EN­COUR­AG­ING RE­SEARCH RE­SULTS

Hartford Courant (Sunday) - - Breast Cancer Awareness - By ALIX BOYLE Spe­cial to The Courant

Pa­tients with metastatic breast cancer are liv­ing longer than ever, thanks to a new class of agents that tar­get cell divi­sion to slow the pro­gres­sion of cancer when used with a hor­monal treat­ment.

Breast cancer is con­sid­ered metastatic when it orig­i­nates in the breast and then moves to other or­gans such as the bones or liver.

“The goal of treat­ment is to try to con­trol the dis­ease,” said Dr. Pa­tri­cia DeFusco, an on­col­o­gist and di­rec­tor of the Hart­ford Health­Care Cancer In­sti­tute Breast Pro­gram. “In the old days the sur­vival rate used to be 18 months to two years. We are more suc­cess­ful now.”

Re­cent stud­ies have shown an im­prove­ment in me­dian sur­vival for pa­tients with metastatic breast cancer from 21 months to 38 months. Me­dian sur­vival in cer­tain sub­sets of women with metastatic breast cancer now ap­proaches five years, DeFusco said. From 2007 to 2016, the breast cancer death rate has de­creased by 1.8 per­cent per year, ac­cord­ing to Amer­i­can Cancer So­ci­ety sta­tis­tics.

One of these drugs has been stud­ied in clin­i­cal tri­als at Hart­ford Health­Care in al­liance with Me­mo­rial Sloan Ket­ter­ing. Now that re­searchers know that hor­monal treat­ments like letro­zole com­bined with a tar­geted drug like pal­bo­ci­clib slow the pro­gres­sion of metastatic cancer, a next step is to see whether adding pal­bo­ci­clib to hor­monal ther­apy in the post-op­er­a­tive set­ting can pre­vent metas­tases.

Women who have breast cancer tu­mors clas­si­fied as hor­mone re­cep­tor (HR) pos­i­tive and hu­man epi­der­mal growth fac­tor re­cep­tor (HER2) neg­a­tive are at risk for late re­cur­rence, some­times 10 to 20 or more years af­ter the first cancer. A study at the Hos­pi­tal of Cen­tral Con­necti­cut is ex­am­in­ing whether there is any ben­e­fit to adding ri­bo­ci­clib to the stan­dard treat­ment for pa­tients with these types of breast cancer, DeFusco said.

“If it works in peo­ple with metastatic dis­ease maybe it can help women if they are at high risk for a re­cur­rence,” DeFusco said.

Three drugs, brand-named Ibrance (pal­bo­ci­clib), Kisquali (ri­bo­ci­clib) and Verzenio (abe­maci­clib), have been ap­proved to treat metastatic breast cancer. They work by in­ter­fer­ing with cell divi­sion and have been shown to be ex­tremely ef­fec­tive in pro­vid­ing pro­longed pro­gres­sion free-sur­vival, DeFusco said.

These drugs are called cy­clin-de­pen­dent ki­nase 4/6 in­hibitors. CDK4 and CDK6 are en­zymes used in cell divi­sion. In­hibit­ing these en­zymes in­ter­rupts the growth of cancer cells. Adding a CDK4/6 in­hibitor to en­docrine ther­apy has been shown to in­crease sur­vival in women vs. en­docrine ther­apy alone, said Dr. Su­sanna Hong, a Mid­dle­sex Hos­pi­tal on­col­o­gist.

How­ever, the drugs are ex­tremely ex­pen­sive. Out of pocket, Ibrance costs $677 per cap­sule or $12,000 to $15,000 a month.

“Yes, fi­nan­cial tox­i­c­ity is an is­sue,” DeFusco said.

All the drug com­pa­nies have pro­grams to help pa­tients af­ford the drugs, and Hart­ford Hos­pi­tal’s clin­i­cal phar­ma­cists help the on­col­ogy team and the pa­tient through the process of fig­ur­ing out how to af­ford treat­ment. The team re­views a pa­tient’s in­sur­ance to fig­ure out how to min­i­mize the cost to pa­tient.

There can also be phys­i­cal side-ef­fects that need to be man­aged for CDK4/6 in­hibitors, in­clud­ing drops in blood counts, in­creased risk of in­fec­tion, fa­tigue and bone pain. But the drugs work and 70 per­cent of pa­tients tol­er­ate the drugs and reap the ben­e­fits, DeFusco said.

Treat­ment for metastatic breast cancer de­pends of the type of tu­mor, Hong said.

For ex­am­ple, pa­tients with triple-neg­a­tive breast cancer, the most ag­gres­sive type, can only be treated with chemo­ther­apy at present.

How­ever, a form of im­munother­apy, called check­point in­hibitors, is be­ing in­ves­ti­gated for breast cancer pa­tients. A check­point in­hibitor has re­cently been ap­proved for use in women who have metastatic triple neg­a­tive breast cancer that also has high ex­pres­sion of the PDL1 pro­tein.

“Typically, we have cells called T-cells which attack viruses and for­eign cells in our body,” Hong ex­plained. “Cancer cells can at­tach to these cells via the PD-1 path­way, thus in­ac­ti­vat­ing these cells. These med­i­ca­tions pre­vent the cancer cells from in­ac­ti­vat­ing the T-cells. This helps the T-cell see the cancer as for­eign and attack it. At Mid­dle­sex, we are in­volved in a trial uti­liz­ing a type of im­munother­apy af­ter chemo­ther­apy in women with triple neg­a­tive breast cancer, with high ex­pres­sion of PDL1. The im­munother­apy is given af­ter surgery or in the ad­ju­vant set­ting.”

Mid­dle­sex is also par­tic­i­pat­ing in a trial in which women who have had their cancer re­moved and have had it in the lymph nodes are given as­pirin.

“As­pirin is an anti-in­flam­ma­tory, and the goal is to de­ter­mine if this can help pre­vent the cancer from re­turn­ing,” Hong said.

Pa­tients in­ter­ested in par­tic­i­pat­ing in a clin­i­cal trial can check the web­site clin­i­cal­tri­als.gov to see if there are any stud­ies open for their par­tic­u­lar type of dis­ease.

Dr. Pa­tri­cia DeFusco, left, is an on­col­o­gist and di­rec­tor of the Hart­ford Health­Care Cancer In­sti­tute Breast Pro­gram. Dr. Su­sanna Hong, at right, is a med­i­cal on­col­o­gist at Mid­dle­sex Hos­pi­tal in Mid­dle­town.

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