Protection of quality and innovation in radiation oncology: the prospective multicenter trial QUIRO of DEGRO: evaluation of time, attendance of medical staff, and resources during radiotherapy with tomotherapy.

PURPOSE: The technical progress in radiotherapy in recent years has been tremendous. This also implies a change of human and time resources. However, there is a lack of data on this topic. Therefore, the DEGRO initiated several studies in the QUIRO project on this subject. The present publication focuses on results for tomotherapy systems and compares them with other IMRT techniques. METHODS: Over a period of several months, time allocation was documented using a standard form at two university hospitals. The required time for individual steps in the treatment planning process was recorded for all involved professional groups (physicist, technician, and physician) by themselves. The time monitoring at the treatment machines was performed by auxiliary employees (student research assistants). Evaluation of the data was performed for all recorded data as well as by tumor site. A comparison was made between the two involved institutions. RESULTS: A total of 1,691 records were analyzed: 148 from head and neck (H&N) tumors, 460 from prostate cancer, 136 from breast cancer, and 947 from other tumor entities. The mean value of all data from both centers for the definition of the target volumes for H&N tumors took a radiation oncology specialist 75 min, while a physicist needed for the physical treatment planning 214 min. For prostate carcinomas, the times were 60 and 147 min, respectively, and for the group of other entities 63 and 192 min, respectively. For the first radiation treatment, the occupancy time of the linear accelerator room was 31, 26, and 30 min for each entity (H&N, prostate, other entities, respectively). For routine treatments 22, 18, and 21 min were needed for the particular entities. Major differences in the time required for the individual steps were observed between the two centers. CONCLUSION: This study gives an overview of the time and personnel requirements in radiation therapy using a tomotherapy system. The most representative analysis could be done for the room occupancy times during treatment in both centers. Due to the partly small amount of data and differing planning workflows between the two centers, it is problematic to draw a firm conclusion with regard to planning times. Overall, the time required for the tomotherapy treatment and planning is slightly higher compared to other IMRT techniques.

Hypofractionation with simultaneous integrated boost for early breast cancer: results of the German multicenter phase II trial (ARO-2010-01).

PURPOSE: To evaluate the feasibility of hypofractionation with SIB in all settings in Germany to prepare a multicenter treatment comparison. METHODS: Eligible patients had histopathologically confirmed breast cancer operated by BCS. Patients received WBI 40.0 Gy in 16 fractions of 2.5 Gy. A SIB with 0.5 Gy per fraction was administered to the tumor bed, thereby giving 48.0 Gy in 16 fractions to the boost-PTV sparing heart, LAD, lung, contralateral breast. The primary study objective was feasibility, administration of specified dose in 16 fractions within 22-29 days with adherence to certain dose constraints (heart; LAD; contralateral breast); secondary endpoints were toxicity, QoL. RESULTS: 151 patients were recruited from 7 institutions between 07/11-10/12. 10 patients met exclusion criteria prior to irradiation. All but two patients (99%) received the prescribed dose in the PTVs. Adherence to dose constraints and time limits was achieved in 89% (95% CI 82% to 93%). 11 AE were reported in 10 patients; five related to concurrent endocrine therapy. Two of the AEs were related to radiotherapy: grade 3 hot flushes in two cases. QoL remained unchanged. CONCLUSION: Hypofractionation with a SIB is feasible and was well tolerated in this study.

The bacterial adhesion on and the cytotoxicity of various dental cements used for implant-supported fixed restorations.

OBJECTIVE: Bacterial adhesion on and cytotoxicity of eight luting agents used for implant-supported restorations were investigated. MATERIALS AND METHOD: Surface roughness (Ra), surface free energy (SFE) values and three-dimensional images by atomic-force microscopy of circular specimens were determined. Bacterial suspensions of Streptococcus sanguinis and Streptococcus epidermidis were incubated at 37°C for 2 h. Adhering bacteria were examined with fluorescence dye CytoX-Violet, stained with 4',6-diamidino-2-phenylindole (DAPI) and visualized by fluorescence-microscopy. Cytotoxicity-testing was done with WST-1-tests (water soluble tetrazolium). No significant differences, neither with regard to Ra nor regarding SFE were determined. RESULTS: Adherence of S. sanguinis was less on titanium, TempBondNE and TempBond. TempBond, TempBondNE, RelyX Unicem and Implantlink Semi Classic presented low amounts of S. epidermidis. WST-testing showed high cytotoxic potential of Harvard, Aqualox, TempBondNE and TempBond. No combination of low adherent bacteria with low cytotoxicity was found. CONCLUSION: From a biological in-vitro perspective, none of the cements may be recommended for implant-supported restorations.

