1676PDPhase I combination dose-finding/phase II expansion cohorts of lenvatinib + etoposide + ifosfamide in patients (pts) aged 2 to ≤ 25 years with relapsed/refractory (r/r) osteosarcoma
Abstract Background Lenvatinib (LEN) is a multikinase inhibitor of VEGFR1–3 and other targets. We report data from phase Ib dose-finding and phase II expansion cohorts of LEN + etoposide + ifosfamide in pts with r/r osteosarcoma. Methods Pts were aged 2 to ≤ 25 years with r/r osteosarcoma and...
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| creator | Gaspar, N Sirvent, F J Bautista Venkatramani, R Longhi, A Lervat, C Casanova, M Aerts, I Bielack, S S Entz-Werle, N Strauss, S He, C Thebaud, E Locatelli, F Morland, B Melcon, S Gallego Nieto, A Cañete Marec- Bérard, P Gambart, M Rossig, C Campbell-Hewson, Q |
| description | Abstract
Background
Lenvatinib (LEN) is a multikinase inhibitor of VEGFR1–3 and other targets. We report data from phase Ib dose-finding and phase II expansion cohorts of LEN + etoposide + ifosfamide in pts with r/r osteosarcoma.
Methods
Pts were aged 2 to ≤ 25 years with r/r osteosarcoma and |
| doi_str_mv | 10.1093/annonc/mdz283.009 |
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| fullrecord | <record><control><sourceid>oup</sourceid><recordid>TN_cdi_oup_primary_10_1093_annonc_mdz283_009</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/annonc/mdz283.009</oup_id><sourcerecordid>10.1093/annonc/mdz283.009</sourcerecordid><originalsourceid>FETCH-oup_primary_10_1093_annonc_mdz283_0093</originalsourceid><addsrcrecordid>eNqVkEtOwzAQhi0EEuVxAHazbAVpnKRNmzUU0V0X7CM3mTRGicfymEdZse09uAhX6UlwVS7AZh6a75dGnxA3iRwnsshiZQyZKu7rz3SejaUsTsQgmeZFNJeT5FQMZJFm0WyaTc7FBfOLlDIv0mIgfpJ8lq8eVq1ihCVU1K-1UV6TgZoYo0abWptNbI_AEvDDKsOHe0UtOc9ADXRo3kLI6DXcAnqyxLrGMOuGuFH9YdEGbGDQhMjQeh6B2mANKXjaf-32u-9Q0ylsUTmGd-1bcNgpy1jHDhunKk9uC0MXuxEQeyRWLryrrsRZozrG679-Ke4eF8_3TxG92tI63Su3LRNZHjSVR03lUVMZNGX_xH8BNSt3ng</addsrcrecordid><sourcetype>Publisher</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>1676PDPhase I combination dose-finding/phase II expansion cohorts of lenvatinib + etoposide + ifosfamide in patients (pts) aged 2 to ≤ 25 years with relapsed/refractory (r/r) osteosarcoma</title><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>Gaspar, N ; Sirvent, F J Bautista ; Venkatramani, R ; Longhi, A ; Lervat, C ; Casanova, M ; Aerts, I ; Bielack, S S ; Entz-Werle, N ; Strauss, S ; He, C ; Thebaud, E ; Locatelli, F ; Morland, B ; Melcon, S Gallego ; Nieto, A Cañete ; Marec- Bérard, P ; Gambart, M ; Rossig, C ; Campbell-Hewson, Q</creator><creatorcontrib>Gaspar, N ; Sirvent, F J Bautista ; Venkatramani, R ; Longhi, A ; Lervat, C ; Casanova, M ; Aerts, I ; Bielack, S S ; Entz-Werle, N ; Strauss, S ; He, C ; Thebaud, E ; Locatelli, F ; Morland, B ; Melcon, S Gallego ; Nieto, A Cañete ; Marec- Bérard, P ; Gambart, M ; Rossig, C ; Campbell-Hewson, Q</creatorcontrib><description>Abstract
Background
Lenvatinib (LEN) is a multikinase inhibitor of VEGFR1–3 and other targets. We report data from phase Ib dose-finding and phase II expansion cohorts of LEN + etoposide + ifosfamide in pts with r/r osteosarcoma.
