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

Tutkimustuotosvertaisarvioitu

Standard

2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer : A randomised, Phase 3 trial. / Kellokumpu-Lehtinen, Pirkko Liisa; Harmenberg, Ulrika; Joensuu, Timo; McDermott, Ray; Hervonen, Petteri; Ginman, Claes; Luukkaa, Marjaana; Nyandoto, Paul; Hemminki, Akseli; Nilsson, Sten; McCaffrey, John; Asola, Raija; Turpeenniemi-Hujanen, Taina; Laestadius, Fredrik; Tasmuth, Tiina; Sandberg, Katinka; Keane, Maccon; Lehtinen, Ilari; Luukkaala, Tiina; Joensuu, Heikki.

julkaisussa: LANCET ONCOLOGY, Vuosikerta 14, Nro 2, 02.2013, s. 117-124.

Tutkimustuotosvertaisarvioitu

Harvard

Kellokumpu-Lehtinen, PL, Harmenberg, U, Joensuu, T, McDermott, R, Hervonen, P, Ginman, C, Luukkaa, M, Nyandoto, P, Hemminki, A, Nilsson, S, McCaffrey, J, Asola, R, Turpeenniemi-Hujanen, T, Laestadius, F, Tasmuth, T, Sandberg, K, Keane, M, Lehtinen, I, Luukkaala, T & Joensuu, H 2013, '2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: A randomised, Phase 3 trial', LANCET ONCOLOGY, Vuosikerta. 14, Nro 2, Sivut 117-124. https://doi.org/10.1016/S1470-2045(12)70537-5

APA

Kellokumpu-Lehtinen, P. L., Harmenberg, U., Joensuu, T., McDermott, R., Hervonen, P., Ginman, C., ... Joensuu, H. (2013). 2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: A randomised, Phase 3 trial. LANCET ONCOLOGY, 14(2), 117-124. https://doi.org/10.1016/S1470-2045(12)70537-5

Vancouver

Kellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C et al. 2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: A randomised, Phase 3 trial. LANCET ONCOLOGY. 2013 helmi;14(2):117-124. https://doi.org/10.1016/S1470-2045(12)70537-5

Author

Kellokumpu-Lehtinen, Pirkko Liisa ; Harmenberg, Ulrika ; Joensuu, Timo ; McDermott, Ray ; Hervonen, Petteri ; Ginman, Claes ; Luukkaa, Marjaana ; Nyandoto, Paul ; Hemminki, Akseli ; Nilsson, Sten ; McCaffrey, John ; Asola, Raija ; Turpeenniemi-Hujanen, Taina ; Laestadius, Fredrik ; Tasmuth, Tiina ; Sandberg, Katinka ; Keane, Maccon ; Lehtinen, Ilari ; Luukkaala, Tiina ; Joensuu, Heikki. / 2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer : A randomised, Phase 3 trial. Julkaisussa: LANCET ONCOLOGY. 2013 ; Vuosikerta 14, Nro 2. Sivut 117-124.

Bibtex - Lataa

@article{535f7084b29d44c4bbcabd6fa45e8be3,
title = "2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: A randomised, Phase 3 trial",
abstract = "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/m2 docetaxel intravenously on day 1 of a 3-week cycle, or 50 mg/m2 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. 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.",
author = "Kellokumpu-Lehtinen, {Pirkko Liisa} and Ulrika Harmenberg and Timo Joensuu and Ray McDermott and Petteri Hervonen and Claes Ginman and Marjaana Luukkaa and Paul Nyandoto and Akseli Hemminki and Sten Nilsson and John McCaffrey and Raija Asola and Taina Turpeenniemi-Hujanen and Fredrik Laestadius and Tiina Tasmuth and Katinka Sandberg and Maccon Keane and Ilari Lehtinen and Tiina Luukkaala and Heikki Joensuu",
year = "2013",
month = "2",
doi = "10.1016/S1470-2045(12)70537-5",
language = "English",
volume = "14",
pages = "117--124",
journal = "LANCET ONCOLOGY",
issn = "1470-2045",
publisher = "Elsevier",
number = "2",

}

RIS (suitable for import to EndNote) - Lataa

TY - JOUR

T1 - 2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer

T2 - A randomised, Phase 3 trial

AU - Kellokumpu-Lehtinen, Pirkko Liisa

AU - Harmenberg, Ulrika

AU - Joensuu, Timo

AU - McDermott, Ray

AU - Hervonen, Petteri

AU - Ginman, Claes

AU - Luukkaa, Marjaana

AU - Nyandoto, Paul

AU - Hemminki, Akseli

AU - Nilsson, Sten

AU - McCaffrey, John

AU - Asola, Raija

AU - Turpeenniemi-Hujanen, Taina

AU - Laestadius, Fredrik

AU - Tasmuth, Tiina

AU - Sandberg, Katinka

AU - Keane, Maccon

AU - Lehtinen, Ilari

AU - Luukkaala, Tiina

AU - Joensuu, Heikki

PY - 2013/2

Y1 - 2013/2

N2 - 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/m2 docetaxel intravenously on day 1 of a 3-week cycle, or 50 mg/m2 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. 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.

AB - 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/m2 docetaxel intravenously on day 1 of a 3-week cycle, or 50 mg/m2 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. 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.

UR - http://www.scopus.com/inward/record.url?scp=84873095714&partnerID=8YFLogxK

U2 - 10.1016/S1470-2045(12)70537-5

DO - 10.1016/S1470-2045(12)70537-5

M3 - Article

VL - 14

SP - 117

EP - 124

JO - LANCET ONCOLOGY

JF - LANCET ONCOLOGY

SN - 1470-2045

IS - 2

ER -