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Randomized Controlled Trial Clinical Trial
Impact of neoadjuvant chemoradiotherapy on health-related quality of life in long-term survivors of esophageal or junctional cancer: results from the randomized CROSS trial.
- B J Noordman, M G E Verdam, S M Lagarde, J Shapiro, Hulshof M C C M MCCM Department of Radiation Oncology, Amsterdam, The Netherlands., M I van Berge Henegouwen, Wijnhoven B P L BPL Department of Surgery, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands., Nieuwenhuijzen G A P GAP Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands., J J Bonenkamp, M A Cuesta, Plukker J Th M JTM Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands., E J Spillenaar Bilgen, E W Steyerberg, A van der Gaast, Sprangers M A G MAG Department of Medical Psychology, Amsterdam, The Netherlands., van Lanschot J J B JJB Department of Surgery, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands., and CROSS Study Group.
- Department of Surgery, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands. Electronic address: b.noordman@erasmusmc.nl.
- Ann. Oncol. 2018 Feb 1; 29 (2): 445-451.
BackgroundNeoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard of care for patients with esophageal or junctional cancer, but the long-term impact of nCRT on health-related quality of life (HRQOL) is unknown. The purpose of this study is to compare very long-term HRQOL in long-term survivors of esophageal cancer who received nCRT plus surgery or surgery alone.Patients And MethodsPatients were randomly assigned to receive nCRT (carboplatin/paclitaxel with 41.4-Gy radiotherapy) plus surgery or surgery alone. HRQOL was measured using EORTC-QLQ-C30, EORTC-QLQ-OES24 and K-BILD questionnaires after a minimum follow-up of 6 years. To allow for examination over time, EORTC-QLQ-C30 and QLQ-OES24 questionnaire scores were compared with pretreatment and 12 months postoperative questionnaire scores. Physical functioning (QLQ-C30), eating problems (QLQ-OES24) and respiratory problems (K-BILD) were predefined primary end points. Predefined secondary end points were global quality of life and fatigue (both QLQ-C30).ResultsAfter a median follow-up of 105 months, 123/368 included patients (33%) were still alive (70 nCRT plus surgery, 53 surgery alone). No statistically significant or clinically relevant differential effects in HRQOL end points were found between both groups. Compared with 1-year postoperative levels, eating problems, physical functioning, global quality of life and fatigue remained at the same level in both groups. Compared with pretreatment levels, eating problems had improved (Cohen's d -0.37, P = 0.011) during long-term follow-up, whereas physical functioning and fatigue were not restored to pretreatment levels in both groups (Cohen's d -0.56 and 0.51, respectively, both P < 0.001).ConclusionsAlthough physical functioning and fatigue remain reduced after long-term follow-up, no adverse impact of nCRT is apparent on long-term HRQOL compared with patients who were treated with surgery alone. In addition to the earlier reported improvement in survival and the absence of impact on short-term HRQOL, these results support the view that nCRT according to CROSS can be considered as a standard of care.Trial Registration NumberNetherlands Trial Register NTR487.© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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