According to principal author Thomas Marshall, MD, oncologist, Bedford & Addenbrooke's Cambridge University NHS Trust, and University of Hull, Hull, United Kingdom, previous studies have shown that hot flushes and other quality-of-life adverse effects are major concerns for about one third of women being treated for breast cancer.

No studies to date have demonstrated any particular difference in these effects between tamoxifen and any of the aromatase inhibitors.

The researchers enrolled 107 women in an open label cross-over study and had them complete hot flush frequency diaries, Functional Assessment of Cancer Therapy (FACT) questionnaires, and Mood Rating Score questionnaires. The women were randomized to receive either letrozole or tamoxifen for 6 weeks and then repeated the questionnaires.

The primary outcome of the study was the change in hot flush scales as reported in the patient's diaries. A 53.7% decrease in scores was seen, from 97.0 at baseline to 52.1 at the end of the study.

Mean Mood Rating Scale scores improved from 47.7 to 52.8 at follow-up. Similarly, the total mean FACT score improved from 132.7 to 142.1, which represents a statistically significant change. All of the subscales on the FACT reached statistical significance.

More women on letrozole had higher scores (ie, worse symptoms) on an arthralgia scale compared with those taking tamoxifen, and more women using tamoxifen reported their arthralgia to be mild compared with those taking letrozole.

At the end of the study, two thirds of the women preferred to remain on letrozole therapy, while 24% said they wanted to go back to tamoxifen therapy, and 10% stopped therapy altogether.

Dr. Marshall stressed that this trial involved only women who were intolerant to tamoxifen, and though the improvements in hot flushes scores could not be attributed entirely to a placebo effect, a larger prospective study is needed to determine whether there was a true causal effect for this improvement.

The trial, however, supports the idea that women should be given the option as to which endocrine therapy they would like to receive, and he added that most women appreciated the opportunity to be able to decide how they would manage their own arthralgia and hot flushes.


[Presentation title: Does Switching to Letrozole Improve Hot Flushes, Mood and Quality of Life in Tamoxifen Intolerant Patients? Abstract 2067]

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