Durvalumab for patients with unresectable stage III non-small cell lung cancer and grade 1 radiation pneumonitis following concurrent chemoradiotherapy: a multicenter prospective cohort study
Summary Introduction/Background Durvalumab demonstrated a good efficacy and safety in patients with unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy (CCRT) in the PACIFIC trial. Although a history of radiation pneumonitis (RP) has been reported to increase...
Gespeichert in:
| Veröffentlicht in: | Investigational new drugs 2021-06, Vol.39 (3), p.853-859 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 859 |
|---|---|
| container_issue | 3 |
| container_start_page | 853 |
| container_title | Investigational new drugs |
| container_volume | 39 |
| creator | Sugimoto, Takeya Fujimoto, Daichi Sato, Yuki Tamiya, Motohiro Yokoi, Takashi Tamiya, Akihiro Iwasawa, Shunichiro Hata, Akito Uchida, Junji Fukuda, Yasushi Hara, Satoshi Kanazu, Masaki Hirano, Katsuya Kokubo, Masaki Yamamoto, Nobuyuki |
| description | Summary
Introduction/Background
Durvalumab demonstrated a good efficacy and safety in patients with unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy (CCRT) in the PACIFIC trial. Although a history of radiation pneumonitis (RP) has been reported to increase the risk of pneumonitis associated with programmed death-1 inhibitors, the safety and efficacy of durvalumab in patients with baseline Grade 1 RP have not been assessed. Therefore, we carried out a multicenter prospective cohort study to evaluate the efficacy and safety of durvalumab in these patients.
Patients and Methods
This was a multicenter prospective cohort study of 35 patients with Grade 1 RP after CCRT and before durvalumab initiation. This study was a first prespecified analysis for the first 20 patients with the primary objective of assessing the short-term safety; it was assessed 3 months after durvalumab initiation.
Results
Twenty patients were enrolled in this study between March 1, 2019, and September 3, 2019. Three patients (15%) experienced drug-related Grade ≥3 adverse events, while three patients (15%) had Grade ≥2 pneumonitis/RP within 3 months after durvalumab initiation. Three months after durvalumab initiation, all the patients were alive and four patients (20%) experienced disease progression.
Conclusion
Durvalumab can be a feasible treatment option for patients with stage III NSCLC with baseline Grade 1 RP following CCRT.
(Trial registration number: UMIN000036061. The registration period was between March 2019 and December 2019.) |
| doi_str_mv | 10.1007/s10637-020-01060-8 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_webof</sourceid><recordid>TN_cdi_proquest_journals_2517673871</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2517673871</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-63ebb142f7d2da25264dabf4b8e8af8e9661fb834595da5dbcbcbfac022aa283</originalsourceid><addsrcrecordid>eNqNkc1u1DAUhSMEokPhBVggSyxRwI5jO2GHBigjVWLTfWQ7NzOpEjv4p6N5Ol6td5pSdghFsi35O-ce5xTFW0Y_MkrVp8io5KqkFS0pHmnZPCs2TCheUlnL58WGMqlK2bbqongV4y2llLeqfllccF5TQZt2U_z-msOdnvKsDRl8IItOI7gUyXFMB5JdgAg2aTMBiUnvgex2O-K8K-Osp4lYwGXKbk-sdhYC0a4n-6B7IIzgNqKdd2RxkGfvxjRGnDJN_jieJd7ZHAKOI_YAsz_zPh0g6OX0mWgy5ymNFq_Rdwk-LphkvAPUHXxImCf3p9fFi0FPEd487pfFzfdvN9sf5fXPq932y3VpuRKplByMYXU1qL7qdSUqWffaDLVpoNFDA62UbDANr0Urei16Y_EbtKVVpXXV8Mvi_WqLOX5liKm79Tk4nNhVgimpeKMYUtVKWUwbAwzdEsZZh1PHaHeurFsr67Cy7qGy7mz97tE6mxn6J8mfjhBoVuAIxg_RYj8WnjAsVVIhGq7wRMV2TA-_fOuzSyj98P9SpPlKRyTcHsLfR_4j_z2kv8jr</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2517673871</pqid></control><display><type>article</type><title>Durvalumab