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Open Access 01-12-2022 | Human Papillomavirus | Study protocol

Patient-reported outcomes in terms of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced oropharyngeal cancer patients treated with definitive chemo-radiotherapy: Swall PEG study

Authors: Tatiana Dragan, André Van Gossum, Frederic Duprez, Yassine Lalami, Yolene Lefebvre, Sofiana Mootassim-Billah, Sylvie Beauvois, Akos Gulyban, Christophe Vandekerkhove, Petra Boegner, Marianne Paesmans, Lieveke Ameye, Antoine Digonnet, Marie Quiriny, Didier Dequanter, Samuel Lipski, Esther Willemse, Alejandra Rodriguez, Sebastien Carlot, Yasemin Karaca, Marc Lemort, Patrick Emonts, Clémence Al Wardi, Dirk Van Gestel

Published in: Trials | Issue 1/2022

Abstract

Background

Percutaneous endoscopic gastrostomy (PEG) is often used to provide nutritional support in locally advanced head and neck cancer patients undergoing multimodality treatment. However, there is little published data on the impact of prophylactic versus reactive PEG. PEG placement may affect swallowing-related physiology, function, and quality of life. The Swall PEG study is a randomized controlled phase III trial testing the impact of prophylactic versus reactive PEG on patient-reported outcomes in terms of swallowing and quality of life in oropharyngeal cancer patients.

Methods

Patients with locally advanced oropharyngeal cancer receiving chemo-radiotherapy will be randomized to either the prophylactic or reactive PEG tube group. Randomization will be stratified by human papillomavirus (HPV) status and unilateral versus bilateral positive neck lymph nodes. The primary objective of the study is the patient’s reported outcome in terms of swallowing (MD Anderson Dysphagia Inventory (MDADI)) at 6 months. Secondary objectives include health-related quality of life, dosimetric parameters associated with patient-reported outcomes, chemo-radiation toxicities, PEG tube placement complications, the impact of nutritional status on survival and toxicity outcomes, loco-regional control, overall survival, the impact of HPV and tobacco smoking on survival outcomes and toxicities, and the cost-effectiveness of each treatment strategy.

Discussion

Findings from this study will enhance clinical evidence regarding nutritional management in oropharyngeal cancer patients treated by concurrent chemo-radiation.

Trial registration

ClinicalTrials.gov NCT04019548, study protocol version 2.0_08/08/2019. Registered on 15 July 2019

Global Cancer Observatory. [cited 2021 Mar 22]. Available from: https://gco.iarc.fr/.

Pignon J-P, le Maître A, Maillard E, Bourhis J, MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009;92:4–14 [cited 2018 Apr 12]; Available from: http://linkinghub.elsevier.com/retrieve/pii/S0167814009001881.CrossRef

Bachaud JM, Cohen-Jonathan E, Alzieu C, David JM, Serrano E, Daly-Schveitzer N. Combined postoperative radiotherapy and weekly cisplatin infusion for locally advanced head and neck carcinoma: final report of a randomized trial. Int J Radiat Oncol Biol Phys. 1996;36:999–1004 [cited 2018 Apr 12];Available from: http://www.ncbi.nlm.nih.gov/pubmed/8985019.CrossRef

Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefèbvre J-L, Greiner RH, et al. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004;350:1945–52 [cited 2018 Feb 19];Available from: http://www.ncbi.nlm.nih.gov/pubmed/15128894.CrossRef

Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, et al. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004;350:1937–44 [cited 2018 Apr 27]; Available from: http://www.nejm.org/doi/abs/10.1056/NEJMoa032646.CrossRef

Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, et al. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005;27:843–50 [cited 2018 30]; Available from: http://doi.wiley.com/10.1002/hed.20279.CrossRef

Adelstein DJ, Li Y, Adams GL, Wagner H, Kish JA, Ensley JF, et al. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003;21:92–8 [cited 2019 Jun 19]; Available from: http://www.ncbi.nlm.nih.gov/pubmed/12506176.CrossRef

Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349:2091–8 [cited 2019 Jun 19];Available from: http://www.nejm.org/doi/abs/10.1056/NEJMoa031317.CrossRef

Machtay M, Moughan J, Trotti A, Garden AS, Weber RS, Cooper JS, et al. Factors associated with severe late toxicity after concurrent chemoradiation for locally advanced head and neck cancer: An RTOG analysis. J Clin Oncol. 2008;26:3582–9 [cited 2018 Feb 19]; Available from: http://www.ncbi.nlm.nih.gov/pubmed/18559875.CrossRef

10.

