Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial
Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCR...
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2021 |
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| Übergeordnetes Werk: |
Enthalten in: European journal of cancer - Amsterdam [u.a.] : Elsevier, 1965, 155, Seite 56-63 |
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| Übergeordnetes Werk: |
volume:155 ; pages:56-63 |
| DOI / URN: |
10.1016/j.ejca.2021.06.016 |
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| 245 | 1 | 0 | |a Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial |
| 264 | 1 | |c 2021 | |
| 336 | |a nicht spezifiziert |b zzz |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 520 | |a Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III–IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study’s phase II design and the absence of an overall survival benefit.Trial registration numbers: EudraCT 2014-000175-43 – NCT02453009. | ||
| 650 | 4 | |a Chemo-hormonal therapy | |
| 650 | 4 | |a Combination therapy | |
| 650 | 4 | |a Docetaxel | |
| 650 | 4 | |a Enzalutamide | |
| 650 | 4 | |a Metastatic castration-resistant prostate cancer | |
| 700 | 1 | |a Ortega, Cinzia |e verfasserin |4 aut | |
| 700 | 1 | |a Nolè, Franco |e verfasserin |4 aut | |
| 700 | 1 | |a Gasparro, Donatello |e verfasserin |4 aut | |
| 700 | 1 | |a Mucciarini, Claudia |e verfasserin |4 aut | |
| 700 | 1 | |a Aieta, Michele |e verfasserin |4 aut | |
| 700 | 1 | |a Zagonel, Vittorina |e verfasserin |4 aut | |
| 700 | 1 | |a Iacovelli, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a De Giorgi, Ugo |e verfasserin |4 aut | |
| 700 | 1 | |a Facchini, Gaetano |e verfasserin |4 aut | |
| 700 | 1 | |a Veccia, Antonello |e verfasserin |4 aut | |
| 700 | 1 | |a Palesandro, Erica |e verfasserin |4 aut | |
| 700 | 1 | |a Verri, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Buti, Sebastiano |e verfasserin |0 (orcid)0000-0003-0876-0226 |4 aut | |
| 700 | 1 | |a Razzini, Giorgia |e verfasserin |0 (orcid)0000-0003-3290-1367 |4 aut | |
| 700 | 1 | |a Bozza, Giovanni |e verfasserin |4 aut | |
| 700 | 1 | |a Maruzzo, Marco |e verfasserin |0 (orcid)0000-0002-6256-9249 |4 aut | |
| 700 | 1 | |a Ciccarese, Chiara |e verfasserin |4 aut | |
| 700 | 1 | |a Schepisi, Giuseppe |e verfasserin |0 (orcid)0000-0002-9973-4869 |4 aut | |
| 700 | 1 | |a Rossetti, Sabrina |e verfasserin |4 aut | |
| 700 | 1 | |a Maines, Francesca |e verfasserin |4 aut | |
| 700 | 1 | |a Kinspergher, Stefania |e verfasserin |4 aut | |
| 700 | 1 | |a Fratino, Lucia |e verfasserin |4 aut | |
| 700 | 1 | |a Ermacora, Paola |e verfasserin |4 aut | |
| 700 | 1 | |a Nicodemo, Maurizio |e verfasserin |0 (orcid)0000-0002-5825-0171 |4 aut | |
| 700 | 1 | |a Giordano, Monica |e verfasserin |4 aut | |
| 700 | 1 | |a Sartori, Donata |e verfasserin |4 aut | |
| 700 | 1 | |a Scapoli, Daniela |e verfasserin |4 aut | |
| 700 | 1 | |a Sabbatini, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Lo Re, Giovanni |e verfasserin |4 aut | |
| 700 | 1 | |a Morelli, Franco |e verfasserin |0 (orcid)0000-0003-2378-9094 |4 aut | |
| 700 | 1 | |a D’Angelo, Alessandro |e verfasserin |4 aut | |
| 700 | 1 | |a Vittimberga, Isabella |e verfasserin |4 aut | |
| 700 | 1 | |a Lippe, Paolo |e verfasserin |4 aut | |
| 700 | 1 | |a Carrozza, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Messina, Caterina |e verfasserin |4 aut | |
| 700 | 1 | |a Galli, Luca |e verfasserin |0 (orcid)0000-0001-6008-0266 |4 aut | |
| 700 | 1 | |a Valcamonico, Francesca |e verfasserin |4 aut | |
| 700 | 1 | |a Porta, Camillo |e verfasserin |0 (orcid)0000-0003-2412-1563 |4 aut | |
