Today I presented results from the Breast Cancer Weight Loss trial. This is a phase III study that was designed to evaluate the impact of a telephone-based weight loss intervention on invasive disease free survival in women with stage II-III HER2 negative breast cancer and a body mass index of at least 27kg/m2. The results that we presented at ASCO this year looked at a preplanned sub-study of 542 BWEL participants who completed a quality of life serial study looking at the impact of the intervention on physical functioning and other quality of life metrics over time. We found that women who were randomised to the weight loss intervention had a significant improvement in physical function, the primary outcome of the sub-study, that was maintained through the two-year intervention period. They also experienced significant improvements in global physical and mental health, social roles and activities, and fatigue. All of the benefits, other than fatigue, were maintained through the two-year intervention period.
Could you outline the methodology?
The weight loss intervention is a telephone-based programme that focuses on caloric restriction and increased physical activity. All of the patients that were randomised to the intervention were assigned a health coach. The coaches were all based at Dana-Farber, so the intervention was delivered completely through the telephone and the web. Patients met with their coaches weekly for the first three months then every other week for the rest of the first year and then monthly for the second year of the study.
In addition to that programme, all of the patients in the study received a health education programme that consisted of information about nutrition and physical activity in cancer survivorship.
What did you find?
The findings so far, we’re still waiting to see whether the intervention improved outcomes in terms of cancer recurrence and survival but we presented the quality of life outcomes at the meeting. So we were looking at the impact of the intervention on the physical functioning and quality of life. We found that the intervention was very successful in improving quality of life in patients with early breast cancer and either overweight or obesity.
What impact could these findings have?
These findings are important because we hope that the intervention will also reduce the risk of cancer recurrence and improve mortality. These data that we presented at ASCO this year show that the intervention had concrete benefits for patients, it helped them feel better, it helped them be able to do the things they needed to do in their lives, it helped them to be less tired. So there were very important early findings that the intervention was of enough intensity to have these positive benefits for patients’ quality of life.
We’ve also in the past demonstrated that the intervention did help people lose weight. We saw that the patients randomised to the weight loss intervention lost about 6% of their body weight versus controls in a year. We have already shown that it also improved people’s metabolism and reduced inflammation. We’ve also shown that people that were in the intervention programme exercised more and cut their calories compared to patients who were not in the exercise and nutrition programme.