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Health-related quality of life and cancer Expert Rev. Pharmacoeconomics Outcomes Res. 9(1), 9–11 (2009)
Andrew Bottomley European Organization for Research and Treatment of Cancer, Avenue E. Mounierlaan, 83/11, Brussels, Belgium Tel.: +32 027 741 661 Fax: +32 027 794 568 andrew.bottomley @eortc.be www.eortc.be/home/qol
Andrew Bottomley’s background includes studies as a psychologist in the UK, where he obtained a PhD by examining the impact of group psychological interventions on cancer patients’ health-related quality of life (HRQoL). Dr Bottomley’s passion for more than the last decade and a half has been to understand the consequences of cancer and its treatment on patients’ HRQoL. Since 1998 he has led the European Organisation for Treatment of Cancer (EORTC) Quality of Life Department, based in Brussels, Belgium. Dr Bottomley serves on numerous Editorial Boards. He also serves on the Ethical Committee of the WHO International Agency for Research in Cancer, in Lyon, France, and has served as a scientific advisor the European Commission for the 7th Framework program as well as an ethical advisor for the framework. He is a founding member of the Cochrane collaboration HRQoL methods group.
❚❚How did you first become involved in health-related quality of life research? Perhaps like most people working in cancer, it was a tragedy that set me on this career track. About 25 years ago my then fiancée developed a grade 4 astrocytoma, an aggressive brain cancer. After surgery, she underwent chemotherapy and radiotherapy, but her prognosis was poor. She died in my home after experiencing a low health-related quality of life (HRQoL) and a very short life. From my medical experiences I realized that the methods used by health workers in supporting cancer patients needed to undergo major changes. I understood so little about doctor–patient interaction, about patient choice, about HRQoL and symptom management, and about end-of-life care, and things needed to improve. This lack of information and insight eventually led me to a PhD in psychology, where I looked at cancer patients and psychosocial therapy. This directed me into HRQoL research, where it is possible to make changes that can alter clinical practice for vulnerable cancer sufferers.
EORTC is a wonderful organization that allows me to pursue a HRQoL research agenda for the headquarters and select one that fits the needs of the clinical trials groups that we work with. The EORTC also offers a network that only few can dream of, and we are often lucky enough to work with world leaders in cancer such as Professors Charles Cleeland, Lex Eggermont, Henning Flechtner, Carolyn Gotay, Jan van Meerbeeck, Françoise Meunier, Martine Piccart, Martin Taphoorn, Galina Velikova and the eminent Professor Mirjam Sprangers. My former mentor, Professor Ann Cull, is retiring this year and I am sure she would be embarrassed to hear she was a major guiding light when I arrived at the EORTC. I am also very lucky to have the constant support of Professor Meunier, the Director General of the EORTC, who saw the value of a HRQoL department as early as 1993. She established the department at that time that has grown constantly since. I think we are one of the few active departments specifically focusing on HRQoL in cancer clinical trials in the EU. On a daily basis, I work on the design of ❚❚You are Head of the Quality of Life large randomized clinical trials, working Department at the European with academics, statisticians, clinicians, Organisation for Treatment of Cancer. and more frequently, industry partners. What led to you taking on this role, Much of my time is spent with staff, runand what does it entail? ning a busy and vibrant department, dealWorking at the European Organisation for ing with staff management, recruitment, Treatment of Cancer (EORTC) offers a project management, advising industry wealth of opportunities to undertake crea- on joint trial design and analysis, writing tive, but rigorous, scientific studies. The publications and setting policy on research www.expert-reviews.com
10.1586/14737167.9.1.9
© 2009 Expert Reviews Ltd
ISSN 1473-7167
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Interview
Bottomley
within the EORTC and further afield on HRQoL. Much of my job involves travel, but having done this for over a decade, I am lucky to have a skilled and very motivated team who often share the burden of presentations and travel, and speak on behalf of the interests of the EORTC Quality of Life Department. One of my key roles is fostering international collaboration with our department and the EORTC. To date, we have carried out some highly interesting and specialized work with the MD Anderson Cancer Center (TX, USA), working with Professor Cleeland, the celebrated pain researcher, who wrote, in my view, the best textbook available on pain. Our collaboration has led to excellent output and made good use of resources both in the USA and at the EORTC. On a personal note, they always say that behind every successful man is a busy