Randomized controlled trial of geriatric consultation versus standard care in older adults with hematologic malignancies

We conducted a randomized controlled trial in older adults with hematologic malignancies to determine the impact of geriatrician consultation embedded in our oncology clinic alongside standard care. From February 2015 to May 2018, transplant-ineligible patients aged ≥75 years who presented for initial consultation for lymphoma, leukemia, or multiple myeloma at Dana-Farber Cancer Institute (Boston, MA, USA) were eligible. Pre-frail and frail patients, classified based on phenotypic and deficit-accumulation approaches, were randomized to receive either standard oncologic care with or without consultation with a geriatrician. The primary outcome was 1-year overall survival. Secondary outcomes included unplanned care utilization within 6 months of follow-up and documented end-of-life (EOL) goals-of-care discussions. Clinicians were surveyed as to their impressions of geriatric consultation. One hundred sixty patients were randomized to either geriatric consultation plus standard care (n=60) or standard care alone (n=100). The median age of the patients was 80.4 years (standard deviation = 4.2). Of those randomized to geriatric consultation, 48 (80%) completed at least one visit with a geriatrician. Consultation did not improve survival at 1 year compared to standard care (difference: 2.9%, 95% confidence interval: -9.5% to 15.2%, P=0.65), and did not significantly reduce the incidence of emergency department visits, hospital admissions, or days in hospital. Consultation did improve the odds of having EOL goals-of-care discussions (odds ratio = 3.12, 95% confidence interval: 1.03 to 9.41) and was valued by surveyed hematologic-oncology clinicians, with 62.9%-88.2% of them rating consultation as useful in the management of several geriatric domains

High transferrin saturation predicts inferior clinical outcomes in patients with myelodysplastic syndromes

Iron overload (IO) reflected by elevated ferritin is associated with increased mortality in myelodysplastic syndromes (MDS), however, ferritin is an imperfect metric. Elevated labile plasma iron correlates with clinical outcomes and transferrin saturation (TSAT) >80%, but is not readily measurable. The trajectory of TSAT, and its association with clinical outcomes remain undefined. Canadian MDS registry patients were evaluated. Mean TSAT, mean ferritin and transfusion dose density (TDD) were determined. Survival was evaluated by TSAT and ferritin (80%), (≤500 μg/L, 501-800 μg/L, >800 μg/L). In 718 patients, median age was 74 years; 12%, 31%, 29%, 15% and 13% were IPSS-R very low, low, intermediate, high and very high. TSAT and ferritin were moderately correlated (r=0.63, P80% trended with inferior cardiac death-free survival (P=0.053). In univariate analysis, age, IPSS-R, blast percentage by Eastern Cooperative Oncology Group Performance Status, frailty, Charlson Comorbidity Index, iron chelation (Y/N), TDD, TSAT and ferritin were significantly associated with inferior OS. By multivariable analysis, TSAT >80% (P=0.007) remained significant for OS (R2 30.3%). In MDS, TSAT >80% and ferritin >800 μg/L portended inferior OS, PFS and LFS. TSAT may indicate the presence of oxidative stress, and is readily measurable in a clinical setting. The relationship between TSAT and cardiac death-free survival warrants further study

Publication patterns of cancer cost-effectiveness studies presented at major conferences

OBJECTIVE: To be useful to policymakers and stakeholders, cost-effectiveness analyses (ceas) should be published in a timely manner and without bias. The aims of the present study were to examine the time between conference abstract presentation and subsequent publication, to determine the factors associated with time to publication, to evaluate potential publication bias, and to examine discrepancies in the results between abstract and publication. METHODS: Abstracts of ceas presented at the annual meetings of the American Society of Clinical Oncology (asco), the American Society of Hematology (ash), and the International Society for Pharmacoeconomics and Outcomes Research (ispor) between 1997 and 2007 were reviewed. Time-to-event analysis was performed to assess the timeliness of publication and to examine factors associated with time to publication. Summary statistics were used to assess discrepancies in incremental cost-effectiveness ratios (icers) between abstract and publication. RESULTS: Of 164 abstracts identified, 65 (39.6%) were subsequently published. The 1-, 2-, 3-, and 5-year publication rates were 12.8%, 25%, 34.2%, and 40.5% respectively. Abstracts were more likely to be published if presented at asco than at ispor (hazard ratio: 1.94; p = 0.038). There was no direct evidence of publication bias for abstracts with favourable icers. Comparing icers between abstracts and publications, the mean absolute difference was 23.8%; 50% of studies had a change in icer exceeding 10%. CONCLUSIONS: Publication rates for ceas were low, and publication was not timely with respect to informing the decision-making process for funding. Abstract results often differed from publication results and cannot reliably be used in the decision-making process for funding

Publication Patterns of Cancer Cost-Effectiveness Studies Presented at the American Society of Hematology: Timeliness of Publication, Quality and Possible Bias.