[The significance of radiation therapy for symptomatic vertebral hemangiomas (SVH)]. / Der Stellenwert der Strahlentherapie bei symptomatischen Wirbelkörperhämangiomen (sWKH).

PURPOSE: To evaluate the efficacy of radiation therapy (RT) for symptomatic vertebral hemangioma (SVH). MATERIAL AND METHODS: Based on the Registry for Rare Benign Disorders (RRBD) of the German Cooperative Group on Radiation Therapy for Benign Diseases (GCG-BD), the clinical information, treatment plans and outcome data from seven cooperating German RT institutions were analyzed retrospectively. RESULTS: Over a period of 39 years (1969-2008), a total of 84 patients with 96 symptomatic lesions underwent RT. The predominant indication was pain in 97.6%, and, in addition, 28.6% of patients had neurological deficits. The median total dose was 34 Gy (4.5-45 Gy), and the median single dose 2.0 Gy (0.5-3.0 Gy). After a median follow-up of 68 months (6-422 months), complete symptom relief (CR) occurred in 61.9% of patients, 28.6% had partial relief, and 9.5% had no relief (NR). The overall response rate (CR + PR) was 90.5%. In 26.2% of patients, radiologic signs of remineralization were noted. After a median follow-up of 70 months (8-124 months), symptom progression occurred in eight patients (9.5%). Therefore, the long-term rate of local control was 80.9%. Multivariate statistical analysis revealed a significantly higher rate of symptom relief and local control for total doses > or = 34 Gy. Side effects > RTOG/EORTC grade 2 were not observed. CONCLUSION: RT is a safe and effective for treatment of SVH. Total doses of at least 34 Gy are recommended to achieve optimal treatment response.

A new modification of combining vacuum therapy and brachytherapy in large subfascial soft -tissue sarcomas of the extremities.

PURPOSE: To present a modification of a technique combining the advantages of brachytherapy for local radiation treatment and vacuum therapy for wound conditioning after resection of subfascial soft-tissue sarcomas (STS) of the extremities. PATIENTS AND METHODS: Between January and May 2008, four patients with large (> 10 cm) subfascial STS of the thigh underwent marginal tumor excision followed by early postoperative HDR (high-dose-rate) brachytherapy (iridium-192) and vacuum therapy as part of their interdisciplinary treatment. The sponge of the vacuum system was used to stabilize brachytherapy applicators in parallel positions and to allow for a maximal wound contraction in the early postoperative phase, thus preventing seroma and deterioration of local dose distribution as optimized in computed tomography-(CT-)based three-dimensional conformal treatment planning. In three patients this was followed by external-beam radiotherapy. Acute wound complications and late effects according to LENT-SOMA after 4-8 months of follow-up were recorded. RESULTS: The combination of vacuum and brachytherapy was applicable in all patients. CT scans from the 1st postoperative day showed the shrinkage of the sponge located in the tumor bed with the brachytherapy applicators in the intended position and easily visible. 15-18 Gy in fractions of 3 Gy bid prescribed to 5 mm tissue depth were applied over the next days with removal of the sponge and applicators on days 5-8. No early or late toxicity exceeding grade 2 was observed. The mean Enneking Score for functional outcome was 63% (perfect function = 100%). CONCLUSION: The combination of vacuum and brachytherapy is applicable and safe in the treatment of large subfascial STS.

Accuracy in orthognathic surgery─comparison of preoperative plan and postoperative outcome using computer-assisted two-dimensional cephalometry by the Onyx Ceph® system.

PURPOSE: This retrospective study analyzes deviations between preoperative planning and postoperative outcome in orthognathic surgery using 2D Onyx Ceph®-cephalometric analyzing and planning system. MATERIALS AND METHODS: A total of 100 patients with a mean age 25.1 of years were included in this study. In 33 patients a bilateral sagittal split osteotomy and in seven patients a Le Fort I osteotomy was performed. A total of 60 patients were treated by a bimaxillary approach. Onyx Ceph® was used as cephalometric planning software (Onyx Ceph®), followed by mock operations. Postoperative cephalograms were obtained after 3.3 days and compared to preoperative planning cephalograms for sagittal (SNA, SNB, ANB) and vertical (ArGoMe, ML-NSL, NL-NSL) angle measurements. Real and absolute mean deviation were documented. RESULTS: Absolute mean deviation (degrees) between postoperative and planned jaw movement was lower for the sagittal parameters SNA (0.58), SNB (1.15) and ANB (1.05) compared to the vertical parameters NL-NSL (1.47), ML-NSL (1.96) and ArGoMe (3.20). SNA, SNB and ANB showed constant deviations independent from the extent of jaw movement. With regard to the vertical parameters ML-NSL, ArGoMe and NL-NSL the extent of the postoperative rotational jaw movement was not as much as planned, particularly for vertical shifts of more than 4°. CONCLUSION: By using the 2D Onyx Ceph® cephalometric software for orthognathic surgery, the deviations between planned and actual movements are within an acceptable and predictable range. Planning of extensive vertical alterations may result in greater deviations after surgery.

