Aim: To determine the safety of Coenzyme Q10 (CoQ10) in breast cancer patients receiving doxorubicin treatment. Methods: Phase I randomized, placebo-controlled, cross-over, dose-finding pharmacokinetic study among women with stage I-III breast cancer receiving 4 cycles of doxorubicin plus cyclophosphamide. The study was designed to test the maximum tolerated dose of CoQ10 using up to 1200 mg/day. Eligible patients were randomized to Arm A (CoQ10 after Cycle 3, followed by placebo after Cycle 4) or Arm B (placebo after cycle 3, followed by CoQ10 after cycle 4). CoQ10 concentrations and total antioxidant capacity (TAC) were measured before and after chemotherapy cycles. Non-compartmental pharmacokinetic parameters of doxorubicin and its active metabolites were measured with and without CoQ10. Paired t-tests assessed intra-patient differences in pharmacokinetic parameters, serum CoQ10 concentrations, TAC and adverse events. Results: Six patients received 300 mg/day of CoQ10 [Arm A (n=3), Arm B (n=3)]. One patient received 600 mg/day of CoQ10 but was discontinued due to non-adherence. Serum CoQ10 concentrations were increased in patients receiving 300 mg/day (mean±SD change: CoQ10, 1.6±0.9 ug/mL; placebo, -0.01±0.3 ug/mL; P=0.01). There were no clinically significant pharmacokinetic interactions between 300 mg/day CoQ10 and doxorubicin and no differences in TAC or adverse events during treatment and nontreatment periods. The trial was closed early due to slow accrual. Conclusions: 300 mg/day of CoQ10 with doxorubicin did not change doxorubicin pharmacokinetics and was not associated with treatment-related adverse events. Future studies should evaluate the long-term effects of CoQ10 at 300 mg/day and safety studies should examine higher doses.

Background: Pediatric acute lymphoblastic leukemia (ALL) treatment regimens are lengthy, and there is limited data on the systemic and individual economic burden associated with treatment of ALL. Objective: This study aims to examine healthcare resource utilization (HCRU) and costs accrued during the first year of therapy among pediatric ALL patients, and to compare costs among those who are Commercially and Medicaid insured. Methods: Administrative claims data from 2011-16 were analyzed utilizing IBM MarketScan. Newly-diagnosed ALL patients with at least 12 months of enrollment were studied. Demographics and HCRU and costs were stratified by insurance type. The mean (standard deviation (SD) HCRU and reimbursed costs were measured during the first year post-diagnosis. Multivariable generalized linear models were run for total healthcare costs. Results: 730 (528 Commercial) patients with median age of 6 years were studied. During the 12 months following diagnosis, the mean(SD) inpatient admissions and ER visits for Commercial and Medicaid patients was 6.2(3.7) vs. 6.0(4.6), p=0.6310 and 2.8(6.4) vs. 2.1(2.6),p=0.0380, respectively. Commercial patients experienced more outpatient visits (77.2(28.1) versus 57.4(33.3), p<0.0001) and less pharmacy claims (54.1(22.9) and 61.0(41.8),p<0.0001) versus Medicaid patients. Total healthcare costs were $535,135.89($547,506.23) versus $198,694.94($181,856.27),p<0.0001 for Commercial and Medicaid patients, respectively. When adjusted for age and gender, total healthcare costs in the year post-diagnosis for Commercial patients were 1.60 times the costs in patients with Medicaid. Conclusion: Pediatric ALL patients have high HCRU and incur significant economic burden. The total cost of care for Commercially insured patients is more than double that of Medicaid insured patients.