Yesterday I finally experienced one of the commonest side effects of chemotherapy. I had my third infusion of dacarbazine which went without problems for the first forty minutes or so, then I began to feel nauseous. By the time the infusion was completed I was feeling very green indeed. It was hot in the chemotherapy day unit and I thought I'd feel better once I got outside into the fresh air, unfortunately I only made it to the oncology centre car park before I began to be sick. That lasted for about an hour, it was an interesting experience being driven back to Bath by Katie whilst repeatedly throwing up - not one I can recommend! Luckily the hospital had given us a number of cardboard bowls so at least it wasn't messy (see, there is always a bright side if you look hard enough!). I went to bed when I got home and felt a little easier after I'd had some sleep. I'm still feeling nauseous today but not to the same extent as yesterday. It just goes to show that you can't make any assumptions about how each treatment is going to go, every one can offer a surprise.
I spend a considerable amount of time researching my illness and possible treatments for it. As part of this I often read scientific papers that present the results of clinical trials and other research. A few months ago I read a report on a piece of research that had been done by a UK based team. This looked at the quality of life of people with advanced soft tissue sarcoma (ASTS). I was interested in this paper for two reasons, first because LMS is a type of STS and secondly because quality of life is one of the factors often considered by regulators when deciding whether a new treatment for a condition is cost effective. Simply put a costly drug that fails to provide a decent quality of life for patients may not be worth funding even if it extends the lives of those patients.
The report that I refer to above is entitled "Utility Values for Advanced Soft Tissue Sarcoma Health States from the General Public in the United Kingdom" and was co-authored by Julian F. Guest, Erikas Sladkevicius, Nicholas Gough, Mark Linch and Robert Grimer. The authors of the paper are all involved in research into and/or treatment of sarcoma. The lead author, Julian Guest, also runs his own consultancy business through which this research was conducted. The full report is freely available at this link.
When I read the report I had a number of concerns about the methodology used in the research and the conclusions that the report seemed to support. I'm not one for writing letters to the authors of scientific papers, I've never done that before, however in this case I felt that the research was flawed and could be damaging to the interests of ASTS patients if used by regulatory authorities in their assessment of new treatments.
My main concern about the research was that it involved asking members of the general public to estimate their preferences for various health states associated with different responses to chemotherapy treatment for ASTS. My own experience convinces me that members of the public, most of whom will not even have heard of soft tissue sarcoma, are unlikely to be able to anticipate how they would react to being diagnosed with an advanced form of this disease let alone to meaningfully comment on how they would feel about various health states following chemotherapy treatment for the illness.
I remember well my own initial reaction to my diagnosis which was to fear that I would be unable to enjoy anything in life with this illness hanging over me. I remember too how quickly I adjusted and found that I could enjoy so many things just as I had before I was ill. There is no reason, other than time and cost, that prevented the research being conducted on patients who actually have ASTS. As the authors have themselves accepted in their replies to my concerns, this would be the preferred option for this type of research. I find it interesting to note that two other quality of life studies that did use ASTS patients rather than members of the public both provided higher quality of life estimates than the UK study.
I also have a number of concerns regarding the descriptions of the health states used in the research. Whilst I accept that these seek to describe the experience of the average ASTS patient I found them to be written so as to preclude a reader from understanding that those in each state could have a much more positive experience than suggested by the descriptions. Indeed, some of the health state descriptions preclude a patient from having experiences that I myself have had whilst in those health states.
Having initially shared my concerns with the authors of the paper they provided a reply and suggested that, if I was not satisfied, I should write to the editor of Sarcoma, the journal that published the paper. On receipt of my letter the editor asked the authors for a response which they duly provided. Unfortunately, the editor of Sarcoma has informed me that they are unable to publish either my letter or the response from the authors, however I want to make sure that my concerns are in the public domain and so have decided to share them here. Below I provide links to my letter to the editor of Sarcoma and the response from the authors of the paper.
For completeness, I also include my rather more detailed initial letter to the authors of the report and the response I received from Dr Mark Linch, one of the co-authors.
I'm very supportive of research into patient quality of life in ASTS and other cancers. Such research is of great importance in helping doctors, patients and regulatory authorities decide when certain treatments are appropriate and cost effective. However, research into this topic must be done to the highest standards if it is to be used to make crucial decisions that will have a tremendous impact on patients and their loved ones. In my view, short cuts are not acceptable.