Abstract
15136 Background: An anti-tumor effect of lentinan (LNT), a non-specific immunomodulator, via an immunological response has been reported and combination immunochemotherapy has been examined. However, the survival benefit of LNT for patients with advanced or recurrent gastric cancer (AGC) was unclear in the world. We performed an individual patient data (IPD) meta-analysis in order to evaluate the survival effect of immunochemotherapy using LNT. Methods: A computerized and a manual search procedure were performed to identify all randomized clinical trial (RCT) for chemotherapy in patients (pts) with AGC. Inclusion criteria were RCTs for AGC and to compare any chemotherapy (control group) with the same plus LNT (LNT group). The primary endpoint was overall survival, secondary endpoints includes objective tumor response and toxicity. All analyses were based on IPD. Treatment effects were displayed as hazard ratios estimated by Cox proportional hazard model. A ratio less than unity indicated benefit from LNT. Results: We analyzed IPD of 5 randomized clinical trials for AGC, which met the predetermined inclusion criteria. These 5 trials had a combined total of 650 pts (LNT: 339 pts median age=63, control: 311 pts median age=63). The number of deaths was 83.8% (286/334) in LNT group and 84.8% (262/309) in control group. The overall hazard ratio was 0.83 (95%CI, 0.70–0.98; p=0.03) with no significant heterogeneity between the treatment effects in different trials (χ2 for heterogeneity=3.69; p=0.45). Three hundred and fifty five pts were evaluable for objective tumor response and the response rate was 18.4% (21/185) in LNT group (CR, 0 pts; PR, 21 pts) and 6.3% (5/173) in control (CR, 0 pts; PR, 5 pts). There were no significant differences in the toxicity. Conclusions: This IPD meta-analysis demonstrated that LNT significantly improves both OS and tumor response in pts with AGC. No significant financial relationships to disclose.
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