and dedicated woman, and this could not be more true, as my productivity could not be achieved without the constant support of my wife. My wife and our 6-month-old baby girl tolerate my long working hours in my drive to make the department more of a success and to maintain productivity so we can improve patients HRQoL with new and innovative therapies. ❚❚How has the use of HRQoL assessment tools changed since you took on the role? This has changed dramatically. Over the last decade the quality of tools has improved vastly. For example, the EORTC tools have undergone extensive testing, which frequently takes 4 years before final validation. The translation process proved more complex, but higher quality is now demonstrated and an increasing number of guidelines are being produced. US FDA guidance on patient-reported outcomes detailed the need for robust translations and those not carried out in accordance with rigorous practice will not be accepted. A decade ago it was not common to look at HRQoL in trials, but it is now very common. We have recently reported that the quality of reporting clinical trial results with HRQoL tools has improved; however, there is still room for improvement. New electronic tools, such as personal digital assistant (PDA) and touch-screen technologies have emerged, although more rapidly in the USA than Europe. This is understandable, as clinical trials in Europe are more complex, and different platforms need the correct translations. Therefore, some challenges still exist, but are slowly being overcome. ❚❚In your recent publication in the European Journal of Cancer you discuss the development of a module to supplement the EORTC QLQ-C30. Could you explain the need for this new module? As we note in our European Journal of Cancer article [1] , bone metastases are a frequent complication of cancer that are reported in 70–85% of cancer patients at autopsy. With advances in the systemic treatment of advanced cancer patients with osseous metastases there is a fundamental requirement for the development of a HRQoL assessment tool that is specific to patients with bone metastases, in order to provide a comprehensive evaluation of the benefits and possible side effects of any intervention. Often the objective effects of treatments on bone metastases have proven difficult to measure (e.g., using traditional investigations such as x-rays, CT or MRI) 10
and the assessment of patient-subjective benefit is, therefore, critically important. However, our literature search found that robustly developed bone metastases-specific HRQoL instruments are lacking. Therefore, with the dynamic Canadian clinician, Dr Edward Chow and his team, we set about developing a module. As a result, we now have a new EORTC QLG-valid tool for use internationally with patients with bone mestastases. ❚❚What further validation will the module have to undergo before it can be used in clinical trials? We will undertake more validation at the Phase IV level, which involves large sampling, on an international basis, lead by Dr Chow and Professor Martin Taphoorn, and we are also planning to validate this measure in patients with brain mestastases. ❚❚What other modules are you currently working on? I am always involved in module development, for example, looking at new modules for fatigue and pain. However, more recently my personal interest and those of the EORTC have merged to focus on large Phase III clinical trials with HRQoL end points, as well as policy and strategy work. We hope to have a chance to alter clinical practice in randomized controlled trials, such as the study EORTC published using radiotherapy alone versus radiotherapy with concomitant and adjuvant temozolomide for patients with glioblastoma. This study was led by the pioneering brain expert, Dr Roger Stupp and later Martin Taphoorn and myself, who led the HRQoL part of the study. Our results showed better survival and even some slight improvements in HRQoL in some scales in the temozolomide arm. This information, plus the major clinical difference in survival, changed practice in only a few weeks. ❚❚You are also leading the Patient Reported Outcomes and Behavioural Evidence project, which has recently been awarded a major grant. What are the aims of this project? Patient Reported Outcomes and Behavioural Evidence (PROBE) aims to use existing data from multiple trials collected over many years across different countries [2] . By integrating HRQoL data from over 10,000 patients collected in robust, already published randomized controlled trials, the EORTC is addressing key questions such as:
• Are the measurements of HRQoL as captured by the EORTC QLQ-C30 tool, or any of the 15 individual HRQoL parameters within the QLQ-C30, prognostic of survival? It is also addressing how different languages and cultures shape our understanding of HRQoL and affect the interpretations made from international HRQoL data sets. The initiative is also considering: • Whether the presence of symptom clusters can provide additional prognostic information about the survival chances or well-being of cancer patients • New clinical end points • Whether we can improve the utility of clinical trials by using different time windows, or the collection and analysis of data thus obtained Expert Rev. Pharmacoeconomics Outcomes Res. 9(1), (2009)
