It is becoming essential that clinical trials include estimates of quality of life improvements in their assessments. Recently published is such an assessment of the German CLL4 trial which showed better remissions and longer progression-free survivals, though no difference in overall survival, for younger patients treated with fludarabine plus cyclophosphamide than for fludarabine alone.
Their conclusion is: fludarabine-based chemotherapy results in a small to moderate improvement of quality of life in CLL patients. The disease-associated symptoms of fatigue, insomnia, and appetite loss improved little to moderately after chemotherapy, at least in patients who responded to therapy. No significant differences in quality of life between both treatment arms were observed. The quality of life in CLL patients is significantly impaired compared with the general population, especially regarding role functioning, social functioning, and fatigue symptoms. Because CLL is still an incurable disease with conventional chemotherapy, measurement of quality of life ought to have an important role in future clinical trials.
Unfortunately, quality of life assessments were not made during the chemotherapy, so it was not really possible to look at the impairment in quality of life made by the increased toxicity and weigh up whether the very marginal extra improvement in quality of life was worth going through the toxicity.
3 comments:
Quality of life!! In September I began chemotherapy for CLL with F & P, on the 23rd day I developed tonsillitis – meds were stopped except a daily dose of Allupurinal - I was prescribed Amoxicillin for the tonsils. Within 12 hours I was covered with a hot itching rash and within 36 hours I looked like I had spent ten hours on a sun bed, I became swollen especially my face, eyes, mouth, feet and hands; all meds were stopped (including the Allupurinal) – I had IV antibiotics and immune boosters (subcutaneously) and a high dose of steroids. My skin pealed off twice, I burned and itched for three more weeks – I then developed the chicken pox (another might mare). It has taken eight weeks to recover from the acute allergic reaction which I believe was caused from Amoxicillin with Allupurinal (another medical error perhaps?). Before chemo I lead a very active life within my community and managed to play two rounds of golf a week. I am now too weak to play golf, still suffering from mild skin problems and too nervous to go into crowded places. The reason for chemo was –lymph’s had double within a year, night sweats and small clusters of nodes (neck, breasts and shoulders). It is now December and I have just completed my 2nd chemo with six more to go!! Is it worth it? – if there is only a very marginal improvement in quality of life definitely not. I will continue on with the chemo course because I am already damaged mentally and physically. My quality of life has changed dramatically and so have I!! The positive outcome is that I know I am blessed with a loving husband, caring children and a wonderful supportive community. Jan
I recently attended the NICE conference in Birmingham, and while it was extremely complex, QOL was mentioned several times. Essentially, it appears that the QOL will be taken into account when any proposed change to the NHS system is examined. The inference was that a new treatment would not only have to have a low QUALY(quality of life year) value, presently £20-30K, possible to be a lot lower £12-14K in the future, but a high rating on QOL. It was mentioned by a participant that this would leave most new cancer treatments untenable, depite any adjustment for money saved by adopting a new system. Of course, this does not mean that a clinician cannot use his/her judgment.
Always assuming that quality of life measurements have any real meaning. I find it interesting that NICE was the name given to the evil domineering authority in CS Lewis's book "That Hideous Strength" In that book NICE stood for The National Institute for Coordinated Experiments.
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