Primary Prevention for Gastric Cancer with Helicobacter pylori Eradication and the Cost-Effectiveness Analysis
Date Issued
2006
Date
2006
Author(s)
Lee, Yi-Chia
DOI
zh-TW
Abstract
Part I
Although eradication of Helicobacter pylori (H. pylori) infection can decrease the risk of gastric cancer, the optimal regimen for treating the general population remains unclear. In the first part of thesis, we reported the eradication rate (intention-to-treat and per protocol) of a community-based H. pylori therapy using the strategy of test, treat, retest, and retreat initial treatment failures.
In 2004, a total of 2,658 residents were recruited for 13C urea breath testing. Participants with positive results for infection received a standard 7-day triple therapy (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily), and a 10-day re-treatment (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and levofloxacin 500 mg once daily) if the follow-up tests remained positive. Both H. pylori status and side-effects were assessed 6 weeks after treatment. Among 886 valid reporters, eradication rates with initial therapy were 86.9% (95% confidence interval [CI]: 84.7-89.1%) and 88.7% (95%CI: 86.5-90.9%) by intention-to-treat and per protocol analysis, respectively. Re-treatment eradicated infection in 91.4% (95%CI: 86-96.8%) of 105 non-responders. Adequate compliance was achieved in 798 (90.1%) of 886 subjects receiving the initial treatment and in all 105 re-treated subjects. Mild side effects occurred in 24% of subjects. Overall intention-to-treat and per protocol eradication rates were 97.7% (95%CI: 96.7-98.7%) and 98.8% (95%CI: 98.5-99.3%), respectively, which were only affected by poor compliance (odds ratio [OR], 3.3; 95%CI, 1.99–5.48; P<0.0001).
The results first confirmed that clarithromycin-based initial therapy and levofloxacin-based re-treatment is efficacious on a population basis. This approach is safe, well-tolerated, and achieves high eradication rates. Second, a comprehensive plan using drugs in which the resistance rate is low in a population combined with the strategy of test, treat, retest, and retreat of needed can result in virtual eradication of H. pylori from a population. This provides a model for planning country or region wide eradication programs.
Part II
Though both primary prevention and secondary prevention strategies can reduce the mortality rate of non-cardiac gastric cancer, little is known about their long-term relative cost and benefit. The second part of thesis was to assess the relative cost and effectiveness, optimal initial age and inter-screening interval in a high-risk area regarding primary and secondary preventive strategy.
The base-case estimates, including parameters of natural history of gastric cancer, efficacy of intervention and relevant cost, were derived from two empirical data on two interventions targeting at a high-risk population in two periods, 1995-1999 and 2004-2005. Cost and effectiveness was compared between chemoprevention with 13C urea breath testing followed by H pylori eradication and surveillance strategy for high-risk group based on serum pepsinogen (PG) measurements and confirmed by endoscopy. One-way and probabilistic sensitivity analyses were performed to assess the influences of uncertainty of certain parameters. Our main outcome measure was the cost per life-year gained with 3% annual discounted rate.
The result showed that the incremental cost-effectiveness ratio (ICER) for one-shot chemoprevention at age 30 y versus no screening was US $17,044 per life-year gained. Eradication of H pylori at later age or with a periodic scheme yielded a less favorable result. Annual high-risk screening at age of 50 y versus no screening resulted in an ICER of US $29,741 per life-year gained. ICERs do not substantially vary with surveillance at various initial ages or with different inter-screening intervals. The chemoprevention was more cost-effective than high-risk surveillance, either at ceiling ratios of US $15,762 or up to US $50,000. The results of cost-effectiveness are most sensitive to the infection rate of H pylori and proportion of early gastric cancer in all detectable cases.
In conclusion, we found that early H pylori eradication once in lifetime seems cost-effective than surveillance strategy for high-risk group. However, the choice of population-based preventive strategy is still subject to risk of infection and the detectability of early gastric cancer.
