Taking a Break From Letrozole Therapy After Breast Cancer

voraciousreader

https://www.medscape.com/viewarticle/889157

SOLE was published online November 17 in Lancet Oncology.

The investigators, led by Marco Colleoni, MD, from the International Breast Cancer Study Group in Milan, Italy, conclude that the study results on "intermittent administration [of letrozole] provides clinically relevant information about extended adjuvant endocrine therapy with letrozole and support the safety of this option for temporary treatment breaks in select patients who may require them."

marijen

That study is very interesting. Out of 4851 women, thirteen died of stroke, CNS hemmorage, or cardiac ischemia.

voraciousreader

marj...you need to be very cautious when interpreting the data...we have no idea if the med caused those illnesses and deaths. Instead, those illnesses and deaths, which comprise between <1-1% of patients are simply being “reported." It is up to future studies to decide if they are clinically significant. I will GUESS that those figures are NOT statistically significant with respect to taking the drugs....if they were....now I am thinking of the Vioxx debacle....ANY post marketing of a drug that MIGHT cause a statistically significant increase in strokes, heart attacks, or death, would be pulled from the market.

What I think stands out from this study is the possibility, for some patients, to take a break in treatment. This is especially important for those patients who have side effects that affect quality of life.

marijen

So it looks like they only took ONE three month break in the first five years? Is that correct? Yes I know the 13 might have died anyways with or without the letrozole. But we do know that it affects the heart. I just find it interesting they included it. What about other kinds of death. Heart, stroke and cerebral hemmorage are all related. Just commenting. Again it’s a very interesting study.

voraciousreader

they mention “Intermittent” break of 9 months of therapy and 3 months off in years 1-4.

I think they probably decided BEFORE the study what illnesses and causes of death they were looking for. The initial clinical trial of the med probably gave them enough info with respect to side effects, so they knew what needed documentation in this study

toomuch

Voraciousreader - Thanks for posting! I think that the most interesting thing hidden in the discussion is that the author thinks that in time during the 3 month break from letrozole women may be prescribed other "salvage" therapies like palbociclib or everlimus to keep micromets in check and which will decrease risk of distant mets or recurrence. This obviously has to be studied but could be lead to progress in treating BC like a chronic disease.

voraciousreader

yes...toomuch....i love reading studies like this one because it gives researchers more ideas that need development....that can ultimately help clinicians and their patients. I also applaud all of the participants for taking part in the study. What brave people

BarredOwl

The reference to years 1 to 5 above may be a little confusing. I read this as being an "extended therapy" trial in that the women included in the study all had already completed 4-6 years of endocrine therapy:

"We enrolled postmenopausal women of any age with hormone receptor-positive, lymph node-positive, and operable breast cancer for which they had undergone local treatment (surgery with or without radiotherapy) and had completed 4–6 years of adjuvant endocrine therapy."

BarredOwl

voraciousreader

yes...barred....EXTENDED therapy.....years 1-4..... so, patients had already completed the required years before given the option of continuing and being in the SOLE study....

Agreed. Very confusing for those who didn’t see the word “Extended” in the study group....That said, the numbers are very encouraging!

Now, if we could just get patients to complete the initial 5 years.....from reading this board, we all know all too well how so many patients have difficulty in completing 5 years of therapy....but if they do, this news is good news.....

Hopeful82014

marijen, since heart disease is the leading cause of mortality for women in the USA it's not surprising that a number of women in that study would have died of cardiac-related issues. (Per CDC 2014 statistics) American women overall have a higher chance of cardiac-related death than bc related. And while use of AIs may have contributed to those numbers (we don't know that, one way or another), so could the use of other bc therapy such as herceptin or adriamycin. Lingering neuropathy from other chemotherapeutic agents that inhibits ability to engage in sufficient exercise could also contribute. Those issues were not the subject of the study.