Quality of life after pulmonary stereotactic fractionated radiotherapy (SBRT): Results of the phase II STRIPE trial.


Journal

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
ISSN: 1879-0887
Titre abrégé: Radiother Oncol
Pays: Ireland
ID NLM: 8407192

Informations de publication

Date de publication:
07 2020
Historique:
received: 09 12 2019
revised: 21 02 2020
accepted: 16 03 2020
pubmed: 28 4 2020
medline: 15 4 2021
entrez: 28 4 2020
Statut: ppublish

Résumé

Preserving health related quality of life (HRQOL) plays an important role in considering stereotactic body fractionated radiotherapy (SBRT). The prospective monocenter phase II STRIPE trial investigated long-term HRQOL after SBRT, efficacy and toxicity. Patients with ≤2 pulmonary lesions ≤5 cm were treated with 4DPET/CT-based SBRT (3 × 12.5 Gy or risk-adapted 5 × 7 Gy, to 60% isodose). Follow up (FU) was performed 2 and 7 weeks after SBRT, then 3-monthly for 2 years with assessment of response (primary endpoint: 2-year cumulative incidence of local progression (LP); secondary endpoints: local progression free survival (LPFS), overall survival (OS) and toxicity (CTCAE)). Impact of predefined patient and treatment related factors on HRQOL (EORTC QLQ-C30 and EORTC QLQ-LC13) was evaluated. Between 02/2011 and 11/2014, 100 patients were given SBRT for 56 NSCLC and 44 pulmonary metastases (M1). Long-term FU overall revealed stable Quality of Life (QoL)/Global health status (GHS), functions-scores and symptoms. For QoL/GHS, patients with low (<median) initial QoL/GHS-Score revealed significantly stronger improvement than those with good QoL/GHS-scores (p < 0.001). Probability for LP, LPFS and OS 2 years after SBRT was 8.1% (NSCLC: 7.3%, M1:9.2%), 53.3% (NSCLC: 50.7%, M1: 56.0%) and 62.2% (NSCLC: 57.2%, M1: 68.4%). ≥G3-Toxicity was <4%, but ≥G3 dyspnea was 6% at baseline and 14.5% 2 years after SBRT. These prospective data on representative pulmonary SBRT patients confirm stable preservation of HRQOL after SBRT and demonstrate a QoL/GHS-benefit for patients with low initial QoL/GHS-scores, the regimen of 3 × 12.5 Gy SBRT being efficient and well tolerated. This result may inform shared decision making when discussing SBRT for frail patients.

Sections du résumé

BACKGROUND AND PURPOSE
Preserving health related quality of life (HRQOL) plays an important role in considering stereotactic body fractionated radiotherapy (SBRT). The prospective monocenter phase II STRIPE trial investigated long-term HRQOL after SBRT, efficacy and toxicity.
MATERIALS AND METHODS
Patients with ≤2 pulmonary lesions ≤5 cm were treated with 4DPET/CT-based SBRT (3 × 12.5 Gy or risk-adapted 5 × 7 Gy, to 60% isodose). Follow up (FU) was performed 2 and 7 weeks after SBRT, then 3-monthly for 2 years with assessment of response (primary endpoint: 2-year cumulative incidence of local progression (LP); secondary endpoints: local progression free survival (LPFS), overall survival (OS) and toxicity (CTCAE)). Impact of predefined patient and treatment related factors on HRQOL (EORTC QLQ-C30 and EORTC QLQ-LC13) was evaluated.
RESULTS
Between 02/2011 and 11/2014, 100 patients were given SBRT for 56 NSCLC and 44 pulmonary metastases (M1). Long-term FU overall revealed stable Quality of Life (QoL)/Global health status (GHS), functions-scores and symptoms. For QoL/GHS, patients with low (<median) initial QoL/GHS-Score revealed significantly stronger improvement than those with good QoL/GHS-scores (p < 0.001). Probability for LP, LPFS and OS 2 years after SBRT was 8.1% (NSCLC: 7.3%, M1:9.2%), 53.3% (NSCLC: 50.7%, M1: 56.0%) and 62.2% (NSCLC: 57.2%, M1: 68.4%). ≥G3-Toxicity was <4%, but ≥G3 dyspnea was 6% at baseline and 14.5% 2 years after SBRT.
CONCLUSIONS
These prospective data on representative pulmonary SBRT patients confirm stable preservation of HRQOL after SBRT and demonstrate a QoL/GHS-benefit for patients with low initial QoL/GHS-scores, the regimen of 3 × 12.5 Gy SBRT being efficient and well tolerated. This result may inform shared decision making when discussing SBRT for frail patients.

Identifiants

pubmed: 32339780
pii: S0167-8140(20)30149-3
doi: 10.1016/j.radonc.2020.03.018
pii:
doi:

Types de publication

Clinical Trial, Phase II Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

82-88

Informations de copyright

Copyright © 2020 Elsevier B.V. All rights reserved.

Auteurs

Ursula Nestle (U)

Department of Radiation Oncology, Medical Center, Faculty of Medicine, University of Freiburg, Germany; Department of Radiation Oncology, Kliniken Maria Hilf GmbH Mönchengladbach, Germany.

Sonja Adebahr (S)

Department of Radiation Oncology, Medical Center, Faculty of Medicine, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: sonja.adebahr@uniklinik-freiburg.de.

Klaus Kaier (K)

Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Germany.

Eleni Gkika (E)

Department of Radiation Oncology, Medical Center, Faculty of Medicine, University of Freiburg, Germany.

Tanja Schimek-Jasch (T)

Department of Radiation Oncology, Medical Center, Faculty of Medicine, University of Freiburg, Germany.

Marlene Hechtner (M)

Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center of the Johannes Gutenberg University Mainz, Germany; German Cancer Consortium (DKTK), Partner Site Mainz, Germany.

Felix Momm (F)

Department of Radio-oncology, Ortenau Klinikum Offenburg-Kehl, Germany.

Jan Gaertner (J)

Palliative Care Center Hildegard, Basel, Switzerland.

Gerhild Becker (G)

Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Germany.

Anca-Ligia Grosu (AL)

Department of Radiation Oncology, Medical Center, Faculty of Medicine, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany.

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