Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study

W. J. A. Witlox; B. L. T. Ramaekers; M. A. Joore; A. -M. C. Dingemans; J. Praag; J. Belderbos; C. Tissing-Tan; G. Herder; T. Haitjema; J. F. Ubbels; J. Lagerwaard; S. Y. El Sharouni; J. A. Stigt; E. F. Smitm; H. van Tinteren; V. van der Noort; H. J. M. Groen; D. K. M. De Ruysscher

doi:10.1016/j.radonc.2019.10.016

Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study

W. J. A. Witlox^*, B. L. T. Ramaekers, M. A. Joore, A. -M. C. Dingemans, J. Praag, J. Belderbos, C. Tissing-Tan, G. Herder, T. Haitjema, J. F. Ubbels, J. Lagerwaard, S. Y. El Sharouni, J. A. Stigt, E. F. Smitm, H. van Tinteren, V. van der Noort, H. J. M. Groen, D. K. M. De Ruysscher

^*Corresponding author for this work

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

Abstract

Background and purpose: The NVALT-11/DLCRG-02 phase III trial (clinicaltrials.gov identifier: NCT01282437) showed that, after standard curative intent treatment, prophylactic cranial irradiation (PCI) decreased the incidence of symptomatic brain metastases (BM) in stage III non-small cell lung cancer (NSCLC) patients compared to observation. In this study we assessed the impact of PCI on health-related quality of life (HRQoL). In addition, an exploratory analysis was performed to assess the impact of neurocognitive symptoms and symptomatic BM on HRQoL.

Materials and methods: Stage III NSCLC patients were randomized between PCI and observation. HRQoL was measured using the EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments at completion of standard curative intent treatment and 4 weeks, 3, 6, 12, 24 and 36 months thereafter.

Generalized linear mixed effects (GLM) models were used to assess the impact of PCI compared to observation over time on three HRQoL metrics: the EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores.

Results: In total, 86 and 88 patients were included in the PCI and observation arm, with a median follow-up of 48.5 months (95% CI 39-54 months). Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics. In the GLM models, none of the HRQoL metrics were clinically relevant or statistically significantly different between the PCI and the observation arm (p-values ranged between 0.641 and 0.914).

Original language	English
Pages (from-to)	65-71
Number of pages	7
Journal	Radiotherapy and Oncology
Volume	144
DOIs	https://doi.org/10.1016/j.radonc.2019.10.016
Publication status	Published - Mar 2020

Keywords

Prophylactic cranial irradiation
Non-small cell lung cancer
Health-related quality of life
WHOLE-BRAIN RADIOTHERAPY
HIGH-RISK
RTOG 0212
TRIAL
ONCOLOGY
CHEMORADIOTHERAPY
QUESTIONNAIRE
METASTASES
MEMANTINE
EUROQOL

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Witlox, W. J. A., Ramaekers, B. L. T., Joore, M. A., Dingemans, A. .-M. C., Praag, J., Belderbos, J., Tissing-Tan, C., Herder, G., Haitjema, T., Ubbels, J. F., Lagerwaard, J., El Sharouni, S. Y., Stigt, J. A., Smitm, E. F., van Tinteren, H., van der Noort, V., Groen, H. J. M., & De Ruysscher, D. K. M. (2020). Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study. Radiotherapy and Oncology, 144, 65-71. https://doi.org/10.1016/j.radonc.2019.10.016

@article{df49285f9e13432abe82b1e817a71d65,

title = "Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study",

abstract = "Background and purpose: The NVALT-11/DLCRG-02 phase III trial (clinicaltrials.gov identifier: NCT01282437) showed that, after standard curative intent treatment, prophylactic cranial irradiation (PCI) decreased the incidence of symptomatic brain metastases (BM) in stage III non-small cell lung cancer (NSCLC) patients compared to observation. In this study we assessed the impact of PCI on health-related quality of life (HRQoL). In addition, an exploratory analysis was performed to assess the impact of neurocognitive symptoms and symptomatic BM on HRQoL.Materials and methods: Stage III NSCLC patients were randomized between PCI and observation. HRQoL was measured using the EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments at completion of standard curative intent treatment and 4 weeks, 3, 6, 12, 24 and 36 months thereafter.Generalized linear mixed effects (GLM) models were used to assess the impact of PCI compared to observation over time on three HRQoL metrics: the EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores.Results: In total, 86 and 88 patients were included in the PCI and observation arm, with a median follow-up of 48.5 months (95% CI 39-54 months). Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics. In the GLM models, none of the HRQoL metrics were clinically relevant or statistically significantly different between the PCI and the observation arm (p-values ranged between 0.641 and 0.914).Conclusion: No statistically significant nor a clinically relevant impact of PCI on HRQoL was observed. (C) 2019 Elsevier B.V. All rights reserved.",

keywords = "Prophylactic cranial irradiation, Non-small cell lung cancer, Health-related quality of life, WHOLE-BRAIN RADIOTHERAPY, HIGH-RISK, RTOG 0212, TRIAL, ONCOLOGY, CHEMORADIOTHERAPY, QUESTIONNAIRE, METASTASES, MEMANTINE, EUROQOL",

