Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi
Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to inves...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Merli, Francesco [verfasserIn] Cavallo, Federica [verfasserIn] Salvi, Flavia [verfasserIn] Tucci, Alessandra [verfasserIn] Musuraca, Gerardo [verfasserIn] Nassi, Luca [verfasserIn] Merli, Michele [verfasserIn] Tani, Monica [verfasserIn] Gini, Guido [verfasserIn] Ferrari, Angela [verfasserIn] Molinari, Anna Lia [verfasserIn] Liberati, Anna Marina [verfasserIn] Conconi, Annarita [verfasserIn] Matteucci, Paola [verfasserIn] Bari, Alessia [verfasserIn] Scalone, Renato [verfasserIn] Ferrero, Simone [verfasserIn] Zanni, Manuela [verfasserIn] Mammi, Caterina [verfasserIn] Luminari, Stefano [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2019 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Journal of geriatric oncology - Amsterdam [u.a.] : Elsevier Science, 2010, 11, Seite 37-40 |
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| Übergeordnetes Werk: |
volume:11 ; pages:37-40 |
| DOI / URN: |
10.1016/j.jgo.2019.06.020 |
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| Katalog-ID: |
ELV003401049 |
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| 024 | 7 | |a 10.1016/j.jgo.2019.06.020 |2 doi | |
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| 100 | 1 | |a Merli, Francesco |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi |
| 264 | 1 | |c 2019 | |
| 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 Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%).Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL. | ||
| 650 | 4 | |a Diffuse large B-cell lymphoma | |
| 650 | 4 | |a Older adult patients | |
| 650 | 4 | |a Comprehensive geriatric assessment | |
| 650 | 4 | |a Unfit | |
| 650 | 4 | |a Adapted immunochemotherapy | |
| 650 | 4 | |a Obinutuzumab-miniCHOP | |
| 700 | 1 | |a Cavallo, Federica |e verfasserin |0 (orcid)0000-0003-2047-1099 |4 aut | |
| 700 | 1 | |a Salvi, Flavia |e verfasserin |4 aut | |
| 700 | 1 | |a Tucci, Alessandra |e verfasserin |4 aut | |
| 700 | 1 | |a Musuraca, Gerardo |e verfasserin |4 aut | |
| 700 | 1 | |a Nassi, Luca |e verfasserin |4 aut | |
| 700 | 1 | |a Merli, Michele |e verfasserin |0 (orcid)0000-0002-0905-5927 |4 aut | |
| 700 | 1 | |a Tani, Monica |e verfasserin |4 aut | |
| 700 | 1 | |a Gini, Guido |e verfasserin |4 aut | |
| 700 | 1 | |a Ferrari, Angela |e verfasserin |4 aut | |
| 700 | 1 | |a Molinari, Anna Lia |e verfasserin |4 aut | |
| 700 | 1 | |a Liberati, Anna Marina |e verfasserin |4 aut | |
| 700 | 1 | |a Conconi, Annarita |e verfasserin |4 aut | |
| 700 | 1 | |a Matteucci, Paola |e verfasserin |4 aut | |
| 700 | 1 | |a Bari, Alessia |e verfasserin |4 aut | |
| 700 | 1 | |a Scalone, Renato |e verfasserin |4 aut | |
| 700 | 1 | |a Ferrero, Simone |e verfasserin |4 aut | |
| 700 | 1 | |a Zanni, Manuela |e verfasserin |4 aut | |
| 700 | 1 | |a Mammi, Caterina |e verfasserin |4 aut | |
| 700 | 1 | |a Luminari, Stefano |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of geriatric oncology |d Amsterdam [u.a.] : Elsevier Science, 2010 |g 11, Seite 37-40 |h Online-Ressource |w (DE-627)627611915 |w (DE-600)2556813-9 |w (DE-576)336956584 |x 1879-4076 |7 nnns |
| 773 | 1 | 8 | |g volume:11 |g pages:37-40 |
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10.1016/j.jgo.2019.06.020 doi (DE-627)ELV003401049 (ELSEVIER)S1879-4068(18)30482-X DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.68 bkl Merli, Francesco verfasserin aut Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%).Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL. Diffuse large B-cell lymphoma Older adult patients Comprehensive geriatric assessment Unfit Adapted immunochemotherapy Obinutuzumab-miniCHOP Cavallo, Federica verfasserin (orcid)0000-0003-2047-1099 aut Salvi, Flavia verfasserin aut Tucci, Alessandra verfasserin aut Musuraca, Gerardo verfasserin aut Nassi, Luca verfasserin aut Merli, Michele verfasserin (orcid)0000-0002-0905-5927 aut Tani, Monica verfasserin aut Gini, Guido verfasserin aut Ferrari, Angela verfasserin aut Molinari, Anna Lia verfasserin aut Liberati, Anna Marina verfasserin aut Conconi, Annarita verfasserin aut Matteucci, Paola verfasserin aut Bari, Alessia verfasserin aut Scalone, Renato verfasserin aut Ferrero, Simone verfasserin aut Zanni, Manuela verfasserin aut Mammi, Caterina verfasserin aut Luminari, Stefano verfasserin aut Enthalten in Journal of geriatric oncology Amsterdam [u.a.] : Elsevier Science, 2010 11, Seite 37-40 Online-Ressource (DE-627)627611915 (DE-600)2556813-9 (DE-576)336956584 1879-4076 nnns volume:11 pages:37-40 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA 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_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 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_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 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 44.68 Gerontologie Geriatrie AR 11 37-40 |
| spelling |
10.1016/j.jgo.2019.06.020 doi (DE-627)ELV003401049 (ELSEVIER)S1879-4068(18)30482-X DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.68 bkl Merli, Francesco verfasserin aut Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%).Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL. Diffuse large B-cell lymphoma Older adult patients Comprehensive geriatric assessment Unfit Adapted immunochemotherapy Obinutuzumab-miniCHOP Cavallo, Federica verfasserin (orcid)0000-0003-2047-1099 aut Salvi, Flavia verfasserin aut Tucci, Alessandra verfasserin aut Musuraca, Gerardo verfasserin aut Nassi, Luca verfasserin aut Merli, Michele verfasserin (orcid)0000-0002-0905-5927 aut Tani, Monica verfasserin aut Gini, Guido verfasserin aut Ferrari, Angela verfasserin aut Molinari, Anna Lia verfasserin aut Liberati, Anna Marina verfasserin aut Conconi, Annarita verfasserin aut Matteucci, Paola verfasserin aut Bari, Alessia verfasserin aut Scalone, Renato verfasserin aut Ferrero, Simone verfasserin aut Zanni, Manuela verfasserin aut Mammi, Caterina verfasserin aut Luminari, Stefano verfasserin aut Enthalten in Journal of geriatric oncology Amsterdam [u.a.] : Elsevier Science, 2010 11, Seite 37-40 Online-Ressource (DE-627)627611915 (DE-600)2556813-9 (DE-576)336956584 1879-4076 nnns volume:11 pages:37-40 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA 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_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 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_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 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 44.68 Gerontologie Geriatrie AR 11 37-40 |
| allfields_unstemmed |
10.1016/j.jgo.2019.06.020 doi (DE-627)ELV003401049 (ELSEVIER)S1879-4068(18)30482-X DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.68 bkl Merli, Francesco verfasserin aut Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%).Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL. Diffuse large B-cell lymphoma Older adult patients Comprehensive geriatric assessment Unfit Adapted immunochemotherapy Obinutuzumab-miniCHOP Cavallo, Federica verfasserin (orcid)0000-0003-2047-1099 aut Salvi, Flavia verfasserin aut Tucci, Alessandra verfasserin aut Musuraca, Gerardo verfasserin aut Nassi, Luca verfasserin aut Merli, Michele verfasserin (orcid)0000-0002-0905-5927 aut Tani, Monica verfasserin aut Gini, Guido verfasserin aut Ferrari, Angela verfasserin aut Molinari, Anna Lia verfasserin aut Liberati, Anna Marina verfasserin aut Conconi, Annarita verfasserin aut Matteucci, Paola verfasserin aut Bari, Alessia verfasserin aut Scalone, Renato verfasserin aut Ferrero, Simone verfasserin aut Zanni, Manuela verfasserin aut Mammi, Caterina verfasserin aut Luminari, Stefano verfasserin aut Enthalten in Journal of geriatric oncology Amsterdam [u.a.] : Elsevier Science, 2010 11, Seite 37-40 Online-Ressource (DE-627)627611915 (DE-600)2556813-9 (DE-576)336956584 1879-4076 nnns volume:11 pages:37-40 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA 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_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 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_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 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 44.68 Gerontologie Geriatrie AR 11 37-40 |