Methods
Pts were aged 2 to ≤ 25 years with r/r osteosarcoma and <2 prior VEGF-targeted therapies. The phase Ib starting dose was LEN 11 mg/m2/day + ifosfamide 3000 mg/m2 + etoposide 100 mg/m2 daily/3 days. On determination of the recommended phase II dose (RPh2D) of LEN + chemo, pts were enrolled into the phase II expansion cohort. Primary end points: phase Ib, RPh2D; phase II, 4 months’ progression-free survival (PFS-4).
Results
In the phase Ib dose-finding cohort (n = 22), pts received LEN 11 mg/m2 (n = 7) and 14 mg/m2 (n = 15) + chemo. Dose-limiting toxicities were: Grade (G) 4 thrombocytopenia (n = 1; LEN 11 mg/m2), G4 thrombocytopenia and G3 epistaxis (n = 1; LEN 14 mg/m2), G2 oral dysesthesia, G3 muscle spasm, and G2 back pain (n = 1; LEN 14 mg/m2). RPh2D was LEN 14 mg/m2 + chemo. In the expansion cohort (n = 20), the median number of LEN cycles received was 4 (range: 1–7). As reported in the database, the most frequent treatment-emergent adverse events (TEAEs) were platelet count decreased/thrombocytopenia (50%/30%), neutropenia/neutrophil count decreased (45%/25%), anemia (45%), nausea (40%), ALT increased, diarrhea, and white blood cell count decreased (30% each). Most frequent G ≥ 3 TEAEs were neutropenia/neutrophil count decreased (45%/25%), platelet count decreased/thrombocytopenia (40%/20%), white blood cell count decreased (30%), and anemia (25%). Pneumothorax was observed in the dose-finding cohort (n = 6) and expansion cohort (n = 1); 2 (dose-finding cohort) were ≥G3; and 1 was post-thoracotomy. 4 Pts (dose-finding cohort) discontinued treatment due to TEAEs. There were no treatment-related fatal serious AEs. In the dose-finding combination cohort, 12/18 evaluable pts (66.7%) achieved PFS-4. In the phase II expansion cohort, 5/8 evaluable pts (62.5%) achieved PFS-4.
Conclusions
The combination of RPh2D LEN (14 mg/m2) + chemo had a manageable safety profile with promising preliminary evidence of efficacy.
Clinical trial identification
NCT02432274.
Legal entity responsible for the study
Eisai Inc.
Funding
Eisai Inc.
