TY - JOUR
T1 - Quality of Life Is Associated With Survival in Patients With Gastric Cancer
T2 - Results From the Randomized CRITICS Trial
AU - CRITICS investigators
AU - van Amelsfoort, Romy M.
AU - Walraven, Iris
AU - Kieffer, Jacobien
AU - Jansen, Edwin P.M.
AU - Cats, Annemieke
AU - van Grieken, Nicole C.T.
AU - Meershoek-Klein Kranenbarg, Elma
AU - Putter, Hein
AU - van Sandick, Johanna W.
AU - Sikorska, Karolina
AU - van de Velde, Cornelis J.H.
AU - Aaronson, Neil K.
AU - Verheij, Marcel
AU - Boot, H.
AU - Trip, A.
AU - van Coevorden, F.
AU - Vanhoutvin, S.
AU - Swellengrebel, H. A.M.
AU - Hulshof, M. C.C.M.
AU - van Berge Henegouwen, M. I.
AU - van Laarhoven, H. W.M.
AU - Loosveld, O. J.L.
AU - ten Tije, A. J.
AU - Erdkamp, F. L.G.
AU - Warmerdam, F. A.R.M.
AU - van der Peet, D. L.
AU - Verheul, H. M.W.
AU - Boerma, D.
AU - Los, M.
AU - Slot, A.
AU - Houtsma, D.
AU - Portielje, J. E.A.
AU - Blaisse, R. J.B.
AU - Spillenaar Bilgen, E. J.
AU - Poleé, M. B.
AU - Geenen, M. M.
AU - Hartgrink, H. H.
AU - Braak, J. P.B.M.
AU - Neelis, K. J.
AU - Slingerland, M.
AU - Jansen, R. L.H.
AU - Buijsen, J.
AU - Beeker, A.
AU - Eijsbouts, Q. A.J.
AU - van Riel, J. M.G.H.
AU - Rozema, T.
AU - van Spronsen, D. J.
AU - Meerum Terwogt, J. M.
AU - Tanis, B. C.
AU - van den Berg, H. P.
AU - de Boer, J.
N1 - Funding Information: Funding: This work was supported by funding from KWF Kankerbestrijding, the Dutch Colorectal Cancer group, and F. Hoffmann-La Roche. Publisher Copyright: © 2022 Harborside Press. All rights reserved.
PY - 2022/3/1
Y1 - 2022/3/1
N2 - Background: The evaluation of health-related quality of life (HRQoL) in clinical trials has become increasingly important because it addresses the impact of treatment from the patient’s perspective. The primary aim of this study was to investigate the effect of postoperative chemotherapy and chemoradiotherapy (CRT) after neoadjuvant chemotherapy and surgery with extended (D2) lymphadenectomy on HRQoL in the CRITICS trial. Second, we investigated the potential prognostic value of pretreatment HRQoL on event-free survival (EFS) and overall survival (OS). Patients and Methods: Patients in the CRITICS trial were asked to complete HRQoL questionnaires (EORTC Quality-of-Life Questionnaire-Core 30 and Quality-of-Life Questionnaire gastric cancer–specific module) at baseline, after preoperative chemotherapy, after surgery, after postoperative chemotherapy or CRT, and at 12 months follow-up. Patients with at least 1 evaluable questionnaire (645 of 788 randomized patients) were included in the HRQoL analyses. The predefined endpoints included dysphagia, pain, physical functioning, fatigue, and Quality-of-Life Questionnaire-Core 30 summary score. Linear mixed modeling was used to assess differences over time and at each time point. Associations of baseline HRQoL with EFS and OS were investigated using multivariate Cox proportional hazards analyses. Results: At completion of postoperative chemo(radio)therapy, the chemotherapy group had significantly better physical functioning (P=.02; Cohen’s effect size = 0.42) and less dysphagia (P=.01; Cohen’s effect size = 0.38) compared with the CRT group. At baseline, worse social functioning (hazard ratio [HR], 2.20; 95% CI, 1.36–3.55; P=.001), nausea (HR, 1.89; 95% CI, 1.39–2.56; P<.001), worse WHO performance status (HR, 1.55; 95% CI, 1.13–2.13; P=.007), and histologic subtype (diffuse vs intestinal: HR, 1.94; 95% CI, 1.42–2.67; P<.001; mixed vs intestinal: HR, 2.35; 95% CI, 1.35–4.12; P=.003) were significantly associated with worse EFS and OS. Conclusions: In the CRITICS trial, the chemotherapy group had significantly better physical functioning and less dysphagia after postoperative treatment. HRQoL scales at baseline were significantly associated with EFS and OS.
AB - Background: The evaluation of health-related quality of life (HRQoL) in clinical trials has become increasingly important because it addresses the impact of treatment from the patient’s perspective. The primary aim of this study was to investigate the effect of postoperative chemotherapy and chemoradiotherapy (CRT) after neoadjuvant chemotherapy and surgery with extended (D2) lymphadenectomy on HRQoL in the CRITICS trial. Second, we investigated the potential prognostic value of pretreatment HRQoL on event-free survival (EFS) and overall survival (OS). Patients and Methods: Patients in the CRITICS trial were asked to complete HRQoL questionnaires (EORTC Quality-of-Life Questionnaire-Core 30 and Quality-of-Life Questionnaire gastric cancer–specific module) at baseline, after preoperative chemotherapy, after surgery, after postoperative chemotherapy or CRT, and at 12 months follow-up. Patients with at least 1 evaluable questionnaire (645 of 788 randomized patients) were included in the HRQoL analyses. The predefined endpoints included dysphagia, pain, physical functioning, fatigue, and Quality-of-Life Questionnaire-Core 30 summary score. Linear mixed modeling was used to assess differences over time and at each time point. Associations of baseline HRQoL with EFS and OS were investigated using multivariate Cox proportional hazards analyses. Results: At completion of postoperative chemo(radio)therapy, the chemotherapy group had significantly better physical functioning (P=.02; Cohen’s effect size = 0.42) and less dysphagia (P=.01; Cohen’s effect size = 0.38) compared with the CRT group. At baseline, worse social functioning (hazard ratio [HR], 2.20; 95% CI, 1.36–3.55; P=.001), nausea (HR, 1.89; 95% CI, 1.39–2.56; P<.001), worse WHO performance status (HR, 1.55; 95% CI, 1.13–2.13; P=.007), and histologic subtype (diffuse vs intestinal: HR, 1.94; 95% CI, 1.42–2.67; P<.001; mixed vs intestinal: HR, 2.35; 95% CI, 1.35–4.12; P=.003) were significantly associated with worse EFS and OS. Conclusions: In the CRITICS trial, the chemotherapy group had significantly better physical functioning and less dysphagia after postoperative treatment. HRQoL scales at baseline were significantly associated with EFS and OS.
UR - http://www.scopus.com/inward/record.url?scp=85126389018&partnerID=8YFLogxK
U2 - https://doi.org/10.6004/JNCCN.2021.7057
DO - https://doi.org/10.6004/JNCCN.2021.7057
M3 - Article
C2 - 35276669
SN - 1540-1405
VL - 20
SP - 261
EP - 267
JO - JNCCN Journal of the National Comprehensive Cancer Network
JF - JNCCN Journal of the National Comprehensive Cancer Network
IS - 3
ER -