Compositions and methods for prognosis and treatment of neoplasm

Abstract

A protocol for assessing the prognosis for a patient diagnosed with a neoplasm or suspected of having a neoplasm is provided herein. The protocol involves the steps of determining a mitotic cells to proliferating cells ratio (M:P ratio) in a neoplastic tissue sample obtained from the patient and producing a prognosis for the neoplasm based on the M:P ratio.

1 - 17 . (canceled) 
     
     
         18 . A kit comprising:
 a first binding agent specifically targeting mitotic cells in a sample;   a second binding agent specifically targeting proliferating cells in the sample;   one or more detection reagents for visualizing bound complexes indicative of mitotic and proliferative cells; and   instructions for use,   wherein the kit is used for assessing the prognosis for a patient who has been diagnosed with, or is suspected to have, Luminal B subtype breast cancer or triple negative breast cancer (TNBC).   
     
     
         19 . The kit of  claim 18 , wherein the first binding agent binds to a phosphorylated form of histone H3 and wherein the second binding agent binds Ki-67. 
     
     
         20 . The kit of  claim 18 , wherein the first binding agent is an antibody or a biologically active fragment thereof. 
     
     
         21 . The kit of  claim 18 , wherein the second binding agent is an antibody or a biologically active fragment thereof. 
     
     
         22 . The kit of  claim 18 , wherein the first binding agent and the second binding agent are contained in the same container. 
     
     
         23 . The kit of  claim 18 , wherein the first binding agent and the second binding agent are contained in separate containers. 
     
     
         24 . The kit of  claim 18 , wherein the first binding agent and the second binding agent are labeled with distinct labels. 
     
     
         25 . The kit of  claim 18 , wherein the patient has been subjected to chemotherapy. 
     
     
         26 . A kit comprising:
 a first binding agent specifically targeting mitotic cells in a sample;   a second binding agent specifically targeting proliferating cells in the sample;   one or more detection reagents for visualizing bound complexes indicative of mitotic and proliferative cells; and   instructions for use,   wherein the kit is used for assessing the outcomes in a patient after chemotherapy.   
     
     
         27 . The kit of  claim 26 , wherein the patient has been diagnosed with Luminal B subtype breast cancer or triple negative breast cancer (TNBC). 
     
     
         28 . The kit of  claim 26 , wherein the first binding agent binds to a phosphorylated form of histone H3 and wherein the second binding agent binds Ki-67. 
     
     
         29 . The kit of  claim 26 , wherein the first binding agent is an antibody or a biologically active fragment thereof. 
     
     
         30 . The kit of  claim 26 , wherein the second binding agent is an antibody or a biologically active fragment thereof. 
     
     
         31 . The kit of  claim 26 , wherein the first binding agent and the second binding agent are contained in the same container. 
     
     
         32 . The kit of  claim 26 , wherein the first binding agent and the second binding agent are contained in separate containers. 
     
     
         33 . The kit of  claim 26 , wherein the first binding agent and the second binding agent are labeled with distinct labels.