A European Organisation for Research and Treatment of Cancer phase III trial of adjuvant whole-brain radiotherapy versus observation in patients with one to three brain metastases from solid tumors after surgical resection or radiosurgery: quality-of-life results
- PMID: 23213105
- DOI: 10.1200/JCO.2011.41.0639
A European Organisation for Research and Treatment of Cancer phase III trial of adjuvant whole-brain radiotherapy versus observation in patients with one to three brain metastases from solid tumors after surgical resection or radiosurgery: quality-of-life results
Abstract
Purpose: This phase III trial compared adjuvant whole-brain radiotherapy (WBRT) with observation after either surgery or radiosurgery of a limited number of brain metastases in patients with stable solid tumors. Here, we report the health-related quality-of-life (HRQOL) results.
Patients and methods: HRQOL was a secondary end point in the trial. HRQOL was assessed at baseline, at 8 weeks, and then every 3 months for 3 years with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and Brain Cancer Module. The following six primary HRQOL scales were considered: global health status; physical, cognitive, role, and emotional functioning; and fatigue. Statistical significance required P ≤ .05, and clinical relevance required a ≥ 10-point difference.
Results: Compliance was 88.3% at baseline and dropped to 45.0% at 1 year; thus, only the first year was analyzed. Overall, patients in the observation only arm reported better HRQOL scores than did patients who received WBRT. The differences were statistically significant and clinically relevant mostly during the early follow-up period (for global health status at 9 months, physical functioning at 8 weeks, cognitive functioning at 12 months, and fatigue at 8 weeks). Exploratory analysis of all other HRQOL scales suggested worse scores for the WBRT group, but none was clinically relevant.
Conclusion: This study shows that adjuvant WBRT after surgery or radiosurgery of a limited number of brain metastases from solid tumors may negatively impact some aspects of HRQOL, even if these effects are transitory. Consequently, observation with close monitoring with magnetic resonance imaging (as done in the EORTC trial) is not detrimental for HRQOL.
Trial registration: ClinicalTrials.gov NCT00002899.
Comment in
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On the merits and limitations of whole-brain radiation therapy.J Clin Oncol. 2013 Jan 1;31(1):11-3. doi: 10.1200/JCO.2012.46.0410. Epub 2012 Dec 3. J Clin Oncol. 2013. PMID: 23213090 No abstract available.
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[Quality of life after surgery or radiosurgery of brain metastases and adjuvant whole brain radiotherapy. Short- and long-term prognosis differentiate the treatment strategy in brain metastases].Strahlenther Onkol. 2013 May;189(5):433-5. doi: 10.1007/s00066-013-0334-1. Strahlenther Onkol. 2013. PMID: 23519362 German. No abstract available.
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Does quality of life supplant survival in patients with brain metastasis?J Clin Oncol. 2013 Jul 10;31(20):2635. doi: 10.1200/JCO.2013.48.9286. Epub 2013 Jun 3. J Clin Oncol. 2013. PMID: 23733762 No abstract available.
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Progression-free survival benefit or health-related quality-of-life advantage: which one to choose?J Clin Oncol. 2013 Jul 10;31(20):2635-6. doi: 10.1200/JCO.2013.49.3478. Epub 2013 Jun 3. J Clin Oncol. 2013. PMID: 23733775 No abstract available.
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Reply to M.C. Chamberlain and C. Gemici.J Clin Oncol. 2013 Jul 10;31(20):2636-7. doi: 10.1200/JCO.2013.49.4443. J Clin Oncol. 2013. PMID: 23991432 No abstract available.
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