[Hearing screening at nursery schools: results of an evaluation study]. / Hörscreening an Kindergärten: Ergebnisse einer Evaluierungsstudie.

OBJECTIVE: This study aimed to evaluate the hearing screening of pre-school children at nursery schools in Tyrol, Austria. METHODS AND SAMPLE: 47 nursery schools with a total of 2199 enrolled children participated in the study. At the screening, the children were presented a series of tones at frequencies 0.5 kHz (25dB), 1 kHz, 2 kHz, 3 kHz, and 4 kHz (20 dB each) from portable audiometers. The tones were presented over headphones for each ear separately and at irregular intervals. Failure to respond to any of the frequencies was considered failure of the screening. Parents were then advised in written form to have the child examined by an ENT-specialist. RESULTS: 1832 individuals were screened (coverage: 83% of nursery school children; corresponding to at least 63% of all Tyrolean children aged 3 to 5 years). Of these, 390 failed the test (referral rate: 21% of all screened). Examination through an ENT-specialist occurred with 217 children, and this confirmed the positive test in 139 children (hit rate: 64%). In most cases, a temporary conductive hearing loss due to external or middle ear problems (glue ear, tube dysfunction, cerumen, otitis media) was diagnosed. A sensorineural hearing loss was found in 4 children (in 3 of them bilateral). The need for therapy was recognized in 81 children (4% of all screened). CONCLUSION: Pre-school hearing screening identifies children with ear and hearing problems that need therapeutical intervention. Although the hearing problems are mostly of a temporary nature, some may require monitoring over some period. Also some children with permanent sensorineural hearing loss may be detected through this measure. Hearing screening is an efficient means of assessing ear and hearing problems in pre-school children. However, the follow-up rate needs to be improved for optimizing the efficacy.

The impact of luting agents and stiffness of implant-abutments on marginal adaptation, chipping, and fracture resistance of zirconia crowns.

OBJECTIVES: This in vitro study evaluated the impact of cements and implant analogs with different e-moduli on marginal adaptation, chipping, and the fracture resistance of zirconia crowns. METHODS: 80 crowns (Cercon, DeguDent) were manufactured for 40 polyoxymethylene (POM) and 40 titanium (Ti) one-piece implant analogs and divided into 10 groups: A, zinc oxide phosphate (Hoffmann׳s Cement, Richter&Hoffmann, Berlin, D); B, zinc oxide eugenol (Temp Bond, KerrHawe, Bioggio, CH); C, resin (Variolink II, Ivoclar-Vivadent, Schaan, FL); D, zinc oxide without eugenol (Temp Bond NE, KerrHawe, Bioggio, CH); E, glass ionomer (Ketac Cem, 3M ESPE, Seefeld, D). All samples were thermally mechanically loaded (1.2 × 10(6)× 50 N; 3000 × 5°C/55°C). Marginal adaptation was semiquantitatively evaluated before and after ageing with a scanning electron microscope. After ageing, intact samples underwent a fracture resistance test. RESULTS: The best sealed margins before ageing were achieved with resin and zinc oxide cement and with resin after ageing. Zinc oxide samples showed the most discontinuously sealed margins after ageing and the difference between POM and Ti samples was significant only for zinc oxide. The numbers of samples failing during TCML were as follows: A(Ti - POM)=0-1; B(Ti - POM)=0-5; C(Ti - POM)=1/1; D(Ti - POM)=2-2; E (Ti - POM)=0-2. Fracture resistance test [N]: A(Ti - POM)=1181-801; B(Ti - POM)=1469-1517; C(Ti - POM)=1704-1408; D(Ti - POM)=1992-883; E (Ti - POM)=2750-1015. CONCLUSIONS: TCML reduced the number of perfectly sealed samples and increased the number of chipped samples cemented onto POM implants with zinc oxide. This study could not show any significant impact on the fracture resistance of zirconia when different cements and implant analogs were used.

Radiotherapy for symptomatic vertebral hemangiomas: results of a multicenter study and literature review.

