[Patient-reported outcomes in head and neck cancer treatment: relevance, challenges, and benefit].
Patientenberichtete Endpunkte in der Kopf-Hals-Tumortherapie: Relevanz, Herausforderungen und Nutzen.
Health Technology Assessment
Quality of life
Shared decision making
Side effects
Survival
Journal
HNO
ISSN: 1433-0458
Titre abrégé: HNO
Pays: Germany
ID NLM: 2985099R
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
accepted:
17
05
2023
medline:
29
8
2023
pubmed:
9
7
2023
entrez:
8
7
2023
Statut:
ppublish
Résumé
Next to overall survival, quality of life is becoming more and more pivotal for cancer patients. The various domains of quality of life are complex and have different value to each patient. However, not only patients but also health care professionals, the pharmaceutical industry, and regulatory bodies ask: How can quality of life be reliably ascertained in clinical trials? For this purpose, carefully developed and validated specific questionnaires are needed: the patient-reported outcome measures (PROMs). A key challenge is to define how results based on PROMs can be used for shared decision-making. Next to clinical factors such as health and nutritional status, quality of life acts as a prognostic factor for overall survival in cancer. Thus, it is crucial to take quality of life into account in daily clinical practice. Neben dem möglichst langen Überleben spielt die Lebensqualität nach einer Krebserkrankung immer mehr eine Rolle für die Betroffenen. Die verschiedenen Lebensqualitätsbereiche sind komplex und werden individuell unterschiedlich gewichtet. Nicht nur für die Patient*innen, sondern auch für Ärzt*innen, die pharmazeutische Industrie und auch für die Zulassungsbehörden stellt sich die Frage: Wie kann man in klinischen Studien verlässlich feststellen, wie die Lebensqualität der Patient*innen ist? Dazu werden sorgfältig entwickelte und validierte Fragbögen benötigt, die Patient-Reported Outcome Measures (PROM). Die Herausforderung hierbei ist, Ergebnisse entsprechender Studien dazu nutzen zu können, die gemeinsame Entscheidungsfindung zu verbessern. Neben klinisch bekannten Faktoren wie Allgemein- und Ernährungszustand ist die Lebensqualität ebenfalls ein prognostischer Faktor für das Überleben im Rahmen von onkologischen Erkrankungen. Insofern spielt die Lebensqualität auch vor diesem Hintergrund eine klinisch bedeutsame Rolle und sollte entsprechend berücksichtigt werden.
Autres résumés
Type: Publisher
(ger)
Neben dem möglichst langen Überleben spielt die Lebensqualität nach einer Krebserkrankung immer mehr eine Rolle für die Betroffenen. Die verschiedenen Lebensqualitätsbereiche sind komplex und werden individuell unterschiedlich gewichtet. Nicht nur für die Patient*innen, sondern auch für Ärzt*innen, die pharmazeutische Industrie und auch für die Zulassungsbehörden stellt sich die Frage: Wie kann man in klinischen Studien verlässlich feststellen, wie die Lebensqualität der Patient*innen ist? Dazu werden sorgfältig entwickelte und validierte Fragbögen benötigt, die Patient-Reported Outcome Measures (PROM). Die Herausforderung hierbei ist, Ergebnisse entsprechender Studien dazu nutzen zu können, die gemeinsame Entscheidungsfindung zu verbessern. Neben klinisch bekannten Faktoren wie Allgemein- und Ernährungszustand ist die Lebensqualität ebenfalls ein prognostischer Faktor für das Überleben im Rahmen von onkologischen Erkrankungen. Insofern spielt die Lebensqualität auch vor diesem Hintergrund eine klinisch bedeutsame Rolle und sollte entsprechend berücksichtigt werden.
Identifiants
pubmed: 37422597
doi: 10.1007/s00106-023-01325-7
pii: 10.1007/s00106-023-01325-7
doi:
Types de publication
English Abstract
Journal Article
Review
Langues
ger
Sous-ensembles de citation
IM
Pagination
592-598Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.
