Efficacy and safety of lenvatinib combined with anti-PD-1 antibodies plus GEMOX chemotherapy as non-first-line systemic therapy in advanced gallbladder cancer
Background Lenvatinib, programmed cell death 1 (PD-1) antibodies, and gemcitabine and oxaliplatin (GEMOX) chemotherapy have shown significant antitumor activity as first-line therapy against biliary tract cancer. This study evaluated their efficacy and safety as non-first-line therapy in advanced ga...
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| Veröffentlicht in: | Cancer Immunology, Immunotherapy : CII Immunotherapy : CII, 2024-10, Vol.73 (12), p.240, Article 240 |
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| creator | Tan, Yang Liu, Kai Zhu, Chengpei Wang, Shanshan Wang, Yunchao Xue, Jingnan Ning, Cong Zhang, Nan Chao, Jiashuo Zhang, Longhao Long, Junyu Yang, Xiaobo Zeng, Daobing Zhao, Lijin Zhao, Haitao |
| description | Background
Lenvatinib, programmed cell death 1 (PD-1) antibodies, and gemcitabine and oxaliplatin (GEMOX) chemotherapy have shown significant antitumor activity as first-line therapy against biliary tract cancer. This study evaluated their efficacy and safety as non-first-line therapy in advanced gallbladder cancer (GBC).
Methods
Patients with advanced GBC who received lenvatinib combined with anti-PD-1 antibodies and GEMOX chemotherapy as a non-first-line therapy were retrospectively analyzed. The primary endpoints were overall survival (OS) and progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR) and safety.
Results
A total of 36 patients with advanced GBC were included in this study. The median follow-up time was 11.53 (95% confidence interval (CI): 2.2–20.9) months, and the ORR was 36.1%. The median OS and PFS were 15.1 (95% CI: 3.2–26.9) and 6.1 (95% CI: 4.9–7.2) months, respectively. The disease control rate (DCR) and clinical benefit rate (CBR) were 75% and 61.1%, respectively. Subgroup analysis demonstrated that patients with programmed cell death-ligand 1 (PD-L1) expression had significantly longer PFS and OS than those without PD-L1 expression. Additionally, patients with a neutrophil–lymphocyte ratio (NLR) |
| doi_str_mv | 10.1007/s00262-024-03831-1 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11447189</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3112286185</sourcerecordid><originalsourceid>FETCH-LOGICAL-c312t-c9c3ecdd7555e8de53010b6a82c3d2e6a33ea0f6106e20e9bbf2b149074de24f3</originalsourceid><addsrcrecordid>eNp9kc9uFDEMxkcIREvhBTigSFy4BPJvZmdOCJVtQSoqB5C4RZnE2U2VSZYks2hfhmdtutuWwoGTLfvnz7a-pnlJyVtKyOJdJoR1DBMmMOE9p5g-ao6p4LXUt_Txg_yoeZbzFSGCkWF42hzxgbe96Phx83tprdNK75AKBmVloexQtMhD2KrighuRjtPoAhj0y5V1xYrDXz9ius_GaBxktPFzRufLL5c_kF7DFMsaktpUzYxCDNi6lAv2VQTlXS4wOY3uEBeQMlsVdF2wUt6PXhkDCembUnrePLHKZ3hxG0-a72fLb6ef8MXl-efTDxdYc8oK1oPmoI1ZtG0LvYGWE0rGTvVMc8OgU5yDIrajpANGYBhHy0YqBrIQBpiw_KR5f9DdzOMERkMoSXm5SW5SaSejcvLvTnBruYpbSakQC9oPVeHNrUKKP2fIRU4ua_BeBYhzlpxS1rJB8K6ir_9Br-KcQv1vT7G-o31bKXagdIo5J7D311Aib_yXB_9l9V_u_Ze0Dr16-Mf9yJ3hFeAHINdWWEH6s_s_stczPb5a</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3112286185</pqid></control><display><type>article</type><title>Efficacy and safety of lenvatinib combined with anti-PD-1 antibodies plus GEMOX chemotherapy as non-first-line systemic therapy in advanced gallbladder cancer</title><source>MEDLINE</source><source>Springer Nature OA Free Journals</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><source>SpringerLink Journals - AutoHoldings</source><creator>Tan, Yang ; Liu, Kai ; Zhu, Chengpei ; Wang, Shanshan ; Wang, Yunchao ; Xue, Jingnan ; Ning, Cong ; Zhang, Nan ; Chao, Jiashuo ; Zhang, Longhao ; Long, Junyu ; Yang, Xiaobo ; Zeng, Daobing ; Zhao, Lijin ; Zhao, Haitao</creator><creatorcontrib>Tan, Yang ; Liu, Kai ; Zhu, Chengpei ; Wang, Shanshan ; Wang, Yunchao ; Xue, Jingnan ; Ning, Cong ; Zhang, Nan ; Chao, Jiashuo ; Zhang, Longhao ; Long, Junyu ; Yang, Xiaobo ; Zeng, Daobing ; Zhao, Lijin ; Zhao, Haitao</creatorcontrib><description>Background
