Breast cancer in humans: current clinical practice "justified"

MUNICH – Although men with bad cancer are, on average, older than their female counterparts, and the profiles of bad cancer disease in men and women's bad cancer differ during pregnancy. diagnosis, bad cancer patients seem to respond as well suggest data from several new studies

. The new badyzes were presented as posters here at the 2018 Congress of the European Society of Medical Oncology (ESMO). They were greeted by experts, who pointed out that bad cancer in humans is a rare condition for which there is little data on the incidence and outcome of treatment.

In the first study, Mohamed A. Gouda, MD, Department of Clinical Oncology, Menoufia University, Shebin El Kom, Egypt, reviewed data from the National Cancer Surveillance, Epidemiology and End-of-Life Program. Institute on all cases of bad cancer reported in the United States during a period of 15 years (2000-2015). [19659002] His team identified 6790 men diagnosed during the study period, at an incidence rate of 10.2 per 100,000,000 men.

The incidence rate increased significantly during the study period, with an annual percentage change of 1.9% ( P <0.05

The majority (81.3%) of the cases occurred in Caucasian men (median age: 68 years). Cancer was more likely to occur on the left side, at a rate of 52.3%. Most cases were either regional (43.8%) or localized (46.4%) at the time of diagnosis.

It should be noted that bad cancer was the only primary cancer in 66.3% of patients; it was the first of two primary in 11.6% of patients; and was primary or secondary in 22.1% of patients.

In calculating median survival using the Ederer II method, Gouda found that the median survival observed for bad cancer in men was 70.6% at 5 years and 48.8% in 10 years. 19659009] The five-year relative survival was estimated at 84.0% and the ten-year relative survival was 71.1%.

Addressing Medscape Medical News Gouda explained that it was not clear why bad cancer in men should be found more often on the left side, but it speculated that it could be linked to the disease as a second primary stage in about one-fifth of cases, rather than a phenomenon badociated with case reporting.

"may be another sequela of a previous treatment".

Gouda pointed out that, despite the differences in initial characteristics between male and female patients, bad cancer in humans "is treated the same way as bad cancer in women". He added: "To our knowledge, the course is slightly different".

These conclusions were taken up by a large study conducted in France. In this study, the average age and treatment profile were similar in men and women.

Jean-Sebastien Frenel, MD, Western Cancer Institute, Nantes, France, and colleagues collected data in the Epidemiological Metastatic Breast Cancer Platform, which includes 18 cancer centers Complete French for the period from 2008 to 2014

identified 149 men (0.89%) out of a total of 16,701 evaluable patients with bad cancer. men was 68.1 years, which was significantly older than women at 60.6 years ( P <0.0001).

Men were also significantly more likely than women to have a positive hormone receptor (HRV +) and a negative epidermal growth factor receptor (HER2-) negative disease, at 78.4% versus 65.6% ( P = 0.0019).

Of bad cancer patients treated with HR + / HER2-, 42.9% received first-line hormonal therapy including aromatase-inhibiting tamoxifen with or without LNRH badogue (hormone releasing hormone). luteinizing hormone).

The median progression-free survival (PFS) of these patients was 9.8 months, which was comparable to that observed in a matched group of women. for age, bad cancer histology, bad cancer grade, location of metastasis and adjuvant treatment at 13.0 months ( P = 0.8).

For 27.6% of patients with bad cancer treated with HR + / HER2- treated with first-line chemotherapy, the median progression-free survival was 6.9 months, which was still similar to the 6.3 months observed in a group of matched women.

Median overall survival was comparable between men and women at 41.8 months. and 34.9 months, respectively ( P = 0.745).

"We found that men with HR + / HER2 had survival outcomes similar to those of women with the same cancer," said Frenel in a statement.

"Most patients receiving hormone therapy were tamoxifen-treated, the rest receiving aromatase inhibitors," he continued. "But few patients have received aromatase inhibitors and LHRH badogues, despite some recommendations recommending them to be administered in combination."

Commenting for ESMO, Agnes Jager, MD, PhD, of the Erasmus Institute of Cancer Medicine, Rotterdam, Netherlands, said that a study of this magnitude on men with dementia 'a primary bad cancer' had not been realized yet '.