| 700 | 1 | |a Pappagallo, Giovanni |e verfasserin |4 aut | |
| 700 | 1 | |a Aglietta, Massimo |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t European journal of cancer |d Amsterdam [u.a.] : Elsevier, 1965 |g 155, Seite 56-63 |w (DE-627)266883400 |w (DE-600)1468190-0 |w (DE-576)090954173 |x 1879-2995 |7 nnns |
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10.1016/j.ejca.2021.06.016 doi (DE-627)ELV006548814 (ELSEVIER)S0959-8049(21)00391-9 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl Caffo, Orazio verfasserin (orcid)0000-0001-7968-2531 aut Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III–IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study’s phase II design and the absence of an overall survival benefit.Trial registration numbers: EudraCT 2014-000175-43 – NCT02453009. Chemo-hormonal therapy Combination therapy Docetaxel Enzalutamide Metastatic castration-resistant prostate cancer Ortega, Cinzia verfasserin aut Nolè, Franco verfasserin aut Gasparro, Donatello verfasserin aut Mucciarini, Claudia verfasserin aut Aieta, Michele verfasserin aut Zagonel, Vittorina verfasserin aut Iacovelli, Roberto verfasserin aut De Giorgi, Ugo verfasserin aut Facchini, Gaetano verfasserin aut Veccia, Antonello verfasserin aut Palesandro, Erica verfasserin aut Verri, Elena verfasserin aut Buti, Sebastiano verfasserin (orcid)0000-0003-0876-0226 aut Razzini, Giorgia verfasserin (orcid)0000-0003-3290-1367 aut Bozza, Giovanni verfasserin aut Maruzzo, Marco verfasserin (orcid)0000-0002-6256-9249 aut Ciccarese, Chiara verfasserin aut Schepisi, Giuseppe verfasserin (orcid)0000-0002-9973-4869 aut Rossetti, Sabrina verfasserin aut Maines, Francesca verfasserin aut Kinspergher, Stefania verfasserin aut Fratino, Lucia verfasserin aut Ermacora, Paola verfasserin aut Nicodemo, Maurizio verfasserin (orcid)0000-0002-5825-0171 aut Giordano, Monica verfasserin aut Sartori, Donata verfasserin aut Scapoli, Daniela verfasserin aut Sabbatini, Roberto verfasserin aut Lo Re, Giovanni verfasserin aut Morelli, Franco verfasserin (orcid)0000-0003-2378-9094 aut D’Angelo, Alessandro verfasserin aut Vittimberga, Isabella verfasserin aut Lippe, Paolo verfasserin aut Carrozza, Francesco verfasserin aut Messina, Caterina verfasserin aut Galli, Luca verfasserin (orcid)0000-0001-6008-0266 aut Valcamonico, Francesca verfasserin aut Porta, Camillo verfasserin (orcid)0000-0003-2412-1563 aut Pappagallo, Giovanni verfasserin aut Aglietta, Massimo verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 155, Seite 56-63 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:155 pages:56-63 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie AR 155 56-63 |
| spelling |
10.1016/j.ejca.2021.06.016 doi (DE-627)ELV006548814 (ELSEVIER)S0959-8049(21)00391-9 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl Caffo, Orazio verfasserin (orcid)0000-0001-7968-2531 aut Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III–IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study’s phase II design and the absence of an overall survival benefit.Trial registration numbers: EudraCT 2014-000175-43 – NCT02453009. Chemo-hormonal therapy Combination therapy Docetaxel Enzalutamide Metastatic castration-resistant prostate cancer Ortega, Cinzia verfasserin aut Nolè, Franco verfasserin aut Gasparro, Donatello verfasserin aut Mucciarini, Claudia verfasserin aut Aieta, Michele verfasserin aut Zagonel, Vittorina verfasserin aut Iacovelli, Roberto verfasserin aut De Giorgi, Ugo verfasserin aut Facchini, Gaetano verfasserin aut Veccia, Antonello verfasserin aut Palesandro, Erica verfasserin