Abstract
e13003 Background: We have demonstrated that cancer cells from patients (Pts) with recurrent or metastatic Breast CA frequently show as much or better APOP with Generics compared to Proprietaries (separately submitted to ASCO, 2012). We have compared these observations to in vitro APOP in Pts with NSCLC and Colon CA. Methods: Purified tumor cells from Pt biopsies were placed into short term culture using the microculture kinetic (MiCK) assay. APOP was analyzed every five minutes over 48 hours. APOP was defined in kinetic units (KU) of apoptosis. Significant APOP was > 1.0 KU, significant differences between individual assays were defined as > 0.57 KU based on replicate analyses. Results from Breast CA, Colon CA and NSCLC were compared. Results: 41 Pts with NSCLC, 8 Pts with Colon CA and 67 Pts with Breast CA had successful cultures. Generics produced APOP greater than Proprietaries in 25/32 Pts with NSCLC (78%), 4/7 Pts with Colon CA (57%) and 36/43 Pts (84%) with Breast CA. Generics produced APOP = Proprietaries in 5 Pts with NSCLC (16%), 1 Pt with Colon CA (14%) and 6 Pts (14%) with Breast CA. Proprietaries produced APOP greater than Generics in 2 Pts with NSCLC (6%), 2 Pts with Colon CA (29%) and 1 Pt (2%) with Breast CA. There were 0 Pts with NSCLC, Colon CA or Breast CA in whom no drug produced significant APOP (KU less than 1.0). Proprietaries produced more APOP in Colon CA than in Breast CA (p<0.05). Detailed comparisons of drugs by disease will be presented. Conclusions: Generic drugs can produce APOP in vitro equal to or better than Proprietary drugs in most Pts with NSCLC, Colon CA, and Breast CA. The frequency of Generic drugs being at least as active as Proprietary drugs varies by disease, and was higher in Breast CA compared to Colon CA. However, the MiCK APOP assay can identify which individual Pts might require use of Proprietary drugs. These conclusions justify prospective clinical trials to confirm these in vitro results. Increased use of Generic drugs based on the APOP assay may help to control healthcare costs.
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