First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial
Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab an...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Cytryn, Samuel L [verfasserIn] Moy, Ryan H [verfasserIn] Cowzer, Darren [verfasserIn] Shah, Ronak H [verfasserIn] Chou, Joanne F [verfasserIn] Joshi, Smita S [verfasserIn] Ku, Geoffrey Y [verfasserIn] Maron, Steven B [verfasserIn] Desai, Avni [verfasserIn] Yang, Jessica [verfasserIn] Sugarman, Ryan [verfasserIn] Rao, Devika [verfasserIn] Goldberg, Zoe [verfasserIn] Charalambous, Carmelina [verfasserIn] Lapshina, Maria [verfasserIn] Antoine, Ariel [verfasserIn] Socolow, Fiona [verfasserIn] Trivedi, Nikhil [verfasserIn] Capanu, Marinela [verfasserIn] Gerdes, Hans [verfasserIn] Schattner, Mark A [verfasserIn] Simmons, Marc [verfasserIn] Lacouture, Mario E [verfasserIn] Paroder, Viktoriya [verfasserIn] Tang, Laura H [verfasserIn] Shia, Jinru [verfasserIn] Ilson, David H [verfasserIn] Solit, David B [verfasserIn] Berger, Michael F [verfasserIn] Janjigian, Yelena Y [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2023 |
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| Übergeordnetes Werk: |
Enthalten in: The lancet |
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| Übergeordnetes Werk: |
volume:24 ; pages:1073-1082 |
| DOI / URN: |
10.1016/S1470-2045(23)00358-3 |
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ELV064952398 |
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| 100 | 1 | |a Cytryn, Samuel L |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial |
| 264 | 1 | |c 2023 | |
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| 520 | |a Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.Funding: Bristol Myers Squibb, Bayer and National Institutes of Health/National Cancer Institute. | ||
| 700 | 1 | |a Moy, Ryan H |e verfasserin |4 aut | |
| 700 | 1 | |a Cowzer, Darren |e verfasserin |4 aut | |
| 700 | 1 | |a Shah, Ronak H |e verfasserin |4 aut | |
| 700 | 1 | |a Chou, Joanne F |e verfasserin |4 aut | |
| 700 | 1 | |a Joshi, Smita S |e verfasserin |4 aut | |
| 700 | 1 | |a Ku, Geoffrey Y |e verfasserin |4 aut | |
| 700 | 1 | |a Maron, Steven B |e verfasserin |4 aut | |
| 700 | 1 | |a Desai, Avni |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Jessica |e verfasserin |4 aut | |
| 700 | 1 | |a Sugarman, Ryan |e verfasserin |4 aut | |
| 700 | 1 | |a Rao, Devika |e verfasserin |4 aut | |
| 700 | 1 | |a Goldberg, Zoe |e verfasserin |4 aut | |
| 700 | 1 | |a Charalambous, Carmelina |e verfasserin |4 aut | |
| 700 | 1 | |a Lapshina, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Antoine, Ariel |e verfasserin |4 aut | |
| 700 | 1 | |a Socolow, Fiona |e verfasserin |4 aut | |
| 700 | 1 | |a Trivedi, Nikhil |e verfasserin |4 aut | |
| 700 | 1 | |a Capanu, Marinela |e verfasserin |4 aut | |
| 700 | 1 | |a Gerdes, Hans |e verfasserin |4 aut | |
| 700 | 1 | |a Schattner, Mark A |e verfasserin |4 aut | |
| 700 | 1 | |a Simmons, Marc |e verfasserin |4 aut | |
| 700 | 1 | |a Lacouture, Mario E |e verfasserin |4 aut | |
| 700 | 1 | |a Paroder, Viktoriya |e verfasserin |4 aut | |
| 700 | 1 | |a Tang, Laura H |e verfasserin |4 aut | |
| 700 | 1 | |a Shia, Jinru |e verfasserin |4 aut | |
| 700 | 1 | |a Ilson, David H |e verfasserin |4 aut | |
| 700 | 1 | |a Solit, David B |e verfasserin |4 aut | |
| 700 | 1 | |a Berger, Michael F |e verfasserin |4 aut | |
| 700 | 1 | |a Janjigian, Yelena Y |e verfasserin |4 aut | |