Lenvatinib, programmed cell death 1 (PD-1) antibodies, and gemcitabine and oxaliplatin (GEMOX) chemotherapy have shown significant antitumor activity as first-line therapy against biliary tract cancer. This study evaluated their efficacy and safety as non-first-line therapy in advanced gallbladder cancer (GBC).
Methods
Patients with advanced GBC who received lenvatinib combined with anti-PD-1 antibodies and GEMOX chemotherapy as a non-first-line therapy were retrospectively analyzed. The primary endpoints were overall survival (OS) and progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR) and safety.
Results
A total of 36 patients with advanced GBC were included in this study. The median follow-up time was 11.53 (95% confidence interval (CI): 2.2–20.9) months, and the ORR was 36.1%. The median OS and PFS were 15.1 (95% CI: 3.2–26.9) and 6.1 (95% CI: 4.9–7.2) months, respectively. The disease control rate (DCR) and clinical benefit rate (CBR) were 75% and 61.1%, respectively. Subgroup analysis demonstrated that patients with programmed cell death-ligand 1 (PD-L1) expression had significantly longer PFS and OS than those without PD-L1 expression. Additionally, patients with a neutrophil–lymphocyte ratio (NLR) < 5.57 had a longer OS than those with an NLR ≥ 5.57. All patients experienced adverse events (AEs), with 61.1% experiencing grade 3 or 4 AEs, including myelosuppression (13.9%) and fatigue (13.3%), alanine transaminase or aspartate transaminase levels (8.3%), and diarrhea (8.3%). No grade 5 AEs were reported.
Conclusion
Anti-PD-1 antibodies combined with lenvatinib and GEMOX chemotherapy are effective and well-tolerated as a non-first-line therapy in advanced GBC. PD-L1 expression and baseline NLR may potentially predict treatment efficacy.</description><identifier>ISSN: 1432-0851</identifier><identifier>ISSN: 0340-7004</identifier><identifier>EISSN: 1432-0851</identifier><identifier>DOI: 10.1007/s00262-024-03831-1</identifier><identifier>PMID: 39358463</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject><![CDATA[Adult ; Aged ; Aged, 80 and over ; Alanine transaminase ; Antibodies ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Antitumor activity ; Apoptosis ; Aspartate transaminase ; Biliary tract ; Biliary tract diseases ; Cancer Research ; Cancer therapies ; Cell death ; Chemotherapy ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - therapeutic use ; Diarrhea ; Disease control ; Female ; Gallbladder cancer ; Gallbladder Neoplasms - drug therapy ; Gallbladder Neoplasms - mortality ; Gemcitabine ; Humans ; Immune Checkpoint Inhibitors - administration & dosage ; Immune Checkpoint Inhibitors - adverse effects ; Immune Checkpoint Inhibitors - therapeutic use ; Immunology ; Leukocytes (neutrophilic) ; Lymphocytes ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Myelosuppression ; Oncology ; Organoplatinum Compounds ; Oxaliplatin ; Patients ; PD-1 protein ; PD-L1 protein ; Phenylurea Compounds - administration & dosage ; Phenylurea Compounds - adverse effects ; Phenylurea Compounds - therapeutic use ; Programmed Cell Death 1 Receptor - antagonists & inhibitors ; Quinolines - administration & dosage ; Quinolines - adverse effects ; Quinolines - therapeutic use ; Retrospective Studies]]></subject><ispartof>Cancer Immunology, Immunotherapy : CII, 2024-10, Vol.73 (12), p.240, Article 240</ispartof><rights>The Author(s) 2024</rights><rights>2024. The Author(s).