Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation
Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of...
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Gespeichert in:
| Autor*in: |
Cohen, Romain [verfasserIn] Raeisi, Morteza [verfasserIn] Chibaudel, Benoist [verfasserIn] Yoshino, Takayuki [verfasserIn] Shi, Qian [verfasserIn] Zalcberg, John R. [verfasserIn] Adams, Richard [verfasserIn] Cremolini, Chiara [verfasserIn] Grothey, Axel [verfasserIn] Mayer, Robert J. [verfasserIn] Van Cutsem, Eric [verfasserIn] Tabernero, Josep [verfasserIn] Bando, Hideaki [verfasserIn] Misumi, Toshihiro [verfasserIn] Overman, Michael J. [verfasserIn] André, Thierry [verfasserIn] de Gramont, Aimery [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2024 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: European journal of cancer - Amsterdam [u.a.] : Elsevier, 1965, 199 |
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| Übergeordnetes Werk: |
volume:199 |
| DOI / URN: |
10.1016/j.ejca.2024.113537 |
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| Katalog-ID: |
ELV066979315 |
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| 100 | 1 | |a Cohen, Romain |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation |
| 264 | 1 | |c 2024 | |
| 336 | |a nicht spezifiziert |b zzz |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
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| 520 | |a Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. This work might be useful as an example of methodology to avoid RCTs when benefit from experimental therapy is likely to be high. | ||
| 650 | 4 | |a Immune checkpoint inhibitors | |
| 650 | 4 | |a Microsatellite instability metastatic colorectal cancer | |
| 650 | 4 | |a Placebo | |
| 650 | 4 | |a Synthetic control arms | |
| 650 | 4 | |a Matching | |
| 700 | 1 | |a Raeisi, Morteza |e verfasserin |4 aut | |
| 700 | 1 | |a Chibaudel, Benoist |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshino, Takayuki |e verfasserin |4 aut | |
| 700 | 1 | |a Shi, Qian |e verfasserin |4 aut | |
| 700 | 1 | |a Zalcberg, John R. |e verfasserin |4 aut | |
| 700 | 1 | |a Adams, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Cremolini, Chiara |e verfasserin |4 aut | |
| 700 | 1 | |a Grothey, Axel |e verfasserin |4 aut | |
| 700 | 1 | |a Mayer, Robert J. |e verfasserin |4 aut | |
| 700 | 1 | |a Van Cutsem, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Tabernero, Josep |e verfasserin |4 aut | |
| 700 | 1 | |a Bando, Hideaki |e verfasserin |4 aut | |
| 700 | 1 | |a Misumi, Toshihiro |e verfasserin |4 aut | |
| 700 | 1 | |a Overman, Michael J. |e verfasserin |4 aut | |
| 700 | 1 | |a André, Thierry |e verfasserin |4 aut | |
| 700 | 1 | |a de Gramont, Aimery |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t European journal of cancer |d Amsterdam [u.a.] : Elsevier, 1965 |g 199 |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.2024.113537 doi (DE-627)ELV066979315 (ELSEVIER)S0959-8049(24)00013-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cohen, Romain verfasserin aut Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation 2024 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. This work might be useful as an example of methodology to avoid RCTs when benefit from experimental therapy is likely to be high. Immune checkpoint inhibitors Microsatellite instability metastatic colorectal cancer Placebo Synthetic control arms Matching Raeisi, Morteza verfasserin aut Chibaudel, Benoist verfasserin aut Yoshino, Takayuki verfasserin aut Shi, Qian verfasserin aut Zalcberg, John R. verfasserin aut Adams, Richard verfasserin aut Cremolini, Chiara verfasserin aut Grothey, Axel verfasserin aut Mayer, Robert J. verfasserin aut Van Cutsem, Eric verfasserin aut Tabernero, Josep verfasserin aut Bando, Hideaki verfasserin aut Misumi, Toshihiro verfasserin aut Overman, Michael J. verfasserin aut André, Thierry verfasserin aut de Gramont, Aimery verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 199 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:199 GBV_USEFLAG_U GBV_ELV SYSFLAG_U 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_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 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_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_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 Onkologie VZ AR 199 |
| spelling |
10.1016/j.ejca.2024.113537 doi (DE-627)ELV066979315 (ELSEVIER)S0959-8049(24)00013-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cohen, Romain verfasserin aut Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation 2024 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. This work might be useful as an example of methodology to avoid RCTs when benefit from experimental therapy is likely to be high. Immune checkpoint inhibitors Microsatellite instability metastatic colorectal cancer Placebo Synthetic control arms Matching Raeisi, Morteza verfasserin aut Chibaudel, Benoist verfasserin aut Yoshino, Takayuki verfasserin aut Shi, Qian verfasserin aut Zalcberg, John R. verfasserin aut Adams, Richard verfasserin aut Cremolini, Chiara verfasserin aut Grothey, Axel verfasserin aut Mayer, Robert J. verfasserin aut Van Cutsem, Eric verfasserin aut Tabernero, Josep verfasserin aut Bando, Hideaki verfasserin aut Misumi, Toshihiro verfasserin aut Overman, Michael J. verfasserin aut André, Thierry verfasserin aut de Gramont, Aimery verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 199 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:199 GBV_USEFLAG_U GBV_ELV SYSFLAG_U 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_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 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_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_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 Onkologie VZ AR 199 |
