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J Thorac Cardiovasc Surg 2009;137:41-42
© 2009 The American Association for Thoracic Surgery
Invited Commentary |
We therefore acknowledge the efforts of Dr Darling and her colleagues in Toronto, who have taken the next step to measure HRQOL as an important outcome variable. This study will not only serve as a point of reference with respect to QOL outcomes for this particular induction treatment strategy but hopefully as a starting point at which QOL instruments are routinely included in future prospective clinical trials for locally advanced esophageal cancer.
I have 3 questions. In this study you used the FACT-E questionnaire to quantitate HRQOL, which is an instrument you have validated in a previous study. Do you believe, however, future refinements to this instrument might be helpful, such as refinements to better capture potentially serious side effects after esophagectomy, such as dumping, reflux, or delayed gastric emptying, which might not be identified with this instrument or any other currently used instruments for that matter?
Dr Darling. Thank you, Dr Kesler. I think that is a very good point.
The item generation for the esophageal cancer subscale was developed from patients with recently diagnosed esophageal cancer rather than from patients after esophagectomy. I agree that it probably does not completely address postesophagectomy problems. We have not initiated any refinements, but I think it warrants further study. I think that we are seeing a little bit of those problems when we look at the eating index after surgical intervention. As we who treat these patients all know, their eating can be significantly affected by dumping syndrome or other problems after esophagectomy, and I think that is being reflected in the eating index. However, it is probably worthwhile for us to take another look at it and to address some of those postesophagectomy issues.
Dr Kesler. Although the patients in this study returned to baseline HRQOL scores relatively quickly after both induction therapy and esophagectomy, the baseline score was measured after disease diagnosis. At diagnosis, most of these patients were symptomatic with dysphagia and weight loss, not to mention having experienced the psychologic consequences of being told they have a cancer that is not frequently cured. Do you think it is possible to somehow establish a baseline HRQOL score reflecting both physical and mental status before illness that would help differentiate the effect of the disease from the effect of the treatment and additionally provide a more accurate reference point to compare against QOL measurements over time?
Dr Darling. That is a very good question also. I think it would be difficult because most of these patients are referred already knowing the diagnosis. The fact that the emotional well-being score remains stable throughout the treatment protocol and thereafter speaks to the resilience of some of these patients with respect to that component of QOL. Therefore I do not think that it would be particularly different if we somehow picked them up before they actually had the diagnosis. We know that if we compare QOL with the Short Form–36 (SF-36), which is designed for normal persons, and measure QOL in patients with cancer, more specifically esophageal cancer, that their QOL is significantly less than we would see in healthy subjects, but I am not sure how to capture them before they have actually been given the diagnosis.
Dr Kesler. Lastly, the finding that patients who died within 1 year of diagnosis, presumably of recurrent disease, demonstrated a significant decrease in QOL compared with 1-year survivors seems fairly intuitive and would be expected. Did the decrease in QOL observed in these patients happen to precede any clinical or radiographic evidence of cancer? As a corollary, do you think this represents a potential marker that can be clinically useful to detect recurrence?
Dr Darling. The decrease in QOL scores did precede the radiologic diagnosis of recurrence. These patients were all on study, and therefore they were receiving routine computed tomographic scans looking for recurrence. But the QOL scores decreased and were not recovering before any imaging changes, and therefore we were already worried. I am sure we all have had those patients in our practice. They just do not get better after esophagectomy, and you are trying to figure out why. I think the FACT-E might be clinically useful in the future as a marker for recurrent disease. I have certainly already adopted it. When I have that patient who is just not getting better, I start looking harder. Just to be clear, these patients were not aware that they had recurrence, and we were not aware that they had recurrence at the time those questionnaires were completed. I do think it will be a useful marker.
Dr Kesler. Thank you. Congratulations.
Dr Darling: Thank you very much.
Dr Scott J. Swanson (New York, NY). I would like to follow up on that last point because it is very intriguing. Do you think if you had not operated on those patients that they would have had a steady decrease in their QOL scores? Is there something about the operation or the intensity of the treatment unmasking their ability to handle cancer, and is it actually speeding up dissemination in some way? What do you think is the actual mechanism that is going on there?
Dr Darling. We know historically that patients who were not cured by means of esophagectomy had a median survival of 9 to 12 months. I think we are actually just seeing that same time course in these patients for whom our treatment protocol did not improve their survival. I do not think it is the effect of the operation or the induction that causes that decrease in QOL score. I think we would have seen it anyway.
Dr Douglas E. Wood (Seattle, Wash). Gail, I am interested in whether you think that the scale that you used, a cancer-specific QOL scale, might be indeed what we want to capture, or might we actually be interested in a more general QOL scale, such as SF-36, for these patients? This is very important work. There is clearly a bias in our medical colleagues that patients have a poor QOL relating to treatment, including esophagectomy, for esophageal cancer. I do not know enough about the scale that you used to know the differences and the nuances and whether our argument might be stronger if we chose a generalized scale.
Dr Darling. Well, I think they are complementary. If you want to compare a healthy population with a disease-specific population, a cancer population, you can use the SF-36. Therefore it depends on your question. We are particularly interested in comparing cancer therapies. We are trying to cure more esophageal cancer but at a price of the toxicity. Therefore our goal in using a cancer-specific instrument was to use it in the future for comparing different treatment protocols. The SF-36 would be useful in addressing a different question, such as whether patients with esophagectomy get back to a "normal" QOL score.
Dr Alec Patterson (St Louis, Mo). Gail, I enjoyed the article.
I noticed that 20% of the patients did not complete the program.
Dr Darling. Yes.
Dr Patterson. Were they all from Toronto? I mean, did you have any handle on the quality of the induction therapy?
Dr Darling. They were essentially all from Toronto. Some of the chemotherapy was delivered elsewhere, but in fact, all the patients who did not complete it were actually at our center. Some were patients who were not overly enthusiastic about chemotherapy and were not tolerant of any side effects. They did not stop for specific toxicity reasons. It was not a case of an outside oncologist not supporting the trial.
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