for patients with unresectable stage III non-small cell lung cancer and grade 1 radiation pneumonitis following concurrent chemoradiotherapy: a multicenter prospective cohort study</title><source>MEDLINE</source><source>SpringerNature Journals</source><source>Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /></source><creator>Sugimoto, Takeya ; Fujimoto, Daichi ; Sato, Yuki ; Tamiya, Motohiro ; Yokoi, Takashi ; Tamiya, Akihiro ; Iwasawa, Shunichiro ; Hata, Akito ; Uchida, Junji ; Fukuda, Yasushi ; Hara, Satoshi ; Kanazu, Masaki ; Hirano, Katsuya ; Kokubo, Masaki ; Yamamoto, Nobuyuki</creator><creatorcontrib>Sugimoto, Takeya ; Fujimoto, Daichi ; Sato, Yuki ; Tamiya, Motohiro ; Yokoi, Takashi ; Tamiya, Akihiro ; Iwasawa, Shunichiro ; Hata, Akito ; Uchida, Junji ; Fukuda, Yasushi ; Hara, Satoshi ; Kanazu, Masaki ; Hirano, Katsuya ; Kokubo, Masaki ; Yamamoto, Nobuyuki</creatorcontrib><description>Summary
Introduction/Background
Durvalumab demonstrated a good efficacy and safety in patients with unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy (CCRT) in the PACIFIC trial. Although a history of radiation pneumonitis (RP) has been reported to increase the risk of pneumonitis associated with programmed death-1 inhibitors, the safety and efficacy of durvalumab in patients with baseline Grade 1 RP have not been assessed. Therefore, we carried out a multicenter prospective cohort study to evaluate the efficacy and safety of durvalumab in these patients.
Patients and Methods
This was a multicenter prospective cohort study of 35 patients with Grade 1 RP after CCRT and before durvalumab initiation. This study was a first prespecified analysis for the first 20 patients with the primary objective of assessing the short-term safety; it was assessed 3 months after durvalumab initiation.
Results
Twenty patients were enrolled in this study between March 1, 2019, and September 3, 2019. Three patients (15%) experienced drug-related Grade ≥3 adverse events, while three patients (15%) had Grade ≥2 pneumonitis/RP within 3 months after durvalumab initiation. Three months after durvalumab initiation, all the patients were alive and four patients (20%) experienced disease progression.
Conclusion
Durvalumab can be a feasible treatment option for patients with stage III NSCLC with baseline Grade 1 RP following CCRT.
(Trial registration number: UMIN000036061. The registration period was between March 2019 and December 2019.)</description><identifier>ISSN: 0167-6997</identifier><identifier>EISSN: 1573-0646</identifier><identifier>DOI: 10.1007/s10637-020-01060-8</identifier><identifier>PMID: 33405089</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adverse events ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Apoptosis ; B7-H1 Antigen - antagonists & inhibitors ; B7-H1 Antigen - immunology ; Carcinoma, Non-Small-Cell Lung - immunology ; Carcinoma, Non-Small-Cell Lung - pathology ; Carcinoma, Non-Small-Cell Lung - therapy ; Chemoradiotherapy ; Chemoradiotherapy - adverse effects ; Chemotherapy ; Cohort analysis ; Female ; Humans ; Immune Checkpoint Inhibitors - adverse effects ; Immune Checkpoint Inhibitors - therapeutic use ; Immunotherapy ; Life Sciences & Biomedicine ; Lung cancer ; Lung Neoplasms - immunology ; Lung Neoplasms - pathology ; Lung Neoplasms - therapy ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Monoclonal antibodies ; Neoplasm Staging ; Non-small cell lung carcinoma ; Oncology ; PD-1 protein ; Pharmacology & Pharmacy ; Pharmacology/Toxicology ; Phase III Studies ; Pneumonitis ; Radiation ; Radiation Pneumonitis - drug therapy ; Radiation Pneumonitis - etiology ; Radiation Pneumonitis - immunology ; Radiation therapy ; Safety ; Science & Technology ; Small cell lung carcinoma ; Targeted cancer therapy</subject><ispartof>Investigational new drugs, 2021-06, Vol.39 (3), p.853-859</ispartof><rights>The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature 2021</rights><rights>The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature 2021.