2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial

多西紫杉醇 医学 前列腺癌 内科学 癌症 泌尿科 随机对照试验 肿瘤科
作者
Pirkko‐Liisa Kellokumpu‐Lehtinen,Ulrika Harmenberg,Timo Joensuu,Ray McDermott,Petteri Hervonen,Claes Ginman,Marjaana Luukkaa,Paul Nyandoto,Akseli Hemminki,Sten Nilsson,John McCaffrey,R. Asola,Taina Turpeenniemi‐Hujanen,Fredrik Laestadius,Tiina Tasmuth,Katinka Sandberg,Maccon Keane,Ilari Lehtinen,Tiina Luukkaala,Heikki Joensuu
出处
期刊:Lancet Oncology [Elsevier BV]
卷期号:14 (2): 117-124 被引量:195
标识
DOI:10.1016/s1470-2045(12)70537-5
摘要

Docetaxel administered every 3 weeks is a standard treatment for castration-resistant advanced prostate cancer. We hypothesised that 2-weekly administration of docetaxel would be better tolerated than 3-weekly docetaxel in patients with castration-resistant advanced prostate cancer, and did a prospective, multicentre, randomised, phase 3 study to compare efficacy and safety.Eligible patients had advanced prostate cancer (metastasis, a prostate-specific-antigen test result of more than 10·0 ng/mL, and WHO performance status score of 0-2), had received no chemotherapy (except with estramustine), had undergone surgical or chemical castration, and had been referred to a treatment centre in Finland, Ireland, or Sweden. Enrolment and treatment were done between March 1, 2004, and May 31, 2009. Randomisation was done centrally and stratified by centre and WHO performance status score of 0-1 vs 2. Patients were assigned 75 mg/m(2) docetaxel intravenously on day 1 of a 3-week cycle, or 50 mg/m(2) docetaxel intravenously on days 1 and 15 of a 4-week cycle. 10 mg oral prednisolone was administered daily to all patients. The primary endpoint was time to treatment failure (TTTF). We assessed data in the per-protocol population. This study is registered with ClinicalTrials.gov, number NCT00255606.177 patients were randomly assigned to the 2-weekly docetaxel group and 184 to the 3-weekly group. 170 patients in the 2-weekly group and 176 in the 3-weekly group were included in the analysis. The 2-weekly administration was associated with significantly longer TTTF than was 3-weekly administration (5·6 months, 95% CI 5·0-6·2 vs 4·9 months, 4·5-5·4; hazard ratio 1·3, 95% CI 1·1-1·6, p=0·014). Grade 3-4 adverse events occurred more frequently in the 3-weekly than in the 2-weekly administration group, including neutropenia (93 [53%] vs 61 [36%]), leucopenia (51 [29%] vs 22 [13%]), and febrile neutropenia (25 [14%] vs six [4%]). Neutropenic infections were reported more frequently in patients who received docetaxel every 3 weeks (43 [24%] vs 11 [6%], p=0·002).Administration of docetaxel every 2 weeks seems to be well tolerated in patients with castration-resistant advanced prostate cancer and could be a useful option when 3-weekly single-dose administration is unlikely to be tolerated.Sanofi.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
SYLH应助zly采纳,获得30
2秒前
完美世界应助娇气的天亦采纳,获得10
4秒前
6秒前
9秒前
科目三应助彭栋采纳,获得10
11秒前
方文浩发布了新的文献求助10
11秒前
ding应助YWang采纳,获得10
14秒前
14秒前
林宝雯关注了科研通微信公众号
19秒前
22秒前
斯文败类应助GGBOND采纳,获得10
22秒前
星辰大海应助科研通管家采纳,获得10
22秒前
李健的小迷弟应助GGBOND采纳,获得10
22秒前
上官若男应助科研通管家采纳,获得10
22秒前
23秒前
大模型应助科研通管家采纳,获得10
23秒前
圆锥香蕉应助科研通管家采纳,获得20
23秒前
星辰大海应助科研通管家采纳,获得10
23秒前
23秒前
23秒前
Bio应助科研通管家采纳,获得30
23秒前
科研通AI5应助科研通管家采纳,获得10
23秒前
斯文败类应助科研通管家采纳,获得10
23秒前
汉堡包应助科研通管家采纳,获得10
23秒前
24秒前
27秒前
29秒前
29秒前
Dotson发布了新的文献求助10
30秒前
sinsinsin发布了新的文献求助10
31秒前
CodeCraft应助娇气的天亦采纳,获得10
32秒前
33秒前
权思远发布了新的文献求助10
33秒前
彭栋发布了新的文献求助10
33秒前
量子星尘发布了新的文献求助10
34秒前
李爱国应助收集快乐采纳,获得10
35秒前
守墓人完成签到 ,获得积分10
36秒前
37秒前
科研通AI5应助xiaoxiao采纳,获得10
40秒前
顾矜应助权思远采纳,获得10
40秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989115
求助须知:如何正确求助?哪些是违规求助? 3531367
关于积分的说明 11253688
捐赠科研通 3269986
什么是DOI,文献DOI怎么找? 1804868
邀请新用户注册赠送积分活动 882078
科研通“疑难数据库(出版商)”最低求助积分说明 809105