PURPOSE: The current study analyzes the potential role of radiotherapy (RT) in symptomatic vertebral hemangioma (SVH). METHODS AND MATERIALS: Seven cooperating German institutions collected clinical information, treatment plans, and outcome data for all patients with SVH referred for local RT. RESULTS: From 1969 to 2008, a total of 84 patients with 96 symptomatic lesions were irradiated for SVH. The primary indication for radiotherapy was pain (97.6%), and 28.6% of patients had additional neurological symptoms. RT was performed at a median total dose of 34 Gy, with a median single dose of 2.0 Gy. After receiving a median follow-up of 68 months, the overall patient response rate was 90.5%. Complete symptom remission occurred in 61.9% of patients, 28.6% of patients had partial pain relief, and 9.5% of patients had no pain relief. In 26.2% of patients, radiological signs of reossification were observed in long-term follow-up but not significantly correlated with pain relief. Most importantly, total doses of >/=34 Gy resulted in significantly greater symptomatic relief and control rate than total doses of <34 Gy. CONCLUSIONS: This study consists of the largest database of cases reported so far using RT for SVH. RT is easy, safe, and effective for pain relief treatment for SVH. Total doses of at least 34 Gy give the best symptomatic response.

Differentiation between recurrent tumor and radiation necrosis in a child with anaplastic ependymoma after chemotherapy and radiation therapy.

BACKGROUND: In patients after treatment for malignant brain tumors, a clear distinction between tumor recurrence and radiation necrosis can be challenging. This case report describes the diagnostic workup in a child with anaplastic ependymoma and inconclusive MRI (magnetic resonance imaging) and PET (positron emission tomography) findings. CASE REPORT: 1.5 years after resection, hyperfractionated radiotherapy and chemotherapy of an anaplastic ependymoma in the right parietal region, the cranial MRI of an 11-year-old girl showed multiple small contrast-enhanced lesions in the frontal cortex. In the following months, these lesions increased in number and size and neurologic symptoms developed. Diagnostic workup included repeated MRI scans, PET with an (18)F-amino acid and (18)F-fluorodeoxyglucose (FDG), as well as a brain biopsy. RESULTS: Amino acid PET, performed when the lesions were still small, showed multiple small areas of mild uptake in close correlation to the MRI lesions. Although not typical, this result was suspicious of tumor seeding, the more since the lesions appeared in gray matter areas outside the high-dose-rate irradiation field. A biopsy, performed 6 months later when the clinical appearance worsened, showed no tumor tissue. FDG PET, performed after the size and number of the lesions had increased, showed no intensely increased glucose metabolism, a high-grade recurrent tumor was therefore very unlikely. In the following months, the clinical picture stabilized. CONCLUSION: The final interpretation of the lesions was multiple focal radiation necrosis based on perfusion abnormalities after chemotherapy and conformal hyperfractionated radiotherapy, probably due to an individually enhanced vulnerability of the cerebral vessels.

Evaluation of dose-volume histograms after prostate seed implantation. 4-year experience.

BACKGROUND AND PURPOSE: Permanent interstitial brachytherapy by seed implantation is a treatment alternative for low-volume low-risk prostate cancer and a complex interdisciplinary treatment with a learning curve. Dose-volume histograms are used to assess postimplant quality. The authors evaluated their learning curve based on dose-volume histograms and analyzed factors influencing implantation quality. PATIENTS AND METHODS: Since 1999, 38 patients with a minimum follow-up of 6 months were treated at the authors' institution with seed implantation using palladium-103 or iodine-125, initially using the preplan method and later real-time planning. Postimplant CT was performed after 4 weeks. The dose-volume indices D90, V100, V150, the Dmax of pre- and postplans, and the size and position of the volume receiving the prescribed dose (high-dose volume) of the postplans were evaluated. In six patients, postplan imaging both by CT and MRI was used and prostate volumes were compared with preimplant transrectal ultrasound volumes. The first five patients were treated under external supervision. RESULTS: Patients were divided into three consecutive groups for analysis of the learning curve (group 1: n = 5 patients treated under external supervision; group 2: n = 13 patients; group 3: n = 20 patients). D90post for the three groups were 79.3%, 74.2%, and 99.9%, the V100post were 78.6%, 73.5%, and 88.2%, respectively. The relationship between high-dose volume and prostate volume showed a similar increase as the D90, while the relationship between high-dose volume lying outside the prostate and prostate volume remained constant. The ratio between prostate volumes from transrectal ultrasound and CT imaging decreased with increasing D90post, while the preplanning D90 and V100 remained constant. The different isotopes used, the method of planning, and the implanted activity per prostate volume did not influence results. CONCLUSION: A learning curve characterized by an increase in the D90post can be observed and results in a stable technique after 18 patients. An important factor influencing the learning curve in addition to the precision of seed positioning is organ volume definition on postimplant imaging.