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>3</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000605583700005</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c375t-63ebb142f7d2da25264dabf4b8e8af8e9661fb834595da5dbcbcbfac022aa283</citedby><cites>FETCH-LOGICAL-c375t-63ebb142f7d2da25264dabf4b8e8af8e9661fb834595da5dbcbcbfac022aa283</cites><orcidid>0000-0003-0615-3000</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10637-020-01060-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10637-020-01060-8$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,781,785,27928,27929,39262,41492,42561,51323</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33405089$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sugimoto, Takeya</creatorcontrib><creatorcontrib>Fujimoto, Daichi</creatorcontrib><creatorcontrib>Sato, Yuki</creatorcontrib><creatorcontrib>Tamiya, Motohiro</creatorcontrib><creatorcontrib>Yokoi, Takashi</creatorcontrib><creatorcontrib>Tamiya, Akihiro</creatorcontrib><creatorcontrib>Iwasawa, Shunichiro</creatorcontrib><creatorcontrib>Hata, Akito</creatorcontrib><creatorcontrib>Uchida, Junji</creatorcontrib><creatorcontrib>Fukuda, Yasushi</creatorcontrib><creatorcontrib>Hara, Satoshi</creatorcontrib><creatorcontrib>Kanazu, Masaki</creatorcontrib><creatorcontrib>Hirano, Katsuya</creatorcontrib><creatorcontrib>Kokubo, Masaki</creatorcontrib><creatorcontrib>Yamamoto, Nobuyuki</creatorcontrib><title>Durvalumab for patients with unresectable stage III non-small cell lung cancer and grade 1 radiation pneumonitis following concurrent chemoradiotherapy: a multicenter prospective cohort study</title><title>Investigational new drugs</title><addtitle>Invest New Drugs</addtitle><addtitle>INVEST NEW DRUG</addtitle><addtitle>Invest New Drugs</addtitle><description>Summary
Introduction/Background
Durvalumab demonstrated a good efficacy and safety in patients with unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy (CCRT) in the PACIFIC trial. Although a history of radiation pneumonitis (RP) has been reported to increase the risk of pneumonitis associated with programmed death-1 inhibitors, the safety and efficacy of durvalumab in patients with baseline Grade 1 RP have not been assessed. Therefore, we carried out a multicenter prospective cohort study to evaluate the efficacy and safety of durvalumab in these patients.
Patients and Methods
This was a multicenter prospective cohort study of 35 patients with Grade 1 RP after CCRT and before durvalumab initiation. This study was a first prespecified analysis for the first 20 patients with the primary objective of assessing the short-term safety; it was assessed 3 months after durvalumab initiation.
Results
Twenty patients were enrolled in this study between March 1, 2019, and September 3, 2019. Three patients (15%) experienced drug-related Grade ≥3 adverse events, while three patients (15%) had Grade ≥2 pneumonitis/RP within 3 months after durvalumab initiation. Three months after durvalumab initiation, all the patients were alive and four patients (20%) experienced disease progression.
Conclusion
Durvalumab can be a feasible treatment option for patients with stage III NSCLC with baseline Grade 1 RP following CCRT.
