Department of Pharmacy, Besançon University Hospital, Besançon, FranceINSERM EPI 106, Dijon, France.
Clin Drug Investig. 2005;25(11):719-29. doi: 10.2165/00044011-200525110-00005.
The cardiotoxicity of anthracyclines remains a key problem in patients with aggressive non-Hodgkin's lymphoma (NHL). With regard to the actual long-term prognosis of aggressive NHL, the development of cardioprotective strategies is mandatory for these patients. A cost-effectiveness analysis was carried out to determine the potential economic profile of dexrazoxane or liposome-encapsulated doxorubicin in patients with aggressive NHL treated with a CHOP regimen (cyclophosphamide, doxorubicin, vincristine, prednisone) as first-line therapy.
A decision-analysis model described clinical events and economic consequences for theoretical patients who were to receive eight consecutive cycles of a CHOP regimen containing 50 mg/m(2) of doxorubicin as first-line chemotherapy. The timeframe of the model was the patient's lifetime. The probabilities were related to the cumulative dose of doxorubicin and age. The study was carried out from the perspective of the French healthcare system. Patients entered the model at 'choose' node: no cardioprotection versus cardioprotection with dexrazoxane or liposome-encapsulated doxorubicin. The model was based on a retrospective epidemiological study and on published data. The clinical end-point was life expectancy. Direct medical costs related to the cardioprotection and the treatment of congestive heart failure were considered. Monetary values for French prices in the year 2002 were used. Several univariate sensitivity analyses were carried out with varying clinical and economic parameters.
Per 100 patients, the two cardioprotective strategies provided similar benefits that were estimated as 24.5 and 13.4 life-years in 60- and 40-year-old patients, respectively. The cost per life-year saved with dexrazoxane was estimated as euro6931 and euro15 599 in 60- and 40-year-old patients, respectively, and euro22 940 and euro44 982, respectively, with liposome-encapsulated doxorubicin. Several sensitivity analyses showed the robustness of the model.
The results suggest the potential clinical and economic usefulness of cardioprotective therapies in patients with aggressive NHL. Prospective studies are needed to confirm these findings.
蒽环类药物的心脏毒性仍然是侵袭性非霍奇金淋巴瘤（NHL）患者的一个关键问题。就侵袭性 NHL 的实际长期预后而言，对于这些患者，必须制定心脏保护策略。本项成本效益分析旨在确定蒽环类药物心脏保护剂右雷佐生或脂质体阿霉素在接受环磷酰胺、多柔比星、长春新碱、泼尼松（CHOP）方案一线治疗的侵袭性 NHL 患者中的潜在经济学特征。
采用决策分析模型描述了理论患者的临床事件和经济后果，这些患者将接受八周期的 CHOP 方案，方案中每周期给予 50mg/m2 多柔比星作为一线化疗。模型的时间范围为患者的整个生命周期。概率与累积多柔比星剂量和年龄相关。研究从法国医疗保健系统的角度进行。患者在“选择”节点进入模型：无心脏保护与右雷佐生或脂质体阿霉素心脏保护。模型基于回顾性流行病学研究和已发表的数据。临床终点为预期寿命。考虑了与心脏保护和充血性心力衰竭治疗相关的直接医疗费用。使用了 2002 年法国价格的货币值。对不同的临床和经济参数进行了多次单变量敏感性分析。
在 100 例患者中，两种心脏保护策略的获益相似，分别为 60 岁和 40 岁患者的 24.5 和 13.4 个生命年。用右雷佐生每挽救 1 个生命年的成本估计分别为 60 岁和 40 岁患者的 6931 欧元和 15599 欧元，用脂质体阿霉素分别为 22940 欧元和 44982 欧元。几项敏感性分析表明模型具有稳健性。
研究结果提示，在侵袭性 NHL 患者中，心脏保护治疗具有潜在的临床和经济效益。需要前瞻性研究来证实这些发现。
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