Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study

In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-ang...
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Autor*in:	Nicolas Isambert [verfasserIn] Alice Hervieu [verfasserIn] Cedric Rébé [verfasserIn] Audrey Hennequin [verfasserIn] Christophe Borg [verfasserIn] Sylvie Zanetta [verfasserIn] Angélique Chevriaux [verfasserIn] Corentin Richard [verfasserIn] Valentin Derangère [verfasserIn] Emeric Limagne [verfasserIn] Julie Blanc [verfasserIn] Aurélie Bertaut [verfasserIn] François Ghiringhelli [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2018

Schlagwörter:	il1 chemoimmunotherapy clinical trial colorectal mdsc clicial trial optimization new targets therapeutic trials

Übergeordnetes Werk:	In: OncoImmunology - Taylor & Francis Group, 2020, 7(2018), 9
Übergeordnetes Werk:	volume:7 ; year:2018 ; number:9

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1080/2162402X.2018.1474319

Katalog-ID:	DOAJ053778391

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allfields	10.1080/2162402X.2018.1474319 doi (DE-627)DOAJ053778391 (DE-599)DOAJ7101ec3870244562a55a18d1cdcd1e75 DE-627 ger DE-627 rakwb eng RC581-607 RC254-282 Nicolas Isambert verfasserin aut Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy. Eligible patients had unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria. Thirty two patients with metastatic colorectal cancer were enrolled. Five patients demonstrated response (Choi criteria) and 22 patients had stable disease as the best 2-month overall response. Median progression-free and overall survival were 5.4 (95% CI, 3.6–6.6) and 14.5 months (95% CI, 9–20.6) respectively. Twenty patients experienced grade 3 toxicity. No grade 4 or 5 toxicity related to therapy occurred. The most common grade 3 adverse events were neutropenia in 8 (25%) patients, digestive side effects in 7 (21.9%) patients and hypertension in 6 (18.75%) patients. No treatment-related deaths or serious adverse events were reported.5-FU plus bevacizumab and anakinra has promising activity and a manageable safety profile, suggesting that this combination might become a potential treatment option for patients with refractory mCRC. il1 chemoimmunotherapy clinical trial colorectal mdsc clicial trial optimization new targets therapeutic trials Immunologic diseases. Allergy Neoplasms. Tumors. Oncology. Including cancer and carcinogens Alice Hervieu verfasserin aut Cedric Rébé verfasserin aut Audrey Hennequin verfasserin aut Christophe Borg verfasserin aut Sylvie Zanetta verfasserin aut Angélique Chevriaux verfasserin aut Corentin Richard verfasserin aut Valentin Derangère verfasserin aut Emeric Limagne verfasserin aut Julie Blanc verfasserin aut Aurélie Bertaut verfasserin aut François Ghiringhelli verfasserin aut In OncoImmunology Taylor & Francis Group, 2020 7(2018), 9 (DE-627)683365428 (DE-600)2645309-5 2162402X nnns volume:7 year:2018 number:9 https://doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/article/7101ec3870244562a55a18d1cdcd1e75 kostenfrei http://dx.doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/toc/2162-402X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_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 2018 9
spelling	10.1080/2162402X.2018.1474319 doi (DE-627)DOAJ053778391 (DE-599)DOAJ7101ec3870244562a55a18d1cdcd1e75 DE-627 ger DE-627 rakwb eng RC581-607 RC254-282 Nicolas Isambert verfasserin aut Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy. Eligible patients had unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria. Thirty two patients with metastatic colorectal cancer were enrolled. Five patients demonstrated response (Choi criteria) and 22 patients had stable disease as the best 2-month overall response. Median progression-free and overall survival were 5.4 (95% CI, 3.6–6.6) and 14.5 months (95% CI, 9–20.6) respectively. Twenty patients experienced grade 3 toxicity. No grade 4 or 5 toxicity related to therapy occurred. The most common grade 3 adverse events were neutropenia in 8 (25%) patients, digestive side effects in 7 (21.9%) patients and hypertension in 6 (18.75%) patients. No treatment-related deaths or serious adverse events were reported.5-FU plus bevacizumab and anakinra has promising activity and a manageable safety profile, suggesting that this combination might become a potential treatment option for patients with refractory mCRC. il1 chemoimmunotherapy clinical trial colorectal mdsc clicial trial optimization new targets therapeutic trials Immunologic diseases. Allergy Neoplasms. Tumors. Oncology. Including cancer and carcinogens Alice Hervieu