Lister-Sharp D, McDonagh M S, Khan K S, Kleijnen J
NHS Centre for Reviews and Dissemination, University of York, York, UK.
Health Technol Assess. 2000;4(17):1-113.
SECOND-LINE TREATMENT, PACLITAXEL (MEDIAN PROGRESSION-FREE SURVIVAL): The median progression-free survival in the paclitaxel arm was 3.5 months. This was significantly longer than the mitomycin control arm (1.6 months, p = 0.026). BREAST CANCER - SECOND-LINE TREATMENT, PACLITAXEL (MEDIAN OVERALL SURVIVAL): The median length of overall survival in the paclitaxel arm was 12.7 months, compared with 8.4 months in the mitomycin arm. BREAST CANCER - SECOND-LINE TREATMENT, PACLITAXEL (QUALITY OF LIFE): Quality of life was not reported. BREAST CANCER - SECOND-LINE TREATMENT, PACLITAXEL (ECONOMIC EVALUATION): The only economic evaluation that compared paclitaxel with control (mitomycin) was submitted in confidence and has been removed from this report. Six economic evaluations involved comparisons of paclitaxel and docetaxel, which are given below. BREAST CANCER - SECOND-LINE TREATMENT, DOCETAXEL: Four randomised controlled Phase III trials were identified: 303 Study, 304 Study, Scand and Bonneterre. A total of 1092 patients were included. One of these was a preliminary report of a study before completion of accrual (Bonneterre). Patients in the 303 Study had previously received chemotherapy involving alkylating agents; those in the other three had received anthracyclines. There were six economic evaluations on docetaxel. BREAST CANCER - SECOND-LINE TREATMENT, DOCETAXEL (QUALITY OF TRIALS): The 303 and 304 Studies were analysed on an intention to treat basis; the Scand trial excluded a single patient. The length of follow-up ranged from 11 months (Scand) to 23 months (303 Study). At least two-thirds of the participants in these trials had died. The Scand study recommended cross-over to alternate treatment on objective signs of disease progression. Patients crossing over in this way were violating the randomisation; however, no details were given concerning whether or not such patients were censored. In the economic analyses, there were no direct comparisons for the estimation of benefits. BREAST CANCER - SECOND-LINE TREATMENT, DOCETAXEL (MEDIAN PROGRESSION-FREE SURVIVAL): The median progression-free survival in the docetaxel arm ranged from 4.75 months (304 Study) to 7 months (Bonneterre). Patients in the docetaxel arms of the 304 and Scand studies had significantly longer progression-free survivals than controls (4.75 months versus 2.75 months, p = 0.001; 6.3 months versus 3 months, p = 0.001). BREAST CANCER - SECOND-LINE TREATMENT, DOCETAXEL (MEDIAN OVERALL SURVIVAL): The median overall survival in the docetaxel arm ranged from 10.4 months (Scand) to 15 months (303 Study). Patients in the docetaxel arms of the 304 Study survived for significantly longer than the mitomycin plus vinblastine arm (11.4 months versus 8.7 months, p = 0.03). BREAST CANCER - SECOND-LINE TREATMENT, DOCETAXEL (QUALITY OF LIFE): Quality of life was evaluated in two of the trials: the 303 and 304 Studies. There were no significant differences between docetaxel and control in either of these trials in terms of global health status, although differences were apparent on some subscales. These did not appear to follow a consistent pattern across the trials. BREAST CANCER - SECOND-LINE TREATMENT, DOCETAXEL (ECONOMIC EVALUATIONS): All six of these involved comparisons of paclitaxel and docetaxel, where the range of cost-utility ratios for incremental quality-adjusted life-years (QALYs) gained was pound 1990-pound 2431. In addition, three analyses compared docetaxel and vinorelbine. The cost-utility ratio for incremental QALYs gained was pound 14,050 in the only one of these carried out in the UK. OVARIAN CANCER - FIRST-LINE TREATMENT, PACLITAXEL: Four randomised controlled Phase III trials were identified: EORTC, TITGANZ, E1193 and CA139-278. (ABSTRACT TRUNCATED)
二线治疗,紫杉醇(无进展生存期中位数):紫杉醇组的无进展生存期中位数为3.5个月。这显著长于丝裂霉素对照组(1.6个月,p = 0.026)。乳腺癌 - 二线治疗,紫杉醇(总生存期中位数):紫杉醇组的总生存期长度中位数为12.7个月,而丝裂霉素组为8.4个月。乳腺癌 - 二线治疗,紫杉醇(生活质量):未报告生活质量情况。乳腺癌 - 二线治疗,紫杉醇(经济学评估):唯一一项比较紫杉醇与对照(丝裂霉素)的经济学评估是以保密形式提交的,已从本报告中删除。六项经济学评估涉及紫杉醇与多西他赛的比较,如下所示。乳腺癌 - 二线治疗,多西他赛:确定了四项随机对照III期试验:303研究、304研究、斯堪的纳维亚研究和博内特雷研究。共纳入1092例患者。其中一项是入组未完成前的研究初步报告(博内特雷研究)。303研究中的患者先前接受过含烷化剂的化疗;其他三项研究中的患者接受过蒽环类药物治疗。有六项关于多西他赛的经济学评估。乳腺癌 - 二线治疗,多西他赛(试验质量):303和304研究按意向性分析;斯堪的纳维亚试验排除了1例患者。随访时间从11个月(斯堪的纳维亚研究)到23个月(303研究)不等。这些试验中至少三分之二的参与者已死亡。斯堪的纳维亚研究建议在疾病进展的客观体征出现时交叉接受替代治疗。以这种方式交叉的患者违反了随机分组;然而,未给出关于此类患者是否被删失的详细信息。在经济学分析中,没有进行直接比较以估计效益。乳腺癌 - 二线治疗,多西他赛(无进展生存期中位数):多西他赛组的无进展生存期中位数从4.75个月(304研究)到7个月(博内特雷研究)不等。304研究和斯堪的纳维亚研究的多西他赛组患者的无进展生存期显著长于对照组(4.75个月对2.75个月,p = 0.001;6.3个月对3个月,p = 0.001)。乳腺癌 - 二线治疗,多西他赛(总生存期中位数):多西他赛组的总生存期中位数从10.4个月(斯堪的纳维亚研究)到15个月(303研究)不等。304研究的多西他赛组患者的生存期显著长于丝裂霉素加长春花碱组(11.4个月对8.7个月,p = 0.03)。乳腺癌 - 二线治疗,多西他赛(生活质量):在两项试验(303和304研究)中评估了生活质量。在这两项试验中,多西他赛与对照组在总体健康状况方面均无显著差异,尽管在一些子量表上存在差异。这些差异在各试验中似乎没有一致的模式。乳腺癌 - 二线治疗,多西他赛(经济学评估):所有这六项评估都涉及紫杉醇与多西他赛的比较,其中每获得一个质量调整生命年(QALY)的成本效用比范围为1990英镑至2431英镑。此外,三项分析比较了多西他赛与长春瑞滨。在英国进行的其中一项分析中,每获得一个增量QALY的成本效用比为14,050英镑。卵巢癌 - 一线治疗,紫杉醇:确定了四项随机对照III期试验:欧洲癌症研究与治疗组织(EORTC)、TITGANZ、E1193和CA139 - 278。(摘要截断)