People who receive more chemotherapeutic or targeted therapeutic agents have an increased overall survival compared to people who receive less. These agents, administered as both first-line or second-line treatments, also led to better overall survival than best supportive care. With the exception of ramucirumab, it remains unclear which other individual agents cause the survival benefit. Although treatment-associated toxicities of grade 3 or more occurred more frequently in arms with an additional chemotherapy or targeted therapy agent, there is no evidence that palliative chemotherapy and/or targeted therapy decrease quality of life. Based on this meta-analysis, palliative chemotherapy and/or targeted therapy can be considered standard care for esophageal and gastroesophageal junction carcinoma.
BackgroundCostly biologicals in palliative oncology are emerging at a rapid pace. For example, in patients with advanced esophageal squamous cell carcinoma addition of cetuximab to a palliative chemotherapy regimen appears to improve survival. However, it simultaneously results in higher costs. We aimed to determine the incremental cost-effectiveness ratio of adding cetuximab to first-line chemotherapeutic treatment of patients with advanced esophageal squamous cell carcinoma, based on data from a randomized controlled phase II trial.MethodsA cost effectiveness analysis model was applied based on individual patient data. It included only direct medical costs from the health-care perspective. Quality-adjusted life-years and incremental cost-effectiveness ratios were calculated. Sensitivity analysis was performed by a Monte Carlo analysis.ResultsAdding cetuximab to a cisplatin-5-fluorouracil first-line regimen for advanced esophageal squamous cell carcinoma resulted in an the incremental cost-effectiveness ratio of €252,203 per quality-adjusted life-year. Sensitivity analysis shows that there is a chance of less than 0.001 that the incremental cost-effectiveness ratio will be less than a maximum willingness to pay threshold of €40,000 per quality-adjusted life-year, which is representative for the threshold used in The Netherlands and other developed countries.ConclusionsAddition of cetuximab to a cisplatin-5-fluorouracil first-line regimen for advanced esophageal squamous cell carcinoma is not cost-effective when appraised according to currently accepted criteria. Cost-effectiveness analyses using outcome data from early clinical trials (i.c. a phase II trial) enable pharmaceutical companies and policy makers to gain early insight into whether a new drug meets the current eligibility standards for reimbursement and thereby potential admittance for use in regular clinical practice.
IntroductionThe low incidence of oesophageal adenocarcinoma (EAC) in Barrett's oesophagus (BE) patients reinforces the need for risk stratification tools to make BE surveillance more effective. Therefore, we have undertaken a systematic review and meta-analysis of published studies on immunohistochemical (IHC) biomarkers in BE to determine the value of IHC biomarkers as neoplastic predictors in BE surveillance.Materials and methodsWe searched MEDLINE, EMBASE, Web of Science, CENTRAL, Pubmed publisher, and Google scholar. All studies on IHC biomarkers in BE surveillance were included. ORs were extracted and meta-analyses performed with a random effects model.Results16 different IHC biomarkers were studied in 36 studies. These studies included 425 cases and 1835 controls. A meta- analysis was performed for p53, aspergillus oryzae lectin (AOL), Cyclin A, Cyclin D and alpha-methylacyl-CoA racemase. Aberrant p53 expression was significantly associated with an increased risk of neoplastic progression with an OR of 3.18 (95% CI 1.68 to 6.03). This association was confirmed for both non-dysplastic BE and BE with low-grade dysplasia (LGD). Another promising biomarker to predict neoplastic progression was AOL, with an OR of 3.04 (95% CI 2.05 to 4.49).DiscussionUse of p53 IHC staining may improve risk stratification in BE surveillance. Aberrant p53 expression in BE patients appeared to be associated with a significantly increased risk of neoplastic progression for both non-dysplastic and LGD BE patients.
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