ABSTRACT
BACKGROUND: The standard of care treatment for soft tissue sarcoma of the extremities is a wide resection in combination with pre- or postoperative radiotherapy with high local control rates, sparing patients the necessity of amputation without compromising on overall survival rates. The currently preferred timing of radiotherapy is under debate. Albeit having higher rates of acute wound complications, late side effects like fibrosis, joint stiffness or edema are less frequent in preoperative compared to postoperative radiotherapy. This can be explained in smaller treatment volumes and a lower dose in the preoperative setting. Particles allow better sparing of surrounding tissues at risk, and carbon ions additionally offer biologic advantages and are preferred in less radiosensitive tumors. Hypofractionation allows for a significantly shorter treatment duration. METHODS: Extrem-ion is a prospective, randomized, monocentric phase II trial. Patients with resectable or marginally resectable, histologically confirmed soft tissue sarcoma of the extremities will be randomized between neoadjuvant proton or neoadjuvant carbon ion radiotherapy in active scanning beam application technique (39 Gy [relative biological effectiveness, RBE] in 13 fractions [5-6 fractions per week] in each arm). The primary objective is the proportion of therapies without wound healing disorder the first 120 days after surgery or discontinuation of treatment for any reason related to the treatment. The secondary endpoints of the study consist of local control, local progression-free survival, disease-free survival, overall survival, and quality of life. DISCUSSION: The aim of this study is to confirm that hypofractionated, preoperative radiotherapy is safe and feasible. The potential for reduced toxicity by the utilization of particle therapy is the rational of this trial. A subsequent randomized phase III trial will compare the hypofractionated proton and carbon ion irradiation in regards to local control. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04946357 ; Retrospectively registered June 30, 2021.
Subject(s)
Sarcoma , Soft Tissue Neoplasms , Carbon/therapeutic use , Clinical Trials, Phase II as Topic , Extremities , Humans , Ions/therapeutic use , Neoadjuvant Therapy/adverse effects , Pilot Projects , Prospective Studies , Protons , Quality of Life , Randomized Controlled Trials as Topic , Sarcoma/drug therapy , Sarcoma/radiotherapy , Sarcoma/surgery , Soft Tissue Neoplasms/drug therapyABSTRACT
BACKGROUND: Traffic accidents and the traumatic injury consequences are frequent causes of mortality and irreversible damage in children and young adults. In motorcycle accidents the injury patterns differ depending on the age of the patient. OBJECTIVE: The aim of this study was to describe the typical injury patterns after motorcycle accidents involving children and adolescents as these can have a decisive influence on the prevention and the adequate treatment in the respective patient groups. MATERIAL AND METHODS: The study included 22,923 patients from the years 2002-2018 which were extracted from the TraumaRegister DGU®. Injury patterns of 4 age categories were analyzed: group 1 (4-15 years), group 2 (16-17 years), group 3 (18-20 years) and group 4 (21-50 years). RESULTS: In both younger age groups, limb injuries mostly of the lower extremities, showed the highest incidence. Moreover, younger patients with traumatic brain injury showed better outcomes despite of initially poor conditions. Ribcage, abdominal, pelvic and spinal injuries are the least frequent in younger patients. In terms of diagnostics, children are less likely to undergo whole-body computed tomography (CT) diagnostics than adults. CONCLUSION: The study revealed age-specific differences with respect to injury patterns in patients involved in motorcycle accidents, either as drivers or co-drivers. Furthermore, the analysis of preclinical and in-hospital treatment elucidated the relevance of preventive and protective measures.
Subject(s)
Accidents, Traffic , Motorcycles , Young Adult , Child , Humans , Adolescent , Infant , Child, Preschool , Incidence , Lower Extremity , HospitalsABSTRACT
BACKGROUND: In the prehospital acute treatment phase of severely injured patients, the stabilization of the vital parameters is paramount. The rapid and precise assessment of the injuries by the emergency physician is crucial for the initial treatment and the selection of the receiving hospital. OBJECTIVE: The aim of this study was to determine whether the prehospital emergency medical assessment has an influence on prehospital and emergency room treatment. MATERIAL AND METHODS: Data from the TraumaRegister DGU® between 2015 and 2019 in Germany were evaluated. The prehospital emergency medical assessment of the injury pattern and severity was recorded using the emergency physician protocol and compared with the in-hospital documented diagnoses using the abbreviated injury scale. RESULTS: A total of 47,838 patients with an average injury severity score (ISS) of 18,7 points (SD 12.3) were included. In summary, 127,739 injured body regions were documented in the hospitals. Of these, a total of 87,921 were correctly suspected by the emergency physician Thus, 39,818 injured body regions were not properly documented. In 42,530 cases a region of the body was suspected to be injured without the suspicion being confirmed in the hospital. Traumatic brain injuries and facial injuries were mostly overdiagnosed (13.5% and 14.7%, respectively documented by an emergency physician while the diagnosis was not confirmed in-hospital). Chest injuries were underdocumented (17.3% missed by an emergency physician while the diagnosis was finally confirmed in-hospital). The total mortality of all groups was very close to the expected mortality calculated with the revised injury severity classification II(RISC II)-score (12.0% vs. 11.3%). CONCLUSION: In the prehospital care of severely injured patients, the overall injury severity is often correctly recorded by the emergency physician and correlates well with the derived treatment, the selection of the receiving hospital as well as the clinical course and the patient outcome; however, the assessment of injuries of individual body regions seems to be challenging in the prehospital setting.
