alexa 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
ISSN: 2168-9784

Journal of Medical Diagnostic Methods
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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

Shuichi Mitsunaga1,2*, Takuji Okusaka3, Masafumi Ikeda1, Masato Ozaka4, Shinichi Ohkawa5, Tatsuya Ioka6, Tomomi Shimura7, Kumi Sato7, Kimio Terao7, Atsushi Ochiai2 and Junji Furuse8

1Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan

2Pathology Division, Research Center for Innovative Oncology, National Cancer Center Hospital East, Chiba, Japan

3Department of Hepatobiliary Pancreatic, National Cancer Center Hospital, Tokyo, Japan

4Gastroenterological Internal Medicine, The Cancer Institute Hospital, Tokyo, Japan

5Division of Hepato-biliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan

6Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and CVD, Osaka, Japan

7Clinical Research Planning Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan

8Department of Medical Oncology, Kyorin University School of Medicine, Tokyo, Japan

*Corresponding Author:
Shuichi Mitsunaga
Department of Hepatobiliary and Pancreatic Oncology
National Cancer Center Hospital East, 6-5-1, Kashiwanoha
Kashiwa, Chiba, 277-8577, Japan
Tel: 81471331111
Fax: +81471330335
E-mail: [email protected]

Received date: November 21, 2016; Accepted date: January 24, 2017; Published date: January 31, 2017

Citation: Mitsunaga S, Okusaka T, Ikeda M, Ozaka M, Ohkawa S, et al. (2017) 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. J Med Diagn Meth 6: 234. doi:10.4172/2168-9784.1000234

Copyright: © 2017 Mitsunaga S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

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%). Six patients (40%) died within 2 months of treatment start. Median overall survival was 2.5 months (95% confidence interval, 1.4-5.8); median progression-free survival was 1.8 months (95% confidence interval, 0.8-3.6). Overall and progression-free survival tended to be longer in patients with modest than in patients with higher elevations of baseline C-reactive protein. Changes in C-reactive protein and IL-6 occurred. Although tocilizumab +gemcitabine was tolerable, results were inconclusive because of the brevity of the evaluation period resulting from the death or premature withdrawal of patients. Dose interruption attributed to haematologic toxicity was frequently observed.

Conclusions: Tocilizumab+gemcitabine failed to show a clear clinical benefit in patients with advanced pancreatic cancer and high inflammatory burden. To evaluate conclusively the benefit of tocilizumab, future study designs should use a comparator treatment that does not interfere with interleukin-6 signalling and that includes better patient selection criteria.

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