Expanded HILUS Trial: A Pooled Analysis of Risk Factors for Toxicity From Stereotactic Body Radiation Therapy of Central and Ultracentral Lung Tumors
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Expanded HILUS Trial : A Pooled Analysis of Risk Factors for Toxicity From Stereotactic Body Radiation Therapy of Central and Ultracentral Lung Tumors. / Lindberg, Sara; Grozman, Vitali; Karlsson, Kristin; Onjukka, Eva; Lindbäck, Elias; Jirf, Karam Al; Lax, Ingmar; Wersäll, Peter; Persson, Gitte Fredberg; Josipovic, Mirjana; Khalil, Azza Ahmed; Møller, Ditte Sloth; Hoffmann, Lone; Knap, Marianne Marquard; Nyman, Jan; Drugge, Ninni; Bergström, Per; Olofsson, Jörgen; Rogg, Lotte Victoria; Hagen, Rebecca Knoph; Frøland, Anne Sofie; Ramberg, Christina; Kristiansen, Charlotte; Jeppesen, Stefan Starup; Nielsen, Tine Bjørn; Lödén, Britta; Rosenbrand, Hans Olov; Engelholm, Silke; Haraldsson, André; Billiet, Charlotte; Lewensohn, Rolf; Lindberg, Karin.
In: International Journal of Radiation Oncology Biology Physics, Vol. 117, No. 5, 2023, p. 1222-1231.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Expanded HILUS Trial
T2 - A Pooled Analysis of Risk Factors for Toxicity From Stereotactic Body Radiation Therapy of Central and Ultracentral Lung Tumors
AU - Lindberg, Sara
AU - Grozman, Vitali
AU - Karlsson, Kristin
AU - Onjukka, Eva
AU - Lindbäck, Elias
AU - Jirf, Karam Al
AU - Lax, Ingmar
AU - Wersäll, Peter
AU - Persson, Gitte Fredberg
AU - Josipovic, Mirjana
AU - Khalil, Azza Ahmed
AU - Møller, Ditte Sloth
AU - Hoffmann, Lone
AU - Knap, Marianne Marquard
AU - Nyman, Jan
AU - Drugge, Ninni
AU - Bergström, Per
AU - Olofsson, Jörgen
AU - Rogg, Lotte Victoria
AU - Hagen, Rebecca Knoph
AU - Frøland, Anne Sofie
AU - Ramberg, Christina
AU - Kristiansen, Charlotte
AU - Jeppesen, Stefan Starup
AU - Nielsen, Tine Bjørn
AU - Lödén, Britta
AU - Rosenbrand, Hans Olov
AU - Engelholm, Silke
AU - Haraldsson, André
AU - Billiet, Charlotte
AU - Lewensohn, Rolf
AU - Lindberg, Karin
N1 - Publisher Copyright: © 2023 Elsevier Inc.
PY - 2023
Y1 - 2023
N2 - Purpose: Stereotactic body radiation therapy for tumors near the central airways implies high-grade toxic effects, as concluded from the HILUS trial. However, the small sample size and relatively few events limited the statistical power of the study. We therefore pooled data from the prospective HILUS trial with retrospective data from patients in the Nordic countries treated outside the prospective study to evaluate toxicity and risk factors for high-grade toxic effects. Methods and Materials: All patients were treated with 56 Gy in 8 fractions. Tumors within 2 cm of the trachea, the mainstem bronchi, the intermediate bronchus, or the lobar bronchi were included. The primary endpoint was toxicity, and the secondary endpoints were local control and overall survival. Clinical and dosimetric risk factors were analyzed for treatment-related fatal toxicity in univariable and multivariable Cox regression analyses. Results: Of 230 patients evaluated, grade 5 toxicity developed in 30 patients (13%), of whom 20 patients had fatal bronchopulmonary bleeding. The multivariable analysis revealed tumor compression of the tracheobronchial tree and maximum dose to the mainstem or intermediate bronchus as significant risk factors for grade 5 bleeding and grade 5 toxicity. The 3-year local control and overall survival rates were 84% (95% CI, 80%-90%) and 40% (95% CI, 34%-47%), respectively. Conclusions: Tumor compression of the tracheobronchial tree and high maximum dose to the mainstem or intermediate bronchus increase the risk of fatal toxicity after stereotactic body radiation therapy in 8 fractions for central lung tumors. Similar dose constraints should be applied to the intermediate bronchus as to the mainstem bronchi.
AB - Purpose: Stereotactic body radiation therapy for tumors near the central airways implies high-grade toxic effects, as concluded from the HILUS trial. However, the small sample size and relatively few events limited the statistical power of the study. We therefore pooled data from the prospective HILUS trial with retrospective data from patients in the Nordic countries treated outside the prospective study to evaluate toxicity and risk factors for high-grade toxic effects. Methods and Materials: All patients were treated with 56 Gy in 8 fractions. Tumors within 2 cm of the trachea, the mainstem bronchi, the intermediate bronchus, or the lobar bronchi were included. The primary endpoint was toxicity, and the secondary endpoints were local control and overall survival. Clinical and dosimetric risk factors were analyzed for treatment-related fatal toxicity in univariable and multivariable Cox regression analyses. Results: Of 230 patients evaluated, grade 5 toxicity developed in 30 patients (13%), of whom 20 patients had fatal bronchopulmonary bleeding. The multivariable analysis revealed tumor compression of the tracheobronchial tree and maximum dose to the mainstem or intermediate bronchus as significant risk factors for grade 5 bleeding and grade 5 toxicity. The 3-year local control and overall survival rates were 84% (95% CI, 80%-90%) and 40% (95% CI, 34%-47%), respectively. Conclusions: Tumor compression of the tracheobronchial tree and high maximum dose to the mainstem or intermediate bronchus increase the risk of fatal toxicity after stereotactic body radiation therapy in 8 fractions for central lung tumors. Similar dose constraints should be applied to the intermediate bronchus as to the mainstem bronchi.
U2 - 10.1016/j.ijrobp.2023.06.246
DO - 10.1016/j.ijrobp.2023.06.246
M3 - Journal article
C2 - 37423292
AN - SCOPUS:85166571260
VL - 117
SP - 1222
EP - 1231
JO - International Journal of Radiation Oncology, Biology, Physics
JF - International Journal of Radiation Oncology, Biology, Physics
SN - 0360-3016
IS - 5
ER -
ID: 363407709