| Title | Phase II Study of Recombinant Antitumor and Antivirus Protein Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Standard Treatment |
| Authors | Jia Ru Wang Yan Mao Xiao-Yang Li Shan-Shan Xu Nong Xiong Jian-Ping Shen Lin Bai Li Liu Wei Liu Lie-Jun Ge Fei-Jiao Chen Yu-Ling Lin Li Xu Jian-Ming |
| Affiliation | Affiliated Hospital Cancer Center, Academy of Military Medical Sciences, Beijing, People's Republic of China jmxu2003@163.com. Aviation General Hospital of China Medical University, Beijing, People's Republic of China The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China The First Affiliated Hospital of Nanchang University, Nanchang, People's Republic of China Peking University Cancer Hospital and Institute, Beijing, People's Republic of China General Hospital of the Chinese People's Liberation Army, Beijing, People's Republic of China The Fourth Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China. |
| Issue Date | 2015 |
| Citation | The oncologist.2015. |
| Abstract | To observe the efficacy, safety, and optimal dosage of recombinant antitumor and antivirus protein (Novaferon) in treating patients with metastatic colorectal cancer (mCRC) who failed at least two prior palliative regimens.We enrolled 108 patients from May 2011 to December 2012. According to different treatment modalities and therapeutic dosages, the participants were randomly divided into four cohorts at a 2:2:2:1 ratio: (a) 20 μg Novaferon (Genova Biotech, Beijing, People's Republic of China, http://www.genovabiotech.net) injected twice per week, (b) 20 μg Novaferon injected 3 times per week, (c) 40 μg Novaferon injected 3 times per week, or (d) saline injected 3 times per week. The primary endpoint was overall survival.There was no significant difference in overall survival among the four cohorts. The 20-μg dose of Novaferon injected 3 times per week had the highest disease control rate (44.0%) at 6 weeks but without significant differences when compared with placebo (p = .159). Major adverse events with Novaferon were influenza-like symptoms, bone marrow suppression, liver dysfunction, and gastrointestinal discomfort. The level of natural killer cells increased and regulatory T cells decreased significantly after treatment with Novaferon, whereas levels in the placebo group remained the same.Novaferon showed moderate efficacy and was well tolerated in patients with mCRC, especially with the 20-μg dose injected 3 times per week. Furthermore, Novaferon might improve immune function of these patients.?AlphaMed Press; the data published online to support this summary is the property of the authors. |
| URI | http://hdl.handle.net/20.500.11897/341273 |
| ISSN | 1549-490X |
| DOI | 10.1634/theoncologist.2014-0439 |
| Indexed | SCI(E) PubMed |
| Appears in Collections: | 北京肿瘤医院 |
