Journal of Medical Diagnostic Methods
Open Access
ISSN: 2168-9784
+44 1300 500008
ISSN: 2168-9784
+44 1300 500008
Shuichi Mitsunaga
National Cancer Center Hospital East,
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577
Japan
Research Article
Multicenter, Open-Label, Phase I/II Study of Tocilizumab, an Anti–Interleukin-6 Receptor Monoclonal Antibody, Combined with Gemcitabine in Patients with Advanced Pancreatic Cancer
Author(s): Shuichi Mitsunaga, Takuji Okusaka, Masafumi Ikeda, Masato Ozaka, Shinichi Ohkawa, Tatsuya Ioka, Tomomi Shimura, Kumi Sato, Kimio Terao, Atsushi Ochiai and Junji FuruseShuichi Mitsunaga, Takuji Okusaka, Masafumi Ikeda, Masato Ozaka, Shinichi Ohkawa, Tatsuya Ioka, Tomomi Shimura, Kumi Sato, Kimio Terao, Atsushi Ochiai and Junji Furuse
Background: To assess the efficacy, safety and pharmacokinetics of tocilizumab + gemcitabine in patients with advanced pancreatic cancer.
Methods: Patients with treatment-naive advanced pancreatic cancer and high inflammatory burden (C-reactive protein ≥ 2 mg/dl) without obvious infections received tocilizumab (8 mg/kg) intravenously every 2 weeks with intravenous gemcitabine (1,000 mg/m2) on days 1, 8 and 15 of each 4-week cycle until disease progression or study withdrawal. Interleukin-6 signalling inhibition biomarkers were measured. Efficacy analyses included overall survival, progression-free survival, tumour response and clinical symptoms. Adverse events and laboratory parameters were also assessed.
Results: Fifteen patients received tocilizumab+gemcitabine. Tumour response was observed in two patients (13.. View More»
DOI:
10.4172/2168-9784.1000234