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10.1016/S1470-2045(23)00358-3 doi (DE-627)ELV064952398 (ELSEVIER)S1470-2045(23)00358-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cytryn, Samuel L verfasserin aut First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.Funding: Bristol Myers Squibb, Bayer and National Institutes of Health/National Cancer Institute. Moy, Ryan H verfasserin aut Cowzer, Darren verfasserin aut Shah, Ronak H verfasserin aut Chou, Joanne F verfasserin aut Joshi, Smita S verfasserin aut Ku, Geoffrey Y verfasserin aut Maron, Steven B verfasserin aut Desai, Avni verfasserin aut Yang, Jessica verfasserin aut Sugarman, Ryan verfasserin aut Rao, Devika verfasserin aut Goldberg, Zoe verfasserin aut Charalambous, Carmelina verfasserin aut Lapshina, Maria verfasserin aut Antoine, Ariel verfasserin aut Socolow, Fiona verfasserin aut Trivedi, Nikhil verfasserin aut Capanu, Marinela verfasserin aut Gerdes, Hans verfasserin aut Schattner, Mark A verfasserin aut Simmons, Marc verfasserin aut Lacouture, Mario E verfasserin aut Paroder, Viktoriya verfasserin aut Tang, Laura H verfasserin aut Shia, Jinru verfasserin aut Ilson, David H verfasserin aut Solit, David B verfasserin aut Berger, Michael F verfasserin aut Janjigian, Yelena Y verfasserin aut Enthalten in The lancet <London> / Oncology London : The Lancet Publ. 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10.1016/S1470-2045(23)00358-3 doi (DE-627)ELV064952398 (ELSEVIER)S1470-2045(23)00358-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cytryn, Samuel L verfasserin aut First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.Funding: Bristol Myers Squibb, Bayer and National Institutes of Health/National Cancer Institute. Moy, Ryan H verfasserin aut Cowzer, Darren verfasserin aut Shah, Ronak H verfasserin aut Chou, Joanne F verfasserin aut Joshi, Smita S verfasserin aut Ku, Geoffrey Y verfasserin aut Maron, Steven B verfasserin aut Desai, Avni verfasserin aut Yang, Jessica verfasserin aut Sugarman, Ryan verfasserin aut Rao, Devika verfasserin aut Goldberg, Zoe verfasserin aut Charalambous, Carmelina verfasserin aut Lapshina, Maria verfasserin aut Antoine, Ariel verfasserin aut Socolow, Fiona verfasserin aut Trivedi, Nikhil verfasserin aut Capanu, Marinela verfasserin aut Gerdes, Hans verfasserin aut Schattner, Mark A verfasserin aut Simmons, Marc verfasserin aut Lacouture, Mario E verfasserin aut Paroder, Viktoriya verfasserin aut Tang, Laura H verfasserin aut Shia, Jinru verfasserin aut Ilson, David H verfasserin aut Solit, David B verfasserin aut Berger, Michael F verfasserin aut Janjigian, Yelena Y verfasserin aut Enthalten in The lancet <London> / Oncology London : The Lancet Publ. Group, 2000 24, Seite 1073-1082 Online-Ressource (DE-627)325349770 (DE-600)2035574-9 (DE-576)100517544 1474-5488 nnns volume:24 pages:1073-1082 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_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_213 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_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2424 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 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_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 Onkologie VZ AR 24 1073-1082 |
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10.1016/S1470-2045(23)00358-3 doi (DE-627)ELV064952398 (ELSEVIER)S1470-2045(23)00358-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cytryn, Samuel L verfasserin aut First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.Funding: Bristol Myers Squibb, Bayer and National Institutes of Health/National Cancer Institute. Moy, Ryan H verfasserin aut Cowzer, Darren verfasserin aut Shah, Ronak H verfasserin aut Chou, Joanne F verfasserin aut Joshi, Smita S verfasserin aut Ku, Geoffrey Y verfasserin aut Maron, Steven B verfasserin aut Desai, Avni verfasserin aut Yang, Jessica verfasserin aut Sugarman, Ryan verfasserin aut Rao, Devika verfasserin aut Goldberg, Zoe verfasserin aut Charalambous, Carmelina verfasserin aut Lapshina, Maria verfasserin aut Antoine, Ariel verfasserin aut Socolow, Fiona verfasserin aut Trivedi, Nikhil verfasserin aut Capanu, Marinela verfasserin aut Gerdes, Hans verfasserin aut Schattner, Mark A verfasserin aut Simmons, Marc verfasserin aut Lacouture, Mario E verfasserin aut Paroder, Viktoriya verfasserin aut Tang, Laura H verfasserin aut Shia, Jinru verfasserin aut Ilson, David