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Phase II Study of Recombinant Antitumor and Antivirus Protein Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Standard Treatment
Phase II Study of Recombinant Antitumor and Antivirus Protein Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Standard Treatment
- Source :
- The Oncologist. 20:619-620
- Publication Year :
- 2015
- Publisher :
- Oxford University Press (OUP), 2015.
-
Abstract
- Lessons Learned Novaferon showed moderate efficacy and was well-tolerated in patients with metastatic colorectal cancer (mCRC), especially with the 20 μg injected 3 times a week strategy. Although Novaferon did not provide a survival benefit for mCRC patients who have failed standard treatment, it may play a role in improvement of immune function. Background. 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. Methods. 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. Results. 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. Conclusion. 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.
- Subjects :
- Adult
Male
Cancer Research
medicine.medical_specialty
Palliative care
Drug-Related Side Effects and Adverse Reactions
Dose
Colorectal cancer
Phases of clinical research
Placebo
Gastroenterology
Internal medicine
medicine
Humans
Treatment Failure
Neoplasm Metastasis
Adverse effect
Aged
business.industry
Clinical Trial Results
Standard treatment
Palliative Care
Middle Aged
medicine.disease
Recombinant Proteins
Surgery
Oncology
Bone marrow suppression
Female
Interferons
Colorectal Neoplasms
business
Subjects
Details
- ISSN :
- 1549490X and 10837159
- Volume :
- 20
- Database :
- OpenAIRE
- Journal :
- The Oncologist
- Accession number :
- edsair.doi.dedup.....647f440ba9ce0fb99213e93c7e325e35
- Full Text :
- https://doi.org/10.1634/theoncologist.2014-0439