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贝伐珠单抗联合 FOLFIRI 方案对比 FOLFIRI 单药一线治疗韩国转移性结直肠癌的临床疗效和成本效果。

Clinical and cost effectiveness of bevacizumab + FOLFIRI combination versus FOLFIRI alone as first-line treatment of metastatic colorectal cancer in South Korea.

机构信息

Sungkyunkwan University School of Pharmacy, Seoul, Republic of Korea.

出版信息

Clin Ther. 2012 Jun;34(6):1408-19. doi: 10.1016/j.clinthera.2012.05.001. Epub 2012 May 31.

Abstract

BACKGROUND

Bevacizumab has been extensively investigated in combination with various standard chemotherapies in the treatment of metastatic colorectal cancer (mCRC). However, a comparison to irinotecan + infusional 5-fluorouracil/leucovorin (FOLFIRI) is lacking.

OBJECTIVE

To explore clinical effectiveness and cost-effectiveness of adding bevacizumab to a regimen of FOLFIRI for the first-line treatment of mCRC in the Republic of Korea by conducting an indirect treatment comparison.

METHODS

A health-economic model was developed to investigate the possible health outcomes (life-years gained [LYG]), direct costs, and incremental cost-effectiveness ratio (ICER) of adding bevacizumab to a FOLFIRI regimen. Data on progression-free and overall survival were derived from randomized clinical trials and were used in the indirect treatment comparison. The annual discount rate for costs and outcomes was 5%. A lifetime horizon of 8 years was used. Sensitivity analyses were carried out on all pivotal model assumptions.

RESULTS

Incremental mean overall survival among patients treated with bevacizumab + FOLFIRI varied between 8.6 and 15.7 months compared with patients treated with FOLFIRI alone. The deterministic base-case result was 1.177 LYG. The discounted ICERs ranged from μ31.8 to μ39.5 million/LYG, with the base-case result being μ34.5 million/LYG. Treatment effect had the most impact on the outcomes in this model.

CONCLUSIONS

Although there is no formal threshold for ICER per LYG in Korea, funding may be considered for bevacizumab + FOLFIRI, particularly if the severity and end-of-life nature of mCRC is taken into account.

摘要

背景

贝伐珠单抗已广泛应用于联合多种标准化疗方案治疗转移性结直肠癌(mCRC)。然而,目前仍缺乏其与伊立替康+持续滴注氟尿嘧啶/亚叶酸(FOLFIRI)方案的比较。

目的

通过间接治疗比较,探讨在韩国,贝伐珠单抗联合 FOLFIRI 方案作为 mCRC 一线治疗的临床疗效和成本效益。

方法

建立健康经济学模型,以评估在 FOLFIRI 方案基础上加用贝伐珠单抗治疗 mCRC 可能获得的健康结果(获益寿命年)、直接成本和增量成本效果比(ICER)。无进展生存期和总生存期的数据来源于随机临床试验,并应用于间接治疗比较。成本和结果的年度贴现率为 5%,使用 8 年的生命周期。对所有关键模型假设进行敏感性分析。

结果

与单独使用 FOLFIRI 方案相比,接受贝伐珠单抗+FOLFIRI 方案治疗的患者的中位总生存期的增量均值在 8.6 至 15.7 个月之间。确定性基础案例结果为 1.177 个获益寿命年。经贴现后的 ICER 范围为 3180 万韩元至 3950 万韩元/获益寿命年,基础案例结果为 3450 万韩元/获益寿命年。在该模型中,治疗效果对结果的影响最大。

结论

尽管韩国尚未制定每获益寿命年的 ICER 正式阈值,但如果考虑到 mCRC 的严重程度和临终性质,可能会考虑为贝伐珠单抗+FOLFIRI 方案提供资金。

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