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.