Phase II Trial of Adjuvant Atezolizumab Therapy in Elderly Patients with Completely Resected Stage II/III Non-Small Cell Lung Cancer: RELIANCE Trial
Atezolizumab following platinum chemotherapy and complete pulmonary resection has become the new standard of adjuvant care for patients with stage II-III non-small cell lung cancer (NSCLC) expressing programmed death-ligand 1 (PD-L1). However, the efficacy and safety of postoperative adjuvant therap...
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| Veröffentlicht in: | Clinical lung cancer 2024-05, Vol.25 (3), p.280-283 |
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| creator | Matsubara, Taichi Yamaguchi, Masafumi Shimokawa, Mototsugu Okamoto, Isamu |
| description | Atezolizumab following platinum chemotherapy and complete pulmonary resection has become the new standard of adjuvant care for patients with stage II-III non-small cell lung cancer (NSCLC) expressing programmed death-ligand 1 (PD-L1). However, the efficacy and safety of postoperative adjuvant therapy and subsequent atezolizumab in patients aged 75 and older have not been established.
Patients with completely resected stage II–III NSCLC aged 75 and older will be prospectively registered in this single-arm phase II study. The enrolled patients will receive cisplatin plus vinorelbine (CDDP + VNR) followed by atezolizumab for up to 12 months. PD-L1 expression in at least 1% of cells will be confirmed by immunohistochemical staining. We plan to enroll 33 patients over 1 year at 25 institutions in Japan. The primary endpoint is the completion rate of adjuvant treatment (CDDP + VNR initiation to atezolizumab completion).
The present study represents the first prospective trial of the tolerability of postoperative adjuvant therapy with immune checkpoint inhibitors in elderly individuals. The results of this trial might help promote postoperative adjuvant immunotherapy in the future for the elderly. |
| doi_str_mv | 10.1016/j.cllc.2024.01.009 |
| format | Article |
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Patients with completely resected stage II–III NSCLC aged 75 and older will be prospectively registered in this single-arm phase II study. The enrolled patients will receive cisplatin plus vinorelbine (CDDP + VNR) followed by atezolizumab for up to 12 months. PD-L1 expression in at least 1% of cells will be confirmed by immunohistochemical staining. We plan to enroll 33 patients over 1 year at 25 institutions in Japan. The primary endpoint is the completion rate of adjuvant treatment (CDDP + VNR initiation to atezolizumab completion).
The present study represents the first prospective trial of the tolerability of postoperative adjuvant therapy with immune checkpoint inhibitors in elderly individuals. The results of this trial might help promote postoperative adjuvant immunotherapy in the future for the elderly.</description><identifier>ISSN: 1525-7304</identifier><identifier>EISSN: 1938-0690</identifier><identifier>DOI: 10.1016/j.cllc.2024.01.009</identifier><identifier>PMID: 38368174</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adjuvant therapy ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized - administration & dosage ; Antibodies, Monoclonal, Humanized - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - pathology ; Carcinoma, Non-Small-Cell Lung - surgery ; Chemotherapy, Adjuvant - methods ; Cisplatin - administration & dosage ; Cisplatin - therapeutic use ; Female ; Humans ; Immunotherapy ; Lung Neoplasms - drug therapy ; Lung Neoplasms - pathology ; Lung Neoplasms - surgery ; Male ; Neoplasm Staging ; NSCLC ; Older patients ; Pneumonectomy ; Prospective Studies ; Vinorelbine - administration & dosage ; Vinorelbine - therapeutic use</subject><ispartof>Clinical lung cancer, 2024-05, Vol.25 (3), p.280-283</ispartof><rights>2024</rights><rights>Copyright © 2024. Published by Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c307t-c47a78164010b062e4f531e8e4143ff355508d620c72a8ac7afc7c879aabb58b3</cites><orcidid>0000-0001-8140-4565 ; 0000-0002-5601-4749</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38368174$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Matsubara, Taichi</creatorcontrib><creatorcontrib>Yamaguchi, Masafumi</creatorcontrib><creatorcontrib>Shimokawa, Mototsugu</creatorcontrib><creatorcontrib>Okamoto, Isamu</creatorcontrib><title>Phase II Trial of Adjuvant Atezolizumab Therapy in Elderly Patients with Completely Resected Stage II/III Non-Small Cell Lung Cancer: RELIANCE Trial</title><title>Clinical lung cancer</title><addtitle>Clin Lung Cancer</addtitle><description>Atezolizumab following platinum chemotherapy and complete pulmonary resection has become the new standard of adjuvant care for patients with stage II-III non-small cell lung cancer (NSCLC) expressing programmed death-ligand 1 (PD-L1). However, the efficacy and safety of postoperative adjuvant therapy and subsequent atezolizumab in patients aged 75 and older have not been established.
