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

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. HRQOL was a secondary end poi...

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Vydáno v:	Journal of clinical oncology Ročník 31; číslo 1; s. 65
Hlavní autoři:	Soffietti, Riccardo, Kocher, Martin, Abacioglu, Ufuk M, Villa, Salvador, Fauchon, François, Baumert, Brigitta G, Fariselli, Laura, Tzuk-Shina, Tzahala, Kortmann, Rolf-Dieter, Carrie, Christian, Ben Hassel, Mohamed, Kouri, Mauri, Valeinis, Egils, van den Berge, Dirk, Mueller, Rolf-Peter, Tridello, Gloria, Collette, Laurence, Bottomley, Andrew
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 01.01.2013
Témata:	Brain Neoplasms - radiotherapy Brain Neoplasms - secondary Cranial Irradiation Europe Follow-Up Studies Health Status Humans International Agencies Neoplasm Staging Neoplasms - complications Neoplasms - pathology Neoplasms - surgery Patient Compliance Postoperative Complications Prognosis Quality of Life Radiosurgery - adverse effects Radiotherapy, Adjuvant Survival Rate Europe
ISSN:	1527-7755, 1527-7755
On-line přístup:	Zjistit podrobnosti o přístupu
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Abstract	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. 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. 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. 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.
AbstractList	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.PURPOSEThis 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.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.PATIENTS AND METHODSHRQOL 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.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.RESULTSCompliance 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.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.CONCLUSIONThis 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. 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. 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. 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. 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.
Author	Kocher, Martin Tzuk-Shina, Tzahala Mueller, Rolf-Peter Ben Hassel, Mohamed Abacioglu, Ufuk M Kortmann, Rolf-Dieter Tridello, Gloria Bottomley, Andrew Carrie, Christian Kouri, Mauri Villa, Salvador Fauchon, François Collette, Laurence Fariselli, Laura Soffietti, Riccardo Valeinis, Egils Baumert, Brigitta G van den Berge, Dirk
Author_xml	– sequence: 1 givenname: Riccardo surname: Soffietti fullname: Soffietti, Riccardo email: riccardo.soffietti@unito.it organization: University of Torino and San Giovanni Battista Hospital, Turin, Italy. riccardo.soffietti@unito.it – sequence: 2 givenname: Martin surname: Kocher fullname: Kocher, Martin – sequence: 3 givenname: Ufuk M surname: Abacioglu fullname: Abacioglu, Ufuk M – sequence: 4 givenname: Salvador surname: Villa fullname: Villa, Salvador – sequence: 5 givenname: François surname: Fauchon fullname: Fauchon, François – sequence: 6 givenname: Brigitta G surname: Baumert fullname: Baumert, Brigitta G – sequence: 7 givenname: Laura surname: Fariselli fullname: Fariselli, Laura – sequence: 8 givenname: Tzahala surname: Tzuk-Shina fullname: Tzuk-Shina, Tzahala – sequence: 9 givenname: Rolf-Dieter surname: Kortmann fullname: Kortmann, Rolf-Dieter – sequence: 10 givenname: Christian surname: Carrie fullname: Carrie, Christian – sequence: 11 givenname: Mohamed surname: Ben Hassel fullname: Ben Hassel, Mohamed – sequence: 12 givenname: Mauri surname: Kouri fullname: Kouri, Mauri – sequence: 13 givenname: Egils surname: Valeinis fullname: Valeinis, Egils – sequence: 14 givenname: Dirk surname: van den Berge fullname: van den Berge, Dirk – sequence: 15 givenname: Rolf-Peter surname: Mueller fullname: Mueller, Rolf-Peter – sequence: 16 givenname: Gloria surname: Tridello fullname: Tridello, Gloria – sequence: 17 givenname: Laurence surname: Collette fullname: Collette, Laurence – sequence: 18 givenname: Andrew surname: Bottomley fullname: Bottomley, Andrew
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/23213105$$D View this record in MEDLINE/PubMed
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SubjectTerms	Brain Neoplasms - radiotherapy Brain Neoplasms - secondary Cranial Irradiation Europe Follow-Up Studies Health Status Humans International Agencies Neoplasm Staging Neoplasms - complications Neoplasms - pathology Neoplasms - surgery Patient Compliance Postoperative Complications Prognosis Quality of Life Radiosurgery - adverse effects Radiotherapy, Adjuvant Survival Rate
Title	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
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