LETTER TO THE EDITOR Quality of Life in Patients With Esophageal Squamous Cell Cancer Receiving Surgery or Definitive Chemoradiotherapy: Results From a Randomized Controlled Trial To the Editor:
T
eoh and colleagues1 should be commended for undertaking a difficult multicenter randomized controlled trial comparing standard esophagectomy with definitive chemoradiotherapy (CRT) for mid- or lowerthird esophageal squamous cell cancer and for incorporating an assessment of healthrelated quality of life (HRQL).2 We have several questions about the trial that require clarification. First, how many patients completed HRQL questionnaires at each assessment point? Missing HRQL questionnaires may occur because of ill health or death, and they are rarely missing at random. There were differences reported in HRQL outcomes between the surgery and CRT groups at baseline, and this may have occurred because of differential questionnaire response rates in each arm of the trial. Second, who completed the HRQL questionnaires in this study? The purpose of HRQL assessment is to capture participant’s experience and views. Questionnaires completed by researchers, nurses, or doctors may be subject to observer bias, leading to either an over- or under estimation of HRQL, and it is unclear whether HRQL questionnaires
were prospectively completed by participants themselves. Third, what were the confidence intervals for the HRQL outcomes? Without the presentation of these data, it is difficult to determine what the real effects of surgery and CRT on HRQL might be. Finally, why was there such a delay for the publication of the HRQL data, 5 years after the original trial? While it is appreciated that journal space is required to describe clinical and HRQL outcomes, presentation of data with this time gap does not allow clinical decision making to be based on combined clinical and HRQL outcomes, which is essential to inform practice. We are currently undertaking a feasibility randomized trial comparing chemotherapy and surgery with definitive CRT in patients with esophageal squamous cell cancer.3 Recruitment is challenging because very few patients with localized squamous cell cancer present in the UK and because of strong clinician and patient preferences for surgical and nonsurgical treatments. Our study is integrating qualitative research methods to understand barriers to trial recruitment,4 and it incorporates a comprehensive assessment of HRQL with patients themselves completing questionnaires at each time point. We believe that it is still necessary to undertake a full pragmatic multicenter trial comparing surgical and nonsurgical treatments in esophageal squamous cell cancer, but whether sufficient numbers of patients can be recruited in Western parts of the world is uncertain, and it is possible that such a trial could only be performed if patients with esophageal adenocarcinoma were included. For this to be achieved, more data about longterm outcomes of definitive CRT in adenocarcinoma of the esophagus are needed, and such a trial must ensure that a detailed HRQL assessment is performed with patients completing questionnaires themselves.5
Jane M. Blazeby, MD University of Bristol Bristol, UK [email protected] Sara Brookes, PhD University of Bristol Bristol, UK S. Mike Griffin, MD Newcastle Upon Tyne NHS Foundation Trust Newcastle upon Tyne, UK Tom Crosby Velindre Hospital, Cardiff, UK Jenny Donovan, PhD University of Bristol Bristol, UK Will Hollingworth, PhD University of Bristol Bristol, UK
REFERENCES 1. Teoh A, Chiu P, Wong T, et al. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation results from a randomized trial. Ann Surg. 2011;253:1–5. 2. Chiu P, Chan A, Leung S, et al. Multicenter prospective randomized trial comparing standard esophagectomy with chemoradiotherapy for treatment of squamous esophageal cancer: early results from the Chinese University Research Group for Esophageal Cancer (CURE). J Gastrointest Surg. 2005;9:794–802. 3. Blazeby J, Brookes ST, Griffin M, et al. Oesophageal squamous cell cancer: chemoradiotherapy versus chemotherapy and surgery—a feasibility study NIHR Research for patient benefit grant PBPG-0807–14131. http://www.nhs.uk/Conditions/ Cancer-of-the-oesophagus/Pages/clinical-trialdetails.aspx?TrialId=ISRCTN89052791& Condition=Cancer,oesophageal&pn=1&Rec=0& CT=0. Accessed March 7, 2012. 4. Donovan J, Mills N, Smith M, et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Br Med J. 2002;325:766–770. 5. Orringer MB. Defining a “successful” esophagectomy. Ann Surg. 2011;253:6.