Références
Aaronson N, Ahmedzai S, Bergmann B et al (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. J Natl Cancer Inst 85:365–376
pubmed: 8433390
Bergelt C, Scholl I, Härter M (2016) Chancen und Barrieren partizipativer Entscheidungsfindung in der Onkologie. Forum DKG 31:140–143
Bergner M, Bobbitt RA, Carter WB et al (1981) The Sickness Impact Profile: development and final revision of a health status measure. Med Care 19:787–805
pubmed: 7278416
Bjordal K, De Graeff A (2000) A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients. Eur J Cancer 36:1796–1807
pubmed: 10974628
Böhme S, Singer S, Kauffmann S et al (2022) Es braucht neue Ansätze für Lebensqualitätsdaten. Monit Versorgungsforsch 15:43–47
Brazier J, Deverill M (1999) A checklist for judging preference-based measures of health related quality of life: Learning from psychometrics. Health Econ 8:41–51
pubmed: 10082142
Bundesgesundheitsministerium (2020) Ziele des Nationalen Krebsplans
Bussmann L, Laban S, Wittekindt C et al (2020) Comparative effectiveness trial of transoral head and neck surgery followed by adjuvant radio(chemo)therapy versus primary radiochemotherapy for oropharyngeal cancer (TopROC). BMC Cancer 20:701
pubmed: 32727416
pmcid: 7389683
Cella DF, Tulsky DS, Gray G et al (1993) The functional assessment of cancer therapy scale: Development and validation of the general measure. J Clin Oncol 11:570–579
pubmed: 8445433
Chen AY, Frankowski R, Bishop-Leone J et al (2001) 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 Neck Surg 127:870–876
Cocks K, Contente M, Simpson S et al (2019) A Q‑TWiST analysis comparing Nivolumab and therapy of investigator’s choice in patients with recurrent/metastatic platinum-refractory squamous cell carcinoma of the head and neck. PharmacoEconomics 37:1041–1047
pubmed: 30972702
pmcid: 6830425
De Haes JC, Van Knippenberg FC, Neijt JP (1990) Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. Br J Cancer 62:1034–1038
pubmed: 2257209
pmcid: 1971567
Eichler M, Singer S, Hentschel L et al (2022) Health Related Quality of Life is a prognostic factor for 1‑year-survival in sarcoma patients—Results of a Nationwide Observational Study (PROSa). Br J Cancer 126:1346–1354
pubmed: 35058591
pmcid: 9042816
Elwyn G, Durand MA, Song JL et al (2017) A three-talk model for shared decision making: multistage consultation process. BMJ 359:7
Fahsl S, Keszte J, Boehm A et al (2012) Clinical relevance of quality of life data in laryngectomized patients. Laryngoscope 122:1532–1538
pubmed: 22460390
Fried TR, Bradley EH, Towle VR et al (2002) Understanding the treatment preferences of seriously ill patients. N Engl J Med 346:1061–1066
pubmed: 11932474
Group TE (1990) EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 16:199–208
Group W (1994) The development of the WHO quality of life assessment instrument (WHOQOL). In: Orley J, Kukyen W (Hrsg) Quality of life assessment:international perspectives. Springer, Heidelberg
Hajdu SF, Wessel I, Dalton SO et al (2022) Swallowing exercise during head and neck cancer treatment: results of a randomized trial. Dysphagia 37:749–762
pubmed: 34117531
Hassan SJ, Weymuller EA Jr. (1993) Assessment of quality of life in head and neck cancer patients. Head Neck 15:485–496
pubmed: 8253555
Hoffmann TK (2022) The ORATOR trials—an update: Primary surgery or radiotherapy for HPV-associated oropharyngeal cancer. HNO 70:579–580
pubmed: 35727350
John MT, Patrick DL, Slade GD (2002) The German version of the oral health impact profile—translation and psychometric properties. Eur J Oral Sci 110:425–433
pubmed: 12507215
Kaplan RM, Debon M, Anderson BF (1991) Effects of number of rating scale points upon utilities in a quality of well-being scale. Med Care 29:1061–1064
pubmed: 1921526
Kemmler G, Gamper E, Nerich V et al (2019) German value sets for the EORTC QLU-C10D, a cancer-specific utility instrument based on the EORTC QLQ-C30. Qual Life Res 28:3197–3211
pubmed: 31485913
pmcid: 6863792
Koerber SA, Seither B, Slynko A et al (2019) Chemoradiation in female patients with anal cancer: Patient-reported outcome of acute and chronic side effects. Tumori 105:174–180
pubmed: 30484384
Lapen K, King C, Braunstein LZ et al (2022) A comparison of patient- and clinician-reported acute toxic effects during radiation therapy for primary breast cancer. Int J Radiat Oncol Biol Phys 114:301–309
pubmed: 35675851
List MA, D’antonio LL, Cella DF et al (1996) The performance status scale for head and neck cancer patients and the functional assessment of cancer therapy-head and neck scale. A study of utility and validity. Cancer 77:2294–2301
