Lenvatinib in patients with advanced or metastatic thymic carcinoma (REMORA): a multicentre, phase 2 trial
Thymic carcinoma is a rare malignant disease and standard treatment for advanced or metastatic thymic carcinoma previously treated with platinum-based chemotherapy has not been established. Lenvatinib is a novel multi-targeted inhibitor of VEGFR, FGFR, RET, c-Kit, and other kinases. The aim of this...
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| Veröffentlicht in: | The lancet oncology 2020-06, Vol.21 (6), p.843-850 |
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| creator | Sato, Jun Satouchi, Miyako Itoh, Shoichi Okuma, Yusuke Niho, Seiji Mizugaki, Hidenori Murakami, Haruyasu Fujisaka, Yasuhito Kozuki, Toshiyuki Nakamura, Kenichi Nagasaka, Yukari Kawasaki, Mamiko Yamada, Tomoaki Machida, Ryunosuke Kuchiba, Aya Ohe, Yuichiro Yamamoto, Noboru |
| description | Thymic carcinoma is a rare malignant disease and standard treatment for advanced or metastatic thymic carcinoma previously treated with platinum-based chemotherapy has not been established. Lenvatinib is a novel multi-targeted inhibitor of VEGFR, FGFR, RET, c-Kit, and other kinases. The aim of this trial was to assess the activity and safety of lenvatinib as a second-line treatment in thymic carcinoma.
This single-arm, phase 2 trial done in eight institutions in Japan (five cancer centres, two medical university hospitals, and one public hospital) enrolled patients with pathologically confirmed unresectable advanced or metastatic thymic carcinoma that progressed following at least one platinum-based chemotherapy. Key inclusion criteria were age 20 years or older, at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received 24 mg of lenvatinib orally once daily in 4-week cycles until disease progression or occurrence of unacceptable adverse events. The primary endpoint was objective response rate evaluated at the data cutoff date (Feb 22, 2019), by independent central review in the intention-to-treat population. This trial is registered on JMACCT, JMA-IIA00285, and on UMIN-CTR, UMIN000026777.
Between April 21, 2017, and Feb 22, 2018, 42 patients were enrolled and all patients were included in the activity and safety analysis. The median follow-up period was 15·5 months (IQR 13·1–17·5). The objective response rate was 38% (90% CI 25·6–52·0, p |
| doi_str_mv | 10.1016/S1470-2045(20)30162-5 |
| format | Article |
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This single-arm, phase 2 trial done in eight institutions in Japan (five cancer centres, two medical university hospitals, and one public hospital) enrolled patients with pathologically confirmed unresectable advanced or metastatic thymic carcinoma that progressed following at least one platinum-based chemotherapy. Key inclusion criteria were age 20 years or older, at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received 24 mg of lenvatinib orally once daily in 4-week cycles until disease progression or occurrence of unacceptable adverse events. The primary endpoint was objective response rate evaluated at the data cutoff date (Feb 22, 2019), by independent central review in the intention-to-treat population. This trial is registered on JMACCT, JMA-IIA00285, and on UMIN-CTR, UMIN000026777.
Between April 21, 2017, and Feb 22, 2018, 42 patients were enrolled and all patients were included in the activity and safety analysis. The median follow-up period was 15·5 months (IQR 13·1–17·5). The objective response rate was 38% (90% CI 25·6–52·0, p<0·0001). 16 (38%) of 42 patients had a partial response and 24 (57%) had stable disease. The most frequent grade 3 treatment-related adverse events were hypertension (27 [64%]) and palmar-plantar erythrodysaesthesia syndrome (three [7%]). No patient died from adverse events.
The activity and safety of lenvatinib in patients with advanced or metastatic thymic carcinoma was confirmed. These results suggest that lenvatinib could become a standard treatment option for patients with previously treated advanced or metastatic thymic carcinoma.
Center for Clinical Trials, Japan Medical Association.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(20)30162-5</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Angiogenesis ; c-Kit protein ; Cancer therapies ; Chemotherapy ; Clinical trials ; Cytotoxicity ; Disease control ; Drug dosages ; Electrocardiography ; Fibroblast growth factor receptors ; Hematology ; Hypertension ; Laboratories ; Medical prognosis ; Metastases ; Metastasis ; Oncology ; Patients ; Platinum ; Registration ; Safety ; Solid tumors ; Studies ; Thymus ; Thyroid cancer ; Urinalysis ; Vascular endothelial growth factor receptors</subject><ispartof>The lancet oncology, 2020-06, Vol.21 (6), p.843-850</ispartof><rights>2020 Elsevier Ltd</rights><rights>2020. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c422t-29adb36aed8d7fb9541b496a94bcc1f4908a759e6717d895a7a639d36ae4199f3</citedby><cites>FETCH-LOGICAL-c422t-29adb36aed8d7fb9541b496a94bcc1f4908a759e6717d895a7a639d36ae4199f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2425648583?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids></links><search><creatorcontrib>Sato, Jun</creatorcontrib><creatorcontrib>Satouchi, Miyako</creatorcontrib><creatorcontrib>Itoh, Shoichi</creatorcontrib><creatorcontrib>Okuma, Yusuke</creatorcontrib><creatorcontrib>Niho, Seiji</creatorcontrib><creatorcontrib>Mizugaki, Hidenori</creatorcontrib><creatorcontrib>Murakami, Haruyasu</creatorcontrib><creatorcontrib>Fujisaka, Yasuhito</creatorcontrib><creatorcontrib>Kozuki, Toshiyuki</creatorcontrib><creatorcontrib>Nakamura, Kenichi</creatorcontrib><creatorcontrib>Nagasaka, Yukari</creatorcontrib><creatorcontrib>Kawasaki, Mamiko</creatorcontrib><creatorcontrib>Yamada, Tomoaki</creatorcontrib><creatorcontrib>Machida, Ryunosuke</creatorcontrib><creatorcontrib>Kuchiba, Aya</creatorcontrib><creatorcontrib>Ohe, Yuichiro</creatorcontrib><creatorcontrib>Yamamoto, Noboru</creatorcontrib><title>Lenvatinib in patients with advanced or metastatic thymic carcinoma (REMORA): a multicentre, phase 2 trial</title><title>The lancet oncology</title><description>Thymic carcinoma is a rare malignant disease and standard treatment for advanced or metastatic thymic carcinoma previously treated with platinum-based chemotherapy has not been established. Lenvatinib is a novel multi-targeted inhibitor of VEGFR, FGFR, RET, c-Kit, and other kinases. The aim of this trial was to assess the activity and safety of lenvatinib as a second-line treatment in thymic carcinoma.
