Objective Preclinical studies suggest that robotic carotid artery stenting (CAS) could be superior to manual CAS. However, very limited comparative data exists comparing robotic and manual CAS patients. In addition, no data exists comparing the costs of manual and robotic CAS. Methods All robotic CAS cases at 2 academic neurosurgery centers were retrospectively reviewed and 1:1 propensity matched with manual CAS cases. Personnel costs, supply costs, and total procedure costs were collected in collaboration with hospital administration using time‐driven activity‐based cost‐analysis (TDABC). Results 24 robotic CAS cases were performed between 2019 and 2023. Co‐morbidities and baseline procedural characteristics were well‐matched between robotic and manual cases. Unplanned manual conversion was observed in only one robotic case (4.2%). Robotic CAS complications and outcomes were comparable to manual. Robotic CAS was associated with a significantly increased fluoroscopy time (29.0 vs. 19.2 min.; p<0.001). Robotic procedure time (88.9±18.2 min.) was significantly (p=0.003) higher than manual (68.72±22.4 min.). Health professional costs ($1,589.71±176.92, $1,375.99±233.39, p<0.005), supply cost ($3,918.25±421.20, $2,152.74±1,030.26, p<0.001) and total procedure costs ($5,306.11±608.95, $3,437.56±1,165.67, p<0.001) were greater for robotic CAS. Conclusions With a low rate of technical failure and post‐operative complications, we show robotic carotid artery stenting is safe and feasible in the first multi‐center and largest sample to date. In addition, robotic CAS achieves comparable clinical outcomes. Robotic CAS was associated with increased fluoroscopy time, but fluoroscopy time decreased as operators gained familiarity with the CorPath GRX. Robotic CAS was associated with a greater procedural cost, which was driven by greater personnel and supply costs. Our findings highlight the need for further studies to optimize robotic CAS and reduce its associated costs.
A Phase I Study of EKB-569 in Combination with Capecitabine in Patients with Advanced Colorectal Cancer
Abstract Purpose: To determine the maximum tolerated dose (MTD), characterize the principal toxicities, and assess the pharmacokinetics of EKB-569, an oral selective irreversible inhibitor of the epidermal growth factor receptor tyrosine kinase, in combination with capecitabine in patients with advanced colorectal cancer. Experimental Design: Patients were treated with EKB-569 daily for 21 days and capecitabine twice daily for 14 days of a 21-day cycle. The dose levels of EKB-569 (mg/day) and capecitabine (mg/m2 twice daily) assessed were 25/750, 50/750, 50/1,000 and 75/1,000. An expanded cohort was enrolled at the MTD to better study toxicity and efficacy. Samples of plasma were collected to characterize the pharmacokinetics of the agents. Treatment efficacy was assessed every other cycle. Results: A total of 37 patients, the majority of whom had prior chemotherapy, received a total of 163 cycles of treatment. Twenty patients were treated at the MTD, 50 mg EKB-569, daily and 1,000 mg/m2 capecitabine twice daily. Dose-limiting toxicities were diarrhea and rash. No patients had complete or partial responses but 48% had stable disease. The conversion of capecitabine to 5-fluorouracil was higher for the combination of EKB-569 and capecitabine (321 ± 151 ng*h/mL) than for capecitabine alone (176 ± 62 ng*hours/mL; P = 0.0037). Conclusion: In advanced colorectal cancer, 50 mg EKB-569 daily can be safely combined with 1,000 mg/m2 capecitabine twice a day. A statistically significant increase in plasma levels of 5-fluorouracil for the combination of EKB-569 and capecitabine may be due to the single-dose versus multiple-dose exposure difference, variability in exposure or a potential drug interaction.