verfasserin aut Cedric Rébé verfasserin aut Audrey Hennequin verfasserin aut Christophe Borg verfasserin aut Sylvie Zanetta verfasserin aut Angélique Chevriaux verfasserin aut Corentin Richard verfasserin aut Valentin Derangère verfasserin aut Emeric Limagne verfasserin aut Julie Blanc verfasserin aut Aurélie Bertaut verfasserin aut François Ghiringhelli verfasserin aut In OncoImmunology Taylor & Francis Group, 2020 7(2018), 9 (DE-627)683365428 (DE-600)2645309-5 2162402X nnns volume:7 year:2018 number:9 https://doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/article/7101ec3870244562a55a18d1cdcd1e75 kostenfrei http://dx.doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/toc/2162-402X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_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 2018 9
allfields_unstemmed	10.1080/2162402X.2018.1474319 doi (DE-627)DOAJ053778391 (DE-599)DOAJ7101ec3870244562a55a18d1cdcd1e75 DE-627 ger DE-627 rakwb eng RC581-607 RC254-282 Nicolas Isambert verfasserin aut Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy. Eligible patients had unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria. Thirty two patients with metastatic colorectal cancer were enrolled. Five patients demonstrated response (Choi criteria) and 22 patients had stable disease as the best 2-month overall response. Median progression-free and overall survival were 5.4 (95% CI, 3.6–6.6) and 14.5 months (95% CI, 9–20.6) respectively. Twenty patients experienced grade 3 toxicity. No grade 4 or 5 toxicity related to therapy occurred. The most common grade 3 adverse events were neutropenia in 8 (25%) patients, digestive side effects in 7 (21.9%) patients and hypertension in 6 (18.75%) patients. No treatment-related deaths or serious adverse events were reported.5-FU plus bevacizumab and anakinra has promising activity and a manageable safety profile, suggesting that this combination might become a potential treatment option for patients with refractory mCRC. il1 chemoimmunotherapy clinical trial colorectal mdsc clicial trial optimization new targets therapeutic trials Immunologic diseases. Allergy Neoplasms. Tumors. Oncology. Including cancer and carcinogens Alice Hervieu verfasserin aut Cedric Rébé verfasserin aut Audrey Hennequin verfasserin aut Christophe Borg verfasserin aut Sylvie Zanetta verfasserin aut Angélique Chevriaux verfasserin aut Corentin Richard verfasserin aut Valentin Derangère verfasserin aut Emeric Limagne verfasserin aut Julie Blanc verfasserin aut Aurélie Bertaut verfasserin aut François Ghiringhelli verfasserin aut In OncoImmunology Taylor & Francis Group, 2020 7(2018), 9 (DE-627)683365428 (DE-600)2645309-5 2162402X nnns volume:7 year:2018 number:9 https://doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/article/7101ec3870244562a55a18d1cdcd1e75 kostenfrei http://dx.doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/toc/2162-402X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_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 2018 9
allfieldsGer	10.1080/2162402X.2018.1474319 doi (DE-627)DOAJ053778391 (DE-599)DOAJ7101ec3870244562a55a18d1cdcd1e75 DE-627 ger DE-627 rakwb eng RC581-607 RC254-282 Nicolas Isambert verfasserin aut Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy. Eligible patients had unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria. Thirty two patients with metastatic colorectal cancer were enrolled. Five patients demonstrated response (Choi criteria) and 22 patients had stable disease as the best 2-month overall response. Median progression-free and overall survival were 5.4 (95% CI, 3.6–6.6) and 14.5 months (95% CI, 9–20.6) respectively. Twenty patients experienced grade 3 toxicity. No grade 4 or 5 toxicity related to therapy occurred. The most common grade 3 adverse events were neutropenia in 8 (25%) patients, digestive side effects in 7 (21.9%) patients and hypertension in 6 (18.75%) patients. No treatment-related deaths or serious adverse events were reported.5-FU plus bevacizumab and anakinra has promising activity and a manageable safety profile, suggesting that this combination might become a potential treatment option for patients with refractory mCRC. il1 chemoimmunotherapy clinical trial colorectal mdsc clicial trial optimization new targets therapeutic trials Immunologic diseases. Allergy Neoplasms. Tumors. Oncology. Including cancer and carcinogens Alice Hervieu verfasserin aut Cedric Rébé verfasserin aut Audrey Hennequin verfasserin aut Christophe Borg verfasserin aut Sylvie Zanetta verfasserin aut Angélique Chevriaux verfasserin aut Corentin Richard verfasserin aut Valentin Derangère verfasserin aut Emeric Limagne verfasserin aut Julie Blanc verfasserin aut Aurélie Bertaut verfasserin aut François Ghiringhelli verfasserin aut In OncoImmunology Taylor & Francis Group, 2020 7(2018), 9 (DE-627)683365428 (DE-600)2645309-5 2162402X nnns volume:7 year:2018 number:9 https://doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/article/7101ec3870244562a55a18d1cdcd1e75 kostenfrei http://dx.doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/toc/2162-402X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_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 2018 9