This single-arm, phase 2 trial done in eight institutions in Japan (five cancer centres, two medical university hospitals, and one public hospital) enrolled patients with pathologically confirmed unresectable advanced or metastatic thymic carcinoma that progressed following at least one platinum-based chemotherapy. Key inclusion criteria were age 20 years or older, at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received 24 mg of lenvatinib orally once daily in 4-week cycles until disease progression or occurrence of unacceptable adverse events. The primary endpoint was objective response rate evaluated at the data cutoff date (Feb 22, 2019), by independent central review in the intention-to-treat population. This trial is registered on JMACCT, JMA-IIA00285, and on UMIN-CTR, UMIN000026777.
Between April 21, 2017, and Feb 22, 2018, 42 patients were enrolled and all patients were included in the activity and safety analysis. The median follow-up period was 15·5 months (IQR 13·1–17·5). The objective response rate was 38% (90% CI 25·6–52·0, p<0·0001). 16 (38%) of 42 patients had a partial response and 24 (57%) had stable disease. The most frequent grade 3 treatment-related adverse events were hypertension (27 [64%]) and palmar-plantar erythrodysaesthesia syndrome (three [7%]). No patient died from adverse events.
The activity and safety of lenvatinib in patients with advanced or metastatic thymic carcinoma was confirmed. These results suggest that lenvatinib could become a standard treatment option for patients with previously treated advanced or metastatic thymic carcinoma.
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Jun</au><au>Satouchi, Miyako</au><au>Itoh, Shoichi</au><au>Okuma, Yusuke</au><au>Niho, Seiji</au><au>Mizugaki, Hidenori</au><au>Murakami, Haruyasu</au><au>Fujisaka, Yasuhito</au><au>Kozuki, Toshiyuki</au><au>Nakamura, Kenichi</au><au>Nagasaka, Yukari</au><au>Kawasaki, Mamiko</au><au>Yamada, Tomoaki</au><au>Machida, Ryunosuke</au><au>Kuchiba, Aya</au><au>Ohe, Yuichiro</au><au>Yamamoto, Noboru</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Lenvatinib in patients with advanced or metastatic thymic carcinoma (REMORA): a multicentre, phase 2 trial</atitle><jtitle>The lancet oncology</jtitle><date>2020-06</date><risdate>2020</risdate><volume>21</volume><issue>6</issue><spage>843</spage><epage>850</epage><pages>843-850</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><abstract>Thymic carcinoma is a rare malignant disease and standard treatment for advanced or metastatic thymic carcinoma previously treated with platinum-based chemotherapy has not been established. Lenvatinib is a novel multi-targeted inhibitor of VEGFR, FGFR, RET, c-Kit, and other kinases. The aim of this trial was to assess the activity and safety of lenvatinib as a second-line treatment in thymic carcinoma.
This single-arm, phase 2 trial done in eight institutions in Japan (five cancer centres, two medical university hospitals, and one public hospital) enrolled patients with pathologically confirmed unresectable advanced or metastatic thymic carcinoma that progressed following at least one platinum-based chemotherapy. Key inclusion criteria were age 20 years or older, at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received 24 mg of lenvatinib orally once daily in 4-week cycles until disease progression or occurrence of unacceptable adverse events. The primary endpoint was objective response rate evaluated at the data cutoff date (Feb 22, 2019), by independent central review in the intention-to-treat population. This trial is registered on JMACCT, JMA-IIA00285, and on UMIN-CTR, UMIN000026777.
Between April 21, 2017, and Feb 22, 2018, 42 patients were enrolled and all patients were included in the activity and safety analysis. The median follow-up period was 15·5 months (IQR 13·1–17·5). The objective response rate was 38% (90% CI 25·6–52·0, p<0·0001). 16 (38%) of 42 patients had a partial response and 24 (57%) had stable disease. The most frequent grade 3 treatment-related adverse events were hypertension (27 [64%]) and palmar-plantar erythrodysaesthesia syndrome (three [7%]). No patient died from adverse events.
The activity and safety of lenvatinib in patients with advanced or metastatic thymic carcinoma was confirmed. These results suggest that lenvatinib could become a standard treatment option for patients with previously treated advanced or metastatic thymic carcinoma.
Center for Clinical Trials, Japan Medical Association.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><doi>10.1016/S1470-2045(20)30162-5</doi><tpages>8</tpages></addata></record> |
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| subjects | Angiogenesis c-Kit protein Cancer therapies Chemotherapy Clinical trials Cytotoxicity Disease control Drug dosages Electrocardiography Fibroblast growth factor receptors Hematology Hypertension Laboratories Medical prognosis Metastases Metastasis Oncology Patients Platinum Registration Safety Solid tumors Studies Thymus Thyroid cancer Urinalysis Vascular endothelial growth factor receptors |
| title | Lenvatinib in patients with advanced or metastatic thymic carcinoma (REMORA): a multicentre, phase 2 trial |
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