Disclosure
A. Longhi: Non-remunerated activity/ies, non-financial support: PharmaMar, Takeda; Research grant / Funding (institution): Takeda. M. Casanova: Advisory / Consultancy, advisory role: Bayer; Advisory / Consultancy, advisory role: Lilly; Advisory / Consultancy, advisory role: Roche; Advisory / Consultancy, advisory role: Tesaro. S.S. Bielack: Travel / Accommodation / Expenses, site fees for study preparation: Eisai; Travel / Accommodation / Expenses, personal fees from Clinigen: Clinigen; Travel / Accommodation / Expenses, personal fees from Lilly: Lilly; Travel / Accommodation / Expenses, personal fees from Novartis: Novartis; Travel / Accommodation / Expenses, personal fees from Bayer: Bayer; Travel / Accommodation / Expenses, personal fees from Pfizer: Pfizer; Travel / Accommodation / Expenses, personal fees from Isofol: Isofol; Travel / Accommodation / Expenses, personal fees from Sensorion: Sensorion; Travel / Accommodation / Expenses, personal fees from Ipsen: Ipsen; Advisory / Consultancy, Institution negotiating consultancy agreement with Eisai: Eisai. S. Gallego Melcon: Travel / Accommodation / Expenses: Loxo Oncology; Advisory / Consultancy: Bayer, Eusa. All other authors have declared no conflicts of interest.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdz283.009</identifier><language>eng</language><publisher>Oxford University Press</publisher><ispartof>Annals of oncology, 2019-10, Vol.30 (Supplement_5)</ispartof><rights>European Society for Medical Oncology 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2019</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids></links><search><creatorcontrib>Gaspar, N</creatorcontrib><creatorcontrib>Sirvent, F J Bautista</creatorcontrib><creatorcontrib>Venkatramani, R</creatorcontrib><creatorcontrib>Longhi, A</creatorcontrib><creatorcontrib>Lervat, C</creatorcontrib><creatorcontrib>Casanova, M</creatorcontrib><creatorcontrib>Aerts, I</creatorcontrib><creatorcontrib>Bielack, S S</creatorcontrib><creatorcontrib>Entz-Werle, N</creatorcontrib><creatorcontrib>Strauss, S</creatorcontrib><creatorcontrib>He, C</creatorcontrib><creatorcontrib>Thebaud, E</creatorcontrib><creatorcontrib>Locatelli, F</creatorcontrib><creatorcontrib>Morland, B</creatorcontrib><creatorcontrib>Melcon, S Gallego</creatorcontrib><creatorcontrib>Nieto, A Cañete</creatorcontrib><creatorcontrib>Marec- Bérard, P</creatorcontrib><creatorcontrib>Gambart, M</creatorcontrib><creatorcontrib>Rossig, C</creatorcontrib><creatorcontrib>Campbell-Hewson, Q</creatorcontrib><title>1676PDPhase I combination dose-finding/phase II expansion cohorts of lenvatinib + etoposide + ifosfamide in patients (pts) aged 2 to ≤ 25 years with relapsed/refractory (r/r) osteosarcoma</title><title>Annals of oncology</title><description>Abstract
Background
Lenvatinib (LEN) is a multikinase inhibitor of VEGFR1–3 and other targets. We report data from phase Ib dose-finding and phase II expansion cohorts of LEN + etoposide + ifosfamide in pts with r/r osteosarcoma.
Methods
Pts were aged 2 to ≤ 25 years with r/r osteosarcoma and <2 prior VEGF-targeted therapies. The phase Ib starting dose was LEN 11 mg/m2/day + ifosfamide 3000 mg/m2 + etoposide 100 mg/m2 daily/3 days. On determination of the recommended phase II dose (RPh2D) of LEN + chemo, pts were enrolled into the phase II expansion cohort. Primary end points: phase Ib, RPh2D; phase II, 4 months’ progression-free survival (PFS-4).
Results
In the phase Ib dose-finding cohort (n = 22), pts received LEN 11 mg/m2 (n = 7) and 14 mg/m2 (n = 15) + chemo. Dose-limiting toxicities were: Grade (G) 4 thrombocytopenia (n = 1; LEN 11 mg/m2), G4 thrombocytopenia and G3 epistaxis (n = 1; LEN 14 mg/m2), G2 oral dysesthesia, G3 muscle spasm, and G2 back pain (n = 1; LEN 14 mg/m2). RPh2D was LEN 14 mg/m2 + chemo. In the expansion cohort (n = 20), the median number of LEN cycles received was 4 (range: 1–7). As reported in the database, the most frequent treatment-emergent adverse events (TEAEs) were platelet count decreased/thrombocytopenia (50%/30%), neutropenia/neutrophil count decreased (45%/25%), anemia (45%), nausea (40%), ALT increased, diarrhea, and white blood cell count decreased (30% each). Most frequent G ≥ 3 TEAEs were neutropenia/neutrophil count decreased (45%/25%), platelet count decreased/thrombocytopenia (40%/20%), white blood cell count decreased (30%), and anemia (25%). Pneumothorax was observed in the dose-finding cohort (n = 6) and expansion cohort (n = 1); 2 (dose-finding cohort) were ≥G3; and 1 was post-thoracotomy. 4 Pts (dose-finding cohort) discontinued treatment due to TEAEs. There were no treatment-related fatal serious AEs. In the dose-finding combination cohort, 12/18 evaluable pts (66.7%) achieved PFS-4. In the phase II expansion cohort, 5/8 evaluable pts (62.5%) achieved PFS-4.
