SWOG 1609 cohort 48: anti–CTLA‐4 and anti–PD‐1 for advanced gallbladder cancer
Introduction Most patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open‐label study was designed to evaluate the anticancer activity of nivol...
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| Vydáno v: | Cancer Ročník 130; číslo 17; s. 2918 - 2927 |
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| Hlavní autoři: | , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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United States
Wiley Subscription Services, Inc
01.09.2024
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| ISSN: | 0008-543X, 1097-0142, 1097-0142 |
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| Abstract | Introduction
Most patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open‐label study was designed to evaluate the anticancer activity of nivolumab plus ipilimumab in patients with advanced gallbladder cancer.
Methods
Nineteen patients with advanced gallbladder cancer refractory to ≥1 previous therapy received nivolumab 240 mg intravenously every 2 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks until disease progression or unacceptable toxicity. The primary end point was confirmed radiographic overall response rate (ORR) (complete response [CR] + partial response [PR] confirmed on subsequent scan); secondary end points included unconfirmed overall response, clinical benefit rate (confirmed and unconfirmed responses + stable disease >6 months), progression‐free survival, overall survival, and toxicity.
Results
The confirmed ORR was 16% (CR, n = 1 [5%]; PR, n = 2 [11%]); all were microsatellite stable, and the confirmed CR had undetectable programmed death‐ligand 1 by immunohistochemistry. The unconfirmed ORR and clinical benefit rates were both 32%. The median duration of response was 14.8 months (range, 4–35.1+ months). The 6‐month progression‐free survival was 26% (95% CI, 12–55). The median overall survival was 7.0 months (95% CI, 3.9–19.1). The most common toxicities were fatigue (32%), anemia (26%), and anorexia (26%). Aspartate aminotransferase elevation was the most common grade 3/4 toxicity (11%). There was 1 possibly related death (sepsis with attendant hepatic failure).
Conclusions
Ipilimumab plus nivolumab was well tolerated and showed modest efficacy with durable responses in previously treated patients with advanced gallbladder cancer.
Clinical Trial Registration
NCT02834013 (ClincialTrials.gov).
Plain Language Summary
This prospective study assessed the efficacy and safety of nivolumab plus ipilimumab in 19 patients with advanced gallbladder cancer refractory to previous therapy. The combination demonstrated modest efficacy with a 16% confirmed overall response rate, durable responses, and manageable toxicities, suggesting potential benefits for this challenging patient population.
Ipilimumab plus nivolumab demonstrated modest efficacy with durable responses and manageable toxicity in previously treated patients with advanced gallbladder cancer. |
|---|---|
| AbstractList | IntroductionMost patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open‐label study was designed to evaluate the anticancer activity of nivolumab plus ipilimumab in patients with advanced gallbladder cancer.MethodsNineteen patients with advanced gallbladder cancer refractory to ≥1 previous therapy received nivolumab 240 mg intravenously every 2 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks until disease progression or unacceptable toxicity. The primary end point was confirmed radiographic overall response rate (ORR) (complete response [CR] + partial response [PR] confirmed on subsequent scan); secondary end points included unconfirmed overall response, clinical benefit rate (confirmed and unconfirmed responses + stable disease >6 months), progression‐free survival, overall survival, and toxicity.ResultsThe confirmed ORR was 16% (CR, n = 1 [5%]; PR, n = 2 [11%]); all were microsatellite stable, and the confirmed CR had undetectable programmed death‐ligand 1 by immunohistochemistry. The unconfirmed ORR and clinical benefit rates were both 32%. The median duration of response was 14.8 months (range, 4–35.1+ months). The 6‐month progression‐free survival was 26% (95% CI, 12–55). The median overall survival was 7.0 months (95% CI, 3.9–19.1). The most common toxicities were fatigue (32%), anemia (26%), and anorexia (26%). Aspartate aminotransferase elevation was the most common grade 3/4 toxicity (11%). There was 1 possibly related