Disclosure: The authors declare no conflicts of interest. C 2012 by Lippincott Williams & Wilkins Copyright ISSN: 0003-4932/12/25905-e0081 DOI: 10.1097/SLA.0b013e3182480871
Annals of Surgery r Volume 259, Number 5, May 2014
www.annalsofsurgery.com | e81
Copyright © 2012 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
T
eoh and colleagues1 should be commended for undertaking a difficult multicenter randomized controlled trial comparing standard esophagectomy with definitive chemoradiotherapy (CRT) for mid- or lowerthird esophageal squamous cell cancer and for incorporating an assessment of healthrelated quality of life (HRQL).2 We have several questions about the trial that require clarification. First, how many patients completed HRQL questionnaires at each assessment point? Missing HRQL questionnaires may occur because of ill health or death, and they are rarely missing at random. There were differences reported in HRQL outcomes between the surgery and CRT groups at baseline, and this may have occurred because of differential questionnaire response rates in each arm of the trial. Second, who completed the HRQL questionnaires in this study? The purpose of HRQL assessment is to capture participant’s experience and views. Questionnaires completed by researchers, nurses, or doctors may be subject to observer bias, leading to either an over- or under estimation of HRQL, and it is unclear whether HRQL questionnaires
were prospectively completed by participants themselves. Third, what were the confidence intervals for the HRQL outcomes? Without the presentation of these data, it is difficult to determine what the real effects of surgery and CRT on HRQL might be. Finally, why was there such a delay for the publication of the HRQL data, 5 years after the original trial? While it is appreciated that journal space is required to describe clinical and HRQL outcomes, presentation of data with this time gap does not allow clinical decision making to be based on combined clinical and HRQL outcomes, which is essential to inform practice. We are currently undertaking a feasibility randomized trial comparing chemotherapy and surgery with definitive CRT in patients with esophageal squamous cell cancer.3 Recruitment is challenging because very few patients with localized squamous cell cancer present in the UK and because of strong clinician and patient preferences for surgical and nonsurgical treatments. Our study is integrating qualitative research methods to understand barriers to trial recruitment,4 and it incorporates a comprehensive assessment of HRQL with patients themselves completing questionnaires at each time point. We believe that it is still necessary to undertake a full pragmatic multicenter trial comparing surgical and nonsurgical treatments in esophageal squamous cell cancer, but whether sufficient numbers of patients can be recruited in Western parts of the world is uncertain, and it is possible that such a trial could only be performed if patients with esophageal adenocarcinoma were included. For this to be achieved, more data about longterm outcomes of definitive CRT in adenocarcinoma of the esophagus are needed, and such a trial must ensure that a detailed HRQL assessment is performed with patients completing questionnaires themselves.5
Jane M. Blazeby, MD University of Bristol Bristol, UK [email protected] Sara Brookes, PhD University of Bristol Bristol, UK S. Mike Griffin, MD Newcastle Upon Tyne NHS Foundation Trust Newcastle upon Tyne, UK Tom Crosby Velindre Hospital, Cardiff, UK Jenny Donovan, PhD University of Bristol Bristol, UK Will Hollingworth, PhD University of Bristol Bristol, UK
REFERENCES 1. Teoh A, Chiu P, Wong T, et al. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation results from a randomized trial. Ann Surg. 2011;253:1–5. 2. Chiu P, Chan A, Leung S, et al. Multicenter prospective randomized trial comparing standard esophagectomy with chemoradiotherapy for treatment of squamous esophageal cancer: early results from the Chinese University Research Group for Esophageal Cancer (CURE). J Gastrointest Surg. 2005;9:794–802. 3. Blazeby J, Brookes ST, Griffin M, et al. Oesophageal squamous cell cancer: chemoradiotherapy versus chemotherapy and surgery—a feasibility study NIHR Research for patient benefit grant PBPG-0807–14131. http://www.nhs.uk/Conditions/ Cancer-of-the-oesophagus/Pages/clinical-trialdetails.aspx?TrialId=ISRCTN89052791& Condition=Cancer,oesophageal&pn=1&Rec=0& CT=0. Accessed March 7, 2012. 4. Donovan J, Mills N, Smith M, et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Br Med J. 2002;325:766–770. 5. Orringer MB. Defining a “successful” esophagectomy. Ann Surg. 2011;253:6.
Disclosure: The authors declare no conflicts of interest. C 2012 by Lippincott Williams & Wilkins Copyright ISSN: 0003-4932/12/25905-e0081 DOI: 10.1097/SLA.0b013e3182480871
Annals of Surgery r Volume 259, Number 5, May 2014
www.annalsofsurgery.com | e81
Copyright © 2012 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
