RT Book, Section
A1 Barnett, Chad M.
A1 Boster, Bonnie Lin
A1 Michaud, Laura Boehnke
A2 DiPiro, Joseph T.
A2 Talbert, Robert L.
A2 Yee, Gary C.
A2 Matzke, Gary R.
A2 Wells, Barbara G.
A2 Posey, L. Michael
SR Print(0)
ID 1164185033
T1 Breast Cancer
T2 Pharmacotherapy: A Pathophysiologic Approach, 10e
YR 2017
FD 2017
PB McGraw-Hill Education
PP New York, NY
SN 9781259587481
LK accesspharmacy.mhmedical.com/content.aspx?aid=1164185033
RD 2024/04/25
AB Content  UpdateJune  3,  2019Alpelisib  Approved  for  PIK3CA  Mutated  Breast  Cancers:  Alpelisib  (Piqray®)  is  the  first  PI3K  inhibitor  approved  by  the  FDA  and  is  indicated  for  adults  with  hormone  receptor  (HR)  positive  and  human  epidermal  growth  factor  (HER2)  negative  advanced  or  metastatic  breast  who  have  progressed  on  prior  endocrine  therapy.  PIK3CA  mutations  are  common,  occurring  in  about  35%  of  all  breast  cancers.  In  the  SOLAR-1  trial,  the  median  progression  free  survival  was  11.0  months  in  the  alpelisib  arm  compared  to  5.7  months  in  the  placebo  group  (HR  0.65,  95%  CI  0.50–1.25,  P=.00065).  Overall  response  rate  is  36%,  compared  to  16%  in  the  placebo  group.  The  most  common  adverse  effects  are  hyperglycemia,  nausea  and  rash.