aut Verri, Elena verfasserin aut Buti, Sebastiano verfasserin (orcid)0000-0003-0876-0226 aut Razzini, Giorgia verfasserin (orcid)0000-0003-3290-1367 aut Bozza, Giovanni verfasserin aut Maruzzo, Marco verfasserin (orcid)0000-0002-6256-9249 aut Ciccarese, Chiara verfasserin aut Schepisi, Giuseppe verfasserin (orcid)0000-0002-9973-4869 aut Rossetti, Sabrina verfasserin aut Maines, Francesca verfasserin aut Kinspergher, Stefania verfasserin aut Fratino, Lucia verfasserin aut Ermacora, Paola verfasserin aut Nicodemo, Maurizio verfasserin (orcid)0000-0002-5825-0171 aut Giordano, Monica verfasserin aut Sartori, Donata verfasserin aut Scapoli, Daniela verfasserin aut Sabbatini, Roberto verfasserin aut Lo Re, Giovanni verfasserin aut Morelli, Franco verfasserin (orcid)0000-0003-2378-9094 aut D’Angelo, Alessandro verfasserin aut Vittimberga, Isabella verfasserin aut Lippe, Paolo verfasserin aut Carrozza, Francesco verfasserin aut Messina, Caterina verfasserin aut Galli, Luca verfasserin (orcid)0000-0001-6008-0266 aut Valcamonico, Francesca verfasserin aut Porta, Camillo verfasserin (orcid)0000-0003-2412-1563 aut Pappagallo, Giovanni verfasserin aut Aglietta, Massimo verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 155, Seite 56-63 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:155 pages:56-63 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie AR 155 56-63 |
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10.1016/j.ejca.2021.06.016 doi (DE-627)ELV006548814 (ELSEVIER)S0959-8049(21)00391-9 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl Caffo, Orazio verfasserin (orcid)0000-0001-7968-2531 aut Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III–IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study’s phase II design and the absence of an overall survival benefit.Trial registration numbers: EudraCT 2014-000175-43 – NCT02453009. Chemo-hormonal therapy Combination therapy Docetaxel Enzalutamide Metastatic castration-resistant prostate cancer Ortega, Cinzia verfasserin aut Nolè, Franco verfasserin aut Gasparro, Donatello verfasserin aut Mucciarini, Claudia verfasserin aut Aieta, Michele verfasserin aut Zagonel, Vittorina verfasserin aut Iacovelli, Roberto verfasserin aut De Giorgi, Ugo verfasserin aut Facchini, Gaetano verfasserin aut Veccia, Antonello verfasserin aut Palesandro, Erica verfasserin aut Verri, Elena verfasserin aut Buti, Sebastiano verfasserin (orcid)0000-0003-0876-0226 aut Razzini, Giorgia verfasserin (orcid)0000-0003-3290-1367 aut Bozza, Giovanni verfasserin aut Maruzzo, Marco verfasserin (orcid)0000-0002-6256-9249 aut Ciccarese, Chiara verfasserin aut Schepisi, Giuseppe verfasserin (orcid)0000-0002-9973-4869 aut Rossetti, Sabrina verfasserin aut Maines, Francesca verfasserin aut Kinspergher, Stefania verfasserin aut Fratino, Lucia verfasserin aut Ermacora, Paola verfasserin aut Nicodemo, Maurizio verfasserin (orcid)0000-0002-5825-0171 aut Giordano, Monica verfasserin aut Sartori, Donata verfasserin aut Scapoli, Daniela verfasserin aut Sabbatini, Roberto verfasserin aut Lo Re, Giovanni verfasserin aut Morelli, Franco verfasserin (orcid)0000-0003-2378-9094 aut D’Angelo, Alessandro verfasserin aut Vittimberga, Isabella verfasserin aut Lippe, Paolo verfasserin aut Carrozza, Francesco verfasserin aut Messina, Caterina verfasserin aut Galli, Luca verfasserin (orcid)0000-0001-6008-0266 aut Valcamonico, Francesca verfasserin aut Porta, Camillo verfasserin (orcid)0000-0003-2412-1563 aut Pappagallo, Giovanni verfasserin aut Aglietta, Massimo verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 155, Seite 56-63 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:155 pages:56-63 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie AR 155 56-63 |
