A randomized, multicenter phase III clinical trial comparing gemcitabine and cisplatin with 5-fluorouracil and cisplatin in the treatment of recurrent or metastatic nasopharyngeal carcinoma.

6028 Background: Cisplatin plus fluorouracil (PF) is main therapy for metastatic nasopharyngeal carcinoma (NPC). However, the efficacy is not satisfactory, especially in patients with metastasis after radical radiotherapy. The purpose of this study was to investigate the efficacy and toxicity of Nimotuzumab combined with PF in patients with metastatic NPC after radical radiotherapy. Methods: Patients with untreated metastatic NPC after radical radiotherapy were recruited from 9 hospitals in China with Simon’s two-stage design. All patients received Nimotuzumab (200mg/w) and cisplatin (100mg/m2, day 1) plus fluorouracil (4g/m², day 1-4) every 3 weeks until progressive disease (PD) or unacceptable toxicity or a maximum of 6 cycles. If patients had still not progressed at this stage, Nimotuzumab (200mg/w) as monotherapy would be delivered until PD. This study was registered in ClinicalTrials.gov, Number NCT01616849. Results: Between Jun, 2012 and April, 2015, 35 patients were enrolled (Table). The objective response rate (ORR) and disease control rate (DCR) were 71.4% and 85.7%, and the median time of progression free survival (PFS) and overall survival (OS) were 6.97 and 11.01 months. The most common toxicities were leukopenia (94.1%), vomiting (97.1%) and nausea (97.1%); the grade 3/4 toxicities were leukopenia (62.9%) and mucositis (20.0%). There was only 1 patient have mild hypotension which related to Nimotuzumab. The ORR, DCR, median time of PFS and OS were 88.9%, 100.0%, 7.29 and 11.47 months in patients who received a total dose of Nimotuzumab ≥ 2400mg, respectively. Conclusions: Nimotuzumab combined with PF has achieved encouraging efficacy with an acceptable safety profile in metastatic NPC after radical radiotherapy. A phase III randomised study is needed. Clinical trial information: NCT01616849. [Table: see text]

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RESULTS OF THE DOUBLE-BLIND, RANDOMIZED, MULTICENTER, PHASE III CLINICAL TRIAL OF THYMOGLOBULIN VERSUS ATGAM IN THE TREATMENT OF ACUTE GRAFT REJECTION EPISODES AFTER RENAL TRANSPLANTATION1,2

Transplantation Journal ◽

10.1097/00007890-199807150-00005 ◽

1998 ◽

Vol 66 (1) ◽

pp. 29-37 ◽

Cited By ~ 217

Author(s):

A. Osama Gaber ◽

M. Roy First ◽

Raymond J. Tesi ◽

Robert S. Gaston ◽

Robert Mendez ◽

...

Keyword(s):

Clinical Trial ◽

Graft Rejection ◽

Phase Iii ◽

Double Blind ◽

Phase Iii Clinical Trial ◽

Acute Graft Rejection ◽

Multicenter Phase ◽

Acute Graft

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Oncorine, the World First Oncolytic Virus Medicine and its Update in China

Current Cancer Drug Targets ◽

10.2174/1568009618666171129221503 ◽

2018 ◽

Vol 18 (2) ◽

pp. 171-176 ◽

Cited By ~ 43

Author(s):

Min Liang

Keyword(s):

Clinical Trial ◽

Nasopharyngeal Carcinoma ◽

Oncolytic Virus ◽

Therapeutic Strategy ◽

Oncolytic Viruses ◽

Phase Iii ◽

Chinese Market ◽

Phase Iii Clinical Trial ◽

The World ◽

Commercial Research

The oncolytic viruses now hold a promise of new therapeutic strategy for cancer. Its concept has inspired a wave of commercial research and development activities for the products of this category in China since 1998. The first commercialized oncolytic virus product in the world, Oncorine (H101), developed by Shanghai Sunway Biotech Co., Ltd since 1999, was approved by Chinese SFDA in November, 2005 for nasopharyngeal carcinoma in combination with chemotherapy after the phase III clinical trial, and finally acquired GMP certificate in August, 2006. This review introduces how Oncorine was successfully developed in China, and how the Chinese market responded after it was launched into the market in 2006.

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