Skip to main content
Top
Gepubliceerd in: Quality of Life Research 1/2021

13-09-2020

Randomized Clinical Trial on Reduction of Radiotherapy Dose to the Elective Neck in Head and Neck Squamous Cell Carcinoma: Results on the Quality of Life

Auteurs: S. Deschuymer, D. Nevens, F. Duprez, J. F. Daisne, M. Voordeckers, W. De Neve, S. Nuyts

Gepubliceerd in: Quality of Life Research | Uitgave 1/2021

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

Abstract

Purpose

A randomized trial was initiated to investigate whether a reduction of the dose to the elective nodal sites would result in less toxicity and improvement in Quality of Life (QoL) without compromising tumor control. This paper aimed to compare QoL in both treatment arms.

Methods

Two-hundred head and neck cancer patients treated with radiotherapy (RT) or chemo-RT were randomized (all stages, mean age: 60 years, M/F: 82%/18%). The elective nodal volumes of patients randomized in the experimental arm were treated up to a 40 Gy equivalent dose. In the standard arm, the elective nodal volumes were treated up to a 50 Gy equivalent dose. The QoL data were collected using The European Organization for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and the EORTC Head and Neck Cancer module (H&N35).

Results

A trend toward less decline in QoL during treatment was observed in the 40 Gy arm compared to the 50 Gy arm. Statistically significant differences for global health status, physical functioning, emotional functioning, speech problems, and trouble with social eating in favor of the 40 Gy arm were observed. A clinically relevant better outcome in the 40 Gy arm was found for physical functioning at the end of therapy.