death (sepsis with attendant hepatic failure).ConclusionsIpilimumab plus nivolumab was well tolerated and showed modest efficacy with durable responses in previously treated patients with advanced gallbladder cancer.Clinical Trial RegistrationNCT02834013 (ClincialTrials.gov).Plain Language SummaryThis prospective study assessed the efficacy and safety of nivolumab plus ipilimumab in 19 patients with advanced gallbladder cancer refractory to previous therapy. The combination demonstrated modest efficacy with a 16% confirmed overall response rate, durable responses, and manageable toxicities, suggesting potential benefits for this challenging patient population. Most patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open-label study was designed to evaluate the anticancer activity of nivolumab plus ipilimumab in patients with advanced gallbladder cancer.INTRODUCTIONMost patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open-label study was designed to evaluate the anticancer activity of nivolumab plus ipilimumab in patients with advanced gallbladder cancer.Nineteen patients with advanced gallbladder cancer refractory to ≥1 previous therapy received nivolumab 240 mg intravenously every 2 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks until disease progression or unacceptable toxicity. The primary end point was confirmed radiographic overall response rate (ORR) (complete response [CR] + partial response [PR] confirmed on subsequent scan); secondary end points included unconfirmed overall response, clinical benefit rate (confirmed and unconfirmed responses + stable disease >6 months), progression-free survival, overall survival, and toxicity.METHODSNineteen patients with advanced gallbladder cancer refractory to ≥1 previous therapy received nivolumab 240 mg intravenously every 2 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks until disease progression or unacceptable toxicity. The primary end point was confirmed radiographic overall response rate (ORR) (complete response [CR] + partial response [PR] confirmed on subsequent scan); secondary end points included unconfirmed overall response, clinical benefit rate (confirmed and unconfirmed responses + stable disease >6 months), progression-free survival, overall survival, and toxicity.The confirmed ORR was 16% (CR, n = 1 [5%]; PR, n = 2 [11%]); all were microsatellite stable, and the confirmed CR had undetectable programmed death-ligand 1 by immunohistochemistry. The unconfirmed ORR and clinical benefit rates were both 32%. The median duration of response was 14.8 months (range, 4-35.1+ months). The 6-month progression-free survival was 26% (95% CI, 12-55). The median overall survival was 7.0 months (95% CI, 3.9-19.1). The most common toxicities were fatigue (32%), anemia (26%), and anorexia (26%). Aspartate aminotransferase elevation was the most common grade 3/4 toxicity (11%). There was 1 possibly related death (sepsis with attendant hepatic failure).RESULTSThe confirmed ORR was 16% (CR, n = 1 [5%]; PR, n = 2 [11%]); all were microsatellite stable, and the confirmed CR had undetectable programmed death-ligand 1 by immunohistochemistry. The unconfirmed ORR and clinical benefit rates were both 32%. The median duration of response was 14.8 months (range, 4-35.1+ months). The 6-month progression-free survival was 26% (95% CI, 12-55). The median overall survival was 7.0 months (95% CI, 3.9-19.1). The most common toxicities were fatigue (32%), anemia (26%), and anorexia (26%). Aspartate aminotransferase elevation was the most common grade 3/4 toxicity (11%). There was 1 possibly related death (sepsis with attendant hepatic failure).Ipilimumab plus nivolumab was well tolerated and showed modest efficacy with durable responses in previously treated patients with advanced gallbladder cancer.CONCLUSIONSIpilimumab plus nivolumab was well tolerated and showed modest efficacy with durable responses in previously treated patients with advanced gallbladder cancer.NCT02834013 (ClincialTrials.gov).CLINICAL TRIAL REGISTRATIONNCT02834013 (ClincialTrials.gov).This prospective study assessed the efficacy and safety of nivolumab plus ipilimumab in 19 patients with advanced gallbladder cancer refractory to previous therapy. The combination demonstrated modest efficacy with a 16% confirmed overall response rate, durable responses, and manageable toxicities, suggesting potential benefits for this challenging patient population.PLAIN LANGUAGE SUMMARYThis prospective study assessed the efficacy and safety of nivolumab