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Comparison of Adjuvant Therapies Using Quality-Of-Life Considerations

Published online by Cambridge University Press:  10 March 2009

Richard D. Gelber
Affiliation:
Harvard medical School and School of Public HealthDana-Farber Cancer Institute, Boston
A. Goldhirsch
Affiliation:
Ospedale San Giovanni, Bellinzona Ospedale Civico, Lugano Ospedale Beata Vergine, Mendrisio

Extract

The benefit for patients with operable breast cancer treated with adjuvant systemic therapy is small, if reduction of early mortality within the context of randomized control trials is used for treatment comparison. One might consider that the 75%–85% of patients who die despite treatment are overtreated, as are patients who remain alive even without therapy within a given time frame. Larger treatment benefits in terms of avoided or delayed breast cancer relapse have been demonstrated even at early phases of follow-up in the vast majority of adjuvant trials. Exposure of all patients to adjuvant therapy at a time at which no symptoms of disease are present is detrimental in terms of quality of life.

Based on our assumption that the quality of life of the patient is typically altered both by subjective toxic effects of adjuvant treatment and by the appearance of relapse, we developed a method of comparing treatment effects in terms of time without symptoms of disease and toxicity of treatment (TWiST). Because the impact of treatment on relapse rates appears earlier than survival effects in all adjuvant therapy trials, and because the value of time without relapse in terms of the quality of life of the patients is as yet poorly defined, we have generalized our method of comparing treatment attitudes to include individual qualitative judgment values. The experience gained from integrating quality-of-life issues into clinical trials for breast cancer might also be applied to other diseases characterized by a chronic course, toxic treatments, and gains in periods of relative or absolute freedom from toxic effects and progressive disease.

Type
Special Section: Technology Assessment and Surgical Policy
Copyright
Copyright © Cambridge University Press 1989

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