Phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320)
Summary Background Amrubicin (AMR) is a completely synthetic 9-aminoanthracycline and clinically active against non-small cell lung cancer (NSCLC). We conducted a phase I study of AMR and erlotinib (ERL) combination therapy in previously treated patients with advanced NSCLC and have already reported...
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| Veröffentlicht in: | Investigational new drugs 2021-04, Vol.39 (2), p.530-536 |
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| creator | Otani, Sakiko Sasaki, Jiichiro Nakahara, Yoshiro Fukui, Tomoya Igawa, Satoshi Naoki, Katsuhiko Bessho, Akihiro Hosokawa, Shinobu Fukamatsu, Nobuaki Nakamura, Yukiko Kasai, Takashi Sugiyama, Tomohide Tokito, Takaaki Seki, Nobuhiko Hamada, Akinobu Okamoto, Hiroaki Masuda, Noriyuki |
| description | Summary
Background
Amrubicin (AMR) is a completely synthetic 9-aminoanthracycline and clinically active against non-small cell lung cancer (NSCLC). We conducted a phase I study of AMR and erlotinib (ERL) combination therapy in previously treated patients with advanced NSCLC and have already reported the safety and effectiveness.
Methods
We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC harboring wild-type EGFR, PS 0–1 and |
| doi_str_mv | 10.1007/s10637-020-01031-z |
| format | Article |
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Background
Amrubicin (AMR) is a completely synthetic 9-aminoanthracycline and clinically active against non-small cell lung cancer (NSCLC). We conducted a phase I study of AMR and erlotinib (ERL) combination therapy in previously treated patients with advanced NSCLC and have already reported the safety and effectiveness.
Methods
We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC harboring wild-type EGFR, PS 0–1 and < 75 years of age. Patients were treated at 3-week intervals with AMR plus ERL. The primary endpoint was the PFS, and the secondary endpoints were the response rate (RR), disease control rate (DCR), overall survival (OS) and toxicity. The trough ERL concentration (C
trough
) was measured as an exploratory study to analyze the relationship between the efficacy/safety and pharmacokinetics.
Results
From June 2013 to July 2016, 25 patients were enrolled in this trial. The PFS according to the central test was 3.6 months (95% confidence interval 2.1–5.1). The RR and DCR were 24.0% and 64.0%, respectively. We had no treatment-related deaths in this study.
Conclusions
The PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy in the historical setting, but the primary endpoint was not met in this trial. In our study, the pharmacokinetic analysis showed that the C
trough
of ERL was elevated with combination therapy. This combination therapy might be a viable treatment for previously treated NSCLC patients without a driver oncogene mutation.
Clinical trial information
UMIN 000010582.</description><identifier>ISSN: 0167-6997</identifier><identifier>EISSN: 1573-0646</identifier><identifier>DOI: 10.1007/s10637-020-01031-z</identifier><identifier>PMID: 33159674</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Aged ; Anthracyclines - administration & dosage ; Anthracyclines - adverse effects ; Anthracyclines - pharmacokinetics ; Anthracyclines - therapeutic use ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - pharmacokinetics ; Antineoplastic Agents - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; c-Met protein ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - genetics ; Combination therapy ; Confidence intervals ; Disease control ; Epidermal growth factor ; Epidermal growth factor receptors ; ErbB Receptors - genetics ; Erlotinib Hydrochloride - administration & dosage ; Erlotinib Hydrochloride - adverse effects ; Erlotinib Hydrochloride - pharmacokinetics ; Erlotinib Hydrochloride - therapeutic use ; Growth factors ; Health services ; Humans ; Inhibitor drugs ; Lung cancer ; Lung Neoplasms - drug therapy ; Lung Neoplasms - genetics ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Mutation ; Non-small cell lung carcinoma ; Oncology ; Patients ; Pharmacokinetics ; Pharmacology ; Pharmacology/Toxicology ; Phase II Studies ; Progression-Free Survival ; Safety ; Small cell lung carcinoma ; Targeted cancer therapy ; Therapy ; Toxicity</subject><ispartof>Investigational new drugs, 2021-04, Vol.39 (2), p.530-536</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2020</rights><rights>Springer Science+Business Media, LLC, part of Springer Nature 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c326t-a002835e0dff9a8c24885f7038a2343aa2732877cb54610d5abc77ffed84f9b33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10637-020-01031-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10637-020-01031-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33159674$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Otani, Sakiko</creatorcontrib><creatorcontrib>Sasaki, Jiichiro</creatorcontrib><creatorcontrib>Nakahara, Yoshiro</creatorcontrib><creatorcontrib>Fukui, Tomoya</creatorcontrib><creatorcontrib>Igawa, Satoshi</creatorcontrib><creatorcontrib>Naoki, Katsuhiko</creatorcontrib><creatorcontrib>Bessho, Akihiro</creatorcontrib><creatorcontrib>Hosokawa, Shinobu</creatorcontrib><creatorcontrib>Fukamatsu, Nobuaki</creatorcontrib><creatorcontrib>Nakamura, Yukiko</creatorcontrib><creatorcontrib>Kasai, Takashi</creatorcontrib><creatorcontrib>Sugiyama, Tomohide</creatorcontrib><creatorcontrib>Tokito, Takaaki</creatorcontrib><creatorcontrib>Seki, Nobuhiko</creatorcontrib><creatorcontrib>Hamada, Akinobu</creatorcontrib><creatorcontrib>Okamoto, Hiroaki</creatorcontrib><creatorcontrib>Masuda, Noriyuki</creatorcontrib><title>Phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320)</title><title>Investigational new drugs</title><addtitle>Invest New Drugs</addtitle><addtitle>Invest New Drugs</addtitle><description>Summary
Background
Amrubicin (AMR) is a completely synthetic 9-aminoanthracycline and clinically active against non-small cell lung cancer (NSCLC). We conducted a phase I study of AMR and erlotinib (ERL) combination therapy in previously treated patients with advanced NSCLC and have already reported the safety and effectiveness.