</rights><rights>The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2024 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c312t-c9c3ecdd7555e8de53010b6a82c3d2e6a33ea0f6106e20e9bbf2b149074de24f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11447189/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11447189/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,41120,41488,42189,42557,51319,51576,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39358463$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tan, Yang</creatorcontrib><creatorcontrib>Liu, Kai</creatorcontrib><creatorcontrib>Zhu, Chengpei</creatorcontrib><creatorcontrib>Wang, Shanshan</creatorcontrib><creatorcontrib>Wang, Yunchao</creatorcontrib><creatorcontrib>Xue, Jingnan</creatorcontrib><creatorcontrib>Ning, Cong</creatorcontrib><creatorcontrib>Zhang, Nan</creatorcontrib><creatorcontrib>Chao, Jiashuo</creatorcontrib><creatorcontrib>Zhang, Longhao</creatorcontrib><creatorcontrib>Long, Junyu</creatorcontrib><creatorcontrib>Yang, Xiaobo</creatorcontrib><creatorcontrib>Zeng, Daobing</creatorcontrib><creatorcontrib>Zhao, Lijin</creatorcontrib><creatorcontrib>Zhao, Haitao</creatorcontrib><title>Efficacy and safety of lenvatinib combined with anti-PD-1 antibodies plus GEMOX chemotherapy as non-first-line systemic therapy in advanced gallbladder cancer</title><title>Cancer Immunology, Immunotherapy : CII</title><addtitle>Cancer Immunol Immunother</addtitle><addtitle>Cancer Immunol Immunother</addtitle><description>Background
Lenvatinib, programmed cell death 1 (PD-1) antibodies, and gemcitabine and oxaliplatin (GEMOX) chemotherapy have shown significant antitumor activity as first-line therapy against biliary tract cancer. This study evaluated their efficacy and safety as non-first-line therapy in advanced gallbladder cancer (GBC).
Methods
Patients with advanced GBC who received lenvatinib combined with anti-PD-1 antibodies and GEMOX chemotherapy as a non-first-line therapy were retrospectively analyzed. The primary endpoints were overall survival (OS) and progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR) and safety.
Results
A total of 36 patients with advanced GBC were included in this study. The median follow-up time was 11.53 (95% confidence interval (CI): 2.2–20.9) months, and the ORR was 36.1%. The median OS and PFS were 15.1 (95% CI: 3.2–26.9) and 6.1 (95% CI: 4.9–7.2) months, respectively. The disease control rate (DCR) and clinical benefit rate (CBR) were 75% and 61.1%, respectively. Subgroup analysis demonstrated that patients with programmed cell death-ligand 1 (PD-L1) expression had significantly longer PFS and OS than those without PD-L1 expression. Additionally, patients with a neutrophil–lymphocyte ratio (NLR) < 5.57 had a longer OS than those with an NLR ≥ 5.57. All patients experienced adverse events (AEs), with 61.1% experiencing grade 3 or 4 AEs, including myelosuppression (13.9%) and fatigue (13.3%), alanine transaminase or aspartate transaminase levels (8.3%), and diarrhea (8.3%). No grade 5 AEs were reported.