H verfasserin aut Solit, David B verfasserin aut Berger, Michael F verfasserin aut Janjigian, Yelena Y verfasserin aut Enthalten in The lancet <London> / Oncology London : The Lancet Publ. Group, 2000 24, Seite 1073-1082 Online-Ressource (DE-627)325349770 (DE-600)2035574-9 (DE-576)100517544 1474-5488 nnns volume:24 pages:1073-1082 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_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_213 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_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2424 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 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_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 Onkologie VZ AR 24 1073-1082 |
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10.1016/S1470-2045(23)00358-3 doi (DE-627)ELV064952398 (ELSEVIER)S1470-2045(23)00358-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cytryn, Samuel L verfasserin aut First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.Funding: Bristol Myers Squibb, Bayer and National Institutes of Health/National Cancer Institute. Moy, Ryan H verfasserin aut Cowzer, Darren verfasserin aut Shah, Ronak H verfasserin aut Chou, Joanne F verfasserin aut Joshi, Smita S verfasserin aut Ku, Geoffrey Y verfasserin aut Maron, Steven B verfasserin aut Desai, Avni verfasserin aut Yang, Jessica verfasserin aut Sugarman, Ryan verfasserin aut Rao, Devika verfasserin aut Goldberg, Zoe verfasserin aut Charalambous, Carmelina verfasserin aut Lapshina, Maria verfasserin aut Antoine, Ariel verfasserin aut Socolow, Fiona verfasserin aut Trivedi, Nikhil verfasserin aut Capanu, Marinela verfasserin aut Gerdes, Hans verfasserin aut Schattner, Mark A verfasserin aut Simmons, Marc verfasserin aut Lacouture, Mario E verfasserin aut Paroder, Viktoriya verfasserin aut Tang, Laura H verfasserin aut Shia, Jinru verfasserin aut Ilson, David H verfasserin aut Solit, David B verfasserin aut Berger, Michael F verfasserin aut Janjigian, Yelena Y verfasserin aut Enthalten in The lancet <London> / Oncology London : The Lancet Publ. Group, 2000 24, Seite 1073-1082 Online-Ressource (DE-627)325349770 (DE-600)2035574-9 (DE-576)100517544 1474-5488 nnns volume:24 pages:1073-1082 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_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_213 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_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2424 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 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_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 Onkologie VZ AR 24 1073-1082 |
| allfieldsSound |
10.1016/S1470-2045(23)00358-3 doi (DE-627)ELV064952398 (ELSEVIER)S1470-2045(23)00358-3 DE-627 ger DE-627 rda eng 610 VZ 44.81 bkl Cytryn, Samuel L verfasserin aut First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.Funding: Bristol Myers Squibb, Bayer and National Institutes of Health/National Cancer Institute. Moy, Ryan H verfasserin aut Cowzer, Darren verfasserin aut Shah, Ronak H verfasserin aut Chou, Joanne F verfasserin aut Joshi, Smita S verfasserin aut Ku, Geoffrey Y verfasserin aut Maron, Steven B verfasserin aut Desai, Avni verfasserin aut Yang, Jessica verfasserin aut Sugarman, Ryan verfasserin aut Rao, Devika verfasserin aut Goldberg, Zoe verfasserin aut Charalambous, Carmelina verfasserin aut Lapshina, Maria verfasserin aut Antoine, Ariel verfasserin aut Socolow, Fiona verfasserin aut Trivedi, Nikhil verfasserin aut Capanu, Marinela verfasserin aut Gerdes, Hans verfasserin aut Schattner, Mark A verfasserin aut Simmons, Marc verfasserin aut Lacouture, Mario E verfasserin aut Paroder, Viktoriya verfasserin aut Tang, Laura H verfasserin aut Shia, Jinru verfasserin aut Ilson, David H verfasserin aut Solit, David B verfasserin aut Berger, Michael F verfasserin aut Janjigian, Yelena Y verfasserin aut Enthalten in The lancet <London> / Oncology London : The Lancet Publ. Group, 2000 24, Seite 1073-1082 Online-Ressource (DE-627)325349770 (DE-600)2035574-9 (DE-576)100517544 1474-5488 nnns volume:24 pages:1073-1082 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_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_213 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_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2424 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 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_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 Onkologie VZ AR 24 1073-1082 |