allfieldsSound	10.1080/2162402X.2018.1474319 doi (DE-627)DOAJ053778391 (DE-599)DOAJ7101ec3870244562a55a18d1cdcd1e75 DE-627 ger DE-627 rakwb eng RC581-607 RC254-282 Nicolas Isambert verfasserin aut Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy. Eligible patients had unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria. Thirty two patients with metastatic colorectal cancer were enrolled. Five patients demonstrated response (Choi criteria) and 22 patients had stable disease as the best 2-month overall response. Median progression-free and overall survival were 5.4 (95% CI, 3.6–6.6) and 14.5 months (95% CI, 9–20.6) respectively. Twenty patients experienced grade 3 toxicity. No grade 4 or 5 toxicity related to therapy occurred. The most common grade 3 adverse events were neutropenia in 8 (25%) patients, digestive side effects in 7 (21.9%) patients and hypertension in 6 (18.75%) patients. No treatment-related deaths or serious adverse events were reported.5-FU plus bevacizumab and anakinra has promising activity and a manageable safety profile, suggesting that this combination might become a potential treatment option for patients with refractory mCRC. il1 chemoimmunotherapy clinical trial colorectal mdsc clicial trial optimization new targets therapeutic trials Immunologic diseases. Allergy Neoplasms. Tumors. Oncology. Including cancer and carcinogens Alice Hervieu verfasserin aut Cedric Rébé verfasserin aut Audrey Hennequin verfasserin aut Christophe Borg verfasserin aut Sylvie Zanetta verfasserin aut Angélique Chevriaux verfasserin aut Corentin Richard verfasserin aut Valentin Derangère verfasserin aut Emeric Limagne verfasserin aut Julie Blanc verfasserin aut Aurélie Bertaut verfasserin aut François Ghiringhelli verfasserin aut In OncoImmunology Taylor & Francis Group, 2020 7(2018), 9 (DE-627)683365428 (DE-600)2645309-5 2162402X nnns volume:7 year:2018 number:9 https://doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/article/7101ec3870244562a55a18d1cdcd1e75 kostenfrei http://dx.doi.org/10.1080/2162402X.2018.1474319 kostenfrei https://doaj.org/toc/2162-402X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_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 2018 9
language	English
source	In OncoImmunology 7(2018), 9 volume:7 year:2018 number:9
sourceStr	In OncoImmunology 7(2018), 9 volume:7 year:2018 number:9
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	il1 chemoimmunotherapy clinical trial colorectal mdsc clicial trial optimization new targets therapeutic trials Immunologic diseases. Allergy Neoplasms. Tumors. Oncology. Including cancer and carcinogens
isfreeaccess_bool	true
container_title	OncoImmunology
authorswithroles_txt_mv	Nicolas Isambert @@aut@@ Alice Hervieu @@aut@@ Cedric Rébé @@aut@@ Audrey Hennequin @@aut@@ Christophe Borg @@aut@@ Sylvie Zanetta @@aut@@ Angélique Chevriaux @@aut@@ Corentin Richard @@aut@@ Valentin Derangère @@aut@@ Emeric Limagne @@aut@@ Julie Blanc @@aut@@ Aurélie Bertaut @@aut@@ François Ghiringhelli @@aut@@
publishDateDaySort_date	2018-01-01T00:00:00Z
hierarchy_top_id	683365428
id	DOAJ053778391
language_de	englisch
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callnumber-first	R - Medicine
author	Nicolas Isambert
spellingShingle	Nicolas Isambert misc RC581-607 misc RC254-282 misc il1 misc chemoimmunotherapy misc clinical trial misc colorectal misc mdsc misc clicial trial optimization misc new targets misc therapeutic trials misc Immunologic diseases. Allergy misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study
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topic_title	RC581-607 RC254-282 Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study il1 chemoimmunotherapy clinical trial colorectal mdsc clicial trial optimization new targets therapeutic trials
topic	misc RC581-607 misc RC254-282 misc il1 misc chemoimmunotherapy misc clinical trial misc colorectal misc mdsc misc clicial trial optimization misc new targets misc therapeutic trials misc Immunologic diseases. Allergy misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
