Journal
PHARMACEUTICS
Volume 14, Issue 3, Pages -Publisher
MDPI
DOI: 10.3390/pharmaceutics14030509
Keywords
adjuvant chemotherapy; chitinase 3-like 1 protein; chitooligosaccharide; pancreatic cancer; YKL-40
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Funding
- Department of Oncology, Herlev and Gentofte Hospital
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This phase 2 trial evaluated the efficacy and safety of chitooligosaccharides in addition to adjuvant chemotherapy in patients with pancreatic ductal adenocarcinoma. Despite premature termination of the trial, the results suggest that chitooligosaccharides may be safe for use in this patient population.
The antitumor activity of chitooligosaccharides has been suggested. This phase 2 trial evaluated the efficacy and safety of T-ChOS (TM), in addition to adjuvant chemotherapy, in patients after resection of pancreatic ductal adenocarcinoma (PDAC). In this single-center, randomized, double-blind, placebo-controlled trial using patients >= 18 years of age after complete macroscopic resection for PDAC, patients were randomly assigned (1:1) to either a continuous oral T-ChOS group or a placebo group, in combination with gemcitabine (GEM) and oral capecitabine (CAP), for a maximum of six cycles. The primary endpoint was disease-free survival (DFS). Recruitment was stopped prematurely in July 2018, with 21 of planned 180 patients included, due to poor accrual and because modified FOLFIRINOX replaced GEM/CAP for the target population. Nine patients received T-ChOS and twelve received the placebo. The median DFS was 10.8 months (95% CI 5.9-15.7) for the T-ChOS arm and 8.4 months (95% CI 0-21.5) in the placebo arm. Overall, seven patients (78%) in the T-ChOS arm and eight patients (67%) in the placebo arm experienced at least one grade 3-4 treatment-related adverse event, most frequently neutropenia. Altogether, the addition of T-ChOS to chemotherapy in patients after resection of PDAC seems safe. However, the clinical benefit cannot be assessed due to the premature cessation of the trial.
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