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J. Belderbos



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    MO23 - Radiotherapy II: Lung Toxicity, Target Definition and Quality Assurance (ID 107)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      MO23.03 - Dutch Radiotherapy Lung Audit: Results of a National Pilot (ID 2128)

      10:30 - 12:00  |  Author(s): J. Belderbos

      • Abstract
      • Presentation
      • Slides

      Background
      The Dutch Society for Radiotherapy and Oncology (NVRO) aims to ensure transparency regarding clinical outcome, quality and safety of lung cancer treatments in radiotherapy departments throughout The Netherlands. Auditing is considered the best instrument to achieve this. The quality of the radiotherapy will become transparent by using objective and reliable data from accurate registration of clinical outcome linked to patient and treatment characteristics The results of the audit are communicated to the health professionals that supplied the data. This outcome registration will provide the local health professionals with a robust instrument to compare and improve their lung cancer treatments. The decision was made to seek collaboration with the thoracic surgeons as their group were already committed to the DICA (Dutch Institute for Clinical Auditing) .

      Methods
      The Quality Assurance Committee of the NVRO, in collaboration with a platform of Dutch radiation oncologists dedicated to lung cancer treatment, received a grant to set-up a quality assurance program for lung cancer treatment. Quality indicators to be collected were defined within the platform of Dutch radiation oncologists and a database was setup in October 2012. All patients receiving primary thoracic radiation treatment with curative intent for (primary or recurrent) stage I-IIIB lung cancer will be included in the registry. Information will be collected on patient, tumor and treatment characteristics, the incidence and severity of acute toxicity, mortality within three months of radical radiotherapy and the time interval between diagnostic work-up and start of radiotherapy The adherence to the NVRO and Dutch guidelines will be registered and analyzed, as well as the use of new treatment techniques like stereotactic radiotherapy and image-guided radiotherapy. A pilot phase was initiated to test the feasibility of enrolling patients from six participating centers.

      Results
      The pilot-database was tested in 6 Dutch centers: NKI-AVL (Amsterdam), MAASTRO clinic (Maastricht), RIF (Leeuwarden), RISO (Deventer), UMC Radboud (Nijmegen) and ARTI (Arnhem). A total of 196 patients were entered from January to June 2013. Analysis of the patients entered is ongoing. We expect to have a national roll-out in October 2013. The patient records were very complete with a few exceptions: lung function tests, the Mean Lung Dose / Lung V20, gross tumor volume (23% missing) and the non-mandatory follow-up items. The mean age was 68 years (range 41-90) with 57% males. Charlson comorbidity index ≥ 2 was scored in 39% of patients. Most patients (66%) were cN+ with 14% T4 tumours. Most patients received IMRT or VMAT irradiation. Ninety-five percent of patients completed treatment. All registered patients had position verification during irradiation, mostly 3D (70%). Acute 3-month toxicity (grade≥ III) was registered in 18% of patients and 3-month mortality was 4.4%.

      Conclusion
      This national audit on outcome after radiotherapy is directed towards an improvement of care for lung cancer patients and will help to direct evidence into clinical practice. It is expected to have an important impact on quality assurance ,safety and possibly patient mortality.

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    P3.08 - Poster Session 3 - Radiotherapy (ID 199)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      P3.08-014 - Very high radiation dose escalation in NSCLC does not lead to unexpected toxicity: A planned toxicity analysis of the PET-boost study (NCT01024829) (ID 1925)

      09:30 - 16:30  |  Author(s): J. Belderbos

      • Abstract

      Background
      Locoregional failure rates are high in patients with locally advanced non-small cell lung cancer (NSCLC), even when using concurrent chemoradiation. Recurrences have been shown to be predominantly located in the primary tumor, more specifically in areas with a high FDG-uptake that can be identified on a pre-treatment FDG PET-CT scan. Improved tumor control could be accomplished by dose escalation. The PET-boost trial is an ongoing randomized phase II trial investigating radiation dose-escalation using an individualized, accelerated schedule either to the entire primary tumor or to the regions of high FGD-uptake (>50% SUVmax) within the primary tumor. We present a preliminary analysis of the acute toxicity of the first 45 patients.

      Methods
      Patients with NSCLC stage IB-III with a primary tumor diameter ≥4 cm are eligible. Patients are treated with concurrent or sequential chemoradiation or radiotherapy only. Permitted regimens are: daily dose cisplatin (only in concurrent chemoradiation) or cisplatin-etoposide in concurrent and sequential chemoradiation. Eligible patients receive a planning PET-CT scan on which an IMRT plan is constructed up to a dose of 66 Gy in 24 fractions of 2.75 Gy to the involved lymph nodes and the primary tumor. In patients where normal tissue constraints allow further dose escalation to the primary tumor up to a minimal dose of 72 Gy of ≥ 3 Gy-fractions, 2 plans (with equal mean lung dose) are constructed: either giving the integrated boost to the entire primary tumor (Arm A) or redistributing the boost to areas of high FGD-uptake (>50% SUVmax) in the tumor (Arm B), up to a maximal prescribed dose of 129.6 Gy in 24 fractions of 5.4 Gy. All pts are followed according to study protocol. Toxicity is scored according to the CTCv3.0 criteria. Primary endpoint of this study is local progression-free survival at 1 year. Secondary endpoints are acute and late toxicity, overall survival and quality of life.

      Results
      Between 2010 and 2013 71 patients were registered of which 45 were randomized: 22 pts to arm A and 23 to arm B. In both arms, median follow up was 13.3 months. Patient and tumor characteristics were equally distributed in both arms. Thirty-seven patients (82.2%) had stage III lung cancer. Concurrent chemoradiotherapy was given in 25 patients (55.6%). Mean GTV was 154.2 cm ³ (range 26-416 cm³). Mean fraction size in both arms was 3.46 Gy (range 3.0-5.4 Gy). Baseline toxicity grade 3 occurred in 4 patients (8.8%) consisting of dyspnea in 1 patient, cough in 2 patients and renal dysfunction in 1 patient. During treatment grade ≥3 hematologic toxicity was seen in 6 patients (13.3%), whereas 2 patients (4.4%) suffered from cardiac toxicity grade 4 (ischemia/infarction). Seven patients (15.6%) had grade ≥3 dysphagia. 82.2% of the patients finished treatment according to study protocol. Radiation treatment was completed in all patients. Seven patients have died of which 3 (6.6%) due to pulmonary hemorrhage.

      Conclusion
      This first toxicity analysis of the multicenter phase II randomized PET-boost trial at a median follow up of 13.3 months did not reveal any unexpected acute or late toxicity.