Quality of Life Is Associated With Survival in Patients With Gastric Cancer: Results From the Randomized CRITICS Trial

on behalf of the CRITICS Investigators; R. M. van Amelsfoort; I. Walraven; J. Kieffer; E. P. M. Jansen; A. Cats; N. C. T. van Grieken; E. Meershoek-Klein Kranenbarg; H. Putter; J. W. van Sandick; K. Sikorska; C. J. H. van de Velde; N. K. Aaronson; M. Verheij; H. Boot; A. Trip; F. van Coevorden; S. Vanhoutvin; H. A. M. Swellengrebel; M. C. C. M. Hulshof; M. I. van Berge Henegouwen; H. W. M. van Laarhoven; O. J. L. Loosveld; A. J. ten Tije; F. L. G. Erdkamp; F. A. R. M. Warmerdam; D. L. van der Peet; H. M. W. Verheul; J. E. A. Portielje; E. J. Spillenaar Bilgen; M. B. Poleé; M. M. Geenen; K. J. Neelis; M. Slingerland; R. L. H. Jansen; D. J. van Spronsen; B. C. Tanis; R. van Hillegersberg; M. Koopman; M. O. den Boer; G. J. Creemers; H. P. van den Berg; A. Baars; M. I. E. Appels; J. M. Smit; E. W. Muller; J. de Boer; M. A. van Dijk; A. van der Gaast; J. M. M. B. Otten; H. M. Ceha

doi:10.6004/jnccn.2021.7057

Quality of Life Is Associated With Survival in Patients With Gastric Cancer: Results From the Randomized CRITICS Trial

on behalf of the CRITICS Investigators, R. M. van Amelsfoort, I. Walraven, J. Kieffer, E. P. M. Jansen, A. Cats, N. C. T. van Grieken, E. Meershoek-Klein Kranenbarg, H. Putter, J. W. van Sandick, K. Sikorska, C. J. H. van de Velde, N. K. Aaronson, M. Verheij^*, H. Boot, A. Trip, F. van Coevorden, S. Vanhoutvin, H. A. M. Swellengrebel, M. C. C. M. HulshofM. I. van Berge Henegouwen, H. W. M. van Laarhoven, O. J. L. Loosveld, A. J. ten Tije, F. L. G. Erdkamp, F. A. R. M. Warmerdam, D. L. van der Peet, H. M. W. Verheul, J. E. A. Portielje, E. J. Spillenaar Bilgen, M. B. Poleé, M. M. Geenen, K. J. Neelis, M. Slingerland, R. L. H. Jansen, D. J. van Spronsen, B. C. Tanis, R. van Hillegersberg, M. Koopman, M. O. den Boer, G. J. Creemers, H. P. van den Berg, A. Baars, M. I. E. Appels, J. M. Smit, E. W. Muller, J. de Boer, M. A. van Dijk, A. van der Gaast, J. M. M. B. Otten, H. M. Ceha

^*Corresponding author for this work

Medical Oncology

Research output: Contribution to journal › Article › Academic › peer-review

8 Citations (Scopus)

Abstract

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

Original language	English
Pages (from-to)	261-267
Number of pages	7
Journal	JNCCN Journal of the National Comprehensive Cancer Network
Volume	20
Issue number	3
DOIs	https://doi.org/10.6004/jnccn.2021.7057
Publication status	Published - Mar 2022

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10.6004/jnccn.2021.7057

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on behalf of the CRITICS Investigators, van Amelsfoort, R. M., Walraven, I., Kieffer, J., Jansen, E. P. M., Cats, A., van Grieken, N. C. T., Meershoek-Klein Kranenbarg, E., Putter, H., van Sandick, J. W., Sikorska, K., van de Velde, C. J. H., Aaronson, N. K., Verheij, M., Boot, H., Trip, A., van Coevorden, F., Vanhoutvin, S., Swellengrebel, H. A. M., ... Ceha, H. M. (2022). Quality of Life Is Associated With Survival in Patients With Gastric Cancer: Results From the Randomized CRITICS Trial. JNCCN Journal of the National Comprehensive Cancer Network, 20(3), 261-267. https://doi.org/10.6004/jnccn.2021.7057

@article{afc0c51b9fc5440bb1b0ed9e75f9ccbe,

title = "Quality of Life Is Associated With Survival in Patients With Gastric Cancer: Results From the Randomized CRITICS Trial",

abstract = "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{\textquoteright}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{\textquoteright}s effect size = 0.42) and less dysphagia (P=.01; Cohen{\textquoteright}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",

