A Systemic Review and Meta-analysis of the Incidence Rate of Interstitial Lung Disease in Patients with Unresectable Pancreatic Cancer Treated with Gemcitabine and Nab-paclitaxel Combination Therapy in the Japanese Population.

Objective Drug-induced interstitial lung disease (DI-ILD) is an adverse effect of the combination of gemcitabine and nab-paclitaxel (GnP) treatment that has raised concerns because the incidence rate of DI-ILD in the real world is higher than that reported in initial clinical trials. The present study assessed the cumulative incidence rate of DI-ILD among patients treated with GnP based on previously published studies and explored any potential bias in the results. Methods We conducted a meta-analysis in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analysis guidelines. The MEDLINE, Scopus, and Cochrane Library databases were searched from 2013 to 2024, using specific keywords. Randomized controlled trials, prospective studies, retrospective studies, and case-control studies that reported the incidence of interstitial lung disease (ILD) among patients treated with GnP were included. Two reviewers independently extracted the data from the included studies. Results Nine studies involving 1,980 patients were included in this analysis. Nine studies were conducted in Japan. The pooled incidence of DI-ILD was 5.9%. A subgroup analysis revealed that smaller studies reported higher incidence rates (≤200 vs. ≥201 cases: 9.4% vs. 4.1%). There was significant heterogeneity and publication bias, suggesting that the variability in incidence rates was due to the study size and potential biases. Conclusion The pooled incidence of ILD among patients treated with GnP was 5.9%. However, the results should be interpreted with caution because of the heterogeneity and publication bias. Further global studies are required to determine the true incidence of ILD.