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Phase II Trial of the Combination of Alectinib with Bevacizumab in Alectinib Refractory ALK -Positive Nonsquamous Non-Small-Cell Lung Cancer (NLCTG1501)
Anaplastic lymphoma kinase ( )-positive lung cancer is a rare cancer that occurs in approximately 5% of non-small-cell lung cancer (NSCLCs) patients. Despite the excellent efficacy of ALK-tyrosine kinase inhibitor in -positive NSCLCs, most patients experience resistance. We conducted a phase II stud...
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Published in: | Cancers 2022-12, Vol.15 (1), p.204 |
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creator | Watanabe, Satoshi Sakai, Kazuko Matsumoto, Naoya Koshio, Jun Ishida, Akira Abe, Tetsuya Ishikawa, Daisuke Tanaka, Tomohiro Aoki, Ami Kajiwara, Tomosue Koyama, Kenichi Miura, Satoru Goto, Yuka Sekiya, Tomoki Suzuki, Ryo Kushiro, Kohei Fujisaki, Toshiya Yanagimura, Naohiro Ohtsubo, Aya Shoji, Satoshi Nozaki, Koichiro Saida, Yu Yoshizawa, Hirohisa Nishio, Kazuto Kikuchi, Toshiaki |
description | Anaplastic lymphoma kinase (
)-positive lung cancer is a rare cancer that occurs in approximately 5% of non-small-cell lung cancer (NSCLCs) patients. Despite the excellent efficacy of ALK-tyrosine kinase inhibitor in
-positive NSCLCs, most patients experience resistance. We conducted a phase II study to investigate the combination of alectinib with bevacizumab in
-positive NSCLC patients after failure of alectinib. In this study,
-positive nonsquamous NSCLC patients previously treated with alectinib received bevacizumab 15 mg/kg on day 1 every 3 weeks and alectinib 600 mg/day until disease progression. The primary endpoints were progression-free survival (PFS) and the safety of alectinib and bevacizumab. The secondary endpoints included overall survival (OS) and correlation of circulating tumor DNA and plasma proteins with PFS. Of the 12 patients treated, the median PFS was 3.1 months (95% CI 1.2-16.1), and the median OS was 24.1 months (95% CI 8.3-not estimable). The
fusion gene in circulating tumor DNA was significantly correlated with shorter PFS (1.2 months vs. 11.4 months, HR 5.2,
= 0.0153). Two patients experienced grade 3 adverse events; however, none of the patients required dose reduction. Although the primary endpoint was not met, alectinib combined with bevacizumab showed clinical efficacy in
-positive patients. |
doi_str_mv | 10.3390/cancers15010204 |
format | article |
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)-positive lung cancer is a rare cancer that occurs in approximately 5% of non-small-cell lung cancer (NSCLCs) patients. Despite the excellent efficacy of ALK-tyrosine kinase inhibitor in
-positive NSCLCs, most patients experience resistance. We conducted a phase II study to investigate the combination of alectinib with bevacizumab in
-positive NSCLC patients after failure of alectinib. In this study,
-positive nonsquamous NSCLC patients previously treated with alectinib received bevacizumab 15 mg/kg on day 1 every 3 weeks and alectinib 600 mg/day until disease progression. The primary endpoints were progression-free survival (PFS) and the safety of alectinib and bevacizumab. The secondary endpoints included overall survival (OS) and correlation of circulating tumor DNA and plasma proteins with PFS. Of the 12 patients treated, the median PFS was 3.1 months (95% CI 1.2-16.1), and the median OS was 24.1 months (95% CI 8.3-not estimable). The
fusion gene in circulating tumor DNA was significantly correlated with shorter PFS (1.2 months vs. 11.4 months, HR 5.2,
= 0.0153). Two patients experienced grade 3 adverse events; however, none of the patients required dose reduction. Although the primary endpoint was not met, alectinib combined with bevacizumab showed clinical efficacy in
-positive patients.</description><identifier>ISSN: 2072-6694</identifier><identifier>EISSN: 2072-6694</identifier><identifier>DOI: 10.3390/cancers15010204</identifier><identifier>PMID: 36612200</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Angiogenesis ; Bevacizumab ; Biomarkers ; c-Met protein ; Cancer therapies ; Enzyme inhibitors ; Epidermal growth factor ; Fusion protein ; Genes ; Hypotheses ; Kinases ; Lung cancer ; Mutation ; Non-small cell lung carcinoma ; Patients ; Plasma ; Plasma proteins ; Protein-tyrosine kinase ; Proteins ; Small cell lung carcinoma ; Statistical analysis ; Toxicity ; Tumors ; Vascular endothelial growth factor</subject><ispartof>Cancers, 2022-12, Vol.15 (1), p.204</ispartof><rights>2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2022 by the authors. 