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10.1016/j.jgo.2019.06.020 doi (DE-627)ELV003401049 (ELSEVIER)S1879-4068(18)30482-X DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.68 bkl Merli, Francesco verfasserin aut Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%).Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL. Diffuse large B-cell lymphoma Older adult patients Comprehensive geriatric assessment Unfit Adapted immunochemotherapy Obinutuzumab-miniCHOP Cavallo, Federica verfasserin (orcid)0000-0003-2047-1099 aut Salvi, Flavia verfasserin aut Tucci, Alessandra verfasserin aut Musuraca, Gerardo verfasserin aut Nassi, Luca verfasserin aut Merli, Michele verfasserin (orcid)0000-0002-0905-5927 aut Tani, Monica verfasserin aut Gini, Guido verfasserin aut Ferrari, Angela verfasserin aut Molinari, Anna Lia verfasserin aut Liberati, Anna Marina verfasserin aut Conconi, Annarita verfasserin aut Matteucci, Paola verfasserin aut Bari, Alessia verfasserin aut Scalone, Renato verfasserin aut Ferrero, Simone verfasserin aut Zanni, Manuela verfasserin aut Mammi, Caterina verfasserin aut Luminari, Stefano verfasserin aut Enthalten in Journal of geriatric oncology Amsterdam [u.a.] : Elsevier Science, 2010 11, Seite 37-40 Online-Ressource (DE-627)627611915 (DE-600)2556813-9 (DE-576)336956584 1879-4076 nnns volume:11 pages:37-40 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA 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_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 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_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 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 44.68 Gerontologie Geriatrie AR 11 37-40 |
| allfieldsSound |
10.1016/j.jgo.2019.06.020 doi (DE-627)ELV003401049 (ELSEVIER)S1879-4068(18)30482-X DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.68 bkl Merli, Francesco verfasserin aut Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%).Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL. Diffuse large B-cell lymphoma Older adult patients Comprehensive geriatric assessment Unfit Adapted immunochemotherapy Obinutuzumab-miniCHOP Cavallo, Federica verfasserin (orcid)0000-0003-2047-1099 aut Salvi, Flavia verfasserin aut Tucci, Alessandra verfasserin aut Musuraca, Gerardo verfasserin aut Nassi, Luca verfasserin aut Merli, Michele verfasserin (orcid)0000-0002-0905-5927 aut Tani, Monica verfasserin aut Gini, Guido verfasserin aut Ferrari, Angela verfasserin aut Molinari, Anna Lia verfasserin aut Liberati, Anna Marina verfasserin aut Conconi, Annarita verfasserin aut Matteucci, Paola verfasserin aut Bari, Alessia verfasserin aut Scalone, Renato verfasserin aut Ferrero, Simone verfasserin aut Zanni, Manuela verfasserin aut Mammi, Caterina verfasserin aut Luminari, Stefano verfasserin aut Enthalten in Journal of geriatric oncology Amsterdam [u.a.] : Elsevier Science, 2010 11, Seite 37-40 Online-Ressource (DE-627)627611915 (DE-600)2556813-9 (DE-576)336956584 1879-4076 nnns volume:11 pages:37-40 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA 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_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 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_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 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 44.68 Gerontologie Geriatrie AR 11 37-40 |
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Enthalten in Journal of geriatric oncology 11, Seite 37-40 volume:11 pages:37-40 |
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Diffuse large B-cell lymphoma Older adult patients Comprehensive geriatric assessment Unfit Adapted immunochemotherapy Obinutuzumab-miniCHOP |
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Merli, Francesco @@aut@@ Cavallo, Federica @@aut@@ Salvi, Flavia @@aut@@ Tucci, Alessandra @@aut@@ Musuraca, Gerardo @@aut@@ Nassi, Luca @@aut@@ Merli, Michele @@aut@@ Tani, Monica @@aut@@ Gini, Guido @@aut@@ Ferrari, Angela @@aut@@ Molinari, Anna Lia @@aut@@ Liberati, Anna Marina @@aut@@ Conconi, Annarita @@aut@@ Matteucci, Paola @@aut@@ Bari, Alessia @@aut@@ Scalone, Renato @@aut@@ Ferrero, Simone @@aut@@ Zanni, Manuela @@aut@@ Mammi, Caterina @@aut@@ Luminari, Stefano @@aut@@ |
