Breast Cancer Clinical Trials And Quality Of Life (QOL) A Quality And Value Assesment

Even though the incorporation of Quality of Life (QOL) in clinical studies of cancer treatment trials began more than 30 years ago, it was reported that only 60 such trials included QOL in the study, before the year 2000. But it is changing, a research team led by Julie Lemieux, MD, from the Université Laval in Québec City, Quebec, Canada.found that during the period of 2001-2009, this number jumped to 190. The report is an extension to the study carried out by the same group previously. Dr. Patricia Ganz, the editor of the editorial accompanying the report says that these researchers are extending our understanding of how QOL and treatment trials interact;

how measurement of QOL outcomes adds value to randomized clinical trials in breast cancer. During the past decade, an impressive number of trials were published (n = 190) that added to those previously reported on (n = 66), reflecting the increasing interest in the inclusion of QOL and patient-reported outcomes in clinical trials, as well as the high volume of treatment and behavioral intervention research focused on patients with breast cancer

The authors also found limitations to these studies even thought he incorporation of QOL is increasing in the Cancer treatment clinical trials. The inconsistencies lies in the quality statical methods, description of statistical power and/or sample size calculation for the QOL outcomes, documentation of missing data, and reporting of the clinical significance of the QOL findings.

The authors provide the following recommendations based on their updated review findings:

1) QOL should be included as a secondary endpoint in adjuvant therapy trials only when the treatment expectation is equivalence or noninferiority, for example, when treatment decisions will be based on differences in patient outcomes between study arms or when the trial focuses on a vulnerable population (eg, elderly women) or is testing substantially different modalities (eg, endocrine vs chemotherapy) or a new treatment for which descriptive information is needed; 

2) QOL assessments should be included in metastatic breast cancer treatment trials only when a minimal survival difference is expected or the treatments have substantial differences in toxicity or descriptive information about a new treatment is needed; 

3) QOL-specific sample size calculations should be performed and QOL should be measured only in the subset of the study population that was defined by these calculations; 

4) when QOL is not the primary trial endpoint, the results should ideally appear in a companion article published at the same time as the medical outcomes article, so that a complete appraisal of the risks and benefits of the intervention can be evaluated (

1. Lemieux J, 
2. Goodwin PJ, 
3. Bordeleau LJ, 
4. Lauzier S, 
5. Theberge V

. Quality-of-life measurement in randomized clinical trials in breast cancer: an updated systematic review (2001-2009). J Natl Cancer Inst. 2010;103(3):xxx-xxx.).

Full Text of the article at the JNCI, The Journal Of The National Cancer Institute