This justifies our current clinical practice
Dr. Agnes Jager

"This new study shows that the prognosis of men and women is similar, which is of great value because it justifies our current clinical practice," she said. "We are currently treating men with bad cancer in the same way as women, which is now corroborated by this data."

She noted, however, that the study was small and that there was a lack of data on the extent of progress. disease, BRCA mutation status and type of chemotherapy used.

"More detailed information and longer-term follow-up will indicate if there are specific male characteristics or prognostic factors, Let us change the practice in the future," she added.

First Randomized Trial

In the Male-GBG54 study, Mattea Reinisch, the first prospective randomized trial to examine different hormonal treatments in men with bad cancer, MD, PhD, Kliniken Essen-Mitte, Essen, Germany, and their colleagues compared tamoxifen with or without a gonadotropin releasing hormone (GnRHa) badogue to an aromatase inhibitor plus a GnRHa.

For the study, 55 patients with bad cancer in humans with HR + disease were randomized to receive one of three treatment regimens for 6 months: [19659030] 20 mg tamoxifen daily,

tamoxifen plus GnRHa administered subcutaneously every 3 months; or

exemestane ( Aromasin Pharmacia and Upjohn), 25 mg / day higher GnRHa

. Of the 46 men for whom complete data were available, subjects treated with tamoxifen experienced an increase in estradiol levels of 67% at 3 months and 41% at 6 months.

In contrast, in both arms in which men received hormonal treatment with a GnRH badogue, estradiol levels fell and continued to remain low. The group taking GnRHa-badociated tamoxifen decreased by 85% at 3 months, while those who received exemestane plus GnRHa decreased by 73%. This continued for 6 months, with respective decreases of 59% and 63%.

Tamoxifen therapy had little effect on quality of life or erectile function related to health. The researchers noted, however, that both measures were severely affected by patients treated with exemestane + GnRHa.

"The removal of peripheral estradiol is a necessary condition for the therapeutic benefit of endocrine therapy in men with bad cancer receiving an aromatase." Reinisch in a press release. [19659012] "In the tamoxifen monotherapy group, estradiol values ​​increased. These changes are known to bad cancer patients and were expected, "said Reinisch.

that" tamoxifen monotherapy should remain the standard hormone treatment for men with bad cancer. Side effects are moderate and do not affect badual behavior.

"The combination with GnRH has a profound influence on the well-being and erectile function of patients," she noted.

Jager, an expert at ESMO, said the researchers "should be commended" for conducting a randomized trial "in such a rare study population.

" However, it is unfortunate that the removal of 3-month-old estradiol was the main criterion for evaluation, "she said.

" Although it is relevant to know if and to what extent Estradiol Levels As far as I know, the 3 month deletion of oestradiol is not a valid or clinically useful endpoint for efficacy. of treatment with the endocrine system, "she said.

Tamoxifen allowed an increase in estradiol levels at 3 and 6 months" is not new, although the degree of Increase somewhat somewhat unexpected. "

Overall, Jager pointed out that the evaluation criterion used in the study meant that the ques Whether a NRLR "Because of the serious side effects of LHRH agonists in humans and the negative impact on quality of life, clarity about it is of great clinical importance" , she said.

Dr. Stefan Zimmerman, from the Vaud University Hospital Center, Switzerland, also commented for ESMO that, taken as a whole, studies show that "male patients with bad cancer seem to be benefiting from bad cancer." Endocrine treatment to the same degree as women [19659014] "These research findings add to current literature suggesting that adding GnRH badogues could improve tamoxifen alone, but studies with clinical parameters are needed, "he said in a statement.

Zimmerman nevertheless pointed out that" it is urgent that strategies that have proven to be effective in delaying resistance to HIV. " Endocrine therapy in women is also being explored in men with advanced bad cancer, including CDK4 / 6 inhibitors. "

Male-GBG54 study was funded over there Claudia von Schilling Foundation and was conducted in collaboration with Pfizer. Doctors Gouda, Frénel and Reinisch did not reveal any relevant financial relationship.

2018 Congress of the European Society of Medical Oncology (ESMO). Abstracts 259P, 294PD and 273PD, presented on October 22, 2018.

For more information on Medscape Oncology, follow us on Twitter: @MedscapeOnc