Conclusions
The combination of RPh2D LEN (14 mg/m2) + chemo had a manageable safety profile with promising preliminary evidence of efficacy.
Clinical trial identification
NCT02432274.
Legal entity responsible for the study
Eisai Inc.
Funding
Eisai Inc.
Disclosure
A. Longhi: Non-remunerated activity/ies, non-financial support: PharmaMar, Takeda; Research grant / Funding (institution): Takeda. M. Casanova: Advisory / Consultancy, advisory role: Bayer; Advisory / Consultancy, advisory role: Lilly; Advisory / Consultancy, advisory role: Roche; Advisory / Consultancy, advisory role: Tesaro. S.S. Bielack: Travel / Accommodation / Expenses, site fees for study preparation: Eisai; Travel / Accommodation / Expenses, personal fees from Clinigen: Clinigen; Travel / Accommodation / Expenses, personal fees from Lilly: Lilly; Travel / Accommodation / Expenses, personal fees from Novartis: Novartis; Travel / Accommodation / Expenses, personal fees from Bayer: Bayer; Travel / Accommodation / Expenses, personal fees from Pfizer: Pfizer; Travel / Accommodation / Expenses, personal fees from Isofol: Isofol; Travel / Accommodation / Expenses, personal fees from Sensorion: Sensorion; Travel / Accommodation / Expenses, personal fees from Ipsen: Ipsen; Advisory / Consultancy, Institution negotiating consultancy agreement with Eisai: Eisai. S. Gallego Melcon: Travel / Accommodation / Expenses: Loxo Oncology; Advisory / Consultancy: Bayer, Eusa. All other authors have declared no conflicts of interest.</description><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid/><recordid>eNqVkEtOwzAQhi0EEuVxAHazbAVpnKRNmzUU0V0X7CM3mTRGicfymEdZse09uAhX6UlwVS7AZh6a75dGnxA3iRwnsshiZQyZKu7rz3SejaUsTsQgmeZFNJeT5FQMZJFm0WyaTc7FBfOLlDIv0mIgfpJ8lq8eVq1ihCVU1K-1UV6TgZoYo0abWptNbI_AEvDDKsOHe0UtOc9ADXRo3kLI6DXcAnqyxLrGMOuGuFH9YdEGbGDQhMjQeh6B2mANKXjaf-32u-9Q0ylsUTmGd-1bcNgpy1jHDhunKk9uC0MXuxEQeyRWLryrrsRZozrG679-Ke4eF8_3TxG92tI63Su3LRNZHjSVR03lUVMZNGX_xH8BNSt3ng</recordid><startdate>20191001</startdate><enddate>20191001</enddate><creator>Gaspar, N</creator><creator>Sirvent, F J Bautista</creator><creator>Venkatramani, R</creator><creator>Longhi, A</creator><creator>Lervat, C</creator><creator>Casanova, M</creator><creator>Aerts, I</creator><creator>Bielack, S S</creator><creator>Entz-Werle, N</creator><creator>Strauss, S</creator><creator>He, C</creator><creator>Thebaud, E</creator><creator>Locatelli, F</creator><creator>Morland, B</creator><creator>Melcon, S Gallego</creator><creator>Nieto, A Cañete</creator><creator>Marec- Bérard, P</creator><creator>Gambart, M</creator><creator>Rossig, C</creator><creator>Campbell-Hewson, Q</creator><general>Oxford University Press</general><scope/></search><sort><creationdate>20191001</creationdate><title>1676PDPhase I combination dose-finding/phase II expansion cohorts of lenvatinib + etoposide + ifosfamide in patients (pts) aged 2 to ≤ 25 years with relapsed/refractory (r/r) osteosarcoma</title><author>Gaspar, N ; Sirvent, F J Bautista ; Venkatramani, R ; Longhi, A ; Lervat, C ; Casanova, M ; Aerts, I ; Bielack, S S ; Entz-Werle, N ; Strauss, S ; He, C ; Thebaud, E ; Locatelli, F ; Morland, B ; Melcon, S Gallego ; Nieto, A Cañete ; Marec- Bérard, P ; Gambart, M ; Rossig, C ; Campbell-Hewson, Q</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-oup_primary_10_1093_annonc_mdz283_0093</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gaspar, N</creatorcontrib><creatorcontrib>Sirvent, F J Bautista</creatorcontrib><creatorcontrib>Venkatramani, R</creatorcontrib><creatorcontrib>Longhi, A</creatorcontrib><creatorcontrib>Lervat, C</creatorcontrib><creatorcontrib>Casanova, M</creatorcontrib><creatorcontrib>Aerts, I</creatorcontrib><creatorcontrib>Bielack, S S</creatorcontrib><creatorcontrib>Entz-Werle, N</creatorcontrib><creatorcontrib>Strauss, S</creatorcontrib><creatorcontrib>He, C</creatorcontrib><creatorcontrib>Thebaud, E</creatorcontrib><creatorcontrib>Locatelli, F</creatorcontrib><creatorcontrib>Morland, B</creatorcontrib><creatorcontrib>Melcon, S Gallego</creatorcontrib><creatorcontrib>Nieto, A Cañete</creatorcontrib><creatorcontrib>Marec- Bérard, P</creatorcontrib><creatorcontrib>Gambart, M</creatorcontrib><creatorcontrib>Rossig, C</creatorcontrib><creatorcontrib>Campbell-Hewson, Q</creatorcontrib><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gaspar, N</au><au>Sirvent, F J Bautista</au><au>Venkatramani, R</au><au>Longhi, A</au><au>Lervat, C</au><au>Casanova, M</au><au>Aerts, I</au><au>Bielack, S S</au><au>Entz-Werle, N</au><au>Strauss, S</au><au>He, C</au><au>Thebaud, E</au><au>Locatelli, F</au><au>Morland, B</au><au>Melcon, S Gallego</au><au>Nieto, A Cañete</au><au>Marec- Bérard, P</au><au>Gambart, M</au><au>Rossig, C</au><au>Campbell-Hewson, Q</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>1676PDPhase I combination dose-finding/phase II expansion cohorts of lenvatinib + etoposide + ifosfamide in patients (pts) aged 2 to ≤ 25 years with relapsed/refractory (r/r) osteosarcoma</atitle><jtitle>Annals of oncology</jtitle><date>2019-10-01</date><risdate>2019</risdate><volume>30</volume><issue>Supplement_5</issue><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Abstract
Background
Lenvatinib (LEN) is a multikinase inhibitor of VEGFR1–3 and other targets. We report data from phase Ib dose-finding and phase II expansion cohorts of LEN + etoposide + ifosfamide in pts with r/r osteosarcoma.
Methods
Pts were aged 2 to ≤ 25 years with r/r osteosarcoma and <2 prior VEGF-targeted therapies. The phase Ib starting dose was LEN 11 mg/m2/day + ifosfamide 3000 mg/m2 + etoposide 100 mg/m2 daily/3 days. On determination of the recommended phase II dose (RPh2D) of LEN + chemo, pts were enrolled into the phase II expansion cohort. Primary end points: phase Ib, RPh2D; phase II, 4 months’ progression-free survival (PFS-4).