pubmed: 8635098
List MA, Rutherford JL, Stracks J et al (2004) Prioritizing treatment outcomes: head and neck cancer patients versus nonpatients. Head Neck 26:163–170
pubmed: 14762885
List MA, Stracks J, Colangelo L et al (2000) How Do head and neck cancer patients prioritize treatment outcomes before initiating treatment? J Clin Oncol 18:877–884
pubmed: 10673531
Loser A, Avanesov M, Thieme A et al (2022) Nutritional status impacts quality of life in head and neck cancer patients undergoing (chemo)radiotherapy: results from the prospective HEADNUT trial. Nutr Cancer 74:2887–2895
pubmed: 35209777
Mchorney CA, Bricker DE, Kramer AE et al (2000) The SWAL-QOL outcomes tool for oropharyngeal dysphagia in adults: I. Conceptual foundation and item development. Dysphagia 15:115–121
pubmed: 10839823
Mchorney CA, Bricker DE, Robbins J et al (2000) The SWAL-QOL outcomes tool for oropharyngeal dysphagia in adults: II. Item reduction and preliminary scaling. Dysphagia 15:122–133
pubmed: 10839824
Mchorney CA, Ware JE Jr., Lu JF et al (1994) The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 32:40–66
pubmed: 8277801
Mehanna HM, De Boer MF, Morton RP (2008) The association of psycho-social factors and survival in head and neck cancer. Clin Otolaryngol 33:83–89
pubmed: 18429854
Messing BP, Ward EC, Lazarus CL et al (2017) Prophylactic swallow therapy for patients with head and neck cancer undergoing chemoradiotherapy: a randomized trial. Dysphagia 32:487–500
pubmed: 28444488
pmcid: 5515964
Meyer A, Dietz A, Wollbrück D et al (2012) Schluckstörungen nach Kehlkopfteilresektion: Auftrittshäufigkeit und Prädiktoren. HNO 60:892–900
pubmed: 22903464
Meyer F, Fortin A, Gelinas M et al (2009) Health-related quality of life as a survival predictor for patients with localized head and neck cancer treated with radiation therapy. J Clin Oncol 27:2970–2976
pubmed: 19451440
Mogadas S, Busch CJ, Pflug C et al (2020) Influence of radiation dose to pharyngeal constrictor muscles on late dysphagia and quality of life in patients with locally advanced oropharyngeal carcinoma. Strahlenther Onkol 196:522–529
pubmed: 32006068
Mowery YM, Salama JK (2022) Interpreting ORATOR: lessons learned from a randomized comparison of primary surgical and radiation approaches for early-stage oropharyngeal cancer. J Clin Oncol 40:814–817
pubmed: 35077196
Musoro J, Coens C, Singer S et al (2020) Minimally important differences for interpreting European Organisation for Research and Treatment for Cancer Quality of life Core Questionnaire scores in patients with head and neck cancer. Head Neck 42:3141–3152
pubmed: 32627261
Nguyen H, Butow P, Dhillon H et al (2020) Using patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) in routine head and neck cancer care: What do health professionals perceive as barriers and facilitators? J Med Imaging Radiat Oncol 64:704–710
pubmed: 32394587
Nichols AC, Theurer J, Prisman E et al (2019) Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial. Lancet Oncol 20:1349–1359
pubmed: 31416685
Nichols AC, Theurer J, Prisman E et al (2022) Randomized trial of radiotherapy versus transoral robotic surgery for oropharyngeal squamous cell carcinoma: long-term results of the ORATOR trial. J Clin Oncol 40:866–875
pubmed: 34995124
Palma DA, Prisman E, Berthelet E et al (2022) Assessment of toxic effects and survival in treatment deescalation with radiotherapy vs transoral surgery for HPV-associated oropharyngeal squamous cell carcinoma: the ORATOR2 phase 2 randomized clinical trial. JAMA Oncol 8:1–7
pubmed: 35482348
pmcid: 8874872
Quinten C, Coens C, Mauer M et al (2009) Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. Lancet Oncol 10:865–871
pubmed: 19695956
Rammant E, Ost P, Swimberghe M et al (2019) Patient- versus physician-reported outcomes in prostate cancer patients receiving hypofractionated radiotherapy within a randomized controlled trial. Strahlenther Onkol 195:393–401
pubmed: 30406289
Reeve B, Wyrwich K, Wu A et al (2013) ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res 22:1889–1905
pubmed: 23288613
Rischin D, Harrington KJ, Greil R et al (2022) Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048. Oral Oncol 128:105815
pubmed: 35381576
Rogers SN, Barber B (2017) Using PROMs to guide patients and practitioners through the head and neck cancer journey. Patient Relat Outcome Meas 8:133–142
pubmed: 29184455
pmcid: 5687779
