Document Detail

2-Weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial.
MedLine Citation:
PMID:  23294853     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: 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.
METHODS: 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, number NCT00255606.
FINDINGS: 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).
INTERPRETATION: 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.
FUNDING: Sanofi.
Pirkko-Liisa Kellokumpu-Lehtinen; Ulrika Harmenberg; Timo Joensuu; Ray McDermott; Petteri Hervonen; Claes Ginman; Marjaana Luukkaa; Paul Nyandoto; Akseli Hemminki; Sten Nilsson; John McCaffrey; Raija Asola; Taina Turpeenniemi-Hujanen; Fredrik Laestadius; Tiina Tasmuth; Katinka Sandberg; Maccon Keane; Ilari Lehtinen; Tiina Luukkaala; Heikki Joensuu;
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2013-01-04
Journal Detail:
Title:  The Lancet. Oncology     Volume:  14     ISSN:  1474-5488     ISO Abbreviation:  Lancet Oncol.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-01     Completed Date:  2013-03-25     Revised Date:  2014-08-18    
Medline Journal Info:
Nlm Unique ID:  100957246     Medline TA:  Lancet Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  117-24     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 Elsevier Ltd. All rights reserved.
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MeSH Terms
Aged, 80 and over
Antineoplastic Agents / administration & dosage*,  adverse effects,  therapeutic use*
Drug Administration Routes
Middle Aged
Prospective Studies
Prostatic Neoplasms / drug therapy*,  psychology
Quality of Life
Taxoids / administration & dosage*,  adverse effects,  therapeutic use*
Treatment Failure
Reg. No./Substance:
0/Antineoplastic Agents; 0/Taxoids; 15H5577CQD/docetaxel
Comment In:
Nat Rev Urol. 2013 Mar;10(3):123   [PMID:  23358518 ]
Nat Rev Clin Oncol. 2013 Mar;10(3):123   [PMID:  23337917 ]
Lancet Oncol. 2013 Feb;14(2):98-9   [PMID:  23294852 ]

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