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2019-01-01T00:00:00Z |
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3610 |
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Merli, Francesco |
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Merli, Francesco ddc 610 bkl 44.81 bkl 44.68 misc Diffuse large B-cell lymphoma misc Older adult patients misc Comprehensive geriatric assessment misc Unfit misc Adapted immunochemotherapy misc Obinutuzumab-miniCHOP Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi |
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610 DE-600 44.81 bkl 44.68 bkl Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi Diffuse large B-cell lymphoma Older adult patients Comprehensive geriatric assessment Unfit Adapted immunochemotherapy Obinutuzumab-miniCHOP |
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ddc 610 bkl 44.81 bkl 44.68 misc Diffuse large B-cell lymphoma misc Older adult patients misc Comprehensive geriatric assessment misc Unfit misc Adapted immunochemotherapy misc Obinutuzumab-miniCHOP |
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ddc 610 bkl 44.81 bkl 44.68 misc Diffuse large B-cell lymphoma misc Older adult patients misc Comprehensive geriatric assessment misc Unfit misc Adapted immunochemotherapy misc Obinutuzumab-miniCHOP |
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ddc 610 bkl 44.81 bkl 44.68 misc Diffuse large B-cell lymphoma misc Older adult patients misc Comprehensive geriatric assessment misc Unfit misc Adapted immunochemotherapy misc Obinutuzumab-miniCHOP |
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Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi |
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Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi |
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Merli, Francesco |
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Merli, Francesco Cavallo, Federica Salvi, Flavia Tucci, Alessandra Musuraca, Gerardo Nassi, Luca Merli, Michele Tani, Monica Gini, Guido Ferrari, Angela Molinari, Anna Lia Liberati, Anna Marina Conconi, Annarita Matteucci, Paola Bari, Alessia Scalone, Renato Ferrero, Simone Zanni, Manuela Mammi, Caterina Luminari, Stefano |
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Merli, Francesco |
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10.1016/j.jgo.2019.06.020 |
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verfasserin |
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obinutuzumab and minichop for unfit patients with diffuse large b-cell lymphoma. a phase ii study by fondazione italiana linfomi |
| title_auth |
Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi |
| abstract |
Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%).Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL. |
| abstractGer |
Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%).Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL. |
| abstract_unstemmed |
Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%).Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL. |
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| title_short |
Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi |
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Cavallo, Federica Salvi, Flavia Tucci, Alessandra Musuraca, Gerardo Nassi, Luca Merli, Michele Tani, Monica Gini, Guido Ferrari, Angela Molinari, Anna Lia Liberati, Anna Marina Conconi, Annarita Matteucci, Paola Bari, Alessia Scalone, Renato Ferrero, Simone Zanni, Manuela Mammi, Caterina Luminari, Stefano |
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Cavallo, Federica Salvi, Flavia Tucci, Alessandra Musuraca, Gerardo Nassi, Luca Merli, Michele Tani, Monica Gini, Guido Ferrari, Angela Molinari, Anna Lia Liberati, Anna Marina Conconi, Annarita Matteucci, Paola Bari, Alessia Scalone, Renato Ferrero, Simone Zanni, Manuela Mammi, Caterina Luminari, Stefano |
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| doi_str |
10.1016/j.jgo.2019.06.020 |
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2024-07-06T19:29:34.114Z |
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