Results
In the phase Ib dose-finding cohort (n = 22), pts received LEN 11 mg/m2 (n = 7) and 14 mg/m2 (n = 15) + chemo. Dose-limiting toxicities were: Grade (G) 4 thrombocytopenia (n = 1; LEN 11 mg/m2), G4 thrombocytopenia and G3 epistaxis (n = 1; LEN 14 mg/m2), G2 oral dysesthesia, G3 muscle spasm, and G2 back pain (n = 1; LEN 14 mg/m2). RPh2D was LEN 14 mg/m2 + chemo. In the expansion cohort (n = 20), the median number of LEN cycles received was 4 (range: 1–7). As reported in the database, the most frequent treatment-emergent adverse events (TEAEs) were platelet count decreased/thrombocytopenia (50%/30%), neutropenia/neutrophil count decreased (45%/25%), anemia (45%), nausea (40%), ALT increased, diarrhea, and white blood cell count decreased (30% each). Most frequent G ≥ 3 TEAEs were neutropenia/neutrophil count decreased (45%/25%), platelet count decreased/thrombocytopenia (40%/20%), white blood cell count decreased (30%), and anemia (25%). Pneumothorax was observed in the dose-finding cohort (n = 6) and expansion cohort (n = 1); 2 (dose-finding cohort) were ≥G3; and 1 was post-thoracotomy. 4 Pts (dose-finding cohort) discontinued treatment due to TEAEs. There were no treatment-related fatal serious AEs. In the dose-finding combination cohort, 12/18 evaluable pts (66.7%) achieved PFS-4. In the phase II expansion cohort, 5/8 evaluable pts (62.5%) achieved PFS-4.
Conclusions
The combination of RPh2D LEN (14 mg/m2) + chemo had a manageable safety profile with promising preliminary evidence of efficacy.
Clinical trial identification
NCT02432274.
Legal entity responsible for the study
Eisai Inc.
Funding
Eisai Inc.
Disclosure
A. Longhi: Non-remunerated activity/ies, non-financial support: PharmaMar, Takeda; Research grant / Funding (institution): Takeda. M. Casanova: Advisory / Consultancy, advisory role: Bayer; Advisory / Consultancy, advisory role: Lilly; Advisory / Consultancy, advisory role: Roche; Advisory / Consultancy, advisory role: Tesaro. S.S. Bielack: Travel / Accommodation / Expenses, site fees for study preparation: Eisai; Travel / Accommodation / Expenses, personal fees from Clinigen: Clinigen; Travel / Accommodation / Expenses, personal fees from Lilly: Lilly; Travel / Accommodation / Expenses, personal fees from Novartis: Novartis; Travel / Accommodation / Expenses, personal fees from Bayer: Bayer; Travel / Accommodation / Expenses, personal fees from Pfizer: Pfizer; Travel / Accommodation / Expenses, personal fees from Isofol: Isofol; Travel / Accommodation / Expenses, personal fees from Sensorion: Sensorion; Travel / Accommodation / Expenses, personal fees from Ipsen: Ipsen; Advisory / Consultancy, Institution negotiating consultancy agreement with Eisai: Eisai. S. Gallego Melcon: Travel / Accommodation / Expenses: Loxo Oncology; Advisory / Consultancy: Bayer, Eusa. All other authors have declared no conflicts of interest.</abstract><pub>Oxford University Press</pub><doi>10.1093/annonc/mdz283.009</doi></addata></record> |
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| ispartof | Annals of oncology, 2019-10, Vol.30 (Supplement_5) |
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| source | Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| title | 1676PDPhase I combination dose-finding/phase II expansion cohorts of lenvatinib + etoposide + ifosfamide in patients (pts) aged 2 to ≤ 25 years with relapsed/refractory (r/r) osteosarcoma |
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