Quality of life as a primary end point in oncology



http://www.springerlink.com/content/q2u4u6n081877641/

Fausto Roila1 and Enrico Cortesi2
(1) Medical Oncology Division, Policlinico Hospital, Perugia, Italy
(2) Department of Experimental Medicine, , ?La Sapienza? University,
Rome, Italy

Abstract Background:In cancer clinical trials, the standard end points
include response rates, progression free and overall survival, toxicity.
These evaluation criteria do not measure how the cancer and its treatment
affect the quality of life of cancer patients.

Design:The relevant literature was reviewed for the purposes of
determining when, how and why quality of life should be measured in cancer
clinical trials. The resulting clinical benefits were also reviewed.

Results:

Along with survival, quality of life is the main endpoint of comparative
clinical trials. Its evaluation can provide physicians and patients with
important information and help to identify a better treatment.

Cancer-specific questionnaires with forms for specific tumour types sites
have been developed and have proven to be more sensitive to changes than
generic questionnaires.

Quality-of-life evaluation before the start of treatment may be an
important prognostic factor, even independent from performance status.

Clinical benefit assessment presents important shortcomings and the
clinical relevance of this evaluation should be interpreted with caution.

Conclusions:Quality of life is a fundamental task of oncological research.

More studies are necessary to overcome the difficulties in assessing and
interpreting this concept and the clinical benefits based on it.

This revised version was published online in June 2006 with corrections to
the Cover Date.



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