Background Wound complications are common after resection of soft tissue sarcomas, with published infection rates ranging from 10% to 35%. Multiple studies have reported on the atypical flora comprising these infections, which are often polymicrobial and contain anaerobic bacteria, and recent studies have noted the high prevalence of anaerobic bacterial infections after soft tissue sarcoma resection [26,35]. Based on this, our institution changed clinical practice to include an antibiotic with anaerobic coverage in addition to the standard first-generation cephalosporin for prophylaxis during soft tissue sarcoma resections. The current study was undertaken to evaluate whether this change was associated with a change in major wound complications, and if the change should therefore be adopted for future patients. Questions/purposes (1) After controlling for potentially confounding variables, was the broadening of the prophylactic antibiotic spectrum to cover anaerobic bacteria associated with a lower odds of major wound complications after soft tissue sarcoma resection? (2) Was the broadening of the prophylactic antibiotic spectrum to cover anaerobic bacteria associated with a lower odds of surgical Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request. Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use.
e16150 Background: Immune checkpoint inhibition has demonstrated modest activity in biliary tract carcinoma (BTC). Augmentation of the immune response by ablative procedures to improve efficacy of immune checkpoint inhibition has been previously demonstrated in hepatocellular carcinoma, however the outcome of the combination of immune checkpoint inhibition with tremelimumab (anti-CTLA4) and durvalumab (anti-PD1) with ablation in advanced biliary tract carcinoma is unclear. The primary objective of this study was to establish the efficacy via 6-month progression-free survival (PFS) of combining tremelimumab and durvalumab in patients with advanced BTC either alone or with tumor ablation. Secondary objectives were safety and feasibility of combination treatment. An exploratory objective was overall survival (OS). Methods: Eligible patients had histologically confirmed advanced or unresectable BTC (intra- or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary cancer) who had progressed on, been intolerant to, or refused prior chemotherapy. Disease had to be technically amenable to cryoablation with at least two measurable lesions. Adequate organ function and an ECOG of 0 or 1 were required. Patients were treated with tremelimumab and durvalumab with or without tumor ablation. Tremelimumab and durvalumab were administered intravenously every 28 days for four cycles followed by durvalumab every 28 days until disease progression. Cryoablation was performed on day 36. Patients were imaged every 8 weeks and response was defined per RECIST v 1.1 criteria. Results: In total, 22 patients have been enrolled into the BTC cohort. Half underwent ablation and half received immunotherapy alone. The median age was 59 years (range 21-80). All patients had received prior systemic chemotherapy, locally advanced disease was present in 68% of patients. Median PFS was 2.1m and median OS was 5.6 m. DCR was 45% (SD). Median OS and PFS was similar in the group that received ablation vs immunotherapy alone with a median OS of 6.8 m vs 6.7 m and 2.0 m vs 2.7 m respectively. The most common grade 3- 4 adverse events were lymphopenia (27%), increased AST (41%), increased alkaline phosphatase (32%) and elevated bilirubin (27%). Conclusions: Combination checkpoint inhibition combined with tumor ablative procedures is a safe and effective treatment strategy for patients with advanced BTC, however the addition of ablative therapy may not enhance efficacy in this small cohort of patients. Results illustrate the poor prognosis of advanced BTC and may represent a non-chemotherapeutic approach to treatment in this patient population. Further studies are warranted to identify patient populations most likely to respond to these interventions. Clinical trial information: NCT02821754.
Introduction: Mixed phenotype acute leukemia (MPAL) is exceeding rare, making up less than 1% of all acute leukemias1, 2. It harbors features of both acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). Most cases have features of B-ALL; those with features of T-ALL are particularly uncommon2. We treated a 74-year-old retired male with T/myeloid MPAL. His disease progressed through 7 lines of therapy over 18 months, resulting in significant cytopenias and toxicity. Given the refractory nature of his disease to numerous ALL and AML-inspired regimens, we wanted to better understand trends in survival for this rare disease. Methods: The Surveillance, Epidemiology, and End-Result (SEER)-18 database was utilized, which encompasses 28% of the U.S. population. Patients of all ages diagnosed with T/myeloid MPAL between 2010-2016 were included. Patients with T-ALL and AML were used as comparators. The primary endpoint was disease-specific survival. Variables assessed included age, race/ethnicity, insurance type, geographical location, rural vs. urban location and socioeconomic status using county level data. Categorical variables were compared with the chi-square and fisher's exact test and survival was characterized with the cox proportional hazard model. This study was exempt from the IRB. Results: Ninety-five cases of T/myeloid MPAL were reported from 2010-2016 through the SEER-18 database. T/myeloid MPAL demonstrated a broad age distribution (median age: 40, IQR: 17-61), in comparison to T-ALL which mostly affected adolescence/young adults (median age: 17.5, IQR: 9-35) and AML which mostly affected older adults (median age: 67, IQR: 53-78) (figure 1). The 5-year survival was 50.4%, which was higher than AML (23.3%) and lower than T-ALL (70.6%) (figure 2). Survival did not change from 2010 to 2016. After adjusting for age, race/ethnicity, insurance type, geographical location, urban vs. rural location, and county level surrogates for poverty, the only two variables that significantly impacted survival were increasing age (HR 3.41, 95%CI: 2.13-5.46, p<.0001) and Medicaid insurance (HR 3.2, 95%CI: 1.27-8.09, p=.014) (figure 3-4). Estimated 5-year survival ranged from over 70% for children, adolescence and young adults to only 16% for older adults. Discussion: T/myeloid MPAL affects people of all ages. Given its rarity, there are no actively enrolling clinical trials or randomized controlled trials from which to guide management. Treatments are largely extrapolated from T-ALL and AML2. Despite newer FDA approved drugs for T-ALL and AML and improvements in allotransplant, survival has not improved and remains dismal for elderly patients. Older patients may have more aggressive disease biology and are often not candidates for intensive chemotherapy or allotransplant due to comorbidities and diminished reserve. Patient age very likely contributes to the difference in survival between T/myeloid MPAL and T-ALL or AML however Medicaid insurance also adversely affected survival in T/myeloid MPAL. This etiology is unclear, however could relate to decreased access to care. Conclusion: T/myeloid MPAL is an exceedingly rare disease with dismal outcomes in the elderly. A better understanding of the disease biology in elderly patients, insurance related barriers to care, and more personalized treatments are needed to improve patient outcomes. References: 1. Mantutes E, Pickl WF, Van't Veer M, et al. Mixed-Phenotype acute leukemia: clinical and laboratory features and outcome in 100 patients defined according to the WHO 2008 classification: Blood 2001; 117:3163. 2. Wolach, O., & Stone, R. M. (2015). How I treat mixed-phenotype acute leukemia. Blood, 125(16), 2477-2485. Disclosures No relevant conflicts of interest to declare.
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