Methods
We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC harboring wild-type EGFR, PS 0–1 and < 75 years of age. Patients were treated at 3-week intervals with AMR plus ERL. The primary endpoint was the PFS, and the secondary endpoints were the response rate (RR), disease control rate (DCR), overall survival (OS) and toxicity. The trough ERL concentration (C
trough
) was measured as an exploratory study to analyze the relationship between the efficacy/safety and pharmacokinetics.
Results
From June 2013 to July 2016, 25 patients were enrolled in this trial. The PFS according to the central test was 3.6 months (95% confidence interval 2.1–5.1). The RR and DCR were 24.0% and 64.0%, respectively. We had no treatment-related deaths in this study.
Conclusions
The PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy in the historical setting, but the primary endpoint was not met in this trial. In our study, the pharmacokinetic analysis showed that the C
trough
of ERL was elevated with combination therapy. This combination therapy might be a viable treatment for previously treated NSCLC patients without a driver oncogene mutation.
Clinical trial information
UMIN 000010582.</description><subject>Adult</subject><subject>Aged</subject><subject>Anthracyclines - administration & dosage</subject><subject>Anthracyclines - adverse effects</subject><subject>Anthracyclines - pharmacokinetics</subject><subject>Anthracyclines - therapeutic use</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - pharmacokinetics</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>c-Met protein</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - genetics</subject><subject>Combination therapy</subject><subject>Confidence intervals</subject><subject>Disease control</subject><subject>Epidermal growth factor</subject><subject>Epidermal growth factor receptors</subject><subject>ErbB Receptors - genetics</subject><subject>Erlotinib Hydrochloride - administration & dosage</subject><subject>Erlotinib Hydrochloride - adverse effects</subject><subject>Erlotinib Hydrochloride - pharmacokinetics</subject><subject>Erlotinib Hydrochloride - therapeutic use</subject><subject>Growth factors</subject><subject>Health services</subject><subject>Humans</subject><subject>Inhibitor drugs</subject><subject>Lung cancer</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - genetics</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Mutation</subject><subject>Non-small cell lung carcinoma</subject><subject>Oncology</subject><subject>Patients</subject><subject>Pharmacokinetics</subject><subject>Pharmacology</subject><subject>Pharmacology/Toxicology</subject><subject>Phase II Studies</subject><subject>Progression-Free Survival</subject><subject>Safety</subject><subject>Small cell 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II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320)</title><author>Otani, Sakiko ; Sasaki, Jiichiro ; Nakahara, Yoshiro ; Fukui, Tomoya ; Igawa, Satoshi ; Naoki, Katsuhiko ; Bessho, Akihiro ; Hosokawa, Shinobu ; Fukamatsu, Nobuaki ; Nakamura, Yukiko ; Kasai, Takashi ; Sugiyama, Tomohide ; Tokito, Takaaki ; Seki, Nobuhiko ; Hamada, Akinobu ; Okamoto, Hiroaki ; Masuda, Noriyuki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c326t-a002835e0dff9a8c24885f7038a2343aa2732877cb54610d5abc77ffed84f9b33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anthracyclines - administration & dosage</topic><topic>Anthracyclines - adverse effects</topic><topic>Anthracyclines - pharmacokinetics</topic><topic>Anthracyclines - therapeutic use</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - pharmacokinetics</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>c-Met protein</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - genetics</topic><topic>Combination therapy</topic><topic>Confidence intervals</topic><topic>Disease control</topic><topic>Epidermal growth factor</topic><topic>Epidermal growth factor receptors</topic><topic>ErbB Receptors - genetics</topic><topic>Erlotinib Hydrochloride - administration & dosage</topic><topic>Erlotinib Hydrochloride - adverse effects</topic><topic>Erlotinib Hydrochloride - pharmacokinetics</topic><topic>Erlotinib Hydrochloride - therapeutic use</topic><topic>Growth factors</topic><topic>Health services</topic><topic>Humans</topic><topic>Inhibitor drugs</topic><topic>Lung cancer</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - genetics</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Mutation</topic><topic>Non-small cell lung carcinoma</topic><topic>Oncology</topic><topic>Patients</topic><topic>Pharmacokinetics</topic><topic>Pharmacology</topic><topic>Pharmacology/Toxicology</topic><topic>Phase