plus ipilimumab in 19 patients with advanced gallbladder cancer refractory to previous therapy. The combination demonstrated modest efficacy with a 16% confirmed overall response rate, durable responses, and manageable toxicities, suggesting potential benefits for this challenging patient population. Most patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open-label study was designed to evaluate the anticancer activity of nivolumab plus ipilimumab in patients with advanced gallbladder cancer. Nineteen patients with advanced gallbladder cancer refractory to ≥1 previous therapy received nivolumab 240 mg intravenously every 2 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks until disease progression or unacceptable toxicity. The primary end point was confirmed radiographic overall response rate (ORR) (complete response [CR] + partial response [PR] confirmed on subsequent scan); secondary end points included unconfirmed overall response, clinical benefit rate (confirmed and unconfirmed responses + stable disease >6 months), progression-free survival, overall survival, and toxicity. The confirmed ORR was 16% (CR, n = 1 [5%]; PR, n = 2 [11%]); all were microsatellite stable, and the confirmed CR had undetectable programmed death-ligand 1 by immunohistochemistry. The unconfirmed ORR and clinical benefit rates were both 32%. The median duration of response was 14.8 months (range, 4-35.1+ months). The 6-month progression-free survival was 26% (95% CI, 12-55). The median overall survival was 7.0 months (95% CI, 3.9-19.1). The most common toxicities were fatigue (32%), anemia (26%), and anorexia (26%). Aspartate aminotransferase elevation was the most common grade 3/4 toxicity (11%). There was 1 possibly related death (sepsis with attendant hepatic failure). Ipilimumab plus nivolumab was well tolerated and showed modest efficacy with durable responses in previously treated patients with advanced gallbladder cancer. NCT02834013 (ClincialTrials.gov). This prospective study assessed the efficacy and safety of nivolumab plus ipilimumab in 19 patients with advanced gallbladder cancer refractory to previous therapy. The combination demonstrated modest efficacy with a 16% confirmed overall response rate, durable responses, and manageable toxicities, suggesting potential benefits for this challenging patient population. Ipilimumab plus nivolumab demonstrated modest efficacy with durable responses and manageable toxicity in previously treated patients with advanced gallbladder cancer. This prospective study assessed the efficacy and safety of nivolumab plus ipilimumab in 19 patients with advanced gallbladder cancer refractory to prior therapy. The combination demonstrated modest efficacy with a 16% confirmed overall response rate, durable responses, and manageable toxicities, suggesting potential benefits for this challenging patient population. Ipilimumab plus nivolumab demonstrated modest efficacy with durable responses and manageable toxicity in previously treated patients with advanced gallbladder cancer. Introduction Most patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open‐label study was designed to evaluate the anticancer activity of nivolumab plus ipilimumab in patients with advanced gallbladder cancer. Methods Nineteen patients with advanced gallbladder cancer refractory to ≥1 previous therapy received nivolumab 240 mg intravenously every 2 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks until disease progression or unacceptable toxicity. The primary end point was confirmed radiographic overall response rate (ORR) (complete response [CR] + partial response [PR] confirmed on subsequent scan); secondary end points included unconfirmed overall response, clinical benefit rate (confirmed and unconfirmed responses + stable disease >6 months), progression‐free survival, overall survival, and toxicity. Results The confirmed ORR was 16% (CR, n = 1 [5%]; PR, n = 2 [11%]); all were microsatellite stable, and the confirmed CR had undetectable programmed death‐ligand 1 by immunohistochemistry. The unconfirmed ORR and clinical benefit rates were both 32%. The median duration of response was 14.8 months (range, 4–35.1+ months). The 6‐month progression‐free survival was 26% (95% CI, 12–55). The median overall survival was 7.0 months (95% CI, 3.9–19.1). The most common toxicities were fatigue (32%), anemia (26%), and anorexia (26%). Aspartate aminotransferase elevation was the most common grade 3/4 toxicity (11%). There was 1 possibly related death (sepsis