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OA24 - Radiotherapy of Lung Cancer: Recent Developments (ID 411)
- Event: WCLC 2016
- Type: Oral Session
- Track: Radiotherapy
- Presentations: 1
OA24.05 - The Nordic HILUS-Trial - First Report of a Phase II Trial of SBRT of Centrally Located Lung Tumors (ID 6140)
14:20 - 15:50 | Author(s): M. Hoyer
Early attempts of stereotactic body radiation therapy (SBRT) of centrally located lung tumors resulted in high toxicity, questioning the utility of the method in this situation. Since then, different risk adapted fractionation schedules with acceptable toxic effects have been reported from various institutions. However, consensus on the tolerability of centrally located structures to high-fraction doses is still lacking and the clinical toxic effects in relation to dose to organs at risk (OAR) need to be evaluated.
We here report a first toxicity analysis of the HILUS-trial – a prospective Nordic multicenter non-randomized phase II trial of SBRT to centrally located lung tumors. Patients with a centrally located tumor (defined as ≤1cm from the proximal bronchial tree) from either a primary non-small cell lung cancer (NSCLC) or a progressive metastasis from another solid tumor were eligible for the trial. Maximum tumor diameter was 5 cm. Patients receiving concomitant systemic anticancer therapy or with tumors reaching through the wall of a main bronchus were not eligible. All the patients were treated with 7Gyx8 and stratified to either arm A (=tumors close to a main bronchus) or arm B (=tumors close to a lobar bronchus). The aim was to include 30 patients in each arm. Follow-up was conducted every 3[rd] month during the first 2 years and thereafter every 6[th] month. The trial was approved by ethical committees in each country.
Seventy-four patients (42 in arm A and 31 in arm B) were included between 2011 and 2016. Sixty-five patients experienced side effects from the study treatment; the most common being grade 1-2 dyspnea, grade 1-2 cough and grade 1-2 fatigue. Twenty-one patients (28%) experienced grade 3-5 side effects (atrioventricular block, bleeding, dyspnea, empyema, fatigue, fever, fistula, lung infection, pain, pneumonitis, pneumothorax and ventricular arrhythmia). Seven patients (6 in group A and 1 in group B) may have suffered grade 5 side effects; six patients experienced lethal hemoptysis after a median of 15.5 months (2.5-21months) and one patient suffered from a lethal pneumonitis 5 months post study treatment. Grade 4-5 side effects occurred more frequently in group A than in group B (19% vs 3%). Further analyses of risk factors for serious toxicity in relation to dose-volume parameters and patient- and tumor characteristics will be presented.
SBRT of centrally located tumors may be afflicted with high risk of serious toxicity and further evaluation of clinical and dose-volume dependent risk factors are highly warranted.
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