Rogers SN, Gwanne S, Lowe D et al (2002) The addition of mood and anxiety domains to the University of Washington quality of life scale. Head Neck 24:521–529
pubmed: 12112548
Rosenthal DI, Mendoza TR, Chambers MS et al (2007) Measuring head and neck cancer symptom burden: the development and validation of the M. D. Anderson symptom inventory, head and neck module. Head Neck 29:923–931
pubmed: 17358040
Roth AJ, Kornblith AB, Batel-Copel L et al (1998) Rapid screening for psychologic distress in men with prostate carcinoma: a pilot study. Cancer 82:1904–1908
pubmed: 9587123
Rummans TA, Bostwick JM, Clark MM et al (2000) Maintaining quality of life at the end of life. Mayo Clin Proc 75:1305–1310
pubmed: 11126840
Sherbourne CD, Sturm R, Wells KB (1999) What outcomes matter to patients? J Gen Intern Med 14:357–363
pubmed: 10354256
pmcid: 1496594
Shune SE, Karnell LH, Karnell MP et al (2012) Association between severity of dysphagia and survival in patients with head and neck cancer. Head Neck 34:776–784
pubmed: 22127835
Singer S, Amdal CD, Hammerlid E et al (2019) 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 41:1725–1737
pubmed: 30636188
Singer S, Araújo C, Arraras J et al (2015) Measuring quality of life in head and neck cancer patients—Update of the EORTC QLQ-H&N module, phase III. Head Neck 37:1358–1367
pubmed: 24832623
Singer S, Danker H, Guntinas-Lichius O et al (2014) Quality of life before and after total laryngectomy—Results of a multi-centre prospective cohort study. Head Neck 36:359–368
pubmed: 23728844
Singer S, Hammerlid E, Tomaszewska IM et al (2022) Methodological approach for determining the minimal important difference and minimal important change scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-HN43) exemplified by the swallowing scale. Qual Life Res 31:841–853
pubmed: 34272632
Singer S, Jordan S, Locati L et al (2017) The EORTC module for quality of life in patients with thyroid cancer—phase III. Endocr Relat Cancer 24:197–207
pubmed: 28223365
Singer S, Papsdorf K, Gäbelein G et al (2015) Lebensqualität als prognostischer Faktor für das Überleben bei Patienten mit Ösophaguskarzinom. Onkologe 21:57–61
Singer S, Vogel H‑J, Guntinas-Lichius O et al (2019) Multicenter prospective study on the use and outcome of rehabilitation after total laryngectomy in Germany. Head Neck 41:1070–1079
pubmed: 30548728
Slade GD (1998) Assessing change in quality of life using the oral health impact profile. Commun Dent Oral Epidemiol 26:52–61
Smets EMA, Garssen B, Bonke B et al (1995) The multidimensional fatigue inventory (MFI) Psychometric qualities of an instrument to assess fatigue. J Psychosom Res 39:315–325
pubmed: 7636775
Steen-Olsen EB, Stormoen DR, Kristensen CA et al (2022) Patient-reported outcome during radiotherapy for head and neck cancer: the use of different PRO questionnaires. Eur Arch Otorhinolaryngol 279:4199–4206
pubmed: 35357578
Stein JD, Newman-Casey PA, Mrinalini T et al (2014) Cost-effectiveness of bevacizumab and ranibizumab for newly diagnosed neovascular macular degeneration. Ophthalmology 121:936–945
pubmed: 24405740
Taylor K, Amdal CD, Bjordal K et al (2023) Serious long-term effects of head and neck cancer from the survivors’ point of view. Healthcare 11:906
pubmed: 36981562
pmcid: 10048748
Teckie S, Gross ND (2022) The ORATOR trials have spoken-where do we go from here? JAMA Oncol 8:1–2
pubmed: 35482361
Tribius S, Raguse MC, Voigt C et al (2015) Residual deficits in quality of life one year after intensity-modulated radiotherapy in patients with locally advanced head and neck cancer: results of a prospective study. Strahlenther Onkol 191:501–510
pubmed: 25747264
Vaandering A, Jansen N, Weltens C et al (2023) Radiotherapy-specific quality indicators at national level: How to make it happen. Radiother Oncol 178:9
Ware JE Jr., Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473–483
pubmed: 1593914
Yeung AR, Pugh SL, Klopp AH et al (2020) Improvement in patient-reported outcomes with intensity-modulated radiotherapy (RT) compared with standard RT: a report from the NRG oncology RTOG 1203 study. J Clin Oncol 38:1685
pubmed: 32073955
pmcid: 7238486
Zebralla V, Müller J, Wald T et al (2020) Obtaining patient-reported outcomes electronically with “Oncofunction” in head and neck cancer patients during aftercare. Front Oncol 10, Article Number 549915. https://doi.org/10.3389/fonc.2020.549915
Zigmond AS, Snaith RP (1983) The hospital anxiety and depression scale. Acta Psychiatr Scand 67:361–370
pubmed: 6880820