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Cytryn, Samuel L @@aut@@ Moy, Ryan H @@aut@@ Cowzer, Darren @@aut@@ Shah, Ronak H @@aut@@ Chou, Joanne F @@aut@@ Joshi, Smita S @@aut@@ Ku, Geoffrey Y @@aut@@ Maron, Steven B @@aut@@ Desai, Avni @@aut@@ Yang, Jessica @@aut@@ Sugarman, Ryan @@aut@@ Rao, Devika @@aut@@ Goldberg, Zoe @@aut@@ Charalambous, Carmelina @@aut@@ Lapshina, Maria @@aut@@ Antoine, Ariel @@aut@@ Socolow, Fiona @@aut@@ Trivedi, Nikhil @@aut@@ Capanu, Marinela @@aut@@ Gerdes, Hans @@aut@@ Schattner, Mark A @@aut@@ Simmons, Marc @@aut@@ Lacouture, Mario E @@aut@@ Paroder, Viktoriya @@aut@@ Tang, Laura H @@aut@@ Shia, Jinru @@aut@@ Ilson, David H @@aut@@ Solit, David B @@aut@@ Berger, Michael F @@aut@@ Janjigian, Yelena Y @@aut@@ |
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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">ELV064952398</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20231008073218.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">231004s2023 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/S1470-2045(23)00358-3</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV064952398</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S1470-2045(23)00358-3</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">Cytryn, Samuel L</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2023</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">Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. 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Cytryn, Samuel L |
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First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial |
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First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial |
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Cytryn, Samuel L Moy, Ryan H Cowzer, Darren Shah, Ronak H Chou, Joanne F Joshi, Smita S Ku, Geoffrey Y Maron, Steven B Desai, Avni Yang, Jessica Sugarman, Ryan Rao, Devika Goldberg, Zoe Charalambous, Carmelina Lapshina, Maria Antoine, Ariel Socolow, Fiona Trivedi, Nikhil Capanu, Marinela Gerdes, Hans Schattner, Mark A Simmons, Marc Lacouture, Mario E Paroder, Viktoriya Tang, Laura H Shia, Jinru Ilson, David H Solit, David B Berger, Michael F Janjigian, Yelena Y |
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first-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the usa: a single-arm, single-centre, phase 2 trial |
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First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial |
| abstract |
Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.Funding: Bristol Myers Squibb, Bayer and National Institutes of Health/National Cancer Institute. |
| abstractGer |
Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.Funding: Bristol Myers Squibb, Bayer and National Institutes of Health/National Cancer Institute. |
| abstract_unstemmed |