topic_unstemmed	misc RC581-607 misc RC254-282 misc il1 misc chemoimmunotherapy misc clinical trial misc colorectal misc mdsc misc clicial trial optimization misc new targets misc therapeutic trials misc Immunologic diseases. Allergy misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
topic_browse	misc RC581-607 misc RC254-282 misc il1 misc chemoimmunotherapy misc clinical trial misc colorectal misc mdsc misc clicial trial optimization misc new targets misc therapeutic trials misc Immunologic diseases. Allergy misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
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title	Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study
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title_full	Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study
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author_browse	Nicolas Isambert Alice Hervieu Cedric Rébé Audrey Hennequin Christophe Borg Sylvie Zanetta Angélique Chevriaux Corentin Richard Valentin Derangère Emeric Limagne Julie Blanc Aurélie Bertaut François Ghiringhelli
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title_sort	fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (irafu): a single-arm phase 2 study
callnumber	RC581-607
title_auth	Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study
abstract	In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy. Eligible patients had unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria. Thirty two patients with metastatic colorectal cancer were enrolled. Five patients demonstrated response (Choi criteria) and 22 patients had stable disease as the best 2-month overall response. Median progression-free and overall survival were 5.4 (95% CI, 3.6–6.6) and 14.5 months (95% CI, 9–20.6) respectively. Twenty patients experienced grade 3 toxicity. No grade 4 or 5 toxicity related to therapy occurred. The most common grade 3 adverse events were neutropenia in 8 (25%) patients, digestive side effects in 7 (21.9%) patients and hypertension in 6 (18.75%) patients. No treatment-related deaths or serious adverse events were reported.5-FU plus bevacizumab and anakinra has promising activity and a manageable safety profile, suggesting that this combination might become a potential treatment option for patients with refractory mCRC.
abstractGer	In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy. Eligible patients had unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria. Thirty two patients with metastatic colorectal cancer were enrolled. Five patients demonstrated response (Choi criteria) and 22 patients had stable disease as the best 2-month overall response. Median progression-free and overall survival were 5.4 (95% CI, 3.6–6.6) and 14.5 months (95% CI, 9–20.6) respectively. Twenty patients experienced grade 3 toxicity. No grade 4 or 5 toxicity related to therapy occurred. The most common grade 3 adverse events were neutropenia in 8 (25%) patients, digestive side effects in 7 (21.9%) patients and hypertension in 6 (18.75%) patients. No treatment-related deaths or serious adverse events were reported.5-FU plus bevacizumab and anakinra has promising activity and a manageable safety profile, suggesting that this combination might become a potential treatment option for patients with refractory mCRC.
abstract_unstemmed	In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy. Eligible patients had unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria. Thirty two patients with metastatic colorectal cancer were enrolled. Five patients demonstrated response (Choi criteria) and 22 patients had stable disease as the best 2-month overall response. Median progression-free and overall survival were 5.4 (95% CI, 3.6–6.6) and 14.5 months (95% CI, 9–20.6) respectively. Twenty patients experienced grade 3 toxicity. No grade 4 or 5 toxicity related to therapy occurred. The most common grade 3 adverse events were neutropenia in 8 (25%) patients, digestive side effects in 7 (21.9%) patients and hypertension in 6 (18.75%) patients. No treatment-related deaths or serious adverse events were reported.5-FU plus bevacizumab and anakinra has promising activity and a manageable safety profile, suggesting that this combination might become a potential treatment option for patients with refractory mCRC.
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title_short	Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study
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Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study

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