| allfieldsGer |
10.1016/j.ejca.2021.06.016 doi (DE-627)ELV006548814 (ELSEVIER)S0959-8049(21)00391-9 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl Caffo, Orazio verfasserin (orcid)0000-0001-7968-2531 aut Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III–IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study’s phase II design and the absence of an overall survival benefit.Trial registration numbers: EudraCT 2014-000175-43 – NCT02453009. Chemo-hormonal therapy Combination therapy Docetaxel Enzalutamide Metastatic castration-resistant prostate cancer Ortega, Cinzia verfasserin aut Nolè, Franco verfasserin aut Gasparro, Donatello verfasserin aut Mucciarini, Claudia verfasserin aut Aieta, Michele verfasserin aut Zagonel, Vittorina verfasserin aut Iacovelli, Roberto verfasserin aut De Giorgi, Ugo verfasserin aut Facchini, Gaetano verfasserin aut Veccia, Antonello verfasserin aut Palesandro, Erica verfasserin aut Verri, Elena verfasserin aut Buti, Sebastiano verfasserin (orcid)0000-0003-0876-0226 aut Razzini, Giorgia verfasserin (orcid)0000-0003-3290-1367 aut Bozza, Giovanni verfasserin aut Maruzzo, Marco verfasserin (orcid)0000-0002-6256-9249 aut Ciccarese, Chiara verfasserin aut Schepisi, Giuseppe verfasserin (orcid)0000-0002-9973-4869 aut Rossetti, Sabrina verfasserin aut Maines, Francesca verfasserin aut Kinspergher, Stefania verfasserin aut Fratino, Lucia verfasserin aut Ermacora, Paola verfasserin aut Nicodemo, Maurizio verfasserin (orcid)0000-0002-5825-0171 aut Giordano, Monica verfasserin aut Sartori, Donata verfasserin aut Scapoli, Daniela verfasserin aut Sabbatini, Roberto verfasserin aut Lo Re, Giovanni verfasserin aut Morelli, Franco verfasserin (orcid)0000-0003-2378-9094 aut D’Angelo, Alessandro verfasserin aut Vittimberga, Isabella verfasserin aut Lippe, Paolo verfasserin aut Carrozza, Francesco verfasserin aut Messina, Caterina verfasserin aut Galli, Luca verfasserin (orcid)0000-0001-6008-0266 aut Valcamonico, Francesca verfasserin aut Porta, Camillo verfasserin (orcid)0000-0003-2412-1563 aut Pappagallo, Giovanni verfasserin aut Aglietta, Massimo verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 155, Seite 56-63 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:155 pages:56-63 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie AR 155 56-63 |
| allfieldsSound |
10.1016/j.ejca.2021.06.016 doi (DE-627)ELV006548814 (ELSEVIER)S0959-8049(21)00391-9 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl Caffo, Orazio verfasserin (orcid)0000-0001-7968-2531 aut Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III–IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study’s phase II design and the absence of an overall survival benefit.Trial registration numbers: EudraCT 2014-000175-43 – NCT02453009. Chemo-hormonal therapy Combination therapy Docetaxel Enzalutamide Metastatic castration-resistant prostate cancer Ortega, Cinzia verfasserin aut Nolè, Franco verfasserin aut Gasparro, Donatello verfasserin aut Mucciarini, Claudia verfasserin aut Aieta, Michele verfasserin aut Zagonel, Vittorina verfasserin aut Iacovelli, Roberto verfasserin aut De Giorgi, Ugo verfasserin aut Facchini, Gaetano verfasserin aut Veccia, Antonello verfasserin aut Palesandro, Erica verfasserin aut Verri, Elena verfasserin aut Buti, Sebastiano verfasserin (orcid)0000-0003-0876-0226 aut Razzini, Giorgia verfasserin (orcid)0000-0003-3290-1367 aut Bozza, Giovanni verfasserin aut Maruzzo, Marco verfasserin (orcid)0000-0002-6256-9249 aut Ciccarese, Chiara verfasserin