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.

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.

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43 Background: Oral anticancer drugs are increasingly being used as standard therapy. At Tufts Medical Center Cancer Center, 10% of patients on active cancer treatment are receiving oral chemotherapy. To address barriers to medication education and timely management of treatment effects, we began an initiative involving our pharmacy specialist who reviews newly-started oral chemotherapy treatments for safety concerns, dose appropriateness, and drug interactions. In response to the cultural-linguistic needs of our Chinese patients (20% of our patients, largest minority group) and unique challenges of our patients of lower SES (40% of our patients), we are also leveraging patient navigators (PN) to improve timely care and understanding of and adherence to oral cancer medications for our most vulnerable patients. Methods: PN regularly interact with patients and work closely with the care team to address patients’ concerns. Formal PN visits with patients in clinic are documented in the EMR. To assess the scope of issues related to oral chemotherapy and/or supportive care drugs (e.g. anti-nausea, anti-constipation) and the potential impact in using PN, we reviewed PN encounter notes from the first 6 months of 2016 to identify patient-reported issues. Results: In reviewing 492 PN encounter notes from the first 6 months of 2016 (111 patients were navigated), 138 (28%) of all patient encounters involved assistance related to oral chemotherapy, supportive care drugs, and/or comorbidities medications. Examples of patient-reported issues include confusion about purpose and/or type of drug, dosing scheduling, side effects management, and logistical challenges (e.g. refills, copays, specialty pharmacy orders). Conclusions: From the PN encounter notes, we identified a need for more formalized patient-centered interventions to enhance education, monitoring, and patient-provider communication about oral chemotherapy to proactively resolve medication-related issues. We are piloting an evidence-based approach involving pharmacist-PN-patient teaching sessions, tailored patient education tools, and scheduled check-ins between PN and patients adapted from the MASCC Oral Agent Teaching Tool model.