Background: The addition of nivolumab to chemotherapy improves survival in patients with advanced oesophagogastric (oesophageal, gastric, or gastro-oesophageal junction) adenocarcinoma; however, outcomes remain poor. We assessed the safety and activity of regorafenib in combination with nivolumab and chemotherapy in the first-line treatment of advanced oesophagogastric adenocarcinoma.Methods: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with previously untreated, HER2-negative, metastatic oesophagogastric adenocarcinoma was done at the Memorial Sloan Kettering Cancer Center (New York, NY, USA). Eligible patients had measurable disease or non-measurable disease that was evaluable (defined by Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received FOLFOX chemotherapy (fluorouracil [400 mg/m2 bolus followed by 2400 mg/m2 over 48 h], leucovorin [400 mg/m2], and oxaliplatin [85 mg/m2]) and nivolumab (240 mg) intravenously on days 1 and 15, and oral regorafenib (80 mg) on days 1–21 of a 28-day cycle. Treatment was continued until disease progression (defined by RECIST version 1.1), unacceptable toxicity, or withdrawal of consent. The primary endpoint was 6-month progression-free survival in the per-protocol population (ie, all participants who received a dose of all study treatments). The regimen would be considered worthy of further investigation if at least 24 of 35 patients were progression free at 6 months. Safety was assessed in all participants who received at least one dose of any study treatment. This trial is registered with ClinicalTrials.gov, NCT04757363, and is now complete.Findings: Between Feb 11, 2021, and May 4, 2022, 39 patients were enrolled, received at least one dose of study drug, and were included in safety analyses. 35 patients were evaluable for 6-month progression-free survival. Median age was 57 years (IQR 52–66), nine (26%) patients were women, 26 (74%) were men, 28 (80%) were White, and seven (20%) were Asian. At data cutoff (March 3, 2023), median follow-up was 18·1 months (IQR 12·7–20·4). The primary endpoint was reached, with 25 (71%; 95% CI 54–85) of 35 patients progression free at 6 months. Nine (26%) of 35 patients had disease progression and one (3%) patient died; the death was unrelated to treatment. The most common adverse event of any grade was fatigue (36 [92%] of 39). The most common grade 3 or 4 adverse events were decreased neutrophil count (18 [46%]), hypertension (six [15%]), dry skin, pruritus, or rash (five [13%]), and anaemia (four [10%]). Serious treatment-related adverse events occurred in ten (26%) patients, which were acute kidney injury (three [8%]), hepatotoxicity (two [5%]), sepsis (two [5%]), dry skin, pruritus, or rash (one [3%]), nausea (one [3%]), and gastric perforation (one [3%]). There were no treatment-related deaths.Interpretation: Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.Funding: Bristol Myers Squibb, Bayer and National Institutes of Health/National Cancer Institute. |
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| title_short |
First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial |
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| author2 |
Moy, Ryan H Cowzer, Darren Shah, Ronak H Chou, Joanne F Joshi, Smita S Ku, Geoffrey Y Maron, Steven B Desai, Avni Yang, Jessica Sugarman, Ryan Rao, Devika Goldberg, Zoe Charalambous, Carmelina Lapshina, Maria Antoine, Ariel Socolow, Fiona Trivedi, Nikhil Capanu, Marinela Gerdes, Hans Schattner, Mark A Simmons, Marc Lacouture, Mario E Paroder, Viktoriya Tang, Laura H Shia, Jinru Ilson, David H Solit, David B Berger, Michael F Janjigian, Yelena Y |
| author2Str |
Moy, Ryan H Cowzer, Darren Shah, Ronak H Chou, Joanne F Joshi, Smita S Ku, Geoffrey Y Maron, Steven B Desai, Avni Yang, Jessica Sugarman, Ryan Rao, Devika Goldberg, Zoe Charalambous, Carmelina Lapshina, Maria Antoine, Ariel Socolow, Fiona Trivedi, Nikhil Capanu, Marinela Gerdes, Hans Schattner, Mark A Simmons, Marc Lacouture, Mario E Paroder, Viktoriya Tang, Laura H Shia, Jinru Ilson, David H Solit, David B Berger, Michael F Janjigian, Yelena Y |
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| doi_str |
10.1016/S1470-2045(23)00358-3 |
| up_date |
2024-07-06T21:18:20.023Z |
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1803866026829414400 |
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|
| score |
7.39983 |