Subject(s)
Emergency Medical Services , Multiple Trauma , Wounds and Injuries , Emergency Medical Services/methods , Emergency Treatment , Germany , Humans , Injury Severity Score , Multiple Trauma/diagnosis , Multiple Trauma/therapy , Registries , Wounds and Injuries/diagnosis , Wounds and Injuries/therapyABSTRACT
BACKGROUND: Following surgery for soft tissue sarcoma of the retroperitoneum, the predominant pattern of failure is local recurrence, which remains the main cause of death. Radiotherapy is utilized to reduce recurrence rates but the efficacy of this strategy has not been definitely established. As treatment tolerability is more favorable with preoperative radiotherapy, normofractionated neoadjuvant treatment is the current approach. The final results of the prospective, randomized STRASS (EORTC 62092) trial, which compared the efficacy of this combined treatment to that of surgery alone, are still awaited; preliminary results presented at the 2019 ASCO Annual Meeting indicated that combined treatment is associated with better local control in patients with liposarcoma (74.5% of the cohort, 11% benefit in abdominal progression free survival after 3 years, p = 0.049). Particles allow better sparing of surrounding tissues at risk, e.g., bowel epithelium, and carbon ions additionally offer biologic advantages and are preferred in slow growing tumors. Furthermore, hypofractionation allows for a significantly shorter treatment interval with a lower risk of progression during radiotherapy. METHODS AND DESIGN: We present a prospective, randomized, monocentric phase II trial. Patients with resectable or marginally resectable, histologically confirmed soft tissue sarcoma of the retroperitoneum will be randomized between neoadjuvant proton or neoadjuvant carbon ion radiotherapy in active scanning beam application technique (39 Gy [relative biological effectiveness, RBE] in 13 fractions [5-6 fractions per week] in each arm). The primary objective is the safety and feasibility based on the proportion of grade 3-5 toxicity (CTCAE, version 5.0) in the first 12 months after surgery or discontinuation of treatment for any reason related to the treatment. Local control, local progression-free survival, disease-free survival, overall survival, and quality of life are the secondary endpoints of the study. DISCUSSION: The aim of this study is to confirm that hypofractionated, accelerated preoperative radiotherapy is safe and feasible. The rationale for the use of particle therapy is the potential for reduced toxicity. The data will lay the groundwork for a randomized phase III trial comparing hypofractionated proton and carbon ion irradiation with regard to local control. TRIAL REGISTRATION: ClinicalTrials.gov NCT04219202 . Retrospectively registered on January 6, 2020.
Subject(s)
Neoadjuvant Therapy , Sarcoma , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Humans , Ions , Neoadjuvant Therapy/adverse effects , Neoplasm Recurrence, Local , Pilot Projects , Prospective Studies , Quality of Life , Randomized Controlled Trials as Topic , Sarcoma/radiotherapy , Sarcoma/surgeryABSTRACT
INTRODUCTION: In corneal recipients with herpes infection, acyclovir given for 1 year postoperatively prevents viral reactivation and improves graft outcome. The indication for prophylactic antiviral therapy relies on the preoperative diagnosis of herpes. However, many patients present with corneal scars featuring sequelae of herpes without a proven history of herpes. Here we report the results of a prospective study of anti-herpes simplex virus (anti-HSV) and varicella zoster virus (VZV) antibody testing in the aqueous humor at the time of corneal transplantation to refine the indication of the antiviral treatment. MATERIAL AND METHODS: The study involved 33 keratitis corneal graft recipients, 21 of whom had documented herpes keratitis. A control group was made with 11 cataract patients. An anterior chamber puncture was performed just before surgery. The micro-ELISA test was done on both aqueous humor and serum, and local anti-HSV or VZV antibody synthesis was acknowledged if the ratio of antibody concentrations was above 4. RESULTS: Local antibody synthesis to HSV was detected in 22 cases, to VZV in 9 cases, to both HSV and VZV in 6 cases, and no synthesis in 8 cases. The sensitivity of the test was 65% in patients with a documented history of herpes (14 cases out of 21). Among non-herpetic patients, the test was positive in 9 patients, who thus benefited from postoperative antiviral therapy. No viral reactivation was encountered after a minimum follow-up of 1 year. CONCLUSIONS: Antibody testing in the aqueous humor at the time of keratoplasty is a convenient, inexpensive diagnostic tool in corneal recipients. It provides useful information before prescribing a long and expensive postoperative antiviral therapy.
