Riccardo Soffietti1, Martin Köcher1, Ufuk Abacıoğlu1, S. Villà1, F. Fauchon2,1, Brigitta G. Baumert1, Laura Fariselli1, Tzahala Tzuk-Shina3,1, Rolf‐Dieter Kortmann1, C. Carrié4,1, Mohamed Ben Hassel5,1, Mauri Kouri6,1, Egils Valeinis1, D. Van Den Berge1, R.P. Mueller1, Gloria Tridello1, Laurence Collette7,1, Judith Balmañà3,1
1Riccardo Soffietti, University of Torino and San Giovanni Battista Hospital, Turin; Laura Fariselli, Fondazione Istituto Neurologico “Carlo Besta,” Milan; Gloria Tridello, Azienda Ospedaliera Universitaria Verona, Verona, Italy; Martin Kocher and Rolf-Peter Mueller, University of Cologne, Cologne; Rolf-Dieter Kortmann, University Hospital, Leipzig, Germany; Ufuk M. Abacioglu, Marmara University Hospital, Istanbul, Turkey; Salvador Villa, Hospital Germans Trias i Pujol, ICO, Barcelona, Spain; François...
2Centre de Haute Energie
3Rambam Med Ctr, Technion Israel Institute of Technology
4Centre Leon Berard
5Centre Georges-Francois Leclerc
6Clinicum
7European Org Res & Treatment Canc EORTC Headquart
Tóm tắt
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.
