Absence of Anti-Babesia microti antibody in commercial intravenous immunoglobulin (IVIG).

BACKGROUND: Babesiosis is a worldwide emerging protozoan infection that is associated with a spectrum of disease severity from asymptomatic infection to severe organ damage and death. While effective treatment strategies are available, some immunocompromised patients experience severe acute and prolonged/relapsing illness due in part to an impaired host antibody response. Intravenous immunoglobulin (IVIG) has been used as an adjunctive therapy in some immunocompromised babesiosis patients, but its therapeutic effect is uncertain. We evaluated the presence of Babesia microti antibodies in commercial samples of IVIG. METHODS/PRINCIPLE FINDINGS: The presence of B. microti antibodies in commercial samples of IVIG were tested using an immunofluorescence assay. A subset of samples was then tested for B. microti antibodies using an enzyme linked immunosorbent assay. Out of 57 commercial IVIG samples tested using IFA, and 52 samples tested using ELISA, none were positive for B. microti antibodies. CONCLUSIONS: Commercially available IVIG may not be of therapeutic benefit for babesiosis patients. Additional sampling of IVIG for B. microti antibody and a clinical trial of babesiosis patients given IVIG compared with controls would provide further insight into the use of IVIG for the treatment of babesiosis.

Assessment of patients' understanding of and adherence to oral anticancer medication (OAM): Results of a cross-sectional institutional pilot study.

BACKGROUND: Although oral anticancer medications (OAM) provide opportunity for treatment at home, challenges include prescription filling, monitoring side effects, safe handling, and adherence. We assessed understanding of and adherence to OAM in vulnerable patients. METHODS: This 2018 pilot study defined vulnerable patients based on Chinese language, older age (≥65 years), and subsidized insurance. All participants had a cancer diagnosis and were taking an OAM filled through the hospital's specialty pharmacy. Participants reported on OAM taking (days per week, times per day, special instructions) and handling (handling, storage, disposal). The specialty pharmacist classified patient-reported responses about OAM taking and handling as adequate or inadequate. OAM regimens were classified by complexity. RESULTS: Of 61 eligible patients, 55 participated. Mean age was 68 years (standard deviation [SD] = 12) and 53% were female. Patient subgroups were: 27% Chinese, 64% ≥65 years, and 9% subsidized insurance. Forty-nine percent were on frontline therapy and median time on OAM was 1 year (Quartile 1 = 0.4, Quartile 3 = 1.7). Adequacy of OAM taking (30%) and handling (15%) were low; 15% had adequacy in both. Adequacy of OAM taking and handling did not vary by patient subgroup or regimen complexity. Mean patient-reported adherence was high (5.4, SD = 1, possible range 1-6) and did not vary by adequacy of OAM taking or handling. CONCLUSIONS: Understanding of OAM taking and handling in this group of vulnerable patients was low and did not align with patient-reported adherence. Future interventions should ensure that patients understand how to safely take and handle OAM, thereby optimizing their therapeutic potential.

Enhancing patients' understanding of and adherence to oral anticancer medication: Results of a longitudinal pilot intervention.

BACKGROUND: Oral anticancer medications (OAM) make administration more convenient for patients, but shifts the responsibility of care from clinical providers to the patients themselves. Following an institutional pilot study showing inadequate understanding and adherence among vulnerable patients taking OAM, a longitudinal intervention was developed using an oncology specialty pharmacist and medication navigators to enhance OAM understanding and adherence. METHODS: Patients initiating OAM were approached for four formalized teaching and check-in sessions, supplemented with medication information sheets and individualized calendars. At each session, participants were assessed on their OAM understanding and adherence using teach-back and validated measures. A study evaluation elicited feedback from participants on the usefulness of the intervention. RESULTS: Of 80 eligible patients, 58 (72.5%) received formal OAM teaching from the specialty pharmacist. Of those, 54 (93.1%) enrolled in the study with 39 (72%) completing the intervention for final analysis. At study completion, all participants adequately understood OAM taking, but 41.0% had inadequate understanding of OAM handling. Throughout the study, participants reported issues that were addressed by the intervention team (28.2% to 31.6%) as well as those requiring additional assistance from the treatment team (26.3% to 38.5%), Most participants found the intervention to be very beneficial (initial evaluation, 86.5%; final evaluation, 76.9%). CONCLUSIONS: This pilot intervention addressed gaps identified by our institutional assessment through formalized OAM teaching and follow-up. Improved understanding of taking and handling OAM through this subsequent study illustrated the enhanced effect of a multidisciplinary and multicomponent intervention to better educate and support patients on OAM.

Qualitative and quantitative variations in liver function thresholds among clinical trials in cancer: a need for harmonization.

PURPOSE: The liver is critically involved in drug metabolism pathways and the potential for hepatic toxicity is significant with specific cancer therapeutics. Variations in the definition of liver function thresholds that may generate heterogeneity of toxicity and efficacy outcomes across therapeutics trials in cancer require assessment. METHODS: A random sample of therapeutic trials in cancer (n = 500, general category), trials using hepatotoxic drugs (abiraterone, pazopanib: n = 181), trials using drugs metabolized by the liver (doxorubicin, vincristine: n = 606), and therapeutic trials in hepatic dysfunction (n = 49) were each identified on clinicaltrials.gov. Definitions of liver function thresholds and their distribution were collated and categorized in each group. RESULTS: A third of all trials listed on clinicaltrials.gov across the four categories failed to provide an explicit definition of liver function. Among trials with an explicit definition, a combination of bilirubin and transaminase levels was used in 33-64%, whereas a miscellaneous combination of definitions (in the general category consisting of 11 unique liver function parameters creating 17 unique combinations) was used 29-58% of the time across the four categories of studies. The Child-Pugh or National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG) criteria were rarely employed (0-12% studies). Allowance for Gilbert's disease in bilirubin thresholds was identified in only 6-23% studies and for liver metastases in 2-15% of studies. CONCLUSIONS: There is a marked heterogeneity in the liver function definitions used across cancer clinical trials even when the potential for drug toxicity and altered drug metabolism is significant. Harmonization of criteria will streamline eligibility and mitigate variations in key outcomes across trials.

Imprecise Kidney Function Thresholds in Cancer Clinical Trials and the Potential for Harm.

Current guidance for evaluation of kidney function and drug dosing emphasize using measured or estimated glomerular filtration rate (GFR) rather than measured or estimated creatinine clearance or serum creatinine (Scr) alone. We assessed the definitions of kidney function thresholds for eligibility in cancer clinical trials. A random sample of active Phase I-III trials with cisplatin (n = 465) and studies in cancer with decreased kidney function (n = 74) were identified from clinicaltrials.gov. Among cisplatin trials, kidney function thresholds were defined by Scr alone or a composite of Scr or creatinine clearance in 46% (212/465) of studies. Only 2% (n = 11) used GFR. Among trials in participants with decreased kidney function, the proportion utilizing GFR (14%, 10/74) was modestly higher. Imprecise and logically inconsistent kidney function thresholds are in frequent use in clinical trials in cancer and may cause harm from either toxicity or impaired efficacy. We recommend the adoption and harmonization of recommended standards.