(Trial registration number: UMIN000036061. The registration period was between March 2019 and December 2019.)</description><subject>Adverse events</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Apoptosis</subject><subject>B7-H1 Antigen - antagonists & inhibitors</subject><subject>B7-H1 Antigen - immunology</subject><subject>Carcinoma, Non-Small-Cell Lung - immunology</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Carcinoma, Non-Small-Cell Lung - therapy</subject><subject>Chemoradiotherapy</subject><subject>Chemoradiotherapy - adverse effects</subject><subject>Chemotherapy</subject><subject>Cohort analysis</subject><subject>Female</subject><subject>Humans</subject><subject>Immune Checkpoint Inhibitors - adverse effects</subject><subject>Immune Checkpoint Inhibitors - therapeutic use</subject><subject>Immunotherapy</subject><subject>Life Sciences & Biomedicine</subject><subject>Lung cancer</subject><subject>Lung Neoplasms - immunology</subject><subject>Lung Neoplasms - pathology</subject><subject>Lung Neoplasms - therapy</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Neoplasm Staging</subject><subject>Non-small cell lung carcinoma</subject><subject>Oncology</subject><subject>PD-1 protein</subject><subject>Pharmacology & Pharmacy</subject><subject>Pharmacology/Toxicology</subject><subject>Phase III Studies</subject><subject>Pneumonitis</subject><subject>Radiation</subject><subject>Radiation Pneumonitis - drug therapy</subject><subject>Radiation Pneumonitis - etiology</subject><subject>Radiation Pneumonitis - immunology</subject><subject>Radiation therapy</subject><subject>Safety</subject><subject>Science & Technology</subject><subject>Small cell lung carcinoma</subject><subject>Targeted cancer therapy</subject><issn>0167-6997</issn><issn>1573-0646</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>HGBXW</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNqNkc1u1DAUhSMEokPhBVggSyxRwI5jO2GHBigjVWLTfWQ7NzOpEjv4p6N5Ol6td5pSdghFsi35O-ce5xTFW0Y_MkrVp8io5KqkFS0pHmnZPCs2TCheUlnL58WGMqlK2bbqongV4y2llLeqfllccF5TQZt2U_z-msOdnvKsDRl8IItOI7gUyXFMB5JdgAg2aTMBiUnvgex2O-K8K-Osp4lYwGXKbk-sdhYC0a4n-6B7IIzgNqKdd2RxkGfvxjRGnDJN_jieJd7ZHAKOI_YAsz_zPh0g6OX0mWgy5ymNFq_Rdwk-LphkvAPUHXxImCf3p9fFi0FPEd487pfFzfdvN9sf5fXPq932y3VpuRKplByMYXU1qL7qdSUqWffaDLVpoNFDA62UbDANr0Urei16Y_EbtKVVpXXV8Mvi_WqLOX5liKm79Tk4nNhVgimpeKMYUtVKWUwbAwzdEsZZh1PHaHeurFsr67Cy7qGy7mz97tE6mxn6J8mfjhBoVuAIxg_RYj8WnjAsVVIhGq7wRMV2TA-_fOuzSyj98P9SpPlKRyTcHsLfR_4j_z2kv8jr</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>Sugimoto, Takeya</creator><creator>Fujimoto, Daichi</creator><creator>Sato, Yuki</creator><creator>Tamiya, Motohiro</creator><creator>Yokoi, Takashi</creator><creator>Tamiya, Akihiro</creator><creator>Iwasawa, Shunichiro</creator><creator>Hata, Akito</creator><creator>Uchida, Junji</creator><creator>Fukuda, Yasushi</creator><creator>Hara, Satoshi</creator><creator>Kanazu, Masaki</creator><creator>Hirano, Katsuya</creator><creator>Kokubo, Masaki</creator><creator>Yamamoto, Nobuyuki</creator><general>Springer US</general><general>Springer Nature</general><general>Springer Nature B.V</general><scope>BLEPL</scope><scope>DTL</scope><scope>HGBXW</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>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7WY</scope><scope>7WZ</scope><scope>7X7</scope><scope>7XB</scope><scope>87Z</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>F~G</scope><scope>GHDGH</scope><scope>K60</scope><scope>K6~</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>L.-</scope><scope>M0C</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><orcidid>https://orcid.org/0000-0003-0615-3000</orcidid></search><sort><creationdate>20210601</creationdate><title>Durvalumab for patients with unresectable stage III non-small cell lung cancer and grade 1 radiation pneumonitis following concurrent chemoradiotherapy: a multicenter prospective cohort study</title><author>Sugimoto, Takeya ; Fujimoto, Daichi ; Sato, Yuki ; Tamiya, Motohiro ; Yokoi, Takashi ; Tamiya, Akihiro ; Iwasawa, Shunichiro ; Hata, Akito ; Uchida, Junji ; Fukuda, Yasushi ; Hara, Satoshi ; Kanazu, Masaki ; Hirano, Katsuya ; Kokubo, Masaki ; Yamamoto, Nobuyuki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-63ebb142f7d2da25264dabf4b8e8af8e9661fb834595da5dbcbcbfac022aa283</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Apoptosis</topic><topic>B7-H1 Antigen - antagonists & inhibitors</topic><topic>B7-H1 Antigen - immunology</topic><topic>Carcinoma, Non-Small-Cell