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c421t-a4de20197506f33166f47537ba66c1a166063078d6c1577c8413adf86105be233</citedby><cites>FETCH-LOGICAL-c421t-a4de20197506f33166f47537ba66c1a166063078d6c1577c8413adf86105be233</cites><orcidid>0000-0002-8275-0846 ; 0000-0001-7428-1245 ; 0000-0001-7868-6661 ; 0000-0003-0041-6981</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2761099833/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2761099833?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36612200$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Watanabe, Satoshi</creatorcontrib><creatorcontrib>Sakai, Kazuko</creatorcontrib><creatorcontrib>Matsumoto, Naoya</creatorcontrib><creatorcontrib>Koshio, Jun</creatorcontrib><creatorcontrib>Ishida, Akira</creatorcontrib><creatorcontrib>Abe, Tetsuya</creatorcontrib><creatorcontrib>Ishikawa, Daisuke</creatorcontrib><creatorcontrib>Tanaka, Tomohiro</creatorcontrib><creatorcontrib>Aoki, Ami</creatorcontrib><creatorcontrib>Kajiwara, Tomosue</creatorcontrib><creatorcontrib>Koyama, Kenichi</creatorcontrib><creatorcontrib>Miura, Satoru</creatorcontrib><creatorcontrib>Goto, Yuka</creatorcontrib><creatorcontrib>Sekiya, Tomoki</creatorcontrib><creatorcontrib>Suzuki, Ryo</creatorcontrib><creatorcontrib>Kushiro, Kohei</creatorcontrib><creatorcontrib>Fujisaki, Toshiya</creatorcontrib><creatorcontrib>Yanagimura, Naohiro</creatorcontrib><creatorcontrib>Ohtsubo, Aya</creatorcontrib><creatorcontrib>Shoji, Satoshi</creatorcontrib><creatorcontrib>Nozaki, Koichiro</creatorcontrib><creatorcontrib>Saida, Yu</creatorcontrib><creatorcontrib>Yoshizawa, Hirohisa</creatorcontrib><creatorcontrib>Nishio, Kazuto</creatorcontrib><creatorcontrib>Kikuchi, Toshiaki</creatorcontrib><title>Phase II Trial of the Combination of Alectinib with Bevacizumab in Alectinib Refractory ALK -Positive Nonsquamous Non-Small-Cell Lung Cancer (NLCTG1501)</title><title>Cancers</title><addtitle>Cancers (Basel)</addtitle><description>Anaplastic lymphoma kinase (
)-positive lung cancer is a rare cancer that occurs in approximately 5% of non-small-cell lung cancer (NSCLCs) patients. Despite the excellent efficacy of ALK-tyrosine kinase inhibitor in
-positive NSCLCs, most patients experience resistance. We conducted a phase II study to investigate the combination of alectinib with bevacizumab in
-positive NSCLC patients after failure of alectinib. In this study,
-positive nonsquamous NSCLC patients previously treated with alectinib received bevacizumab 15 mg/kg on day 1 every 3 weeks and alectinib 600 mg/day until disease progression. The primary endpoints were progression-free survival (PFS) and the safety of alectinib and bevacizumab. The secondary endpoints included overall survival (OS) and correlation of circulating tumor DNA and plasma proteins with PFS. Of the 12 patients treated, the median PFS was 3.1 months (95% CI 1.2-16.1), and the median OS was 24.1 months (95% CI 8.3-not estimable). The
fusion gene in circulating tumor DNA was significantly correlated with shorter PFS (1.2 months vs. 11.4 months, HR 5.2,
= 0.0153). Two patients experienced grade 3 adverse events; however, none of the patients required dose reduction. Although the primary endpoint was not met, alectinib combined with bevacizumab showed clinical efficacy in
-positive patients.</description><subject>Angiogenesis</subject><subject>Bevacizumab</subject><subject>Biomarkers</subject><subject>c-Met protein</subject><subject>Cancer therapies</subject><subject>Enzyme inhibitors</subject><subject>Epidermal growth factor</subject><subject>Fusion protein</subject><subject>Genes</subject><subject>Hypotheses</subject><subject>Kinases</subject><subject>Lung cancer</subject><subject>Mutation</subject><subject>Non-small cell lung carcinoma</subject><subject>Patients</subject><subject>Plasma</subject><subject>Plasma proteins</subject><subject>Protein-tyrosine kinase</subject><subject>Proteins</subject><subject>Small cell lung carcinoma</subject><subject>Statistical analysis</subject><subject>Toxicity</subject><subject>Tumors</subject><subject>Vascular endothelial growth 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Trial of the Combination of Alectinib with Bevacizumab in Alectinib Refractory ALK -Positive Nonsquamous Non-Small-Cell Lung Cancer (NLCTG1501)</title><author>Watanabe, Satoshi ; Sakai, Kazuko ; Matsumoto, Naoya ; Koshio, Jun ; Ishida, Akira ; Abe, Tetsuya ; Ishikawa, Daisuke ; Tanaka, Tomohiro ; Aoki, Ami ; Kajiwara, Tomosue ; Koyama, Kenichi ; Miura, Satoru ; Goto, Yuka ; Sekiya, Tomoki ; Suzuki, Ryo ; Kushiro, Kohei ; Fujisaki, Toshiya ; Yanagimura, Naohiro ; Ohtsubo, Aya ; Shoji, Satoshi ; Nozaki, Koichiro ; Saida, Yu ; Yoshizawa, Hirohisa ; Nishio, Kazuto ; Kikuchi, Toshiaki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c421t-a4de20197506f33166f47537ba66c1a166063078d6c1577c8413adf86105be233</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Angiogenesis</topic><topic>Bevacizumab</topic><topic>Biomarkers</topic><topic>c-Met protein</topic><topic>Cancer 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Tetsuya</au><au>Ishikawa, Daisuke</au><au>Tanaka, Tomohiro</au><au>Aoki, Ami</au><au>Kajiwara, Tomosue</au><au>Koyama, Kenichi</au><au>Miura, Satoru</au><au>Goto, Yuka</au><au>Sekiya, Tomoki</au><au>Suzuki, Ryo</au><au>Kushiro, Kohei</au><au>Fujisaki, Toshiya</au><au>Yanagimura, Naohiro</au><au>Ohtsubo, Aya</au><au>Shoji, Satoshi</au><au>Nozaki, Koichiro</au><au>Saida, Yu</au><au>Yoshizawa, Hirohisa</au><au>Nishio, Kazuto</au><au>Kikuchi, Toshiaki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II Trial of the Combination of Alectinib with Bevacizumab in Alectinib Refractory ALK -Positive Nonsquamous Non-Small-Cell Lung Cancer (NLCTG1501)</atitle><jtitle>Cancers</jtitle><addtitle>Cancers (Basel)</addtitle><date>2022-12-29</date><risdate>2022</risdate><volume>15</volume><issue>1</issue><spage>204</spage><pages>204-</pages><issn>2072-6694</issn><eissn>2072-6694</eissn><abstract>Anaplastic lymphoma kinase (
)-positive lung cancer is a rare cancer that occurs in approximately 5% of non-small-cell lung cancer (NSCLCs) patients. Despite the excellent efficacy of ALK-tyrosine kinase inhibitor in
-positive NSCLCs, most patients experience resistance. We conducted a phase II study to investigate the combination of alectinib with bevacizumab in
-positive NSCLC patients after failure of alectinib. In this study,
-positive nonsquamous NSCLC patients previously treated with alectinib received bevacizumab 15 mg/kg on day 1 every 3 weeks and alectinib 600 mg/day until disease progression. The primary endpoints were progression-free survival (PFS) and the safety of alectinib and bevacizumab. The secondary endpoints included overall survival (OS) and correlation of circulating tumor DNA and plasma proteins with PFS. Of the 12 patients treated, the median PFS was 3.1 months (95% CI 1.2-16.1), and the median OS was 24.1 months (95% CI 8.3-not estimable). The
fusion gene in circulating tumor DNA was significantly correlated with shorter PFS (1.2 months vs. 11.4 months, HR 5.2,
= 0.0153). Two patients experienced grade 3 adverse events; however, none of the patients required dose reduction. Although the primary endpoint was not met, alectinib combined with bevacizumab showed clinical efficacy in
-positive patients.</abstract><cop>Switzerland</cop><pub>MDPI AG</pub><pmid>36612200</pmid><doi>10.3390/cancers15010204</doi><orcidid>https://orcid.org/0000-0002-8275-0846</orcidid><orcidid>https://orcid.org/0000-0001-7428-1245</orcidid><orcidid>https://orcid.org/0000-0001-7868-6661</orcidid><orcidid>https://orcid.org/0000-0003-0041-6981</orcidid><oa>free_for_read</oa></addata></record> |
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ispartof | Cancers, 2022-12, Vol.15 (1), p.204 |
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language | eng |
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source | Open Access: PubMed Central; Publicly Available Content Database |
subjects | Angiogenesis Bevacizumab Biomarkers c-Met protein Cancer therapies Enzyme inhibitors Epidermal growth factor Fusion protein Genes Hypotheses Kinases Lung cancer Mutation Non-small cell lung carcinoma Patients Plasma Plasma proteins Protein-tyrosine kinase Proteins Small cell lung carcinoma Statistical analysis Toxicity Tumors Vascular endothelial growth factor |
title | Phase II Trial of the Combination of Alectinib with Bevacizumab in Alectinib Refractory ALK -Positive Nonsquamous Non-Small-Cell Lung Cancer (NLCTG1501) |
url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T11%3A57%3A43IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Phase%20II%20Trial%20of%20the%20Combination%20of%20Alectinib%20with%20Bevacizumab%20in%20Alectinib%20Refractory%20ALK%20-Positive%20Nonsquamous%20Non-Small-Cell%20Lung%20Cancer%20(NLCTG1501)&rft.jtitle=Cancers&rft.au=Watanabe,%20Satoshi&rft.date=2022-12-29&rft.volume=15&rft.issue=1&rft.spage=204&rft.pages=204-&rft.issn=2072-6694&rft.eissn=2072-6694&rft_id=info:doi/10.3390/cancers15010204&rft_dat=%3Cproquest_pubme%3E2761977470%3C/proquest_pubme%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c421t-a4de20197506f33166f47537ba66c1a166063078d6c1577c8413adf86105be233%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2761099833&rft_id=info:pmid/36612200&rfr_iscdi=true |