Conclusion
Anti-PD-1 antibodies combined with lenvatinib and GEMOX chemotherapy are effective and well-tolerated as a non-first-line therapy in advanced GBC. PD-L1 expression and baseline NLR may potentially predict treatment efficacy.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Alanine transaminase</subject><subject>Antibodies</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Antitumor activity</subject><subject>Apoptosis</subject><subject>Aspartate transaminase</subject><subject>Biliary tract</subject><subject>Biliary tract diseases</subject><subject>Cancer Research</subject><subject>Cancer therapies</subject><subject>Cell death</subject><subject>Chemotherapy</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - therapeutic use</subject><subject>Diarrhea</subject><subject>Disease control</subject><subject>Female</subject><subject>Gallbladder cancer</subject><subject>Gallbladder Neoplasms - drug therapy</subject><subject>Gallbladder Neoplasms - mortality</subject><subject>Gemcitabine</subject><subject>Humans</subject><subject>Immune Checkpoint Inhibitors - administration & dosage</subject><subject>Immune Checkpoint Inhibitors - adverse effects</subject><subject>Immune Checkpoint Inhibitors - therapeutic use</subject><subject>Immunology</subject><subject>Leukocytes (neutrophilic)</subject><subject>Lymphocytes</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Myelosuppression</subject><subject>Oncology</subject><subject>Organoplatinum Compounds</subject><subject>Oxaliplatin</subject><subject>Patients</subject><subject>PD-1 protein</subject><subject>PD-L1 protein</subject><subject>Phenylurea Compounds - administration & dosage</subject><subject>Phenylurea Compounds - adverse effects</subject><subject>Phenylurea Compounds - therapeutic use</subject><subject>Programmed Cell Death 1 Receptor - antagonists & inhibitors</subject><subject>Quinolines - administration & dosage</subject><subject>Quinolines - adverse effects</subject><subject>Quinolines - therapeutic use</subject><subject>Retrospective Studies</subject><issn>1432-0851</issn><issn>0340-7004</issn><issn>1432-0851</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><recordid>eNp9kc9uFDEMxkcIREvhBTigSFy4BPJvZmdOCJVtQSoqB5C4RZnE2U2VSZYks2hfhmdtutuWwoGTLfvnz7a-pnlJyVtKyOJdJoR1DBMmMOE9p5g-ao6p4LXUt_Txg_yoeZbzFSGCkWF42hzxgbe96Phx83tprdNK75AKBmVloexQtMhD2KrighuRjtPoAhj0y5V1xYrDXz9ius_GaBxktPFzRufLL5c_kF7DFMsaktpUzYxCDNi6lAv2VQTlXS4wOY3uEBeQMlsVdF2wUt6PXhkDCembUnrePLHKZ3hxG0-a72fLb6ef8MXl-efTDxdYc8oK1oPmoI1ZtG0LvYGWE0rGTvVMc8OgU5yDIrajpANGYBhHy0YqBrIQBpiw_KR5f9DdzOMERkMoSXm5SW5SaSejcvLvTnBruYpbSakQC9oPVeHNrUKKP2fIRU4ua_BeBYhzlpxS1rJB8K6ir_9Br-KcQv1vT7G-o31bKXagdIo5J7D311Aib_yXB_9l9V_u_Ze0Dr16-Mf9yJ3hFeAHINdWWEH6s_s_stczPb5a</recordid><startdate>20241003</startdate><enddate>20241003</enddate><creator>Tan, Yang</creator><creator>Liu, Kai</creator><creator>Zhu, Chengpei</creator><creator>Wang, Shanshan</creator><creator>Wang, Yunchao</creator><creator>Xue, Jingnan</creator><creator>Ning, Cong</creator><creator>Zhang, Nan</creator><creator>Chao, Jiashuo</creator><creator>Zhang, Longhao</creator><creator>Long, Junyu</creator><creator>Yang, Xiaobo</creator><creator>Zeng, Daobing</creator><creator>Zhao, Lijin</creator><creator>Zhao, Haitao</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20241003</creationdate><title>Efficacy and safety of lenvatinib combined with anti-PD-1 antibodies plus GEMOX chemotherapy as non-first-line systemic therapy in advanced gallbladder cancer</title><author>Tan, Yang ; Liu, Kai ; Zhu, Chengpei ; Wang, Shanshan ; Wang, Yunchao ; Xue, Jingnan ; Ning, Cong ; Zhang, Nan ; Chao, Jiashuo ; Zhang, Longhao ; Long, Junyu ; Yang, Xiaobo ; Zeng, Daobing ; Zhao, Lijin ; Zhao, Haitao</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c312t-c9c3ecdd7555e8de53010b6a82c3d2e6a33ea0f6106e20e9bbf2b149074de24f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Alanine transaminase</topic><topic>Antibodies</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Antitumor activity</topic><topic>Apoptosis</topic><topic>Aspartate transaminase</topic><topic>Biliary tract</topic><topic>Biliary tract diseases</topic><topic>Cancer Research</topic><topic>Cancer therapies</topic><topic>Cell death</topic><topic>Chemotherapy</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Deoxycytidine - therapeutic use</topic><topic>Diarrhea</topic><topic>Disease control</topic><topic>Female</topic><topic>Gallbladder cancer</topic><topic>Gallbladder Neoplasms - drug therapy</topic><topic>Gallbladder Neoplasms - mortality</topic><topic>Gemcitabine</topic><topic>Humans</topic><topic>Immune Checkpoint Inhibitors - administration & dosage</topic><topic>Immune Checkpoint Inhibitors - adverse effects</topic><topic>Immune Checkpoint Inhibitors - therapeutic use</topic><topic>Immunology</topic><topic>Leukocytes (neutrophilic)</topic><topic>Lymphocytes</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Myelosuppression</topic><topic>Oncology</topic><topic>Organoplatinum Compounds</topic><topic>Oxaliplatin</topic><topic>Patients</topic><topic>PD-1 protein</topic><topic>PD-L1 protein</topic><topic>Phenylurea Compounds - administration & dosage</topic><topic>Phenylurea Compounds - adverse effects</topic><topic>Phenylurea Compounds - therapeutic use</topic><topic>Programmed Cell Death 1 Receptor - antagonists & inhibitors</topic><topic>Quinolines - administration & dosage</topic><topic>Quinolines - adverse effects</topic><topic>Quinolines - therapeutic use</topic><topic>Retrospective Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tan, Yang</creatorcontrib><creatorcontrib>Liu, Kai</creatorcontrib><creatorcontrib>Zhu, Chengpei</creatorcontrib><creatorcontrib>Wang, Shanshan</creatorcontrib><creatorcontrib>Wang, Yunchao</creatorcontrib><creatorcontrib>Xue, Jingnan</creatorcontrib><creatorcontrib>Ning, Cong</creatorcontrib><creatorcontrib>Zhang, Nan</creatorcontrib><creatorcontrib>Chao, Jiashuo</creatorcontrib><creatorcontrib>Zhang, Longhao</creatorcontrib><creatorcontrib>Long, Junyu</creatorcontrib><creatorcontrib>Yang, Xiaobo</creatorcontrib><creatorcontrib>Zeng, Daobing</creatorcontrib><creatorcontrib>Zhao, Lijin</creatorcontrib><creatorcontrib>Zhao, Haitao</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancer Immunology, Immunotherapy : CII</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tan, Yang</au><au>Liu, Kai</au><au>Zhu, Chengpei</au><au>Wang, Shanshan</au><au>Wang, Yunchao</au><au>Xue, Jingnan</au><au>Ning, Cong</au><au>Zhang, Nan</au><au>Chao, Jiashuo</au><au>Zhang, Longhao</au><au>Long, Junyu</au><au>Yang, Xiaobo</au><au>Zeng, Daobing</au><au>Zhao, Lijin</au><au>Zhao, Haitao</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of lenvatinib combined with anti-PD-1 antibodies plus GEMOX chemotherapy as non-first-line systemic therapy in advanced gallbladder cancer</atitle><jtitle>Cancer Immunology, Immunotherapy : CII</jtitle><stitle>Cancer Immunol Immunother</stitle><addtitle>Cancer Immunol Immunother</addtitle><date>2024-10-03</date><risdate>2024</risdate><volume>73</volume><issue>12</issue><spage>240</spage><pages>240-</pages><artnum>240</artnum><issn>1432-0851</issn><issn>0340-7004</issn><eissn>1432-0851</eissn><abstract>Background
Lenvatinib, programmed cell death 1 (PD-1) antibodies, and gemcitabine and oxaliplatin (GEMOX) chemotherapy have shown significant antitumor activity as first-line therapy against biliary tract cancer. This study evaluated their efficacy and safety as non-first-line therapy in advanced gallbladder cancer (GBC).
