Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program
Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive ni...
Ausführliche Beschreibung
Autor*in: |
Verzoni, Elena [verfasserIn] |
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Englisch |
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2019 |
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Anmerkung: |
© The Author(s). 2019 |
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Übergeordnetes Werk: |
Enthalten in: Journal for ImmunoTherapy of Cancer - London : BioMed Central, 2013, 7(2019), 1 vom: 03. Apr. |
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Übergeordnetes Werk: |
volume:7 ; year:2019 ; number:1 ; day:03 ; month:04 |
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DOI / URN: |
10.1186/s40425-019-0579-z |
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SPR036439339 |
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100 | 1 | |a Verzoni, Elena |e verfasserin |4 aut | |
245 | 1 | 0 | |a Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program |
264 | 1 | |c 2019 | |
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520 | |a Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab. | ||
650 | 4 | |a Immunotherapy |7 (dpeaa)DE-He213 | |
650 | 4 | |a Adverse events |7 (dpeaa)DE-He213 | |
650 | 4 | |a Renal cell carcinoma |7 (dpeaa)DE-He213 | |
650 | 4 | |a Expanded access trials |7 (dpeaa)DE-He213 | |
700 | 1 | |a Cartenì, Giacomo |4 aut | |
700 | 1 | |a Cortesi, Enrico |4 aut | |
700 | 1 | |a Giannarelli, Diana |4 aut | |
700 | 1 | |a De Giglio, Andrea |4 aut | |
700 | 1 | |a Sabbatini, Roberto |4 aut | |
700 | 1 | |a Buti, Sebastiano |4 aut | |
700 | 1 | |a Rossetti, Sabrina |4 aut | |
700 | 1 | |a Cognetti, Francesco |4 aut | |
700 | 1 | |a Rastelli, Francesca |4 aut | |
700 | 1 | |a Sobrero, Alberto |4 aut | |
700 | 1 | |a Turci, Daniele |4 aut | |
700 | 1 | |a Sternberg, Cora N. |4 aut | |
700 | 1 | |a Porta, Camillo |4 aut | |
700 | 1 | |a Cappuzzo, Federico |4 aut | |
700 | 1 | |a Tortora, Giampaolo |4 aut | |
700 | 1 | |a Tassinari, Davide |4 aut | |
700 | 1 | |a Panni, Stefano |4 aut | |
700 | 1 | |a Pazzola, Antonio |4 aut | |
700 | 1 | |a Surico, Gianmarco |4 aut | |
700 | 1 | |a Raimondi, Alessandra |4 aut | |
700 | 1 | |a De Giorgi, Ugo |4 aut | |
700 | 1 | |a Procopio, Giuseppe |4 aut | |
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10.1186/s40425-019-0579-z doi (DE-627)SPR036439339 (SPR)s40425-019-0579-z-e DE-627 ger DE-627 rakwb eng Verzoni, Elena verfasserin aut Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab. Immunotherapy (dpeaa)DE-He213 Adverse events (dpeaa)DE-He213 Renal cell carcinoma (dpeaa)DE-He213 Expanded access trials (dpeaa)DE-He213 Cartenì, Giacomo aut Cortesi, Enrico aut Giannarelli, Diana aut De Giglio, Andrea aut Sabbatini, Roberto aut Buti, Sebastiano aut Rossetti, Sabrina aut Cognetti, Francesco aut Rastelli, Francesca aut Sobrero, Alberto aut Turci, Daniele aut Sternberg, Cora N. aut Porta, Camillo aut Cappuzzo, Federico aut Tortora, Giampaolo aut Tassinari, Davide aut Panni, Stefano aut Pazzola, Antonio aut Surico, Gianmarco aut Raimondi, Alessandra aut De Giorgi, Ugo aut Procopio, Giuseppe aut Enthalten in Journal for ImmunoTherapy of Cancer London : BioMed Central, 2013 7(2019), 1 vom: 03. Apr. (DE-627)750086335 (DE-600)2719863-7 2051-1426 nnns volume:7 year:2019 number:1 day:03 month:04 https://dx.doi.org/10.1186/s40425-019-0579-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 03 04 |
spelling |