Conclusion

QoL during RT for head and neck cancer tends to be less impaired in the 40 Gy arm. However, reducing the dose only on the elective neck does not result in clinically relevant improvement of QoL. Therefore, additional treatment strategies must be examined to further improve the QoL of HNSCC patients.
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
4.
go back to reference Nuyts, S., Dirix, P., Clement, P. M. J., Vander Poorten, V., Delaere, P., Schoenaers, J., et al. (2009). Impact of adding concomitant chemotherapy to hyperfractionated accelerated radiotherapy for advanced head-and-neck squamous cell carcinoma. International Journal of Radiation Oncology, Biology, Physics, 73(4), 1088–1095. https://doi.org/10.1016/j.ijrobp.2008.05.042.CrossRefPubMed Nuyts, S., Dirix, P., Clement, P. M. J., Vander Poorten, V., Delaere, P., Schoenaers, J., et al. (2009). Impact of adding concomitant chemotherapy to hyperfractionated accelerated radiotherapy for advanced head-and-neck squamous cell carcinoma. International Journal of Radiation Oncology, Biology, Physics, 73(4), 1088–1095. https://​doi.​org/​10.​1016/​j.​ijrobp.​2008.​05.​042.CrossRefPubMed
6.
10.
go back to reference Levendag, P. C., Teguh, D. N., Voet, P., van der Est, H., Noever, I., de Kruijf, W. J. M., …, Heijmen, B. J. (2007). Dysphagia disorders in patients with cancer of the oropharynx are significantly affected by the radiation therapy dose to the superior and middle constrictor muscle: A dose-effect relationship. Radiotherapy and Oncology, 85(1), 64–73. https://doi.org/10.1016/j.radonc.2007.07.009.CrossRefPubMed Levendag, P. C., Teguh, D. N., Voet, P., van der Est, H., Noever, I., de Kruijf, W. J. M., …, Heijmen, B. J. (2007). Dysphagia disorders in patients with cancer of the oropharynx are significantly affected by the radiation therapy dose to the superior and middle constrictor muscle: A dose-effect relationship. Radiotherapy and Oncology, 85(1), 64–73. https://​doi.​org/​10.​1016/​j.​radonc.​2007.​07.​009.CrossRefPubMed
13.
go back to reference Maccomb, W. S., & Fletcher, G. H. (1957). Planned combination of surgery and radiation in treatment of advanced primary head and neck cancers. The American Journal of Roentgenology, Radium Therapy, and Nuclear Medicine, 77(3), 397–414.PubMed Maccomb, W. S., & Fletcher, G. H. (1957). Planned combination of surgery and radiation in treatment of advanced primary head and neck cancers. The American Journal of Roentgenology, Radium Therapy, and Nuclear Medicine, 77(3), 397–414.PubMed
14.
go back to reference Nuyts, S., Lambrecht, M., Duprez, F., Daisne, J.-F., Van Gestel, D., Van den Weyngaert, D., … De Neve, W. (2013). Reduction of the dose to the elective neck in head and neck squamous cell carcinoma, a randomized clinical trial using intensity modulated radiotherapy (IMRT). Dosimetrical analysis and effect on acute toxicity. Radiotherapy and Oncology, 109(2), 323–329. https://doi.org/10.1016/j.radonc.2013.06.044 Nuyts, S., Lambrecht, M., Duprez, F., Daisne, J.-F., Van Gestel, D., Van den Weyngaert, D., … De Neve, W. (2013). Reduction of the dose to the elective neck in head and neck squamous cell carcinoma, a randomized clinical trial using intensity modulated radiotherapy (IMRT). Dosimetrical analysis and effect on acute toxicity. Radiotherapy and Oncology, 109(2), 323–329. https://​doi.​org/​10.​1016/​j.​radonc.​2013.​06.​044
15.
go back to reference Nevens, D., Duprez, F., Daisne, J. F., Dok, R., Belmans, A., Voordeckers, M., … Nuyts, S. (2017). Reduction of the dose of radiotherapy to the elective neck in head and neck squamous cell carcinoma; a randomized clinical trial. Effect on late toxicity and tumor control. Radiotherapy and Oncology, 122(2), 171–177. https://doi.org/10.1016/j.radonc.2016.08.009 Nevens, D., Duprez, F., Daisne, J. F., Dok, R., Belmans, A., Voordeckers, M., … Nuyts, S. (2017). Reduction of the dose of radiotherapy to the elective neck in head and neck squamous cell carcinoma; a randomized clinical trial. Effect on late toxicity and tumor control. Radiotherapy and Oncology, 122(2), 171–177. https://​doi.​org/​10.​1016/​j.​radonc.​2016.​08.​009
19.
go back to reference Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., …, de Haes, J. C. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376.CrossRef Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., …, de Haes, J. C. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376.CrossRef
20.
go back to reference Bjordal, K., Hammerlid, E., Ahlner-Elmqvist, M., de Graeff, A., Boysen, M., Evensen, J. F., …, Kaasa, S. (1999). Quality of life in head and neck cancer patients: Validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. Journal of Clinical Oncology, 17(3), 1008–1019. https://doi.org/10.1200/JCO.1999.17.3.1008.CrossRefPubMed Bjordal, K., Hammerlid, E., Ahlner-Elmqvist, M., de Graeff, A., Boysen, M., Evensen, J. F., …, Kaasa, S. (1999). Quality of life in head and neck cancer patients: Validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. Journal of Clinical Oncology, 17(3), 1008–1019. https://​doi.​org/​10.​1200/​JCO.​1999.​17.​3.​1008.CrossRefPubMed
22.
go back to reference Singer, S., Arraras, J. I., Chie, W.-C., Fisher, S. E., Galalae, R., Hammerlid, E., …, Hofmeister, D. (2013). Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients EORTC QLQ-H&N35: A methodological review. Quality of Life Research, 22(8), 1927–1941. https://doi.org/10.1007/s11136-012-0325-1.CrossRefPubMed Singer, S., Arraras, J. I., Chie, W.-C., Fisher, S. E., Galalae, R., Hammerlid, E., …, Hofmeister, D. (2013). Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients EORTC QLQ-H&N35: A methodological review. Quality of Life Research, 22(8), 1927–1941. https://​doi.​org/​10.​1007/​s11136-012-0325-1.CrossRefPubMed
23.
go back to reference Fayers, P. M., Aaronson, N. K., Bjordal, K., Groenvold, M., Curran, D., Bottomley, A. & On behalf of the EORTC Quality of Life Group. (2001). The EORTC QLQ-C30 Scoring Manual (3rd Edition). Brussels: European Organisation for Research and Treatment of Cancer. Fayers, P. M., Aaronson, N. K., Bjordal, K., Groenvold, M., Curran, D., Bottomley, A. & On behalf of the EORTC Quality of Life Group. (2001). The EORTC QLQ-C30 Scoring Manual (3rd Edition). Brussels: European Organisation for Research and Treatment of Cancer.