| allfields_unstemmed |
10.1016/j.ejca.2024.113537 doi (DE-627)ELV066979315 (ELSEVIER)S0959-8049(24)00013-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cohen, Romain verfasserin aut Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation 2024 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. This work might be useful as an example of methodology to avoid RCTs when benefit from experimental therapy is likely to be high. Immune checkpoint inhibitors Microsatellite instability metastatic colorectal cancer Placebo Synthetic control arms Matching Raeisi, Morteza verfasserin aut Chibaudel, Benoist verfasserin aut Yoshino, Takayuki verfasserin aut Shi, Qian verfasserin aut Zalcberg, John R. verfasserin aut Adams, Richard verfasserin aut Cremolini, Chiara verfasserin aut Grothey, Axel verfasserin aut Mayer, Robert J. verfasserin aut Van Cutsem, Eric verfasserin aut Tabernero, Josep verfasserin aut Bando, Hideaki verfasserin aut Misumi, Toshihiro verfasserin aut Overman, Michael J. verfasserin aut André, Thierry verfasserin aut de Gramont, Aimery verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 199 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:199 GBV_USEFLAG_U GBV_ELV SYSFLAG_U 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_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 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_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_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 Onkologie VZ AR 199 |
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10.1016/j.ejca.2024.113537 doi (DE-627)ELV066979315 (ELSEVIER)S0959-8049(24)00013-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cohen, Romain verfasserin aut Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation 2024 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. This work might be useful as an example of methodology to avoid RCTs when benefit from experimental therapy is likely to be high. Immune checkpoint inhibitors Microsatellite instability metastatic colorectal cancer Placebo Synthetic control arms Matching Raeisi, Morteza verfasserin aut Chibaudel, Benoist verfasserin aut Yoshino, Takayuki verfasserin aut Shi, Qian verfasserin aut Zalcberg, John R. verfasserin aut Adams, Richard verfasserin aut Cremolini, Chiara verfasserin aut Grothey, Axel verfasserin aut Mayer, Robert J. verfasserin aut Van Cutsem, Eric verfasserin aut Tabernero, Josep verfasserin aut Bando, Hideaki verfasserin aut Misumi, Toshihiro verfasserin aut Overman, Michael J. verfasserin aut André, Thierry verfasserin aut de Gramont, Aimery verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 199 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:199 GBV_USEFLAG_U GBV_ELV SYSFLAG_U 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_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 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_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_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 Onkologie VZ AR 199 |
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10.1016/j.ejca.2024.113537 doi (DE-627)ELV066979315 (ELSEVIER)S0959-8049(24)00013-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cohen, Romain verfasserin aut Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation 2024 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. This work might be useful as an example of methodology to avoid RCTs when benefit from experimental therapy is likely to be high. Immune checkpoint inhibitors Microsatellite instability metastatic colorectal cancer Placebo Synthetic control arms Matching Raeisi, Morteza verfasserin aut Chibaudel, Benoist verfasserin aut Yoshino, Takayuki verfasserin aut Shi, Qian verfasserin aut Zalcberg, John R. verfasserin aut Adams, Richard verfasserin aut Cremolini, Chiara verfasserin aut Grothey, Axel verfasserin aut Mayer, Robert J. verfasserin aut Van Cutsem, Eric verfasserin aut Tabernero, Josep verfasserin aut Bando, Hideaki verfasserin aut Misumi, Toshihiro verfasserin aut Overman, Michael J. verfasserin aut André, Thierry verfasserin aut de Gramont, Aimery verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1965 199 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-2995 nnns volume:199 GBV_USEFLAG_U GBV_ELV SYSFLAG_U 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_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 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_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_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 Onkologie VZ AR 199 |
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Enthalten in European journal of cancer 199 volume:199 |
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Cohen, Romain @@aut@@ Raeisi, Morteza @@aut@@ Chibaudel, Benoist @@aut@@ Yoshino, Takayuki @@aut@@ Shi, Qian @@aut@@ Zalcberg, John R. @@aut@@ Adams, Richard @@aut@@ Cremolini, Chiara @@aut@@ Grothey, Axel @@aut@@ Mayer, Robert J. @@aut@@ Van Cutsem, Eric @@aut@@ Tabernero, Josep @@aut@@ Bando, Hideaki @@aut@@ Misumi, Toshihiro @@aut@@ Overman, Michael J. @@aut@@ André, Thierry @@aut@@ de Gramont, Aimery @@aut@@ |