author = "{on behalf of the CRITICS Investigators} and {van Amelsfoort}, {R. M.} and I. Walraven and J. Kieffer and Jansen, {E. P. M.} and A. Cats and {van Grieken}, {N. C. T.} and {Meershoek-Klein Kranenbarg}, E. and H. Putter and {van Sandick}, {J. W.} and K. Sikorska and {van de Velde}, {C. J. H.} and Aaronson, {N. K.} and M. Verheij and H. Boot and A. Trip and {van Coevorden}, F. and S. Vanhoutvin and Swellengrebel, {H. A. M.} and Hulshof, {M. C. C. M.} and {van Berge Henegouwen}, {M. I.} and {van Laarhoven}, {H. W. M.} and Loosveld, {O. J. L.} and {ten Tije}, {A. J.} and Erdkamp, {F. L. G.} and Warmerdam, {F. A. R. M.} and {van der Peet}, {D. L.} and Verheul, {H. M. W.} and Portielje, {J. E. A.} and {Spillenaar Bilgen}, {E. J.} and Pole{\'e}, {M. B.} and Geenen, {M. M.} and Neelis, {K. J.} and M. Slingerland and Jansen, {R. L. H.} and {van Spronsen}, {D. J.} and Tanis, {B. C.} and {van Hillegersberg}, R. and M. Koopman and {den Boer}, {M. O.} and Creemers, {G. J.} and {van den Berg}, {H. P.} and A. Baars and Appels, {M. I. E.} and Smit, {J. M.} and Muller, {E. W.} and {de Boer}, J. and {van Dijk}, {M. A.} and {van der Gaast}, A. and Otten, {J. M. M. B.} and Ceha, {H. M.}",

year = "2022",

month = mar,

doi = "10.6004/jnccn.2021.7057",

language = "English",

volume = "20",

pages = "261--267",

journal = "JNCCN Journal of the National Comprehensive Cancer Network",

issn = "1540-1405",

publisher = "Cold Spring Publishing LLC",

number = "3",

}

on behalf of the CRITICS Investigators, van Amelsfoort, RM, Walraven, I, Kieffer, J, Jansen, EPM, Cats, A, van Grieken, NCT, Meershoek-Klein Kranenbarg, E, Putter, H, van Sandick, JW, Sikorska, K, van de Velde, CJH, Aaronson, NK, Verheij, M, Boot, H, Trip, A, van Coevorden, F, Vanhoutvin, S, Swellengrebel, HAM, Hulshof, MCCM, van Berge Henegouwen, MI, van Laarhoven, HWM, Loosveld, OJL, ten Tije, AJ, Erdkamp, FLG, Warmerdam, FARM, van der Peet, DL, Verheul, HMW, Portielje, JEA, Spillenaar Bilgen, EJ, Poleé, MB, Geenen, MM, Neelis, KJ, Slingerland, M, Jansen, RLH, van Spronsen, DJ, Tanis, BC, van Hillegersberg, R, Koopman, M, den Boer, MO, Creemers, GJ, van den Berg, HP, Baars, A, Appels, MIE, Smit, JM, Muller, EW, de Boer, J, van Dijk, MA, van der Gaast, A, Otten, JMMB & Ceha, HM 2022, 'Quality of Life Is Associated With Survival in Patients With Gastric Cancer: Results From the Randomized CRITICS Trial', JNCCN Journal of the National Comprehensive Cancer Network, vol. 20, no. 3, pp. 261-267. https://doi.org/10.6004/jnccn.2021.7057

Quality of Life Is Associated With Survival in Patients With Gastric Cancer: Results From the Randomized CRITICS Trial. / on behalf of the CRITICS Investigators; van Amelsfoort, R. M.; Walraven, I. et al.
In: JNCCN Journal of the National Comprehensive Cancer Network, Vol. 20, No. 3, 03.2022, p. 261-267.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Quality of Life Is Associated With Survival in Patients With Gastric Cancer

T2 - Results From the Randomized CRITICS Trial

AU - on behalf of the CRITICS Investigators

AU - van Amelsfoort, R. M.

AU - Walraven, I.

AU - Kieffer, J.

AU - Jansen, E. P. M.

AU - Cats, A.

AU - van Grieken, N. C. T.

AU - Meershoek-Klein Kranenbarg, E.

AU - Putter, H.

AU - van Sandick, J. W.

AU - Sikorska, K.

AU - van de Velde, C. J. H.

AU - Aaronson, N. K.

AU - Verheij, M.

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 - Portielje, J. E. A.

AU - Spillenaar Bilgen, E. J.

AU - Poleé, M. B.

AU - Geenen, M. M.

AU - Neelis, K. J.

AU - Slingerland, M.

AU - Jansen, R. L. H.

AU - van Spronsen, D. J.

AU - Tanis, B. C.

AU - van Hillegersberg, R.

AU - Koopman, M.

AU - den Boer, M. O.

AU - Creemers, G. J.

AU - van den Berg, H. P.

AU - Baars, A.

AU - Appels, M. I. E.

AU - Smit, J. M.

AU - Muller, E. W.

AU - de Boer, J.

AU - van Dijk, M. A.

AU - van der Gaast, A.

AU - Otten, J. M. M. B.

AU - Ceha, H. M.

PY - 2022/3

Y1 - 2022/3

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

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

UR - http://www.scopus.com/inward/record.url?scp=85126389018&partnerID=8YFLogxK

U2 - 10.6004/jnccn.2021.7057

DO - 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 -

Quality of Life Is Associated With Survival in Patients With Gastric Cancer: Results From the Randomized CRITICS Trial

Abstract

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