10.1186/s40425-019-0579-z doi (DE-627)SPR036439339 (SPR)s40425-019-0579-z-e DE-627 ger DE-627 rakwb eng Verzoni, Elena verfasserin aut Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab. Immunotherapy (dpeaa)DE-He213 Adverse events (dpeaa)DE-He213 Renal cell carcinoma (dpeaa)DE-He213 Expanded access trials (dpeaa)DE-He213 Cartenì, Giacomo aut Cortesi, Enrico aut Giannarelli, Diana aut De Giglio, Andrea aut Sabbatini, Roberto aut Buti, Sebastiano aut Rossetti, Sabrina aut Cognetti, Francesco aut Rastelli, Francesca aut Sobrero, Alberto aut Turci, Daniele aut Sternberg, Cora N. aut Porta, Camillo aut Cappuzzo, Federico aut Tortora, Giampaolo aut Tassinari, Davide aut Panni, Stefano aut Pazzola, Antonio aut Surico, Gianmarco aut Raimondi, Alessandra aut De Giorgi, Ugo aut Procopio, Giuseppe aut Enthalten in Journal for ImmunoTherapy of Cancer London : BioMed Central, 2013 7(2019), 1 vom: 03. Apr. (DE-627)750086335 (DE-600)2719863-7 2051-1426 nnns volume:7 year:2019 number:1 day:03 month:04 https://dx.doi.org/10.1186/s40425-019-0579-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 03 04 |
allfields_unstemmed |
10.1186/s40425-019-0579-z doi (DE-627)SPR036439339 (SPR)s40425-019-0579-z-e DE-627 ger DE-627 rakwb eng Verzoni, Elena verfasserin aut Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab. Immunotherapy (dpeaa)DE-He213 Adverse events (dpeaa)DE-He213 Renal cell carcinoma (dpeaa)DE-He213 Expanded access trials (dpeaa)DE-He213 Cartenì, Giacomo aut Cortesi, Enrico aut Giannarelli, Diana aut De Giglio, Andrea aut Sabbatini, Roberto aut Buti, Sebastiano aut Rossetti, Sabrina aut Cognetti, Francesco aut Rastelli, Francesca aut Sobrero, Alberto aut Turci, Daniele aut Sternberg, Cora N. aut Porta, Camillo aut Cappuzzo, Federico aut Tortora, Giampaolo aut Tassinari, Davide aut Panni, Stefano aut Pazzola, Antonio aut Surico, Gianmarco aut Raimondi, Alessandra aut De Giorgi, Ugo aut Procopio, Giuseppe aut Enthalten in Journal for ImmunoTherapy of Cancer London : BioMed Central, 2013 7(2019), 1 vom: 03. Apr. (DE-627)750086335 (DE-600)2719863-7 2051-1426 nnns volume:7 year:2019 number:1 day:03 month:04 https://dx.doi.org/10.1186/s40425-019-0579-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 03 04 |
allfieldsGer |
10.1186/s40425-019-0579-z doi (DE-627)SPR036439339 (SPR)s40425-019-0579-z-e DE-627 ger DE-627 rakwb eng Verzoni, Elena verfasserin aut Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab. Immunotherapy (dpeaa)DE-He213 Adverse events (dpeaa)DE-He213 Renal cell carcinoma (dpeaa)DE-He213 Expanded access trials (dpeaa)DE-He213 Cartenì, Giacomo aut Cortesi, Enrico aut Giannarelli, Diana aut De Giglio, Andrea aut Sabbatini, Roberto aut Buti, Sebastiano aut Rossetti, Sabrina aut Cognetti, Francesco aut Rastelli, Francesca aut Sobrero, Alberto aut Turci, Daniele aut Sternberg, Cora N. aut Porta, Camillo aut Cappuzzo, Federico aut Tortora, Giampaolo aut Tassinari, Davide aut Panni, Stefano aut Pazzola, Antonio aut Surico, Gianmarco aut Raimondi, Alessandra aut De Giorgi, Ugo aut Procopio, Giuseppe aut Enthalten in Journal for ImmunoTherapy of Cancer London : BioMed Central, 2013 7(2019), 1 vom: 03. Apr. (DE-627)750086335 (DE-600)2719863-7 2051-1426 nnns volume:7 year:2019 number:1 day:03 month:04 https://dx.doi.org/10.1186/s40425-019-0579-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 03 04 |