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2024-01-01T00:00:00Z |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">ELV066979315</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20240224093353.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">240210s2024 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.ejca.2024.113537</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV066979315</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S0959-8049(24)00013-3</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.81</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Cohen, Romain</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2024</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. 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Cohen, Romain |
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Cohen, Romain ddc 610 bkl 44.81 misc Immune checkpoint inhibitors misc Microsatellite instability metastatic colorectal cancer misc Placebo misc Synthetic control arms misc Matching Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation |
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610 VZ 44.81 bkl Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation Immune checkpoint inhibitors Microsatellite instability metastatic colorectal cancer Placebo Synthetic control arms Matching |
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ddc 610 bkl 44.81 misc Immune checkpoint inhibitors misc Microsatellite instability metastatic colorectal cancer misc Placebo misc Synthetic control arms misc Matching |
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Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation |
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Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation |
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Cohen, Romain Raeisi, Morteza Chibaudel, Benoist Yoshino, Takayuki Shi, Qian Zalcberg, John R. Adams, Richard Cremolini, Chiara Grothey, Axel Mayer, Robert J. Van Cutsem, Eric Tabernero, Josep Bando, Hideaki Misumi, Toshihiro Overman, Michael J. André, Thierry de Gramont, Aimery |
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10.1016/j.ejca.2024.113537 |
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efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: a non-randomised evaluation |
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Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation |
| abstract |
Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. This work might be useful as an example of methodology to avoid RCTs when benefit from experimental therapy is likely to be high. |
| abstractGer |
Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. This work might be useful as an example of methodology to avoid RCTs when benefit from experimental therapy is likely to be high. |
| abstract_unstemmed |
Purpose: Immune checkpoint inhibitors (ICIs) appeared active in single-arm trials for patients with chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability (MSI). Given the paucity of randomised controlled trials (RCTs) in this setting, we evaluated the effect size of ICIs using intra-patients comparison and ARCAD database as historical controls.Patients and methods: Individual-patient data from NIPICOL and CheckMate 142 phase II trials that evaluated a combination of ICIs for MSI mCRC patients (N = 176) and from five non-ICI mCRC historical RCTs in second-line or latter (N = 4026) were analyzed. Firstly, promising of ICIs was identified using intra-patient comparison based on growth modulation index (GMI) defined the ratio of progression-free survivals (PFS) on ICIs and previous line of therapy. Survival outcomes of ICIs-treated patients were then compared with those matched non-ICIs treated from ARCAD database historical RCTs.Results: Among ICIs-treated patients, median PFS on ICIs was 32.66 (range 0.10–74.25) versus 4.07 months (range 0.7–49.87) on prior therapy, resulting on median GMI of 4.97 (range 0.07–59.51; hazard-ratio (HR)= 0.16 (95 %CI=0.11–0.22, P < 0.001)). Compared to matched non-ICI patients, in third-line, median overall survival (OS) was not reached with ICIs versus 3.52 months with placebo (HR=0.20, 95 %CI=0.10–0.41, P < 0.001), and 6.51 months with active drugs (HR=0.30, 95 %CI=0.15–0.60, P = 0.001). In second-line, median OS was not reached with ICIs versus 11.7 months with chemotherapy+placebo (HR=0.12, 95 %CI=0.07–0.22, P < 0.001), and 16.3 months with chemotherapy+targeted therapy (HR=0.10, 95 %CI=0.05–0.19, P < 0.001).Conclusion: ICIs demonstrates high effect size for MSI mCRC patients in second-line and later. This work might be useful as an example of methodology to avoid RCTs when benefit from experimental therapy is likely to be high. |
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| title_short |
Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation |
| remote_bool |
true |
| author2 |
Raeisi, Morteza Chibaudel, Benoist Yoshino, Takayuki Shi, Qian Zalcberg, John R. Adams, Richard Cremolini, Chiara Grothey, Axel Mayer, Robert J. Van Cutsem, Eric Tabernero, Josep Bando, Hideaki Misumi, Toshihiro Overman, Michael J. André, Thierry de Gramont, Aimery |
| author2Str |
Raeisi, Morteza Chibaudel, Benoist Yoshino, Takayuki Shi, Qian Zalcberg, John R. Adams, Richard Cremolini, Chiara Grothey, Axel Mayer, Robert J. Van Cutsem, Eric Tabernero, Josep Bando, Hideaki Misumi, Toshihiro Overman, Michael J. André, Thierry de Gramont, Aimery |
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| doi_str |
10.1016/j.ejca.2024.113537 |
| up_date |
2024-07-06T19:40:00.672Z |
| _version_ |
1803859840912588800 |
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|
| score |
7.3991575 |