Methods
Patients with advanced GBC who received lenvatinib combined with anti-PD-1 antibodies and GEMOX chemotherapy as a non-first-line therapy were retrospectively analyzed. The primary endpoints were overall survival (OS) and progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR) and safety.
Results
A total of 36 patients with advanced GBC were included in this study. The median follow-up time was 11.53 (95% confidence interval (CI): 2.2–20.9) months, and the ORR was 36.1%. The median OS and PFS were 15.1 (95% CI: 3.2–26.9) and 6.1 (95% CI: 4.9–7.2) months, respectively. The disease control rate (DCR) and clinical benefit rate (CBR) were 75% and 61.1%, respectively. Subgroup analysis demonstrated that patients with programmed cell death-ligand 1 (PD-L1) expression had significantly longer PFS and OS than those without PD-L1 expression. Additionally, patients with a neutrophil–lymphocyte ratio (NLR) < 5.57 had a longer OS than those with an NLR ≥ 5.57. All patients experienced adverse events (AEs), with 61.1% experiencing grade 3 or 4 AEs, including myelosuppression (13.9%) and fatigue (13.3%), alanine transaminase or aspartate transaminase levels (8.3%), and diarrhea (8.3%). No grade 5 AEs were reported.
Conclusion
Anti-PD-1 antibodies combined with lenvatinib and GEMOX chemotherapy are effective and well-tolerated as a non-first-line therapy in advanced GBC. PD-L1 expression and baseline NLR may potentially predict treatment efficacy.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>39358463</pmid><doi>10.1007/s00262-024-03831-1</doi><oa>free_for_read</oa></addata></record> |
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| ispartof | Cancer Immunology, Immunotherapy : CII, 2024-10, Vol.73 (12), p.240, Article 240 |
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| language | eng |
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| source | MEDLINE; Springer Nature OA Free Journals; PubMed Central; Alma/SFX Local Collection; SpringerLink Journals - AutoHoldings |
| subjects | Adult Aged Aged, 80 and over Alanine transaminase Antibodies Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Antitumor activity Apoptosis Aspartate transaminase Biliary tract Biliary tract diseases Cancer Research Cancer therapies Cell death Chemotherapy Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Diarrhea Disease control Female Gallbladder cancer Gallbladder Neoplasms - drug therapy Gallbladder Neoplasms - mortality Gemcitabine Humans Immune Checkpoint Inhibitors - administration & dosage Immune Checkpoint Inhibitors - adverse effects Immune Checkpoint Inhibitors - therapeutic use Immunology Leukocytes (neutrophilic) Lymphocytes Male Medicine Medicine & Public Health Middle Aged Myelosuppression Oncology Organoplatinum Compounds Oxaliplatin Patients PD-1 protein PD-L1 protein Phenylurea Compounds - administration & dosage Phenylurea Compounds - adverse effects Phenylurea Compounds - therapeutic use Programmed Cell Death 1 Receptor - antagonists & inhibitors Quinolines - administration & dosage Quinolines - adverse effects Quinolines - therapeutic use Retrospective Studies |
| title | Efficacy and safety of lenvatinib combined with anti-PD-1 antibodies plus GEMOX chemotherapy as non-first-line systemic therapy in advanced gallbladder cancer |
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