author = "Witlox, {W. J. A.} and Ramaekers, {B. L. T.} and Joore, {M. A.} and Dingemans, {A. -M. C.} and J. Praag and J. Belderbos and C. Tissing-Tan and G. Herder and T. Haitjema and Ubbels, {J. F.} and J. Lagerwaard and {El Sharouni}, {S. Y.} and Stigt, {J. A.} and Smitm, {E. F.} and {van Tinteren}, H. and {van der Noort}, V. and Groen, {H. J. M.} and {De Ruysscher}, {D. K. M.}",

note = "Publisher Copyright: {\textcopyright} 2019 Elsevier B.V.",

year = "2020",

month = mar,

doi = "10.1016/j.radonc.2019.10.016",

language = "English",

volume = "144",

pages = "65--71",

journal = "Radiotherapy and Oncology",

issn = "0167-8140",

publisher = "Elsevier Ireland Ltd",

}

Witlox, WJA , Ramaekers, BLT , Joore, MA, Dingemans, A-MC, Praag, J, Belderbos, J, Tissing-Tan, C, Herder, G, Haitjema, T, Ubbels, JF, Lagerwaard, J, El Sharouni, SY, Stigt, JA, Smitm, EF, van Tinteren, H, van der Noort, V, Groen, HJM & De Ruysscher, DKM 2020, 'Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study', Radiotherapy and Oncology, vol. 144, pp. 65-71. https://doi.org/10.1016/j.radonc.2019.10.016

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

TY - JOUR

T1 - Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients

T2 - Results from the NVALT-11/DLCRG-02 phase III study

AU - Witlox, W. J. A.

AU - Ramaekers, B. L. T.

AU - Joore, M. A.

AU - Dingemans, A. -M. C.

AU - Praag, J.

AU - Belderbos, J.

AU - Tissing-Tan, C.

AU - Herder, G.

AU - Haitjema, T.

AU - Ubbels, J. F.

AU - Lagerwaard, J.

AU - El Sharouni, S. Y.

AU - Stigt, J. A.

AU - Smitm, E. F.

AU - van Tinteren, H.

AU - van der Noort, V.

AU - Groen, H. J. M.

AU - De Ruysscher, D. K. M.

PY - 2020/3

Y1 - 2020/3

N2 - Background and purpose: The NVALT-11/DLCRG-02 phase III trial (clinicaltrials.gov identifier: NCT01282437) showed that, after standard curative intent treatment, prophylactic cranial irradiation (PCI) decreased the incidence of symptomatic brain metastases (BM) in stage III non-small cell lung cancer (NSCLC) patients compared to observation. In this study we assessed the impact of PCI on health-related quality of life (HRQoL). In addition, an exploratory analysis was performed to assess the impact of neurocognitive symptoms and symptomatic BM on HRQoL.Materials and methods: Stage III NSCLC patients were randomized between PCI and observation. HRQoL was measured using the EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments at completion of standard curative intent treatment and 4 weeks, 3, 6, 12, 24 and 36 months thereafter.Generalized linear mixed effects (GLM) models were used to assess the impact of PCI compared to observation over time on three HRQoL metrics: the EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores.Results: In total, 86 and 88 patients were included in the PCI and observation arm, with a median follow-up of 48.5 months (95% CI 39-54 months). Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics. In the GLM models, none of the HRQoL metrics were clinically relevant or statistically significantly different between the PCI and the observation arm (p-values ranged between 0.641 and 0.914).Conclusion: No statistically significant nor a clinically relevant impact of PCI on HRQoL was observed. (C) 2019 Elsevier B.V. All rights reserved.

AB - Background and purpose: The NVALT-11/DLCRG-02 phase III trial (clinicaltrials.gov identifier: NCT01282437) showed that, after standard curative intent treatment, prophylactic cranial irradiation (PCI) decreased the incidence of symptomatic brain metastases (BM) in stage III non-small cell lung cancer (NSCLC) patients compared to observation. In this study we assessed the impact of PCI on health-related quality of life (HRQoL). In addition, an exploratory analysis was performed to assess the impact of neurocognitive symptoms and symptomatic BM on HRQoL.Materials and methods: Stage III NSCLC patients were randomized between PCI and observation. HRQoL was measured using the EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments at completion of standard curative intent treatment and 4 weeks, 3, 6, 12, 24 and 36 months thereafter.Generalized linear mixed effects (GLM) models were used to assess the impact of PCI compared to observation over time on three HRQoL metrics: the EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores.Results: In total, 86 and 88 patients were included in the PCI and observation arm, with a median follow-up of 48.5 months (95% CI 39-54 months). Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics. In the GLM models, none of the HRQoL metrics were clinically relevant or statistically significantly different between the PCI and the observation arm (p-values ranged between 0.641 and 0.914).Conclusion: No statistically significant nor a clinically relevant impact of PCI on HRQoL was observed. (C) 2019 Elsevier B.V. All rights reserved.

KW - Prophylactic cranial irradiation

KW - Non-small cell lung cancer

KW - Health-related quality of life

KW - WHOLE-BRAIN RADIOTHERAPY

KW - HIGH-RISK

KW - RTOG 0212

KW - TRIAL

KW - ONCOLOGY

KW - CHEMORADIOTHERAPY

KW - QUESTIONNAIRE

KW - METASTASES

KW - MEMANTINE

KW - EUROQOL

U2 - 10.1016/j.radonc.2019.10.016

DO - 10.1016/j.radonc.2019.10.016

M3 - Article

C2 - 31733490

SN - 0167-8140

VL - 144

SP - 65

EP - 71

JO - Radiotherapy and Oncology

JF - Radiotherapy and Oncology

ER -