Wax MK, Ringash J, Bernstein LJ, Cella D, Logemann J, Movsas B, et al. CLINICAL REVIEW Outcomes toolbox for head and neck cancer research. Wiley Period Inc Head Neck. 2015;37:425–39.

11.

Trotti A, Colevas AD, Setser A. Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol. 2007;25:5121–7 [cited 2018 Apr 12]; Available from: http://ascopubs.org/doi/10.1200/JCO.2007.12.4784.CrossRef

12.

Feinstein AR. Clinimetrics [Internet]: Yale University Press; 1987. [cited 2018 Apr 27]. Available from: https://books.google.be/books/about/Clinimetrics.html?id=P6iDQgAACAAJ&redir_esc=y.CrossRef

13.

Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen JF, et al. 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. J Clin Oncol. 1999;17:1008 [cited 2018 Apr 12]; Available from: http://www.ncbi.nlm.nih.gov/pubmed/10071296.CrossRef

14.

Singer S, Arraras JI, Baumann I, Boehm A, Chie W-C, Galalae R, et al. Quality of life in patients with head and neck cancer receiving targeted or multimodal therapy--update of the EORTC QLQ-H&N35, Phase I. Head Neck. 2013;35:1331–8 [cited 2018 Apr 12]; Available from: http://doi.wiley.com/10.1002/hed.23127.CrossRef

15.

Singer S, Arraras JI, Chie W-C, Fisher SE, Galalae R, Hammerlid E, et al. 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. Qual Life Res. 2013;22:1927–41 [cited 2018 Apr 12]; Available from: http://link.springer.com/10.1007/s11136-012-0325-1.CrossRef

16.

Singer S, Amdal CD, Hammerlid E, Tomaszewska IM, Castro Silva J, Mehanna H, et al. International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV. Head Neck. 2019;41:1725–37 [cited 2021 Mar 22]; Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/hed.25609.CrossRef

17.

Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, et al. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001;127:870–6 [cited 2018 Apr 27]; Available from: http://www.ncbi.nlm.nih.gov/pubmed/11448365.

18.

Langendijk JA, Doornaert P, Verdonck-de Leeuw IM, Leemans CR, Aaronson NK, Slotman BJ. Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy. J Clin Oncol. 2008;26:3770–6 [cited 2020 May 3]; Available from: http://ascopubs.org/doi/10.1200/JCO.2007.14.6647.CrossRef

19.

Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, et al. ESPEN Guideline ESPEN guidelines on nutrition in cancer patients *. 2016 [cited 2021 Apr 15]; Available from:. https://doi.org/10.1016/j.clnu.2016.07.015.

20.

Madhoun MF, Blankenship MM, Blankenship DM, Krempl GA, Tierney WM. Prophylactic PEG placement in head and neck cancer: how many feeding tubes are unused (and unnecessary)? World J Gastroenterol. 2011;17:1004–8 [cited 2018 Feb 19]; Available from: http://www.wjgnet.com/1007-9327/full/v17/i8/1004.htm.CrossRef

21.

Shaw SM, Flowers H, O’Sullivan B, Hope A, Liu LWC, Martino R. The effect of prophylactic percutaneous endoscopic gastrostomy (PEG) tube placement on swallowing and swallow-related outcomes in patients undergoing radiotherapy for head and neck cancer: a systematic review. Dysphagia. 2015;30:152–75 [cited 2018 Jul 6]; Available from: http://link.springer.com/10.1007/s00455-014-9592-z.CrossRef

22.

Dragan T, Duprez F, Van GA, Beauvois S, Digonnet A, Lalami Y, et al. Prophylactic gastrostomy in locally advanced head and neck cancer: results of a national survey among radiation oncologists. 2020 [cited 2021 Mar 22]. https://doi.org/10.21203/rs.3.rs-70709/v1.

23.

Moor JW, Patterson J, Kelly C, Paleri V. Prophylactic gastrostomy before chemoradiation in advanced head and neck cancer: a multiprofessional web-based survey to identify current practice and to analyse decision making. Clin Oncol. 2010;22:192–8 [cited 2018 Aug 1]; Available from: https://www.sciencedirect.com/science/article/pii/S0936655510000452?via%3Dihub.CrossRef

24.

Carlsson S, Rydén A, Rudberg I, Bove M, Bergquist H, Finizia C. Validation of the Swedish M. D. Anderson Dysphagia Inventory (MDADI) in patients with head and neck cancer and neurologic swallowing disturbances. Dysphagia. 2012;27:361–9 [cited 2018 Jul 10]; Available from: http://link.springer.com/10.1007/s00455-011-9375-8.CrossRef

25.

