The ‘ideal’ duration of treatment for postmenopausal patients with hormone receptor positive breast cancer is 7-8 years compared to the currently recommended 5 years. Thus mortality and the risk of relapse drop
For postmenopausal women who get breast cancer, prolonging hormone therapy for up to seven or eight years extends life, but beyond this treatment period the risks may outweigh the benefits. This is demonstrated by an Italian multicentre research by the Italian Mammella Group, coordinated by the IRCCS San Martino Polyclinic Hospital in Genoa, presented during the annual meeting of the European Society for Medical Oncology (Esmo) and published at the same time in the prestigious scientific journal The Lancet Oncology. «It is always necessary to carefully evaluate the individual case – comments Lucia Del Mastro, oncologist in charge of the Breast Unit of the IRCCS San Martino and coordinator of the research -. This is the first study on the duration of adjuvant anti-hormonal treatment to have such a long observation period. The results show that prolonged treatment for 5 years with letrozole, in addition to the standard 2-3 years with tamoxifen today, increases the chances of survival of patients and reduces the risk of relapse ».
The “ideal” duration of hormonal treatment
Researchers have been debating for years the “ideal” duration of hormone treatment in patients who have been treated for breast cancer diagnosed early in postmenopause: on the one hand, there is the risk, if the treatment is too short, that the disease will progress and to develop metastases faster; on the other hand, that of exposing oneself “unnecessarily” to highly variable and subjective side effects, such as joint pain, hot flashes and the effect on bone metabolism, with an increased risk of osteoporosis. Some women feel “protected” in continuing the treatment, others, on the contrary, feel “sick” from the treatment and can’t wait to stop it. “What is certain is that it is always necessary to rely on the judgment of a good oncologist, who is able to evaluate the pros and cons of this possible therapeutic choice, based on the national and international guidelines that we have available and which take into account the new scientific evidence that we collect over time – underlines Del Mastro -. The results of our study (phase three, the last one before the approval of a therapy, ed) indicate, for example, that 2-3 years consecutive treatment with tamoxifen followed by 5 years with letrozole should be considered one of the optimal endocrine therapies for women with postmenopausal hormone receptor positive breast cancer diagnosed at first stages (I-III) and operable “.
In Italy 38 thousand new cases in Italy
With 55,000 new cases discovered every year, breast cancer is the most frequent type of cancer in Italy and the majority (about 38,000 cases per year) is diagnosed in postmenopausal women. Fortunately, it also has the highest cure rates (about 90% of patients are alive 10 years after diagnosis), but despite the many advances made, it remains the leading cause of cancer death among Italians. In fact, there are many different types of breast cancer, some much more aggressive than others. The most frequent subtype (about 70% of cases) is precisely that with positive hormone receptors in which hormones, in particular estrogen and progesterone, represent the “fuel” of cancer cells and stimulate their growth. After surgery, these patients are prescribed adjuvant anti-hormone therapy to block the growth and spread of any remaining cancer cells and reduce the risk of recurrence. One of the standard anti-hormone therapy schemes provides a total duration of 5 years: women receive tamoxifen treatment for 2/3 years followed for another 2/3 years by therapy with an aromatase inhibitor, such as letrozole, which prevents androgens to turn into estrogen.
The new study: the balance between benefits and side effects
The GIM4 study
, co-financed by the Ministry of Health and the 5×1000 funds destined for the San Martino Polyclinic, involved 69 hospitals throughout Italy, recruiting 2056 postmenopausal women operated on for positive breast cancer in the span of 5 years, from 2005 to 2010. estrogen receptors and treated for 2/3 years with the anti-hormonal drug tamoxifen. Patients were randomly assigned to receive the aromatase inhibitor letrozole for the next 2/3 years or prolonged treatment with the same drug for 5 years and then followed for an average of 12 years. “The results show that prolonged treatment for 5 years with letrozole increases the chances of survival by 4% and reduces the risk of relapses – concludes the expert -. Today the guidelines recommend a personalized duration of treatment with letrozole based on drug tolerance and risk of relapse, considering that no studies to date have shown an advantage in terms of survival with prolonged hormone therapy beyond 5 years. On the basis of the results of the GIM4 study, and in particular of the observed advantage in overall survival, however, the therapeutic protocol can be modified by providing an optimal duration of 7-8 years for anti-hormonal therapy. Beyond this duration, in the face of the increase in toxicity we do not see an increase in longevity: side effects, such as pain in the joints, muscles, osteoporosis and hypertension, are in fact more frequent. For this it is necessary that the treatment is not continued beyond: this duration appears as the right compromise between a greater efficacy of the therapy and an excessive aggravation of adverse events “.
September 18, 2021 (change September 18, 2021 | 15:07)
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