A multicenter randomized phase II trial on Kanglaite Injection (KLT) plus gemcitabine hydrochloride (GEM) versus GEM in patients with local advanced and metastatic pancreatic cancer.

Abstract

e14510 Background: Pancreatic carcinoma is a malignant cancer with a 5-year survival rate of less than 5%. According to the meta-analysis on 2,422 advanced pancreatic patients reported in 2010 ASCO Annual Meeting, compared with GEM alone, GEM combined with DDP or oxaliplatin or capcitabine were less than 3% in absalute benefit of survival rate. KLT is a nature botanical medicine, which has been combined with GEM in treating pancreatic patients to prolong survival time based on report from China and Russia. Methods: Patients with advanced pancreatic cancer were randomized at 2:1 to KLT+GEM(KG)group and GEM (G) group. All were confirmed by histopathology, with assessable lesions, without previous chemotherapy. KG group: KLT, 200ml/d, i.v. within 80 minutes, d1-5, d8-12, d15-19, 28 days as a cycle. GEM 1000mg/m2, i.v. within 30 minutes, d1,8,15, 28 days as a cycle. G group: The same as KG group but without KLT. Primary endpoint: Median time to progress (mTTP, month). Secondary endpoints: response rate (RR %), disease control rate (DCR %); median overall survival (mOS, month); clinical benefit rate and quality of life (QOL). Results: 58 patients enrolled were randomized to KG group (40 cases) and G group (18 cases). In KG group, mTTP was 5.69 months, mOS was 8.59 months. Compared to G group, patients in KG group had their QOL obviously improved, with a more evident trend of survival benefit, but without significance. Conclusions: KLT+GEM has a trend to improve survival of patients with advanced pancreatic cancer, a large phase III randomized controlled trial is needed. mTTP: KG group versus G group (months, 95%CI). ITT (n=58) PP (n=50) KG G KG G 5.69 (1.97,7.60) 4.38 (2.76,6.35) 6.58 (1.97,8.49) 4.38 (2.76,6.35) P 0.66 0.33