Health-related quality of life & cancer
In considering such issues, we must identify the most robust statistical methods to analyze data derived from different clinical trial settings and create the best methods to interpret these data. The EORTC international collaborative initiative will attempt to address these many unresolved issues over the next 2 years through an extensive analysis of existing EORTC data. PROBE is also holding a free conference in November 2009, which anyone can attend due to the free registration for academics who register by early summer. In addition, 30 travel fellowships of up to €600 each will be awarded. In my view, having chaired various conferences before, training is essential in the QOL field, as we need to ensure that our top clinical trial researchers are fully aware of the methods we use. Please see the PROBE website [2] to register for this unique training opportunity. ❚❚What impact do you hope the results will have on the field? I hope they will change practice and promote HRQoL research, spread the word of HRQoL in developing countries and also help us to train young researchers for the future. We hope PROBE could serve as a repository for other international groups, making more retrospective analysis using existing resources possible. There is a great deal we do not understand about HRQoL, and at times over the last 10 years, while we have made good progress, I have felt frustrated that we have not done more. This peer-reviewed grant from the Pfizer foundation was rare in a world of large grant competition. In the future I hope funding bodies such as the European Commission will support more HRQoL research. It is a field that offers so much promise and illustrates a clear need for funding to help address the many outstanding questions we face.
Interview
I also peer-review many grants with the European Commission, and it is a pleasure to look at some of the high-quality proposals and the standards that are being set by European researchers. We have many clever, bright young researchers coming through to replace our skilled colleagues who will be retiring in the coming decade. ❚❚Finally, as Senior Editor for the journal, what areas do you think will be important to the field over the coming year? There are so many developments that can be looked at. We need to look more closely at the economics of medicine; debate new and existing health economic practices. The price of drugs is constantly increasing, and we need to know who will pay for these in the future. I would like there to be more debate on QALYs and how NICE is using this approach, given that the NICE model is being used in different countries. Inequities exist within some countries such as the UK, where some expensive cancer drugs are either free or not depending on the area in which you live. Do such issues influence HRQoL or life expectancy? What about HRQoL of individuals rather than groups? Little research has been done on this and it is needed. The challenge of understanding HRQoL in children is an important area that requires more study, and at the other end of the spectrum, what about the HRQoL of the elderly? What is an elderly patient? This is a challenge, but needs some attention and the journal would be a great place to publish such research results. In summary, huge opportunities exist for the future. I trust, with the help of the journal’s excellent Editorial Board, we will provide our readers with articles on as yet not fully understood, but amazing, subject areas. Financial & competing interests disclosure
❚❚What other areas is your research currently focusing on? Most of my research is focused on cancer clinical trials. I enjoy the challenge of trying to find the best treatment for each patient, with minimum side effects. Clearly, each trial is a calculated risk, otherwise you would not do it. Sometimes we are lucky, at other times the HRQoL results are not as interesting, which unfortunately is the way with clinical trials. I also have a keen interest in ethics and how trials and studies influence patients. Over the years, I have been both a member of and chaired Ethics Committees with the International Agency of Research in Lyon and at the European Commission. The pleasure here is to get others to see the challenges academic researchers such as myself face, while at the same time protecting patient interests.
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The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
References 1
Chow E, Hird A, Velikova G et al. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for patients with Bone Metastases: The EORTC QLQ-BM22. Eur. J. Cancer DOI: 10.1016/j.ejca.2008.11.013 (2008) (Epub ahead of print).
2
Patient Reported Outcomes and Behavioural Evidence (PROBE) www.eortc.be/probe/index.htm
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