Hale J P, Cohen D R, Maughan T S, Stephens R J
University of Glamorgan, School of Care Sciences, Pontypridd CF37 1DL, UK.
Br J Cancer. 2002 Jun 5;86(11):1684-90. doi: 10.1038/sj.bjc.6600273.
An economic sub-study was run alongside a large multi-centre randomised trial (MRC-CR06) comparing three chemotherapy regimens; de Gramont, Lokich and raltitrexed in patients with metastatic colorectal cancer. Patients in six of 45 centres in the main trial were approached to take part in the sub-study. Chemotherapy delivery costs were assessed in each sub-study centre with external validity verified by questionnaire to all other centres. Patient representativeness was assessed. Stochastic resource use data, including patient borne costs and non-hospital health service resource use were monitored prospectively. Mean total societal costs were de Gramont= 5051 pounds sterling (s.d. 1910 pounds sterling ), raltitrexed= 2616 pounds sterling (s.d. 991 pounds sterling ) and Lokich= 2576 pounds sterling (s.d. 1711 pounds sterling ). In pairwise comparisons, statistically significant mean total cost differences were shown for de Gramont vs Lokich (mean difference= 2475 pounds sterling , 95%CI 914 pounds sterling - 4037 pounds sterling , P<0.01) and for de Gramont vs raltitrexed (mean difference= 2435 pounds sterling, 95%CI 922 pounds sterling - 2948 pounds sterling , P<0.01). Sensitivity analyses showed little effect on overall costs. The main trial showed de Gramont and Lokich to be equally effective in terms of survival, quality of life and response rates but Lokich had higher toxicity and hand-foot syndrome. Raltitrexed showed similar response rates and overall survival but increased toxicity and inferior quality of life making it a clinically inferior regimen despite its ease of administration and costs. For a comparable clinical outcome, Lokich can be administered for approximately half the cost of de Gramont.
一项经济学子研究与一项大型多中心随机试验（MRC-CR06）同时开展，该试验比较了三种化疗方案；在转移性结直肠癌患者中使用的德格拉蒙方案、洛基奇方案和雷替曲塞方案。主试验中45个中心里有6个中心的患者被邀请参与子研究。在每个子研究中心评估化疗实施成本，并通过向所有其他中心发放问卷来验证外部有效性。评估了患者的代表性。前瞻性监测随机资源使用数据，包括患者自付费用和非医院卫生服务资源使用情况。平均社会总成本为：德格拉蒙方案=5051英镑（标准差1910英镑），雷替曲塞方案=2616英镑（标准差991英镑），洛基奇方案=2576英镑（标准差1711英镑）。在两两比较中，德格拉蒙方案与洛基奇方案之间显示出具有统计学意义的平均总成本差异（平均差异=2475英镑，95%置信区间914英镑 - 4037英镑，P<0.01），德格拉蒙方案与雷替曲塞方案之间也显示出具有统计学意义的平均总成本差异（平均差异=2435英镑，95%置信区间922英镑 - 2948英镑，P<0.01）。敏感性分析表明对总体成本影响不大。主试验表明，在生存率、生活质量和缓解率方面，德格拉蒙方案和洛基奇方案同样有效，但洛基奇方案毒性更高且有手足综合征。雷替曲塞方案显示出相似的缓解率和总生存率，但毒性增加且生活质量较差，尽管其给药方便且成本较低，但仍是临床上较差的方案。对于可比的临床结果，洛基奇方案的给药成本约为德格拉蒙方案的一半。