Hutcheson KA, Barrow MP, Lisec A, Barringer DA, Gries K, Lewin JS. What is a clinically relevant difference in MDADI scores between groups of head and neck cancer patients? Laryngoscope. 2016;126:1108–13 [cited 2018 Jul 11]; Available from: http://www.ncbi.nlm.nih.gov/pubmed/26542529.CrossRef

26.

Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, et al. GLIM criteria for the diagnosis of malnutrition – a consensus report from the global clinical nutrition community. Clin Nutr. 2019;38:1–9 [cited 2021 Mar 22]; Available from: https://pubmed.ncbi.nlm.nih.gov/30181091/.CrossRef

27.

Fakhry C, Lacchetti C, Rooper LM, Jordan RC, Rischin D, Sturgis EM, et al. Human papillomavirus testing in head and neck carcinomas: ASCO clinical practice guideline endorsement of the college of American pathologists guideline. J Clin Oncol. 2018;36:3152–61.CrossRef

28.

Biau J, Lapeyre M, Troussier I, Budach W, Giralt J, Grau C, et al. Selection of lymph node target volumes for definitive head and neck radiation therapy: a 2019 Update. Radiother Oncol. 2019;134:1–9. [cited 2019 Jun 19]; Available from:. https://doi.org/10.1016/j.radonc.2019.01.018.CrossRef

29.

Grégoire V, Evans M, Le Q-T, Bourhis J, Budach V, Chen A, et al. Delineation of the primary tumour Clinical Target Volumes (CTV-P) in laryngeal, hypopharyngeal, oropharyngeal and oral cavity squamous cell carcinoma: AIRO, CACA, DAHANCA, EORTC, GEORCC, GORTEC, HKNPCSG, HNCIG, IAG-KHT, LPRHHT, NCIC CTG, NCRI, NRG Oncology, PHNS, SBRT, SOMERA, SRO, SSHNO, TROG consensus guidelines. Radiother Oncol. 2018;126:3–24 [cited 2018 Apr 27]; Available from: https://www.sciencedirect.com/science/article/pii/S0167814017326567?via%3Dihub.CrossRef

30.

Brouwer CL, Steenbakkers RJHM, Bourhis J, Budach W, Grau C, Grégoire V, et al. CT-based delineation of organs at risk in the head and neck region: DAHANCA, EORTC, GORTEC, HKNPCSG, NCIC CTG, NCRI, NRG Oncology and TROG consensus guidelines. Radiother Oncol. 2015;117:83–90 [cited 2019 Jun 15]; Available from: https://www.sciencedirect.com/science/article/pii/S0167814015004016.CrossRef

31.

Christianen MEMC, Langendijk JA, Westerlaan HE, van de Water TA, Bijl HP. Delineation of organs at risk involved in swallowing for radiotherapy treatment planning. Radiother Oncol. 2011;101:394–402 [cited 2019 Feb 14]; Available from: https://www.sciencedirect.com/science/article/pii/S0167814011002076.CrossRef

32.

Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995;31:1341–6 [cited 2018 Apr 12]; Available from: http://linkinghub.elsevier.com/retrieve/pii/036030169500060C.CrossRef

33.

Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228–47 [cited 2018 Feb 19]; Available from: http://www.ncbi.nlm.nih.gov/pubmed/19097774.CrossRef

Title: Patient-reported outcomes in terms of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced oropharyngeal cancer patients treated with definitive chemo-radiotherapy: Swall PEG study
Authors: Tatiana Dragan
André Van Gossum
Frederic Duprez
Yassine Lalami
Yolene Lefebvre
Sofiana Mootassim-Billah
Sylvie Beauvois
Akos Gulyban
Christophe Vandekerkhove
Petra Boegner
Marianne Paesmans
Lieveke Ameye
Antoine Digonnet
Marie Quiriny
Didier Dequanter
Samuel Lipski
Esther Willemse
Alejandra Rodriguez
Sebastien Carlot
Yasemin Karaca
Marc Lemort
Patrick Emonts
Clémence Al Wardi
Dirk Van Gestel
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Human Papillomavirus
Gastrostomy
Radiotherapy
Cytostatic Therapy
Dysphagia
Dysphagia
Oropharyngeal Cancer
Dysphagia
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06991-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Patient-reported outcomes in terms of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced oropharyngeal cancer patients treated with definitive chemo-radiotherapy: Swall PEG study

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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