II Studies</topic><topic>Progression-Free Survival</topic><topic>Safety</topic><topic>Small cell lung carcinoma</topic><topic>Targeted cancer therapy</topic><topic>Therapy</topic><topic>Toxicity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Otani, Sakiko</creatorcontrib><creatorcontrib>Sasaki, Jiichiro</creatorcontrib><creatorcontrib>Nakahara, Yoshiro</creatorcontrib><creatorcontrib>Fukui, Tomoya</creatorcontrib><creatorcontrib>Igawa, 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Akinobu</au><au>Okamoto, Hiroaki</au><au>Masuda, Noriyuki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320)</atitle><jtitle>Investigational new drugs</jtitle><stitle>Invest New Drugs</stitle><addtitle>Invest New Drugs</addtitle><date>2021-04-01</date><risdate>2021</risdate><volume>39</volume><issue>2</issue><spage>530</spage><epage>536</epage><pages>530-536</pages><issn>0167-6997</issn><eissn>1573-0646</eissn><abstract>Summary
Background
Amrubicin (AMR) is a completely synthetic 9-aminoanthracycline and clinically active against non-small cell lung cancer (NSCLC). We conducted a phase I study of AMR and erlotinib (ERL) combination therapy in previously treated patients with advanced NSCLC and have already reported the safety and effectiveness.
Methods
We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC harboring wild-type EGFR, PS 0–1 and < 75 years of age. Patients were treated at 3-week intervals with AMR plus ERL. The primary endpoint was the PFS, and the secondary endpoints were the response rate (RR), disease control rate (DCR), overall survival (OS) and toxicity. The trough ERL concentration (C
trough
) was measured as an exploratory study to analyze the relationship between the efficacy/safety and pharmacokinetics.
Results
From June 2013 to July 2016, 25 patients were enrolled in this trial. The PFS according to the central test was 3.6 months (95% confidence interval 2.1–5.1). The RR and DCR were 24.0% and 64.0%, respectively. We had no treatment-related deaths in this study.
Conclusions
The PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy in the historical setting, but the primary endpoint was not met in this trial. In our study, the pharmacokinetic analysis showed that the C
trough
of ERL was elevated with combination therapy. This combination therapy might be a viable treatment for previously treated NSCLC patients without a driver oncogene mutation.
Clinical trial information
UMIN 000010582.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>33159674</pmid><doi>10.1007/s10637-020-01031-z</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-6997 |
| ispartof | Investigational new drugs, 2021-04, Vol.39 (2), p.530-536 |
| issn | 0167-6997 1573-0646 |
| language | eng |
| recordid | cdi_proquest_journals_2501369379 |
| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adult Aged Anthracyclines - administration & dosage Anthracyclines - adverse effects Anthracyclines - pharmacokinetics Anthracyclines - therapeutic use Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Agents - pharmacokinetics Antineoplastic Agents - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use c-Met protein Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - genetics Combination therapy Confidence intervals Disease control Epidermal growth factor Epidermal growth factor receptors ErbB Receptors - genetics Erlotinib Hydrochloride - administration & dosage Erlotinib Hydrochloride - adverse effects Erlotinib Hydrochloride - pharmacokinetics Erlotinib Hydrochloride - therapeutic use Growth factors Health services Humans Inhibitor drugs Lung cancer Lung Neoplasms - drug therapy Lung Neoplasms - genetics Male Medicine Medicine & Public Health Middle Aged Mutation Non-small cell lung carcinoma Oncology Patients Pharmacokinetics Pharmacology Pharmacology/Toxicology Phase II Studies Progression-Free Survival Safety Small cell lung carcinoma Targeted cancer therapy Therapy Toxicity |
| title | Phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-01T17%3A57%3A20IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Phase%20II%20study%20of%20amrubicin%20plus%20erlotinib%20in%20previously%20treated,%20advanced%20non-small%20cell%20lung%20cancer%20with%20wild-type%20epidermal%20growth%20factor%20receptor%20(TORG1320)&rft.jtitle=Investigational%20new%20drugs&rft.au=Otani,%20Sakiko&rft.date=2021-04-01&rft.volume=39&rft.issue=2&rft.spage=530&rft.epage=536&rft.pages=530-536&rft.issn=0167-6997&rft.eissn=1573-0646&rft_id=info:doi/10.1007/s10637-020-01031-z&rft_dat=%3Cproquest_cross%3E2501369379%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2501369379&rft_id=info:pmid/33159674&rfr_iscdi=true |