aut Schepisi, Giuseppe verfasserin (orcid)0000-0002-9973-4869 aut Rossetti, Sabrina verfasserin aut Maines, Francesca verfasserin aut Kinspergher, Stefania verfasserin aut Fratino, Lucia verfasserin aut Ermacora, Paola verfasserin aut Nicodemo, Maurizio verfasserin (orcid)0000-0002-5825-0171 aut Giordano, Monica verfasserin aut Sartori, Donata verfasserin aut Scapoli, Daniela verfasserin aut Sabbatini, Roberto verfasserin aut Lo Re, Giovanni verfasserin aut Morelli, Franco verfasserin (orcid)0000-0003-2378-9094 aut D’Angelo, Alessandro verfasserin aut Vittimberga, Isabella verfasserin aut Lippe, Paolo verfasserin aut Carrozza, Francesco verfasserin aut Messina, Caterina verfasserin aut Galli, Luca verfasserin (orcid)0000-0001-6008-0266 aut Valcamonico, Francesca verfasserin aut Porta, Camillo verfasserin (orcid)0000-0003-2412-1563 aut Pappagallo, Giovanni verfasserin aut Aglietta, Massimo verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 155, Seite 56-63 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:155 pages:56-63 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie AR 155 56-63 |
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Enthalten in European journal of cancer 155, Seite 56-63 volume:155 pages:56-63 |
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Chemo-hormonal therapy Combination therapy Docetaxel Enzalutamide Metastatic castration-resistant prostate cancer |
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European journal of cancer |
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Caffo, Orazio @@aut@@ Ortega, Cinzia @@aut@@ Nolè, Franco @@aut@@ Gasparro, Donatello @@aut@@ Mucciarini, Claudia @@aut@@ Aieta, Michele @@aut@@ Zagonel, Vittorina @@aut@@ Iacovelli, Roberto @@aut@@ De Giorgi, Ugo @@aut@@ Facchini, Gaetano @@aut@@ Veccia, Antonello @@aut@@ Palesandro, Erica @@aut@@ Verri, Elena @@aut@@ Buti, Sebastiano @@aut@@ Razzini, Giorgia @@aut@@ Bozza, Giovanni @@aut@@ Maruzzo, Marco @@aut@@ Ciccarese, Chiara @@aut@@ Schepisi, Giuseppe @@aut@@ Rossetti, Sabrina @@aut@@ Maines, Francesca @@aut@@ Kinspergher, Stefania @@aut@@ Fratino, Lucia @@aut@@ Ermacora, Paola @@aut@@ Nicodemo, Maurizio @@aut@@ Giordano, Monica @@aut@@ Sartori, Donata @@aut@@ Scapoli, Daniela @@aut@@ Sabbatini, Roberto @@aut@@ Lo Re, Giovanni @@aut@@ Morelli, Franco @@aut@@ D’Angelo, Alessandro @@aut@@ Vittimberga, Isabella @@aut@@ Lippe, Paolo @@aut@@ Carrozza, Francesco @@aut@@ Messina, Caterina @@aut@@ Galli, Luca @@aut@@ Valcamonico, Francesca @@aut@@ Porta, Camillo @@aut@@ Pappagallo, Giovanni @@aut@@ Aglietta, Massimo @@aut@@ |
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2021-01-01T00:00:00Z |
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The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). 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Caffo, Orazio |
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Caffo, Orazio ddc 610 bkl 44.81 misc Chemo-hormonal therapy misc Combination therapy misc Docetaxel misc Enzalutamide misc Metastatic castration-resistant prostate cancer Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial |
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610 DE-600 44.81 bkl Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial Chemo-hormonal therapy Combination therapy Docetaxel Enzalutamide Metastatic castration-resistant prostate cancer |
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ddc 610 bkl 44.81 misc Chemo-hormonal therapy misc Combination therapy misc Docetaxel misc Enzalutamide misc Metastatic castration-resistant prostate cancer |