Although eradication of Helicobacter pylori (H. pylori) infection can decrease the risk of gastric cancer, the optimal regimen for treating the general population remains unclear. In the first part of thesis, we reported the eradication rate (intention-to-treat and per protocol) of a community-based H. pylori therapy using the strategy of test, treat, retest, and retreat initial treatment failures.
In 2004, a total of 2,658 residents were recruited for 13C urea breath testing. Participants with positive results for infection received a standard 7-day triple therapy (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily), and a 10-day re-treatment (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and levofloxacin 500 mg once daily) if the follow-up tests remained positive. Both H. pylori status and side-effects were assessed 6 weeks after treatment. Among 886 valid reporters, eradication rates with initial therapy were 86.9% (95% confidence interval [CI]: 84.7-89.1%) and 88.7% (95%CI: 86.5-90.9%) by intention-to-treat and per protocol analysis, respectively. Re-treatment eradicated infection in 91.4% (95%CI: 86-96.8%) of 105 non-responders. Adequate compliance was achieved in 798 (90.1%) of 886 subjects receiving the initial treatment and in all 105 re-treated subjects. Mild side effects occurred in 24% of subjects. Overall intention-to-treat and per protocol eradication rates were 97.7% (95%CI: 96.7-98.7%) and 98.8% (95%CI: 98.5-99.3%), respectively, which were only affected by poor compliance (odds ratio [OR], 3.3; 95%CI, 1.99–5.48; P<0.0001).
The results first confirmed that clarithromycin-based initial therapy and levofloxacin-based re-treatment is efficacious on a population basis. This approach is safe, well-tolerated, and achieves high eradication rates. Second, a comprehensive plan using drugs in which the resistance rate is low in a population combined with the strategy of test, treat, retest, and retreat of needed can result in virtual eradication of H. pylori from a population. This provides a model for planning country or region wide eradication programs.
Part II
Though both primary prevention and secondary prevention strategies can reduce the mortality rate of non-cardiac gastric cancer, little is known about their long-term relative cost and benefit. The second part of thesis was to assess the relative cost and effectiveness, optimal initial age and inter-screening interval in a high-risk area regarding primary and secondary preventive strategy.
The base-case estimates, including parameters of natural history of gastric cancer, efficacy of intervention and relevant cost, were derived from two empirical data on two interventions targeting at a high-risk population in two periods, 1995-1999 and 2004-2005. Cost and effectiveness was compared between chemoprevention with 13C urea breath testing followed by H pylori eradication and surveillance strategy for high-risk group based on serum pepsinogen (PG) measurements and confirmed by endoscopy. One-way and probabilistic sensitivity analyses were performed to assess the influences of uncertainty of certain parameters. Our main outcome measure was the cost per life-year gained with 3% annual discounted rate.
The result showed that the incremental cost-effectiveness ratio (ICER) for one-shot chemoprevention at age 30 y versus no screening was US $17,044 per life-year gained. Eradication of H pylori at later age or with a periodic scheme yielded a less favorable result. Annual high-risk screening at age of 50 y versus no screening resulted in an ICER of US $29,741 per life-year gained. ICERs do not substantially vary with surveillance at various initial ages or with different inter-screening intervals. The chemoprevention was more cost-effective than high-risk surveillance, either at ceiling ratios of US $15,762 or up to US $50,000. The results of cost-effectiveness are most sensitive to the infection rate of H pylori and proportion of early gastric cancer in all detectable cases.
In conclusion, we found that early H pylori eradication once in lifetime seems cost-effective than surveillance strategy for high-risk group. However, the choice of population-based preventive strategy is still subject to risk of infection and the detectability of early gastric cancer.
Subjects
胃癌
幽門桿菌
疾病自然史
成本效果分析
敏感度分析
gastric cancer
Helicobacter pylori
natural history
cost-effectiveness analysis
sensitivity analysis
SDGs
Type
thesis
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