Abstract Abstract 3816 Background: The timely publication of cancer cost-effectiveness analyses (CEA) is essential to inform decisions regarding new drug adoption by relevant policy makers and stakeholders. This study examined the publication pattern and quality of CEA presented in the annual meetings of the American Society of Hematology (ASH). Methods: ASH abstracts from 1997 to 2007 were reviewed. Abstracts with a malignant focus and that reported primary outcomes of incremental cost per life-year-gained or quality-adjusted-life-year (QALY) were included. Data including ICER (adjusted to USD) and author affiliation to the pharmaceutical industry was extracted. Quality indicators associated with well-performed CEAs were derived from the literature (Weinstein MC et al., JAMA 1996;276:1253-1258) and used to determine abstract quality. A search for subsequent publication of the abstract findings was conducted using Medline. The primary outcome of time-to-publication was determined using Kaplan-Meier statistics. Predictor variables were tested using the log-rank statistic. Results: 29 abstracts met inclusion criteria. Only 13 were published (overall rate of 44.8%). The actuarial 1 and 3 year publication rates were 24.1% and 41.4% respectively (see figure). All but 1 abstract presented at ASH had an ICER less than $100 000/QALY (median$33 000/QALY) with 55.2% disclosing author affiliation to the pharmaceutical industry. Specific to abstracts published after 2001, when ASH instituted a policy of disclosure reporting, the proportion of abstracts reporting pharmaceutical affiliation was 72.7%. No variable or quality indicator predicted for time-to-publication though there was a trend for abstracts reporting dominant ICERs to yield more timely publications (p = 0.075). In terms of quality indicators, the reporting of a societal perspective, lifetime horizon, or a sensitivity analysis was noted in only 37.9%, 24.1% and 62.1% of abstracts, respectively. Conclusions: The publication rate of CEA abstracts from ASH was low and not timely for open discussion among stakeholders. Although there was no direct evidence of bias in abstracts selected for presentation, most reported highly favorable ICERs and consistent author affiliation with the pharmaceutical industry. Overall, the quality of abstracts appeared suboptimal. Disclosures: No relevant conflicts of interest to declare. </jats:sec

Hepatitis B reactivation in HBsAg-/cAb+ patients receiving rituximab: A meta-analysis.

6592 Background: Patients with hepatitis B virus (HBV) who are HBsAg+ are recognized to be at risk of HBV reactivation if rituximab is administered in the absence of antiviral treatment. Recently, it has been reported that patients with so-called “resolved HBV infection”(HBsAg-/cAb+) may also be at risk; however, the degree of risk is not known. Methods: We performed a systematic review of the English and Chinese language literature in Medline (1996 to July week 2 2012) and Embase (1996 to 2012 week 29) using the MeSH terms “lymphoma” and “hepatitis B”. Eligible studies were limited to those reporting primary data on HBV reactivation rates in HBsAg-/cAb+ patients receiving rituximab. We excluded case series with less than 5 patients. Pooled estimates were calculated for HBV reactivation and the impact of HBsAb status on HBV reactivation rate was explored. Results: Data from 445 patients in 12 studies were included. Using a standardized definition of HBV reactivation, (ALT &gt;3 x upper limit of normal AND either an increase in HBV DNA from baseline OR HBsAg seroreversion), the pooled estimate for the risk of HBV reactivation in HBsAg-/cAb+ patients was 5.4% (I2 = 63%, P = 0.009). Significant heterogeneity was apparent. Exploratory analyses suggested that patients were less likely to reactivate if they were HBsAb+ (OR = 0.32; 95% CI 0.12-0.85, P = 0.0285). Conclusions: Our meta-analysis confirms that there is a measurable risk of HBV reactivation in HBsAg-/cAb+ patients exposed to rituximab HBsAb+ patients may be at lower risk than those who are HBsAb-. However, heterogeneity in the risk estimates limits their generalizability. Large prospective studies are needed to clarify the risk of HBV reactivation in HBsAg-/cAb+ patients and to inform decisions about best practice. </jats:p