First evidence for the antitumor activity of nanoliposomal irinotecan with 5-fluorouracil and folinic acid in metastatic biliary tract cancer.

BACKGROUND: Therapeutic options are limited for advanced, metastatic biliary tract cancer. The pivotal NAPOLI-1 trial demonstrated the superior clinical benefit of nanoliposomal irinotecan (Nal-IRI) in gemcitabine-pretreated patients with metastatic pancreatic ductal adenocarcinoma; however, the antitumor activity of Nal-IRI in biliary tract cancer is unknown. This is the first report describing the efficacy of Nal-IRI in biliary tract cancer. METHODS: In this multicenter retrospective cohort analysis, we identified patients with metastatic biliary tract adenocarcinoma who were treated with Nal-IRI in combination with 5-fluorouracil and folinic acid following tumor progression under standard therapy at one of the study centers between May 2016 and January 2019. We assessed disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). RESULTS: There were 14 patients; the median age at the time of diagnosis and the median age at the initiation of Nal-IRI were 59.3 and 60.0 years, respectively. Nal-IRI in combination with 5-fluorouracil and folinic acid was administered as second-, third-, fourth-, and fifth-line treatment in 6 (43%), 5 (36%), 2 (14%), and 1 (7%) patient with metastatic disease, respectively. The objective DCR with Nal-IRI was 50% (7/14 patients). Six patients (43%) had partial response, and one patient (7%) had stable disease. Progressive disease was observed in seven patients. The median PFS and median OS following Nal-IRI initiation were 10.6 and 24.1 months, respectively. CONCLUSIONS: This retrospective analysis provides the first evidence that Nal-IRI might exhibit a clinical meaningful antitumor activity in metastatic biliary tract cancer.

Distinct differences in clinical manifestation and viral laboratory parameters between children and adults with influenza A(H1N1)pdm09 infection--a retrospective comparative analysis.

During the influenza pandemic 2009 children and adults differed in the clinical course of the influenza disease. In following the question arose, if the case definitions used within the national and international organizations are an adequate tool for the clinical diagnosis of influenza in children as well as in adults. Therefore medical charts from 146 children and 229 adults were retrospectively analyzed. In addition, the initial viral loads of all 375 patients and the duration of virus shedding of a subset of 79 patients were also investigated. Children show a wider clinical spectrum including gastro enteric symptoms and also a different spectrum of laboratory parameters like elevated CRP-levels, leucocytosis, and higher viral loads. Further, children show significantly more often complications, for example, myositis that may be underdiagnosed. In patients receiving antiviral-therapy complications occurred significantly less often and the presence of symptoms was significantly shorter compared to the untreated group (2.3 days vs. 6.0 days). In summary, the differences in the clinical picture between children and adults should be taken into consideration for the clinical diagnosis of influenza and also for a future discussion on age specific influenza case definitions.