Why FDA wants more men in breast cancer drug tri­als

The Times of India (New Delhi edition) - - Times Trends - Roni Caryn Rabin

In re­cent years, health of­fi­cials have pushed ag­gres­sively to in­clude more women in clinical tri­als of new drugs. Even sci­en­tists who work with an­i­mals are now en­cour­aged to in­clude mice and rats of both sexes.

But when it comes to breast cancer, it is men who get short shrift. They are of­ten ex­cluded from clinical tri­als of new treat­ments. When breast cancer drugs come to mar­ket, there is lit­tle data to in­di­cate whether they are safe or ef­fec­tive in men. Some drugs are ap­proved only for women.

The disease is ex­tremely rare in men, who ac­count for fewer than 1% of breast cancer cases. None­the­less, the Food and Drug Ad­min­is­tra­tion is call­ing on re­searchers to in­clude male pa­tients in clinical tri­als of breast cancer treat­ments. The guid­ance is a draft rec­om­men­da­tion now open to pub­lic com­ment.

Even if only a few men par­tic­i­pate in each trial, data on them could be pooled. Cou­pled with real-world ex­pe­ri­ence us­ing the med­i­ca­tions, that data could shed light on treat­ment, said Dr Sharon Gior­dano, pro­fes­sor at M D An­der­son Cancer Cen­ter in Hous­ton.

The pro­posed guide­line comes amid grow­ing con­cerns that men with breast cancer — whose disease tends to be di­ag­nosed in more ad­vanced stages — are of­ten

not get­ting op­ti­mal care and may be miss­ing out on life­sav­ing ther­a­pies. One of the largest analy­ses of these pa­tients, pub­lished in ‘An­nals of On­col­ogy’ in 2017, an­a­lysed 1,500 men with breast cancer in Canada, the US and seven Euro­pean coun­tries.

The vast ma­jor­ity of men with breast cancer have tu­mors that are fu­eled by es­tro­gen. But only 77% of them re­ceived anti-es­tro­gen ther­apy, the study found. That means nearly 1 in 4 men who should have re­ceived a po­ten­tially life­sav­ing ther­apy didn’t get it.

The most com­mon treat­ment for men was surgery: a mas­tec­tomy to re­move the breast, or a lumpec­tomy to re­move the tu­mour. But the men had low rates of ra­di­a­tion treat­ment, which is stan­dard care af­ter lumpec­tomy and of­ten rec­om­mended af­ter a mas­tec­tomy. Poor care is all too com­mon when pa­tients suf­fer from rare dis­eases, and for men, breast cancer is a rare disease, doc­tors noted.

Getty Im­ages/iS­tock­photo


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