Citations

TPS594 Background: Effective treatment options are very limited for patients with advanced refractory biliary tract cancer (BTC). Fluoropyrimidine-based chemotherapy regimen such as 5-fluorouracil and irinotecan are frequently utilized for these patients after first-line therapy despite lack of FDA approval. Trifluridine/tipiracil (FTD/TPI) is a novel oral nucleoside with antitumor activity in both fluoropyrimidine sensitive and resistant tumors due to its unique mechanisms of action. Given early toxicity and efficacy data from our previous study on single-agent trifluridine/tipiracil (FTD/TPI) in advanced BTC, the clinical evaluation of its combination with irinotecan represents a rational approach for the treatment of advanced refractory BTC. Methods: This is a single-arm phase II trial with a two-stage design to assess the efficacy of trifluridine/tipiracil (FTD/TPI) and irinotecan in advanced refractory BTC. Key eligibility criteria include histologically confirmed advanced, unresectable BTC who have progressed on at least one line of systemic therapy and have measurable disease per RECIST v1.1. Target accrual is 25. Treatment includes trifluridine/tipiracil (FTD/TPI) 25 mg/m2 on days 1-5 and irinotecan 180 mg/m2 on day 1 in 14-day cycles. Patients will be evaluated for response every 4 cycles and in the absence of disease progression, therapy may be given up to 2 years. The primary end point is the progression-free survival rate at 16 weeks. Secondary endpoints include overall response rate, disease control rate, progression-free survival, overall survival, and incidence of adverse events. Correlative biomarker studies include evaluations of circulating tumor DNA and circulating tumor cells at baseline, after 4 cycles and at progression; and development of patient-derived tumor organoids from pre-treatment biopsies for parallel treatments. This study was approved and funded in part by the National Comprehensive Cancer Network (NCCN) Oncology Research Program from general research support provided by Taiho Oncology, Inc. Clinical trial information: NCT 04072445.

Objectives Pediatric refusal of medical assistance (RMA) is a potentially high-risk event with implications for both individual patient outcomes and greater emergency medical services system efficiency. The purpose of this study was to describe characteristics of pediatric RMA calls and outcomes. Methods Single emergency medical services agency retrospective study of calls between January 1, 2011, and December 31, 2015, for pediatric patients resulting in RMA was performed. Dispatch complaint-matched case-control group was generated from transported patients. Results The percentage of pediatric calls that resulted in RMA was 12.7%, compared with 5% adult calls (P < 0.0001). The 3 most common RMA dispatch complaints were seizures, difficulty breathing, and traffic accidents. Furthermore, 65.1% pediatric RMA calls were emergently dispatched, compared with 56.4% of transported pediatric patients (P = 0.01). Medical control was contacted for 4.6% RMA calls. The average ± SD word count for RMA patient care narratives was 179 ± 99 words, compared with 164 ± 139 words for controls (P = 0.11). Documentation of risk-benefit discussion occurred in 28.6% RMA narratives. Outcome data were available for 83.8% RMA patients. The percentage of RMA patients with documented alternative plans who completed the alternative plan was 61.6%. Within 72 hours of RMA, 5.0% of calls with known outcome resulted in unexpected emergency department visit. No unexpected emergency department visits resulted in admission. Five percent of RMA patients were admitted; 1 patient was admitted to the intensive care unit. No emergent surgeries or deaths occurred during the study period. Conclusions Pediatric RMA is common within our study population, and two thirds involve emergent dispatch. Although outcomes are generally good, refusal documentation is sparse and medical control is seldom contacted. Multiple opportunities for systems improvement exist.

Abstract Background and Objectives The purpose of this study is to present our experience using free fillet flaps to reconstruct massive oncologic defects of the upper and lower extremity. Methods A retrospective chart review was performed to include patients who underwent oncologic resection followed by reconstruction using free fillet flaps from July 2001 to October 2018. Patient demographics, clinical and surgical characteristics, and postoperative complications were reviewed. Results In total, 12 patients were identified and included in this study. Mean age was 48.9 years old. Five patients had extended forequarter amputations and seven patients had external hemipelvectomies, all for locally advanced tumors. Mean tumor size was 15 ± SD 6.4 cm, and negative tumor margins were achieved in all the patients. Mean flap size was 1028 ± SD 869 cm 2 . The mean follow‐up was 13 months. There were no partial or total flap losses in the postoperative period. Two patients had flap‐related postoperative complications, including flap bleeding and wound dehiscence. Median survival was 18 months. Conclusion The free fillet flap is a safe, reliable, and valuable approach for reconstructing oncological defects. It offers the advantage of avoiding donor site morbidity, while providing extensive soft‐tissue coverage as a one‐step solution for massive oncologic defects.