A Prospective Study of Conventionally Fractionated Dose Constraints for Reirradiation of Primary Brain Tumors in Adults.

PURPOSE: Dose constraints for reirradiation of recurrent primary brain tumors are not well-established. This study was conducted to prospectively evaluate composite dose constraints for conventionally fractionated brain reirradiation. METHODS AND MATERIALS: A single-institution, prospective study of adults with previously irradiated, recurrent brain tumors was performed. For 95% of patients, electronic dosimetry records from the first course of radiation (RT1) were obtained and deformed onto the simulation computed tomography for the second course of radiation (RT2). Conventionally fractionated treatment plans for RT2 were developed that met protocol-assigned dose constraints for RT2 alone and the composite dose of RT1 + RT2. Prospective composite dose constraints were based on histology, interval since RT1, and concurrent bevacizumab. Patients were followed with magnetic resonance imaging including spectroscopy and perfusion studies. Primary endpoint was the rate of symptomatic brain necrosis at 6 months after RT2. RESULTS: Patients were enrolled from March 2017 to May 2018; 20 were evaluable. Eighteen had glioma, 1 had atypical choroid plexus papilloma, and 1 had hemangiopericytoma. Nineteen patients were treated with volumetric modulated arc therapy, and one was treated with protons. Median RT1 dose was 57 Gy (range, 50-60 Gy). Median RT1-RT2 interval was 49 months (range, 9-141 months). Median RT2 dose was 42.4 Gy (range, 36-60 Gy). Median planning target volume was 186 cc (range, 8-468 cc). Nineteen of 20 patients (95%) were free of grade 3+ central nervous system necrosis. One patient had grade 3+ necrosis 2 months after RT2; the patient recovered fully and lived another 18 months until dying of disease progression. Median overall survival from RT2 start for all patients was 13.3 months (95% credible interval, 6.3-20.7); for patients with glioblastoma, 11.5 months (95% credible interval, 6.1-20.1). CONCLUSIONS: Brain reirradiation can be safely performed with conventionally fractionated regimens tailored to previous dose distributions. The prospective composite dose constraints described here are a starting point for future studies of conventionally fractionated reirradiation.

Evaluation of PDA Technical Report No 33. Statistical Testing Recommendations for a Rapid Microbiological Method Case Study.

UNLABELLED: New recommendations for the validation of rapid microbiological methods have been included in the revised Technical Report 33 release from the PDA. The changes include a more comprehensive review of the statistical methods to be used to analyze data obtained during validation. This case study applies those statistical methods to accuracy, precision, ruggedness, and equivalence data obtained using a rapid microbiological methods system being evaluated for water bioburden testing. Results presented demonstrate that the statistical methods described in the PDA Technical Report 33 chapter can all be successfully applied to the rapid microbiological method data sets and gave the same interpretation for equivalence to the standard method. The rapid microbiological method was in general able to pass the requirements of PDA Technical Report 33, though the study shows that there can be occasional outlying results and that caution should be used when applying statistical methods to low average colony-forming unit values. LAY ABSTRACT: Prior to use in a quality-controlled environment, any new method or technology has to be shown to work as designed by the manufacturer for the purpose required. For new rapid microbiological methods that detect and enumerate contaminating microorganisms, additional recommendations have been provided in the revised PDA Technical Report No. 33. The changes include a more comprehensive review of the statistical methods to be used to analyze data obtained during validation. This paper applies those statistical methods to analyze accuracy, precision, ruggedness, and equivalence data obtained using a rapid microbiological method system being validated for water bioburden testing. The case study demonstrates that the statistical methods described in the PDA Technical Report No. 33 chapter can be successfully applied to rapid microbiological method data sets and give the same comparability results for similarity or difference as the standard method.

A dosimetric comparative study: volumetric modulated arc therapy vs intensity-modulated radiation therapy in the treatment of nasal cavity carcinomas.

The purpose of this study was to evaluate the differences between volumetric modulated arc therapy (VMAT) and intensity-modulated radiation therapy (IMRT) in the treatment of nasal cavity carcinomas. The treatment of 10 patients, who had completed IMRT treatment for resected tumors of the nasal cavity, was replanned with the Philips Pinnacle(3) Version 9 treatment-planning system. The IMRT plans used a 9-beam technique whereas the VMAT (known as SmartArc) plans used a 3-arc technique. Both types of plans were optimized using Philips Pinnacle(3) Direct Machine Parameter Optimization algorithm. IMRT and VMAT plans' quality was compared by evaluating the maximum, minimum, and mean doses to the target volumes and organs at risk, monitor units (MUs), and the treatment delivery time. Our results indicate that VMAT is capable of greatly reducing treatment delivery time and MUs compared with IMRT. The reduction of treatment delivery time and MUs can decrease the effects of intrafractional uncertainties that can occur because of patient movement during treatment delivery. VMAT's plans further reduce doses to critical structures that are in close proximity to the target volume.