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. 2014 Sep;2(9):91. doi: 10.3978/j.issn.2305-5839.2014.05.08

Table 3. Potential anti-cancer activities of CPI-613 + gemcitabine combination in patients with stage IV pancreatic cancer, based on prolonged OS when compared to the results from Phase III trials of the current most effective chemotherapies in the clinic, FOLFIRINOX and Abraxane + Gemcitabine combination.

Patients
Stage of pancreatic cancer ECOG at baseline Chemotherapy prior to CPI-613 CPI-613
AE (severity gradeb) during study Overall survival (months)c
Identity Race Gender Agea Dose (mg/m2) # Of cycles
Low dose groups: median OS =5.3
001-106 R-A Hispanic Male 50 Stage IV 0 None 70 1 None 1.5
001-107 R-D Caucasian Male 62 Stage IV 0 Gemzar 105 1 None 9
High dose groups: OS =17.8
001-110 M-C Caucasian Female 64 Stage IV 0 None 150 1 Stomach ache (1); swelling around eyes and nose (1); vomiting (1) 7
001-111 B-M Caucasian Female 75 Stage IV 0 Gemzar; FOLFOX + Transferrin laced Oxaliplatin; 5-FU 150 1 Malaise (1); rash (2); rigors (1) 26
001-113 M-W African-American Female 76 Stage IV 0 None 190 2 Headache (1); elevated G-GTP (3) ~43 (still alive)
002-107 PAK Caucasian Male 64 Stage IV 1 Gemzar + Tarceva; Xeloda + investigational drug 320 2 Fatigue (1); weakness (1) 9.5

#, number; AE, adverse event; ECOG, Eastern Cooperative Oncology Group Performance Status; G-GTP, gamma-glutamyl transferase; a, age shown is the age at the start of the trial; b, severity grade was according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Event (CTCAE); c, survival was calculated from the start of the first chemotherapy for stage IV pancreatic cancer till death, which is the same criteria used in the FOLFIRINOX clinical trial (3) and the Abraxane + Gemcitabine combination clinical trials (4).