ABSTRACT
BACKGROUND: An increasing number of studies is now devoted to immunotherapy of cancer. We evaluated the clinical benefit of hepcortespenlisimut-L (Hepko-V5 [formerly known as V5])-an oral therapeutic vaccine designated by the United States Food and Drug Administration (FDA) as an orphan drug for treatment of hepatocellular carcinoma (HCC). V5 was initially developed by us in 2002 to treat hepatitis B or C viral infections and liver cirrhosis. METHODS: The outcome of open-label Phase II trial of daily dose of V5 pill was analyzed retrospectively. Over a period of 5 years, 75 patients with advanced HCC were enrolled, consisting of 29 (38.7%) females and 46 (61.3%) males with a median age of 60 years (mean 61.6±8.1 years). Out of these, 23 (30.7%) had hepatitis B and 34 (45.3%) had hepatitis C infections, including 9 (12%) with dual infection, 4 (5.3%) negative for both viruses, and 5 (6.7%) without established viral diagnosis. Most patients (94.7%) had underlying liver cirrhosis of varying severity. RESULTS: After a median of 2 months of treatment, 50 out of 75 patients had experienced a decline in serum levels of the tumor marker, alpha-fetoprotein (AFP) (66.7%; P=0.006 by Wilcoxon signed rank test). Baseline median AFP levels were 245.2 IU/mL (mean 4,233; range 7.2-92,407; 95% confidence interval [CI] 1,186-7,280) and post-treatment values were 102.3 IU/mL (mean 2,539; range 0.9-54,478; 95% CI 503-4,575). The decrease in AFP was correlated either with tumor clearance or regression on computed tomography scans. The median overall survival time could not be established since 68 out of 75 (90.7%) patients were still alive after median follow-up of 12 months (mean 15±9.7; range 7-59; 95% CI 12.8-17.2). The first patient in this study received immunotherapy 5 years ago and still remains in complete remission. None of the patients experienced any serious adverse effects or toxicity. CONCLUSION: The results indicate that hepcortespenlismut-L is a safe, effective, and fast-acting immunomodulatory intervention for HCC. The Phase III, randomized, double-blind, placebo-controlled trial is now initiated at the Mongolian National Cancer Center to confirm these promising findings.
ABSTRACT
OBJECTIVE: To describe the declining trend in maternal mortality observed in Mongolia from 1992 to 2007 and its acceleration after 2001 following implementation of the Maternal Mortality Reduction Strategy by the Ministry of Health and other partners. METHODS: We performed a descriptive analysis of maternal mortality data collected through Mongolia's vital registration system and provided by the Mongolian Ministry of Health. The observed declining mortality trend was analysed for statistical significance using simple linear regression. We present the maternal mortality ratios from 1992 to 2007 by year and review the basic components of Mongolia's Maternal Mortality Reduction Strategy for 2001-2004 and 2005-2010. FINDINGS: Mongolia achieved a statistically significant annual decrease in its maternal mortality ratio of almost 10 deaths per 100 000 live births over the period 1992-2007. From 2001 to 2007, the maternal mortality ratio in Mongolia decreased approximately 47%, from 169 to 89.6 deaths per 100 000 live births. CONCLUSION: Disparities in maternal mortality represent one of the major persisting health inequities between low- and high-resource countries. Nonetheless, important reductions in low-resource settings are possible through collaborative strategies based on a horizontal approach and the coordinated involvement of key partners, including health ministries, national and international agencies and donors, health-care professionals, the media, nongovernmental organizations and the general public.