with attendant hepatic failure). Conclusions Ipilimumab plus nivolumab was well tolerated and showed modest efficacy with durable responses in previously treated patients with advanced gallbladder cancer. Clinical Trial Registration NCT02834013 (ClincialTrials.gov). Plain Language Summary This prospective study assessed the efficacy and safety of nivolumab plus ipilimumab in 19 patients with advanced gallbladder cancer refractory to previous therapy. The combination demonstrated modest efficacy with a 16% confirmed overall response rate, durable responses, and manageable toxicities, suggesting potential benefits for this challenging patient population. Ipilimumab plus nivolumab demonstrated modest efficacy with durable responses and manageable toxicity in previously treated patients with advanced gallbladder cancer. |
| Author | Ryan, Christopher W. Powers, Benjamin C. Chae, Young Kwang George, Thomas J. Blanke, Charles D. Liao, Chih‐Yi Dennis, Michael J. Kurzrock, Razelle Guadarrama, Elizabeth Patel, Sandip P. Lopez, Gabby Sharon, Elad Othus, Megan Ferri, William A. |
| AuthorAffiliation | b St. Martin’s University, Lacey, WA, USA d Division of Hematology/Oncology, University of Kansas Medical Center, Kansas City, Kansas, USA h Division of Cancer Treatment and Diagnosis, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD, USA j SWOG Statistics and Data Management Center/Fred Hutchinson Cancer Center, Seattle, WA, USA a Division of Medical Oncology, University of California San Diego Moores Cancer Center, La Jolla, CA, USA l Division of Medical Oncology, Medical College of Wisconsin Froedtert Cancer Center, Milwaukee, WI, USA k SWOG Group Chair’s Office, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA i Division of Hematology and Oncology, Oregon Health and Science University Knight Cancer Institute, Portland, OR, USA g Division of Hematology/Oncology, University of Florida Health Cancer Center, Gainesville, FL, USA f Division of Hematology/Oncology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA c |
| AuthorAffiliation_xml | – name: b St. Martin’s University, Lacey, WA, USA – name: i Division of Hematology and Oncology, Oregon Health and Science University Knight Cancer Institute, Portland, OR, USA – name: k SWOG Group Chair’s Office, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA – name: f Division of Hematology/Oncology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA – name: a Division of Medical Oncology, University of California San Diego Moores Cancer Center, La Jolla, CA, USA – name: c Division of Medical Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA – name: l Division of Medical Oncology, Medical College of Wisconsin Froedtert Cancer Center, Milwaukee, WI, USA – name: j SWOG Statistics and Data Management Center/Fred Hutchinson Cancer Center, Seattle, WA, USA – name: g Division of Hematology/Oncology, University of Florida Health Cancer Center, Gainesville, FL, USA – name: e Division of Hematology/Oncology, University of Chicago Comprehensive Cancer Center, Chicago, IL, USA – name: h Division of Cancer Treatment and Diagnosis, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD, USA – name: d Division of Hematology/Oncology, University of Kansas Medical Center, Kansas City, Kansas, USA |
| Author_xml | – sequence: 1 givenname: Sandip P. orcidid: 0000-0002-8387-4840 surname: Patel fullname: Patel, Sandip P. email: spatel@ucsd.edu organization: University of California San Diego Moores Cancer Center – sequence: 2 givenname: Elizabeth surname: Guadarrama fullname: Guadarrama, Elizabeth organization: St. Martin’s University – sequence: 3 givenname: Young Kwang orcidid: 0000-0003-1557-7235 surname: Chae fullname: Chae, Young Kwang organization: Northwestern University Feinberg School of Medicine – sequence: 4 givenname: Michael J. orcidid: 0000-0002-8175-5311 surname: Dennis fullname: Dennis, Michael J. organization: University of California San Diego Moores Cancer Center – sequence: 5 givenname: Benjamin C. surname: Powers fullname: Powers, Benjamin C. organization: University of Kansas Medical Center – sequence: 6 givenname: Chih‐Yi surname: Liao fullname: Liao, Chih‐Yi organization: University of Chicago Comprehensive Cancer Center – sequence: 7 givenname: William A. surname: Ferri fullname: Ferri, William A. organization: University of Pittsburgh School of Medicine – sequence: 8 givenname: Thomas J. orcidid: 0000-0002-6249-9180 surname: George fullname: George, Thomas J. organization: University of Florida Health Cancer