A phase IIb trial of coix seed injection for advanced pancreatic cancer.

Abstract

e15023 Background: Kanglaite injection (KLTi) is a purified botanical extract injection tested for pancreatic cancer. KLTi is derived from Coix seed of the plant Coix lacrama-jobi. KLTi demonstrated growth inhibitory effects in vitro. In xenograft models with PANC-1 cell lines in BALB/C mice, KLTi combined with gemcitabine had synergistic tumor inhibitory activity greater than gemcitabine alone. KLTi is approved and widely used in China to treat non-small cell lung cancer and primary liver cancer. We report final cohort 1 results from a US phase 2b clinical trial. Methods: Eligible patients with histologically confirmed unresectable pancreatic cancer were randomized to a regimen of either KLTi 30g/day plus a standard course of gemcitabine or a standard course of gemcitabine only. The two groups were compared in efficacy, measure by progression-free survival (PFS), and safety. Results: Forty-one patients were randomized to cohort 1 and 38 patients received treatment: 26 received KLTi plus gemcitabine, 12 received gemcitabine only, and 3 received no treatment. The KLTi plus gemcitabine group had a median PFS of 114 days, significantly longer than the median PFS of 57.5 days in the gemcitabine only group (HR 0.338, 95% CI: 0.145, 0.788, p=0.008). The overall response rates were 15.5% (4/26) and 8.3% (1/12) for KLTi plus gemcitabine and gemcitabine only, respectively. Two serious adverse events were possibly related to KLTi; one subject had a pulmonary embolism and the other experienced transient confusion. The adverse events were similar between the groups and consistent with gemcitabine toxicities. Conclusions: Combined with gemcitabine, KLTi injection showed favorable tolerability and encouraging clinical activity for the treatment of advanced pancreatic cancer. Clinical trial information: NCT00733850.