Nuijten M, Meester L, Waibel F, Wait S
MEDTAP, Amsterdam, The Netherlands.
Pharmacoeconomics. 1999 Oct;16(4):379-97. doi: 10.2165/00019053-199916040-00006.
To simulate the treatment of postmenopausal women with advanced breast cancer from second-line hormone therapy to death, and to generate estimates of the cost and effectiveness of letrozole and megestrol in order to determine the incremental cost effectiveness of letrozole, expressed as cost per life-years gained.
A decision-analytic model, using Markov process techniques, was designed to evaluate the lifetime clinical and economic consequences of treatment with letrozole compared with standard care with megestrol. The model was based on clinical trial results showing a clear advantage of letrozole in terms of time to progression and duration of response.
The setting of the study was that of the UK healthcare system in 1996.
A hypothetical cohort of patients, identical to the patients recruited for the AR/BC2 clinical trial, who were postmenopausal women with advanced breast cancer who had previously failed to respond to first-line or adjuvant anti-estrogen therapy.
The dosages of medications were 2.5 and 160 mg/day for letrozole and megestrol, respectively. The analysis covered the period from treatment initiation until death (lifetime model). Effectiveness was expressed as survival and time without progression, and the model also included all relevant economic measures.
Based on the model, the average survival time of the letrozole group was 2.1 years (25.3 months) versus 1.9 years (21.5 months) for the megestrol group, a gain in survival of 2.4 months (10.5%). The average time without progression, cumulatively calculated over the different treatment options, amounted to 20.2 months for letrozole and 17.8 months for megestrol, an increase of 13.7% for the former patients. The total average cost per patient for the treatment of advanced breast cancer starting from second-line hormone therapy until death was higher in the letrozole group at 7547 Pounds versus 6820 Pounds for the megestrol group (discounted at an annual rate of 5%), leading to an incremental cost-effectiveness ratio of 3588 Pounds per life-year gained (1996 values).
Based on the assumptions used in this model, letrozole offers a suitable alternative to megestrol in the treatment of second-line hormone therapy.
模拟绝经后晚期乳腺癌女性从二线激素治疗至死亡的治疗过程,估算来曲唑和甲地孕酮的成本及效果,以确定来曲唑的增量成本效果,用每获得一个生命年的成本来表示。
采用马尔可夫过程技术设计了一个决策分析模型,以评估来曲唑治疗与甲地孕酮标准治疗相比的终身临床和经济后果。该模型基于临床试验结果,该结果显示来曲唑在疾病进展时间和缓解持续时间方面具有明显优势。
研究背景为1996年的英国医疗保健系统。
一个假设的患者队列,与AR/BC2临床试验招募的患者相同,即绝经后晚期乳腺癌女性,她们之前对一线或辅助抗雌激素治疗无反应。
来曲唑和甲地孕酮的药物剂量分别为每日2.5毫克和160毫克。分析涵盖从治疗开始直至死亡的时间段(终身模型)。效果用生存率和无进展时间表示,该模型还纳入了所有相关经济指标。
基于该模型,来曲唑组的平均生存时间为2.1年(25.3个月),而甲地孕酮组为1.9年(21.5个月),生存获益为2.4个月(10.5%)。不同治疗方案累计计算的平均无进展时间,来曲唑组为20.2个月,甲地孕酮组为17.8个月,前者患者增加了13.7%。从二线激素治疗开始直至死亡,来曲唑组晚期乳腺癌患者的总平均成本更高,为7547英镑,而甲地孕酮组为6820英镑(按每年5%的贴现率),导致每获得一个生命年的增量成本效果比为3588英镑(1996年价值)。
基于该模型所采用的假设,来曲唑在二线激素治疗中是甲地孕酮的合适替代药物。