[Nanoliposomal Irinotecan in Combination with Fluorouracil and Folinic Acid, As a New Option for Second-Line Treatment in Metastatic Pancreatic Cancer].

Pancreatic cancer is ranked 4th in Japan in terms of number of deaths so far in 2019, surpassing liver cancer. Unlike other types of cancer, the number of patients in Japan is epidemiologically showing an upward trend, and 70% of cases are unresectable at diagnosis. Therefore, development of chemotherapy that improves the prognosis and maintains and improves the quality of life of the patient is a critical issue. Against this backdrop, the efficacy of nanoliposomal irinotecan(nal-IRI)in combination with fluorouracil and folinic acid(FF)for progressive metastatic pancreatic cancer after previous gemcitabine therapy was confirmed in Europe in 2015 ahead of Japan. In NAPOLI-1, an overseas phase Ⅲ study of this therapy, a significant improvement in overallsurvivalwas shown as compared with patients who received FF alone(median: 6.1 months for nal-IRI plus FF vs 4.2 months for FF alone, p=0.012). Therefore, this study yielded important evidence for second-line treatment of pancreatic cancer around the world. In Japan, a phase Ⅱ study was conducted to confirm the efficacy and safety of this therapy, which found a significant prolongation of progression-free survival(as assessed by the investigator)with this therapy as compared with FF alone(median: 2.7 months for nal-IRI plus FF vs 1.5 months for FF alone, p=0.039). In the latest version of Clinical Practice Guidelines for Pancreatic Cancer published in Japan in July 2019, nal-IRI plus FF therapy was included in a statement as a treatment option after a gemcitabine-based regimen. This paper provides an overview of development of this new nal-IRI plus FF therapy and relevant information. Drug therapies for pancreatic cancer currently being developed in Japan, as well as the position of this therapy in pancreatic cancer therapy in Japan and what the expectations are in the clinical setting, are also discussed.