Patients with completely resected stage II–III NSCLC aged 75 and older will be prospectively registered in this single-arm phase II study. The enrolled patients will receive cisplatin plus vinorelbine (CDDP + VNR) followed by atezolizumab for up to 12 months. PD-L1 expression in at least 1% of cells will be confirmed by immunohistochemical staining. We plan to enroll 33 patients over 1 year at 25 institutions in Japan. The primary endpoint is the completion rate of adjuvant treatment (CDDP + VNR initiation to atezolizumab completion).
The present study represents the first prospective trial of the tolerability of postoperative adjuvant therapy with immune checkpoint inhibitors in elderly individuals. The results of this trial might help promote postoperative adjuvant immunotherapy in the future for the elderly.</description><subject>Adjuvant therapy</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal, Humanized - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Carcinoma, Non-Small-Cell Lung - surgery</subject><subject>Chemotherapy, Adjuvant - methods</subject><subject>Cisplatin - administration & dosage</subject><subject>Cisplatin - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - pathology</subject><subject>Lung Neoplasms - surgery</subject><subject>Male</subject><subject>Neoplasm Staging</subject><subject>NSCLC</subject><subject>Older patients</subject><subject>Pneumonectomy</subject><subject>Prospective Studies</subject><subject>Vinorelbine - administration & dosage</subject><subject>Vinorelbine - therapeutic use</subject><issn>1525-7304</issn><issn>1938-0690</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UU1v1DAQtRCIlsIf4IB85JLUX0kcxGUVLRBpVap2OVuOM-l65SSL7RRtfwc_GK-2cOQyM9K8eTPzHkLvKckpoeX1PjfOmZwRJnJCc0LqF-iS1lxmpKzJy1QXrMgqTsQFehPCnhBWcspeowsueSlpJS7R79udDoDbFm-91Q7PA171--VRTxGvIjzNzj4to-7wdgdeH47YTnjtevDuiG91tDDFgH_ZuMPNPB4cREiNOwhgIvT4PuqHE_l1mxbczFN2P2rncAMpbJbpATd6MuA_4bv1pl3dNOvzFW_Rq0G7AO-e8xX68WW9bb5lm-9f22a1yQwnVcyMqHQlaSkIJR0pGYih4BQkCCr4MPCiKIjsS0ZMxbTUptKDqYysaq27rpAdv0Ifz7wHP_9cIEQ12mDScXqCeQmK1UwywblgCcrOUOPnEDwM6uDtqP1RUaJObqi9OrmhTm4oQlVyIw19eOZfuhH6fyN_5U-Az2cApC8fLXgVTJLUQG99UlD1s_0f_x8ZSJoz</recordid><startdate>202405</startdate><enddate>202405</enddate><creator>Matsubara, Taichi</creator><creator>Yamaguchi, Masafumi</creator><creator>Shimokawa, Mototsugu</creator><creator>Okamoto, Isamu</creator><general>Elsevier Inc</general><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>7X8</scope><orcidid>https://orcid.org/0000-0001-8140-4565</orcidid><orcidid>https://orcid.org/0000-0002-5601-4749</orcidid></search><sort><creationdate>202405</creationdate><title>Phase II Trial of Adjuvant Atezolizumab Therapy in Elderly Patients with Completely Resected Stage II/III Non-Small Cell Lung Cancer: RELIANCE Trial</title><author>Matsubara, Taichi ; Yamaguchi, Masafumi ; Shimokawa, Mototsugu ; Okamoto, Isamu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c307t-c47a78164010b062e4f531e8e4143ff355508d620c72a8ac7afc7c879aabb58b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adjuvant therapy</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal, Humanized - administration & dosage</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Carcinoma, Non-Small-Cell Lung - surgery</topic><topic>Chemotherapy, Adjuvant - methods</topic><topic>Cisplatin - administration & dosage</topic><topic>Cisplatin - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Immunotherapy</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - pathology</topic><topic>Lung Neoplasms - surgery</topic><topic>Male</topic><topic>Neoplasm Staging</topic><topic>NSCLC</topic><topic>Older patients</topic><topic>Pneumonectomy</topic><topic>Prospective Studies</topic><topic>Vinorelbine - administration & dosage</topic><topic>Vinorelbine - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Matsubara, Taichi</creatorcontrib><creatorcontrib>Yamaguchi, Masafumi</creatorcontrib><creatorcontrib>Shimokawa, Mototsugu</creatorcontrib><creatorcontrib>Okamoto, Isamu</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical lung cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Matsubara, Taichi</au><au>Yamaguchi, Masafumi</au><au>Shimokawa, Mototsugu</au><au>Okamoto, Isamu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II Trial of Adjuvant Atezolizumab Therapy in Elderly Patients with Completely Resected Stage II/III Non-Small Cell Lung Cancer: RELIANCE Trial</atitle><jtitle>Clinical lung cancer</jtitle><addtitle>Clin Lung Cancer</addtitle><date>2024-05</date><risdate>2024</risdate><volume>25</volume><issue>3</issue><spage>280</spage><epage>283</epage><pages>280-283</pages><issn>1525-7304</issn><eissn>1938-0690</eissn><abstract>Atezolizumab following platinum chemotherapy and complete pulmonary resection has become the new standard of adjuvant care for patients with stage II-III non-small cell lung cancer (NSCLC) expressing programmed death-ligand 1 (PD-L1). However, the efficacy and safety of postoperative adjuvant therapy and subsequent atezolizumab in patients aged 75 and older have not been established.
Patients with completely resected stage II–III NSCLC aged 75 and older will be prospectively registered in this single-arm phase II study. The enrolled patients will receive cisplatin plus vinorelbine (CDDP + VNR) followed by atezolizumab for up to 12 months. PD-L1 expression in at least 1% of cells will be confirmed by immunohistochemical staining. We plan to enroll 33 patients over 1 year at 25 institutions in Japan. The primary endpoint is the completion rate of adjuvant treatment (CDDP + VNR initiation to atezolizumab completion).
The present study represents the first prospective trial of the tolerability of postoperative adjuvant therapy with immune checkpoint inhibitors in elderly individuals. The results of this trial might help promote postoperative adjuvant immunotherapy in the future for the elderly.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>38368174</pmid><doi>10.1016/j.cllc.2024.01.009</doi><tpages>4</tpages><orcidid>https://orcid.org/0000-0001-8140-4565</orcidid><orcidid>https://orcid.org/0000-0002-5601-4749</orcidid></addata></record> |
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| subjects | Adjuvant therapy Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - pathology Carcinoma, Non-Small-Cell Lung - surgery Chemotherapy, Adjuvant - methods Cisplatin - administration & dosage Cisplatin - therapeutic use Female Humans Immunotherapy Lung Neoplasms - drug therapy Lung Neoplasms - pathology Lung Neoplasms - surgery Male Neoplasm Staging NSCLC Older patients Pneumonectomy Prospective Studies Vinorelbine - administration & dosage Vinorelbine - therapeutic use |
| title | Phase II Trial of Adjuvant Atezolizumab Therapy in Elderly Patients with Completely Resected Stage II/III Non-Small Cell Lung Cancer: RELIANCE Trial |
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