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10.1186/s40425-019-0579-z doi (DE-627)SPR036439339 (SPR)s40425-019-0579-z-e DE-627 ger DE-627 rakwb eng Verzoni, Elena verfasserin aut Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab. Immunotherapy (dpeaa)DE-He213 Adverse events (dpeaa)DE-He213 Renal cell carcinoma (dpeaa)DE-He213 Expanded access trials (dpeaa)DE-He213 Cartenì, Giacomo aut Cortesi, Enrico aut Giannarelli, Diana aut De Giglio, Andrea aut Sabbatini, Roberto aut Buti, Sebastiano aut Rossetti, Sabrina aut Cognetti, Francesco aut Rastelli, Francesca aut Sobrero, Alberto aut Turci, Daniele aut Sternberg, Cora N. aut Porta, Camillo aut Cappuzzo, Federico aut Tortora, Giampaolo aut Tassinari, Davide aut Panni, Stefano aut Pazzola, Antonio aut Surico, Gianmarco aut Raimondi, Alessandra aut De Giorgi, Ugo aut Procopio, Giuseppe aut Enthalten in Journal for ImmunoTherapy of Cancer London : BioMed Central, 2013 7(2019), 1 vom: 03. Apr. (DE-627)750086335 (DE-600)2719863-7 2051-1426 nnns volume:7 year:2019 number:1 day:03 month:04 https://dx.doi.org/10.1186/s40425-019-0579-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 7 2019 1 03 04 |
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Verzoni, Elena @@aut@@ Cartenì, Giacomo @@aut@@ Cortesi, Enrico @@aut@@ Giannarelli, Diana @@aut@@ De Giglio, Andrea @@aut@@ Sabbatini, Roberto @@aut@@ Buti, Sebastiano @@aut@@ Rossetti, Sabrina @@aut@@ Cognetti, Francesco @@aut@@ Rastelli, Francesca @@aut@@ Sobrero, Alberto @@aut@@ Turci, Daniele @@aut@@ Sternberg, Cora N. @@aut@@ Porta, Camillo @@aut@@ Cappuzzo, Federico @@aut@@ Tortora, Giampaolo @@aut@@ Tassinari, Davide @@aut@@ Panni, Stefano @@aut@@ Pazzola, Antonio @@aut@@ Surico, Gianmarco @@aut@@ Raimondi, Alessandra @@aut@@ De Giorgi, Ugo @@aut@@ Procopio, Giuseppe @@aut@@ |
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Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program Immunotherapy (dpeaa)DE-He213 Adverse events (dpeaa)DE-He213 Renal cell carcinoma (dpeaa)DE-He213 Expanded access trials (dpeaa)DE-He213 |
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Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program |
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Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program |
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Verzoni, Elena |
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Journal for ImmunoTherapy of Cancer |
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Verzoni, Elena Cartenì, Giacomo Cortesi, Enrico Giannarelli, Diana De Giglio, Andrea Sabbatini, Roberto Buti, Sebastiano Rossetti, Sabrina Cognetti, Francesco Rastelli, Francesca Sobrero, Alberto Turci, Daniele Sternberg, Cora N. Porta, Camillo Cappuzzo, Federico Tortora, Giampaolo Tassinari, Davide Panni, Stefano Pazzola, Antonio Surico, Gianmarco Raimondi, Alessandra De Giorgi, Ugo Procopio, Giuseppe |
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Verzoni, Elena |
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10.1186/s40425-019-0579-z |
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real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the italian expanded access program |
title_auth |
Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program |
abstract |
Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab. © The Author(s). 2019 |
abstractGer |
Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab. © The Author(s). 2019 |
abstract_unstemmed |
Background The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab. © The Author(s). 2019 |
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Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program |
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Cartenì, Giacomo Cortesi, Enrico Giannarelli, Diana De Giglio, Andrea Sabbatini, Roberto Buti, Sebastiano Rossetti, Sabrina Cognetti, Francesco Rastelli, Francesca Sobrero, Alberto Turci, Daniele Sternberg, Cora N. Porta, Camillo Cappuzzo, Federico Tortora, Giampaolo Tassinari, Davide Panni, Stefano Pazzola, Antonio Surico, Gianmarco Raimondi, Alessandra De Giorgi, Ugo Procopio, Giuseppe |
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