Lung - immunology</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Carcinoma, Non-Small-Cell Lung - therapy</topic><topic>Chemoradiotherapy</topic><topic>Chemoradiotherapy - adverse effects</topic><topic>Chemotherapy</topic><topic>Cohort analysis</topic><topic>Female</topic><topic>Humans</topic><topic>Immune Checkpoint Inhibitors - adverse effects</topic><topic>Immune Checkpoint Inhibitors - therapeutic use</topic><topic>Immunotherapy</topic><topic>Life Sciences & Biomedicine</topic><topic>Lung cancer</topic><topic>Lung Neoplasms - immunology</topic><topic>Lung Neoplasms - pathology</topic><topic>Lung Neoplasms - therapy</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Monoclonal antibodies</topic><topic>Neoplasm Staging</topic><topic>Non-small cell lung carcinoma</topic><topic>Oncology</topic><topic>PD-1 protein</topic><topic>Pharmacology & Pharmacy</topic><topic>Pharmacology/Toxicology</topic><topic>Phase III Studies</topic><topic>Pneumonitis</topic><topic>Radiation</topic><topic>Radiation Pneumonitis - drug therapy</topic><topic>Radiation Pneumonitis - etiology</topic><topic>Radiation Pneumonitis - immunology</topic><topic>Radiation therapy</topic><topic>Safety</topic><topic>Science & Technology</topic><topic>Small cell lung carcinoma</topic><topic>Targeted cancer therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sugimoto, Takeya</creatorcontrib><creatorcontrib>Fujimoto, Daichi</creatorcontrib><creatorcontrib>Sato, Yuki</creatorcontrib><creatorcontrib>Tamiya, Motohiro</creatorcontrib><creatorcontrib>Yokoi, Takashi</creatorcontrib><creatorcontrib>Tamiya, Akihiro</creatorcontrib><creatorcontrib>Iwasawa, Shunichiro</creatorcontrib><creatorcontrib>Hata, Akito</creatorcontrib><creatorcontrib>Uchida, Junji</creatorcontrib><creatorcontrib>Fukuda, Yasushi</creatorcontrib><creatorcontrib>Hara, Satoshi</creatorcontrib><creatorcontrib>Kanazu, Masaki</creatorcontrib><creatorcontrib>Hirano, Katsuya</creatorcontrib><creatorcontrib>Kokubo, Masaki</creatorcontrib><creatorcontrib>Yamamoto, Nobuyuki</creatorcontrib><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Access via ABI/INFORM (ProQuest)</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Global (Alumni Edition)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Business Premium Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Business Premium Collection (Alumni)</collection><collection>Health Research Premium Collection</collection><collection>ABI/INFORM Global (Corporate)</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Business Collection (Alumni Edition)</collection><collection>ProQuest Business Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ABI/INFORM Professional Advanced</collection><collection>ABI/INFORM Global</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Business</collection><collection>ProQuest One Business (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><jtitle>Investigational new drugs</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sugimoto, Takeya</au><au>Fujimoto, Daichi</au><au>Sato, Yuki</au><au>Tamiya, Motohiro</au><au>Yokoi, Takashi</au><au>Tamiya, Akihiro</au><au>Iwasawa, Shunichiro</au><au>Hata, Akito</au><au>Uchida, Junji</au><au>Fukuda, Yasushi</au><au>Hara, Satoshi</au><au>Kanazu, Masaki</au><au>Hirano, Katsuya</au><au>Kokubo, Masaki</au><au>Yamamoto, Nobuyuki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Durvalumab for patients with unresectable stage III non-small cell lung cancer and grade 1 radiation pneumonitis following concurrent chemoradiotherapy: a multicenter prospective cohort study</atitle><jtitle>Investigational new drugs</jtitle><stitle>Invest New Drugs</stitle><stitle>INVEST NEW DRUG</stitle><addtitle>Invest New Drugs</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>39</volume><issue>3</issue><spage>853</spage><epage>859</epage><pages>853-859</pages><issn>0167-6997</issn><eissn>1573-0646</eissn><abstract>Summary
Introduction/Background
Durvalumab demonstrated a good efficacy and safety in patients with unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy (CCRT) in the PACIFIC trial. Although a history of radiation pneumonitis (RP) has been reported to increase the risk of pneumonitis associated with programmed death-1 inhibitors, the safety and efficacy of durvalumab in patients with baseline Grade 1 RP have not been assessed. Therefore, we carried out a multicenter prospective cohort study to evaluate the efficacy and safety of durvalumab in these patients.
