Cabazitaxel plus prednisone for metastatic castration-resistant prostate cancer progressing after docetaxel: results from the German compassionate-use programme.
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Cabazitaxel plus prednisone for metastatic castration-resistant prostate cancer progressing after docetaxel: results from the German compassionate-use programme. / Heidenreich, Axel; Scholz, Hans-Jörg; Rogenhofer, Sebastian; Arsov, Christian; Retz, Margitta; Müller, Stefan C; Albers, Peter; Gschwend, Jürgen; Wirth, Manfred; Steiner, Ursula; Miller, Kurt; Heinrich, Elmar; Trojan, Lutz; Volkmer, Björn; Honecker, Friedemann Ulrich; Bokemeyer, Carsten; Keck, Bastian; Otremba, Burkhard; Ecstein-Fraisse, Evelyne; Pfister, David.
in: EUR UROL, Jahrgang 63, Nr. 6, 6, 2013, S. 977-982.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Cabazitaxel plus prednisone for metastatic castration-resistant prostate cancer progressing after docetaxel: results from the German compassionate-use programme.
AU - Heidenreich, Axel
AU - Scholz, Hans-Jörg
AU - Rogenhofer, Sebastian
AU - Arsov, Christian
AU - Retz, Margitta
AU - Müller, Stefan C
AU - Albers, Peter
AU - Gschwend, Jürgen
AU - Wirth, Manfred
AU - Steiner, Ursula
AU - Miller, Kurt
AU - Heinrich, Elmar
AU - Trojan, Lutz
AU - Volkmer, Björn
AU - Honecker, Friedemann Ulrich
AU - Bokemeyer, Carsten
AU - Keck, Bastian
AU - Otremba, Burkhard
AU - Ecstein-Fraisse, Evelyne
AU - Pfister, David
N1 - Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.
PY - 2013
Y1 - 2013
N2 - BACKGROUND: Cabazitaxel (Cbz) is an approved second-line treatment in metastatic castration-resistant prostate cancer (mCRPC) following docetaxel therapy with a significant survival benefit compared with mitoxantrone. However, grade 3/4 toxicities were reported in 82% of patients.OBJECTIVE: To report on the safety results of mCRPC patients treated within a compassionate-use programme in Germany.DESIGN, SETTING, AND PARTICIPANTS: A total of 111 patients with a mean age of 67.9 yr (range: 49-81 yr) and progressive mCRPC were included. Patients had received a mean number of 12.7 ± 10.8 cycles (range: 6-69 cycles) of docetaxel with a mean cumulative dose of 970.9 mg/m(2); mean time from last docetaxel application to progression was 6.95 mo (range: 2-54 mo). Of the patients, 31.5% progressed by prostate-specific antigen (PSA) increase only; the remainder had a combination of PSA increase and clinical progression.INTERVENTION: Cbz at a dosage of 25mg/m(2) intravenously every 3 wk combined with 5mg of oral prednisone twice a day.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Treatment-associated toxicity was the primary study end point; progression-free and overall survival were secondary end points. A descriptive statistical analysis was performed.RESULTS AND LIMITATIONS: Patients received a mean number of 6.5 ± 2.2 cycles of Cbz and a mean cumulative dose of 160.3 ± 51.5mg/m(2). Grade 3 and 4 treatment-emergent adverse events were recorded in 34 patients (30.6%) and 18 patients (16.2%), respectively. Grade 3/4 anaemia, neutropenia, and thrombocytopenia were reported in 4.5%, 7.2%, and 0.9% of the patients, respectively. Neutropenic fever was reported in 1.8% of the patients. Grade 3/4 gastrointestinal toxicity was identified in 4.5% of the patients. Three patients died because of Cbz-related toxicity. Granulocyte colony-stimulating growth factors were used in 17.1% of patients. The limitations are due to the nonrandomised nature of the trial.CONCLUSIONS: Treatment with Cbz is tolerable and is associated with a low incidence of serious adverse events in a real-world patient population with CRPC. The outcome of serious adverse events can be minimised with proactive treatment management and conscientious monitoring.
AB - BACKGROUND: Cabazitaxel (Cbz) is an approved second-line treatment in metastatic castration-resistant prostate cancer (mCRPC) following docetaxel therapy with a significant survival benefit compared with mitoxantrone. However, grade 3/4 toxicities were reported in 82% of patients.OBJECTIVE: To report on the safety results of mCRPC patients treated within a compassionate-use programme in Germany.DESIGN, SETTING, AND PARTICIPANTS: A total of 111 patients with a mean age of 67.9 yr (range: 49-81 yr) and progressive mCRPC were included. Patients had received a mean number of 12.7 ± 10.8 cycles (range: 6-69 cycles) of docetaxel with a mean cumulative dose of 970.9 mg/m(2); mean time from last docetaxel application to progression was 6.95 mo (range: 2-54 mo). Of the patients, 31.5% progressed by prostate-specific antigen (PSA) increase only; the remainder had a combination of PSA increase and clinical progression.INTERVENTION: Cbz at a dosage of 25mg/m(2) intravenously every 3 wk combined with 5mg of oral prednisone twice a day.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Treatment-associated toxicity was the primary study end point; progression-free and overall survival were secondary end points. A descriptive statistical analysis was performed.RESULTS AND LIMITATIONS: Patients received a mean number of 6.5 ± 2.2 cycles of Cbz and a mean cumulative dose of 160.3 ± 51.5mg/m(2). Grade 3 and 4 treatment-emergent adverse events were recorded in 34 patients (30.6%) and 18 patients (16.2%), respectively. Grade 3/4 anaemia, neutropenia, and thrombocytopenia were reported in 4.5%, 7.2%, and 0.9% of the patients, respectively. Neutropenic fever was reported in 1.8% of the patients. Grade 3/4 gastrointestinal toxicity was identified in 4.5% of the patients. Three patients died because of Cbz-related toxicity. Granulocyte colony-stimulating growth factors were used in 17.1% of patients. The limitations are due to the nonrandomised nature of the trial.CONCLUSIONS: Treatment with Cbz is tolerable and is associated with a low incidence of serious adverse events in a real-world patient population with CRPC. The outcome of serious adverse events can be minimised with proactive treatment management and conscientious monitoring.
KW - Aged
KW - Aged, 80 and over
KW - Anemia
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Compassionate Use Trials
KW - Disease-Free Survival
KW - Fever
KW - Germany
KW - Humans
KW - Kallikreins
KW - Male
KW - Middle Aged
KW - Neutropenia
KW - Prednisone
KW - Prostate-Specific Antigen
KW - Prostatic Neoplasms
KW - Taxoids
KW - Thrombocytopenia
KW - Treatment Failure
KW - Treatment Outcome
U2 - 10.1016/j.eururo.2012.08.058
DO - 10.1016/j.eururo.2012.08.058
M3 - SCORING: Journal article
C2 - 23116658
VL - 63
SP - 977
EP - 982
JO - EUR UROL
JF - EUR UROL
SN - 0302-2838
IS - 6
M1 - 6
ER -