Center – sequence: 9 givenname: Elad orcidid: 0000-0002-0044-9719 surname: Sharon fullname: Sharon, Elad organization: Cancer Therapy Evaluation Program – sequence: 10 givenname: Christopher W. surname: Ryan fullname: Ryan, Christopher W. organization: Oregon Health and Science University Knight Cancer Institute – sequence: 11 givenname: Megan surname: Othus fullname: Othus, Megan organization: SWOG Statistics and Data Management Center/Fred Hutchinson Cancer Center – sequence: 12 givenname: Gabby orcidid: 0009-0005-4174-9071 surname: Lopez fullname: Lopez, Gabby organization: SWOG Statistics and Data Management Center/Fred Hutchinson Cancer Center – sequence: 13 givenname: Charles D. surname: Blanke fullname: Blanke, Charles D. organization: Oregon Health and Science University – sequence: 14 givenname: Razelle surname: Kurzrock fullname: Kurzrock, Razelle organization: Medical College of Wisconsin Froedtert Cancer Center |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38358334$$D View this record in MEDLINE/PubMed |
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| Keywords | biliary tract cancer immune checkpoint inhibitor nivolumab ipilimumab |
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| License | 2024 American Cancer Society. |
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| Notes | Sandip P. Patel, Young Kwang Chae, and Razelle Kurzrock cofirst authors. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Elizabeth Guadarrama does not have a degree (she is still in training) co-first authors Charles D. Blanke: conceptualization; funding acquisition; project administration; resources; writing – review and editing. Michael J. Dennis: formal analysis; writing – original draft; writing – review and editing. William A. Ferri, Jr.: resources; writing – review and editing. Elizabeth Guadarrama: formal analysis; writing – review and editing. Thomas J. George: resources; writing – review and editing; Young Kwang Chae: conceptualization; funding acquisition; resources; writing – original draft; writing – review and editing. Gabby Lopez: formal analysis; writing – review and editing. Chih-Yi Liao: resources; writing – review and editing. Megan Othus: conceptualization; formal analysis; writing – original draft; writing – review and editing. Sandip P. Patel: conceptualization; funding acquisition; project administration; resources; supervision; writing – original draft; writing – review and editing. Benjamin C. Powers: resources; writing – review and editing. Elad Sharon: project administration; resources; writing – review and editing. Christopher W. Ryan: writing – review and editing. Razelle Kurzrock: conceptualization; funding acquisition; project administration; resources; writing – original draft; writing – review and editing. Author Contributions |
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Most patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a... Ipilimumab plus nivolumab demonstrated modest efficacy with durable responses and manageable toxicity in previously treated patients with advanced gallbladder... Most patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable... IntroductionMost patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a... |
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| SubjectTerms | Adult Aged Aged, 80 and over Anemia Anorexia Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Antitumor activity Aspartate aminotransferase biliary tract cancer Chemotherapy Cholangiocarcinoma CTLA-4 Antigen - antagonists & inhibitors Eating disorders Effectiveness Female Gallbladder Gallbladder cancer Gallbladder Neoplasms - drug therapy Gallbladder Neoplasms - pathology Humans immune checkpoint inhibitor Immune checkpoint inhibitors Immune Checkpoint Inhibitors - administration & dosage Immune Checkpoint Inhibitors - adverse effects Immune Checkpoint Inhibitors - therapeutic use Immunohistochemistry Immunotherapy ipilimumab Ipilimumab - administration & dosage Ipilimumab - adverse effects Ipilimumab - therapeutic use Male Middle Aged Monoclonal antibodies Multiagent systems nivolumab Nivolumab - administration & dosage Nivolumab - adverse effects Nivolumab - therapeutic use Programmed Cell Death 1 Receptor - antagonists & inhibitors Progression-Free Survival Prospective Studies Response rates Sepsis Survival Targeted cancer therapy Toxic diseases Toxicity |
| Title | SWOG 1609 cohort 48: anti–CTLA‐4 and anti–PD‐1 for advanced gallbladder cancer |
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