared to NHWs in Texas as a whole, this could be explained by a significant reduction in the age of diagnosis for Hispanics. However, when comparing across Texas, El Paso Hispanics with ALL, AML, and CML have a worse prognosis than in the rest of the state. There appears to be evidence that disparities in outcome by ethnicity may be different in El Paso compared with the rest of Texas. Further study is required to identify factors responsible for the disparity in OS. Disclosures No relevant conflicts of interest to declare.


Lung Cancer ◽  
2012 ◽  
Vol 76 (3) ◽  
pp. 478-485 ◽  
Author(s):  
Johan Vansteenkiste ◽  
John Glaspy ◽  
David Henry ◽  
Heinz Ludwig ◽  
Robert Pirker ◽  
...  

Healthcare ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 380 ◽  
Author(s):  
Jose A. Betancourt ◽  
Matthew A. Rosenberg ◽  
Ashley Zevallos ◽  
Jon R. Brown ◽  
Michael Mileski

The impact of COVID-19 on the U.S. healthcare industry cannot be overstated. Telemedicine utilization increased overnight as all healthcare providers rushed to implement this delivery model to ensure accessibility and continuity of patient care. Our research objective was to determine measures that were implemented to accommodate community and individual patient needs to afford access to critical services and to maintain safety standards. We analyzed literature since 2016 from two databases using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We compared observations, themes, service lines addressed, issues identified, and interventions requiring in-person care. From 44 articles published, we identified ten effectiveness themes overall and drew conclusions on service line successes. COVID-19 has caused rapid expansion in telemedicine. Necessary and required changes in access, risk mitigation, the need for social distancing, compliance, cost, and patient satisfaction are a few of the driving factors. This review showcased the healthcare industry’s ability to rapidly acclimate and change despite the pervasive spread of COVID-19 throughout the U.S. Although imperfect, unique responses were developed within telemedicine platforms to mitigate disruptions broadly and effectively in care and treatment modalities.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4675-4675 ◽  
Author(s):  
Julia Bohlius ◽  
Corinne Brillant ◽  
Michael Clarke ◽  
Sabine Kluge ◽  
Maryann Napoli ◽  
...  

Abstract Background: Erythropoiesis stimulating agents (ESAs) consistently have been shown to decrease transfusions in anemic oncology patients. However, whether they increase mortality in cancer patients is under debate. Results from individual studies conflict, and results from literature based meta-analyses are inconclusive. We conducted a meta-analysis based on individual patient data (IPD) from all available randomized controlled trials (RCTs). Meta-analyses with individual patient data offer several advantages over study-level analysis, including the ability to gain statistical power and increase validity using time-to-event analyses, to adjust for prognostic variables that may have confounded the original treatment comparisons and to investigate subgroups in which treatment may be either more or less effective or harmful. Methods: An international collaboration conducted an individual patent data meta-analysis of ESA effects on mortality in cancer patients. With guidance from an independent steering committee of international experts in hematology, oncology, radiotherapy, epidemiology, medical statistics and a consumer representative, we developed a detailed protocol and statistical analysis plan. Independent RCT investigators and representatives from pharmaceutical companies who submitted data provided additional input through the project’s advisory board. IPD from RCTs of ESA plus red blood cell transfusion (RBCT) (as needed) versus placebo or no ESA plus RBCT (as needed), for prophylaxis or treatment of anemia in cancer patients with or without concurrent antineoplastic therapy, were included. Hazard ratios and 95% confidence intervals (CIs) were calculated per study and meta-analyzed with fixed-effects and random-effects models. Primary endpoints were overall survival (during active study phase and for the longest follow-up available) for patients receiving chemotherapy, and for all cancer patients regardless of anticancer treatment. Stratified multivariable Cox-regression analyses were conducted to assess the impact of baseline imbalances and to identify potential effect modifiers. Duplicate main statistical analyses were conducted independently at two academic statistical departments. Results: Data on 13933 patients enrolled in 53 studies were included in the analysis. Data were provided by the companies Amgen Inc., Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and F. Hoffmann-La Roche Ltd.; and by five independent investigators. Results are currently undergoing internal verification and final evaluation and will be presented at the meeting. Conclusion: Final conclusions will be presented at the meeting. Future analyses using IPD will be conducted to estimate the risks (clots, tumor progression) and potential benefits (transfusion needs and quality of life/fatigue) from other outcomes.


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