Patient Reported Outcomes/QoL/Survivorship

SS 09 - Patient Reported Outcomes/Quality of Life/Survivorship

69 - Good Long-term Quality of Life (QoL) Preservation after Pulmonary Stereotactic Fractionated Radiation Therapy (SBRT) in Frail Patients: Prospective Phase II Stripe Trial

Monday, October 22
8:25 AM - 8:35 AM
Location: Room 008

Good Long-term Quality of Life (QoL) Preservation after Pulmonary Stereotactic Fractionated Radiation Therapy (SBRT) in Frail Patients: Prospective Phase II Stripe Trial
S. Adebahr1,2, U. Nestle1,3, K. Kaier4, E. Gkika1, T. Schimek-Jasch1, F. Momm5, G. Becker6, and A. Grosu7; 1Department of Radiation Oncology, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany, 2German Cancer Consortium (DKTK) Partner Site Freiburg, Freiburg, Germany, 3Kliniken Maria Hilf, Department of Radiation Oncology, Moenchengladbach, Germany, 4Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany, 5Department of Radio-oncology, Ortenau Klinikum Offenburg-Gengenbach, Ofenburg, Germany, 6Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany, 7German Cancer Consortium (DKTK), Partner site Freiburg, Heidelberg, Germany

Purpose/Objective(s): Patients treated with stereotactic fractionated radiation therapy (SBRT) for pulmonary malignancies often reveal high comorbidities. For such patients preserving quality of life (QoL) plays an important role in considering SBRT. The prospective monocenter phase II STRIPE trial investigated QoL up to 2 years after SBRT as secondary endpoint in elderly or frail patients to proof that SBRT has little negative impact on QoL even for patients with initial low QoL scores.

Materials/Methods: Patients with < =2 pulmonary lesions ≤5cm were treated with 4DPET/CT-based SBRT (3X12.5 Gy or risk-adapted 5X7Gy, on 60% isodose). Follow up (FU) was performed 2 and 7 weeks after SBRT, then every 3 months for 2 years with QoL-assessment by EORTC QLQ C30 (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) and the lung specific module QLQ LC 13, toxicity assessment according to CTCAE v4 (Common Terminology Criteria for Adverse Events) and response assessment by CT (according to RECIST v1.1), respectively PET in case of progression. EORTC QLQ-C30 scores were linearly transformed into scales from 0-100 according to EORTC manual. A difference of >10 points was considered clinically relevant. Impact of predefined patient and treatment related factors on the change of predefined QoL scales (QoL/ Global Health Status (GHS), Emotional Function, Physical Function, fatigue and dyspnea) was evaluated. Primary endpoint of the trial was local control (LC) after 2 years, further secondary endpoints were local progression free (LPFS) and overall survival (OS), toxicitiy and marginal recurrence (MR).

Results: 100 patients (63% male, 27% female, mean Charlson Comorbidity Score 6.3) have been treated with SBRT from 02/2011 to 11/2014 for 56 NSCLC and 44 pulmonary metastases. Probability for LC, MR, LPFS and OS 2 years after SBRT was 91.9%, 3.7%, 53.3% and 62.2%. Lower risk for local failure was revealed for 3X12.5Gy (p=0.043) and for Dmin(BED10) in the PTV>100Gy (p=0.023). >=G3-Toxicity was < 4%, except dyspnea: with 6% baseline-Dyspnea >=G3 there was a maximum increase of 8.5% 2 years after SBRT. In concordance there was a clinically relevant increase in dyspnea in QoL assessment (Δ10.2). Long-term FU revealed stable QoL/ GHS, functions-scores and symptoms. Patients with low initial QoL/GHS-Score below the median of 50 revealed significantly stronger improvement regarding patient-reported QoL, dyspnea (both p< 0.001) and fatigue (p< 0.01) than patients with initially good QoL-scores. Conclusion:These prospective data on a representative cohort of frail pulmonary SBRT patients confirm preservation of QoL after treatment and even demonstrate a longterm QoL benefit for patients with low initial Qol scores. This may encourage the use of SBRT in this patient group.

Author Disclosure: S. Adebahr: Lung Cancer; EORTC/ROG. U. Nestle: None. K. Kaier: None. T. Schimek-Jasch: None. F. Momm: None.

Anca Grosu, MD

Disclosure:
No relationships to disclose.

Biography:
Anca-Ligia Grosu, MD
Professor and Chair, Department of Radiation Oncology
Speaker of the Center for Diagnostic and Therapeutic Radiology
Medical Center – University of Freiburg, Germany

Research Focus
• Biological imaging for radiation therapy planning and monitoring: Biomarkers – BioImaging – biological radiotherapy planning (Bio-RTx)
• High precision radiation therapy: Radiosurgery, stereotactic radiotherapy, dose painting, intraoperative radiotherapy, brachytherapy
• Radiotherapy and immunotherapy: Combination of radiotherapy and immunotherapy, radiotherapy and immune system, visualizing immunological processes in PET
• Digital data management in radiation oncology: Electronic patient file, data management, administration
Academic Activity
• Chair of the Department of Radiation Oncology, Medical Center – University of Freiburg
• Speaker of the Center for Diagnostic and Therapeutic Radiology, Medical Center – University of Freiburg (Departments of Radiology, Radiation Oncology, Nuclear Medicine, Neuroradiology)
• Member of the Senate of the Albert-Ludwigs-University Freiburg
• Personal tutor of scholars, appointed by German Academic Scholarship Foundation – Studienstiftung des deutschen Volkes
• Deputy Speaker of the German Cancer Consortium for Translational Cancer Research, partner site Freiburg (DKTK), Medical Center – University of Freiburg
• Member of the Executive Board and Speaker (2012-2016) of the Neuro-Oncological Center, Comprehensive Cancer Center, Medical Center – University of Freiburg (CCCF)
• Adjunct Professor, Department of Radiation Oncology, Ohio State University, Columbus OH, USA
Career
• Chair of the Department of Radiation Oncology, Medical Center – University of Freiburg (since 2007)
• Researcher at Harvard Medical School, Massachusetts General Hospital, Department of Radiation Oncology, Proton Therapy Center (Chair: Prof. T. F. DeLaney), Boston, USA (2006-2007)
• Assistant Medical Director, Department of Radiation Oncology (Chair: Prof. Dr. med. M. Molls), Rechts der Isar Hospital, Technical University, Munich (2000-2006)
• Habilitation (Postdoctoral lecture qualification): “Innovative techniques for high precision radiotherapy in brain tumors” (2003)


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69 - Good Long-term Quality of Life (QoL) Preservation after Pulmonary Stereotactic Fractionated Radiation Therapy (SBRT) in Frail Patients: Prospective Phase II Stripe Trial



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