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ddc 610 bkl 44.81 misc Chemo-hormonal therapy misc Combination therapy misc Docetaxel misc Enzalutamide misc Metastatic castration-resistant prostate cancer |
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Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial |
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Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial |
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Caffo, Orazio |
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European journal of cancer |
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European journal of cancer |
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Caffo, Orazio Ortega, Cinzia Nolè, Franco Gasparro, Donatello Mucciarini, Claudia Aieta, Michele Zagonel, Vittorina Iacovelli, Roberto De Giorgi, Ugo Facchini, Gaetano Veccia, Antonello Palesandro, Erica Verri, Elena Buti, Sebastiano Razzini, Giorgia Bozza, Giovanni Maruzzo, Marco Ciccarese, Chiara Schepisi, Giuseppe Rossetti, Sabrina Maines, Francesca Kinspergher, Stefania Fratino, Lucia Ermacora, Paola Nicodemo, Maurizio Giordano, Monica Sartori, Donata Scapoli, Daniela Sabbatini, Roberto Lo Re, Giovanni Morelli, Franco D’Angelo, Alessandro Vittimberga, Isabella Lippe, Paolo Carrozza, Francesco Messina, Caterina Galli, Luca Valcamonico, Francesca Porta, Camillo Pappagallo, Giovanni Aglietta, Massimo |
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Caffo, Orazio |
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10.1016/j.ejca.2021.06.016 |
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docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: cheiron, a randomised phase ii trial |
| title_auth |
Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial |
| abstract |
Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III–IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study’s phase II design and the absence of an overall survival benefit.Trial registration numbers: EudraCT 2014-000175-43 – NCT02453009. |
| abstractGer |
Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III–IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study’s phase II design and the absence of an overall survival benefit.Trial registration numbers: EudraCT 2014-000175-43 – NCT02453009. |
| abstract_unstemmed |
Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m2, oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1–20.6) in arm DE and 27.8% (95% CI 22.8–39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III–IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study’s phase II design and the absence of an overall survival benefit.Trial registration numbers: EudraCT 2014-000175-43 – NCT02453009. |
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Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial |
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Ortega, Cinzia Nolè, Franco Gasparro, Donatello Mucciarini, Claudia Aieta, Michele Zagonel, Vittorina Iacovelli, Roberto De Giorgi, Ugo Facchini, Gaetano Veccia, Antonello Palesandro, Erica Verri, Elena Buti, Sebastiano Razzini, Giorgia Bozza, Giovanni Maruzzo, Marco Ciccarese, Chiara Schepisi, Giuseppe Rossetti, Sabrina Maines, Francesca Kinspergher, Stefania Fratino, Lucia Ermacora, Paola Nicodemo, Maurizio Giordano, Monica Sartori, Donata Scapoli, Daniela Sabbatini, Roberto Lo Re, Giovanni Morelli, Franco D’Angelo, Alessandro Vittimberga, Isabella Lippe, Paolo Carrozza, Francesco Messina, Caterina Galli, Luca Valcamonico, Francesca Porta, Camillo Pappagallo, Giovanni Aglietta, Massimo |
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| score |
7.4002047 |