Patients and Methods
This was a multicenter prospective cohort study of 35 patients with Grade 1 RP after CCRT and before durvalumab initiation. This study was a first prespecified analysis for the first 20 patients with the primary objective of assessing the short-term safety; it was assessed 3 months after durvalumab initiation.
Results
Twenty patients were enrolled in this study between March 1, 2019, and September 3, 2019. Three patients (15%) experienced drug-related Grade ≥3 adverse events, while three patients (15%) had Grade ≥2 pneumonitis/RP within 3 months after durvalumab initiation. Three months after durvalumab initiation, all the patients were alive and four patients (20%) experienced disease progression.
Conclusion
Durvalumab can be a feasible treatment option for patients with stage III NSCLC with baseline Grade 1 RP following CCRT.
(Trial registration number: UMIN000036061. The registration period was between March 2019 and December 2019.)</abstract><cop>New York</cop><pub>Springer US</pub><pmid>33405089</pmid><doi>10.1007/s10637-020-01060-8</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-0615-3000</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-6997 |
| ispartof | Investigational new drugs, 2021-06, Vol.39 (3), p.853-859 |
| issn | 0167-6997 1573-0646 |
| language | eng |
| recordid | cdi_proquest_journals_2517673871 |
| source | MEDLINE; SpringerNature Journals; Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /> |
| subjects | Adverse events Aged Aged, 80 and over Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Apoptosis B7-H1 Antigen - antagonists & inhibitors B7-H1 Antigen - immunology Carcinoma, Non-Small-Cell Lung - immunology Carcinoma, Non-Small-Cell Lung - pathology Carcinoma, Non-Small-Cell Lung - therapy Chemoradiotherapy Chemoradiotherapy - adverse effects Chemotherapy Cohort analysis Female Humans Immune Checkpoint Inhibitors - adverse effects Immune Checkpoint Inhibitors - therapeutic use Immunotherapy Life Sciences & Biomedicine Lung cancer Lung Neoplasms - immunology Lung Neoplasms - pathology Lung Neoplasms - therapy Male Medicine Medicine & Public Health Middle Aged Monoclonal antibodies Neoplasm Staging Non-small cell lung carcinoma Oncology PD-1 protein Pharmacology & Pharmacy Pharmacology/Toxicology Phase III Studies Pneumonitis Radiation Radiation Pneumonitis - drug therapy Radiation Pneumonitis - etiology Radiation Pneumonitis - immunology Radiation therapy Safety Science & Technology Small cell lung carcinoma Targeted cancer therapy |
| title | Durvalumab for patients with unresectable stage III non-small cell lung cancer and grade 1 radiation pneumonitis following concurrent chemoradiotherapy: a multicenter prospective cohort study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-16T19%3A49%3A39IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_webof&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Durvalumab%20for%20patients%20with%20unresectable%20stage%20III%20non-small%20cell%20lung%20cancer%20and%20grade%201%20radiation%20pneumonitis%20following%20concurrent%20chemoradiotherapy:%20a%20multicenter%20prospective%20cohort%20study&rft.jtitle=Investigational%20new%20drugs&rft.au=Sugimoto,%20Takeya&rft.date=2021-06-01&rft.volume=39&rft.issue=3&rft.spage=853&rft.epage=859&rft.pages=853-859&rft.issn=0167-6997&rft.eissn=1573-0646&rft_id=info:doi/10.1007/s10637-020-01060-8&rft_dat=%3Cproquest_webof%3E2517673871%3C/proquest_webof%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2517673871&rft_id=info:pmid/33405089&rfr_iscdi=true |