PMID- 29156916 OWN - NLM STAT- MEDLINE DCOM- 20180813 LR - 20181202 IS - 2224-5839 (Electronic) IS - 2224-5820 (Linking) VI - 6 IP - Suppl 2 DP - 2017 Dec TI - A critical evaluation of quality of life in clinical trials of breast cancer patients treated with radiation therapy. PG - S223-S232 LID - 10.21037/apm.2017.09.06 [doi] AB - The aim of this study was to investigate the extent to which health-related quality of life (HRQOL) parameters have been reported in phase III trials with breast cancer patients (BCPs) who received radiation therapy (RT). We also examine the frequency and correlates of significant HRQOL gains. A systematic review was conducted. When HRQOL was a study endpoint, we extracted data on the instruments used for HRQOL analysis, assessing if there was formal statistical comparison between study groups and the results of such comparisons as reported by the authors of the studies. In result, 182 trials were included. HRQOL was considered as endpoint in 38 (20.8%) of the studies and it was used as primary endpoint in 10.9% of them. Of 22 trials that had a positive primary endpoint, 18 had a significant benefit in HRQOL, in favor of the experimental arm. Of 13 trials that had a negative primary endpoint, there were no differences in HRQOL among the study groups. With respect to HRQOL assessment, statistical methods and definition of timing of evaluation were described in 32 (84.2%) and 36 (94.7%) trials, respectively. In conclusion, HRQOL has been infrequently investigated in trials in BCP who received RT. Statistical methods and timing of evaluation were infrequently described with sufficient detail to be informative. FAU - Marta, Gustavo N AU - Marta GN AD - Department of Radiation Oncology, Hospital Sirio-Libanes, Sao Paulo, Brazil; Department of Radiology and Oncology of University of Sao Paulo, Radiation Oncology Unit, Instituto do Cancer do Estado de Sao Paulo (ICESP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil. gustavo.marta@hc.fm.usp.br. FAU - Moraes, Fabio Y AU - Moraes FY AD - Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. FAU - Leite, Elton T T AU - Leite ETT AD - Department of Radiation Oncology, Hospital Sirio-Libanes, Sao Paulo, Brazil; Department of Radiology and Oncology of University of Sao Paulo, Radiation Oncology Unit, Instituto do Cancer do Estado de Sao Paulo (ICESP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil. FAU - Chow, Edward AU - Chow E AD - Sunnybrook Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada. FAU - Cella, David AU - Cella D AD - Department of Medical Social Sciences, Northwestern University, Illinois, USA. FAU - Bottomley, Andrew AU - Bottomley A AD - European Organisation for Research and Treatment of Cancer, Brussels, Belgium. LA - eng PT - Journal Article PT - Review PT - Systematic Review DEP - 20171024 PL - China TA - Ann Palliat Med JT - Annals of palliative medicine JID - 101585484 SB - IM MH - Breast Neoplasms/psychology/*radiotherapy MH - Clinical Trials, Phase III as Topic MH - Female MH - Humans MH - *Quality of Life MH - Randomized Controlled Trials as Topic MH - Treatment Outcome OTO - NOTNLM OT - Quality of life (QOL) OT - breast cancer OT - radiation therapy (RT) OT - treatment EDAT- 2017/11/22 06:00 MHDA- 2018/08/14 06:00 CRDT- 2017/11/22 06:00 PHST- 2017/09/12 00:00 [received] PHST- 2017/09/17 00:00 [accepted] PHST- 2017/11/22 06:00 [pubmed] PHST- 2018/08/14 06:00 [medline] PHST- 2017/11/22 06:00 [entrez] AID - apm.2017.09.06 [pii] AID - 10.21037/apm.2017.09.06 [doi] PST - ppublish SO - Ann Palliat Med. 2017 Dec;6(Suppl 2):S223-S232. doi: 10.21037/apm.2017.09.06. Epub 2017 Oct 24.