24.
go back to reference Cocks, K., King, M. T., Velikova, G., Martyn St-James, M., Fayers, P. M., & Brown, J. M. (2011). Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Journal of Clinical Oncology, 29(1), 89–96. https://doi.org/10.1200/JCO.2010.28.0107.CrossRefPubMed Cocks, K., King, M. T., Velikova, G., Martyn St-James, M., Fayers, P. M., & Brown, J. M. (2011). Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Journal of Clinical Oncology, 29(1), 89–96. https://​doi.​org/​10.​1200/​JCO.​2010.​28.​0107.CrossRefPubMed
26.
go back to reference Scott, N. W., Fayers, P. M., Aaronson, N. K., Bottomley, A., Graeff, A., Groenvold, M., Gundy, C., Koller, M., Petersen, M. A., Mirjam A. G., & Sprangers on behalf of the EORTC Quality of Life Group. (2008). EORTC QLQ-C30 Reference values manual. Brussels. EORTC Quality of Life Group Publications. Scott, N. W., Fayers, P. M., Aaronson, N. K., Bottomley, A., Graeff, A., Groenvold, M., Gundy, C., Koller, M., Petersen, M. A., Mirjam A. G., & Sprangers on behalf of the EORTC Quality of Life Group. (2008). EORTC QLQ-C30 Reference values manual. Brussels. EORTC Quality of Life Group Publications.
27.
go back to reference Bottomley, A., Tridello, G., Coens, C., Rolland, F., Tesselaar, M. E. T., Leemans, C. R., …, Lefebvre, J.-L. (2014). An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer, 120(3), 390–398. https://doi.org/10.1002/cncr.28392.CrossRefPubMed Bottomley, A., Tridello, G., Coens, C., Rolland, F., Tesselaar, M. E. T., Leemans, C. R., …, Lefebvre, J.-L. (2014). An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer, 120(3), 390–398. https://​doi.​org/​10.​1002/​cncr.​28392.CrossRefPubMed
32.
go back to reference Kaae, J. K., Johnsen, L., Hansen, C. R., Kristensen, M. H., Brink, C., & Eriksen, J. G. (2019). Relationship between patient and physician-rated xerostomia and dose distribution to the oral cavity and salivary glands for head and neck cancer patients after radiotherapy. Acta oncologica (Stockholm, Sweden), 58(10), 1366–1372. https://doi.org/10.1080/0284186X.2019.1627413.CrossRef Kaae, J. K., Johnsen, L., Hansen, C. R., Kristensen, M. H., Brink, C., & Eriksen, J. G. (2019). Relationship between patient and physician-rated xerostomia and dose distribution to the oral cavity and salivary glands for head and neck cancer patients after radiotherapy. Acta oncologica (Stockholm, Sweden), 58(10), 1366–1372. https://​doi.​org/​10.​1080/​0284186X.​2019.​1627413.CrossRef
33.
go back to reference de Veij Mestdagh, P. D., Jonker, M. C. J., Vogel, W. V., Schreuder, W. H., Donswijk, M. L., Klop, W. M. C., et al. (2018). SPECT/CT-guided lymph drainage mapping for the planning of unilateral elective nodal irradiation in head and neck squamous cell carcinoma. European Archives of Oto-Rhino-Laryngology, 275(8), 2135–2144. https://doi.org/10.1007/s00405-018-5050-0.CrossRefPubMed de Veij Mestdagh, P. D., Jonker, M. C. J., Vogel, W. V., Schreuder, W. H., Donswijk, M. L., Klop, W. M. C., et al. (2018). SPECT/CT-guided lymph drainage mapping for the planning of unilateral elective nodal irradiation in head and neck squamous cell carcinoma. European Archives of Oto-Rhino-Laryngology, 275(8), 2135–2144. https://​doi.​org/​10.​1007/​s00405-018-5050-0.CrossRefPubMed
34.
35.
go back to reference Daisne, J.-F., Installé, J., Bihin, B., Laloux, M., Vander Borght, T., Mathieu, I., et al. (2014). SPECT/CT lymphoscintigraphy of sentinel node(s) for superselective prophylactic irradiation of the neck in cN0 head and neck cancer patients: A prospective phase I feasibility study. Radiation Oncology, 9, 121. https://doi.org/10.1186/1748-717X-9-121.CrossRefPubMed Daisne, J.-F., Installé, J., Bihin, B., Laloux, M., Vander Borght, T., Mathieu, I., et al. (2014). SPECT/CT lymphoscintigraphy of sentinel node(s) for superselective prophylactic irradiation of the neck in cN0 head and neck cancer patients: A prospective phase I feasibility study. Radiation Oncology, 9, 121. https://​doi.​org/​10.​1186/​1748-717X-9-121.CrossRefPubMed
38.
go back to reference Bottomley, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., et al., …, Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium. (2016). Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: A start in setting international standards. The Lancet Oncology, 17(11), e510–e514. https://doi.org/10.1016/S1470-2045(16)30510-1.CrossRefPubMed Bottomley, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., et al., …, Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium. (2016). Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: A start in setting international standards. The Lancet Oncology, 17(11), e510–e514. https://​doi.​org/​10.​1016/​S1470-2045(16)30510-1.CrossRefPubMed
39.
go back to reference Pe, M., Dorme, L., Coens, C., Basch, E., Calvert, M., Campbell, A., Campbell, A., …, Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium (SISAQOL). (2018). Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: A systematic review. The Lancet Oncology, 19(9), e459–e469. https://doi.org/10.1016/S1470-2045(18)30418-2.CrossRefPubMed Pe, M., Dorme, L., Coens, C., Basch, E., Calvert, M., Campbell, A., Campbell, A., …, Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium (SISAQOL). (2018). Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: A systematic review. The Lancet Oncology, 19(9), e459–e469. https://​doi.​org/​10.​1016/​S1470-2045(18)30418-2.CrossRefPubMed
Metagegevens
Titel
Randomized Clinical Trial on Reduction of Radiotherapy Dose to the Elective Neck in Head and Neck Squamous Cell Carcinoma: Results on the Quality of Life
Auteurs
S. Deschuymer
D. Nevens
F. Duprez
J. F. Daisne
M. Voordeckers
W. De Neve
S. Nuyts
Publicatiedatum
13-09-2020
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 1/2021
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-020-02628-w

Andere artikelen Uitgave 1/2021

Quality of Life Research 1/2021 Naar de uitgave