New Drug Therapy Approved for Advanced Breast Cancer Patients

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NEWS New Drug Therapy Approved for Advanced Breast Cancer PatientsFDA has approved lxempra (ixabepilone) for patients with locallyadvanced breast cancer, or with breast cancer that has spread, who havenot responded to certain other drugs. About 180,000 new cases of breastcancer are diagnosed yearly, according to the American Cancer Society.http://www.fda.gov/bbs/topics/NEWS/2007/NEW01732.html<http://www.fda.gov/bbs/topics/NEWS/2007/NEW01732.html>

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32% and 36% of the people that take this wonderfull drug, which may kill them from a blood disorder, caused by the cure, approved by the FDA!

Neutropenia: White Blood Cell Disorders: Merck Manual Home Edition

 

 

 

Neutropenia can develop if neutrophils are used up or destroyed in the bloodstream faster than the bone marrow can make new ones. ...www.merck.com/mmhe/sec14/ch174/ch174b.html

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3%+ will die!

http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD & vmview=abst_detail_view & confID=47 & index=y & abstractID=35083

Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings

Results: 752 patients were randomized. Median age was 53; 84% had visceral disease, 48% and 43% had 1 and =2 prior metastatic regimens. Median of 5 and 4 cycles of ixabepilone + capecitabine and capecitabine were administered. Ixabepilone + capecitabine was superior to capecitabine. Significant benefit was consistently maintained across predefined subgroups, including HER2-/ER- /PR- and HER2+. *Primary analysis of PFS; hazard ratio= 0.75. Grade (G) 3/4 adverse events included neuropathy (ixabepilone + capecitabine 23% vs capecitabine 0%), hand-foot syndrome (18% vs 17%), and fatigue (9% vs 3%). Neuropathy was cumulative and reversible (median time to resolution of G3/4 to baseline/G1 was 6 weeks). G3 and 4 neutropenia were reported in 32% and 36% vs 9% and 2%, respectively; febrile neutropenia was 5% with ixabepilone + capecitabine. Toxic death rate was 3% vs 1%. Patients with liver dysfunction were at greater risk. Conclusions: Ixabepilone + capecitabine has superior efficacy to capecitabine across endpoints and has a manageable safety profile in this heavily pretreated population. It offers a new potential option for patients with MBC.