Cited 104 times in
Efficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC: Results From the Phase 3 TAHOE Study
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2021-10-21T00:17:06Z | - |
dc.date.available | 2021-10-21T00:17:06Z | - |
dc.date.issued | 2021-09 | - |
dc.identifier.issn | 1556-0864 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/185456 | - |
dc.description.abstract | Introduction: DLL3, an atypical Notch ligand, is expressed in SCLC tumors but is not detectable in normal adult tissues. Rovalpituzumab tesirine (Rova-T) is an antibody-drug conjugate containing a DLL3-targeting antibody tethered to a cytotoxic agent pyrrolobenzodiazepine by means of a protease-cleavable linker. The efficacy and safety of Rova-T compared with topotecan as second-line therapy in patients with SCLC expressing high levels of DLL3 (DLL3-high) was evaluated. Methods: The TAHOE study was an open-label, two-to-one randomized, phase 3 study comparing Rova-T with topotecan as second-line therapy in DLL3-high advanced or metastatic SCLC. Rova-T (0.3 mg/kg) was administered intravenously on day 1 of a 42-day cycle for two cycles, with two additional cycles available to patients who met protocol-defined criteria for continued dosing. Topotecan (1.5 mg/m2) was administered intravenously on days 1 to 5 of a 21-day cycle. The primary end point was overall survival (OS). Results: Patients randomized to Rova-T (n = 296) and topotecan (n = 148) were included in the efficacy analyses. The median age was 64 years, and 77% had the extensive disease at initial diagnosis. The median OS (95% confidence interval) was 6.3 months (5.6-7.3) in the Rova-T arm and 8.6 months (7.7-10.1) in the topotecan arm (hazard ratio, 1.46 [95% confidence interval: 1.17-1.82]). An independent data monitoring committee recommended that enrollment be discontinued because of the shorter OS observed with Rova-T compared with topotecan. Safety profiles for both drugs were consistent with previous reports. Conclusions: Compared with topotecan, which is the current standard second-line chemotherapy, Rova-T exhibited an inferior OS and higher rates of serosal effusions, photosensitivity reaction, and peripheral edema in patients with SCLC. A considerable unmet therapeutic need remains in this population. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | JOURNAL OF THORACIC ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / therapeutic use | - |
dc.subject.MESH | Benzodiazepinones | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunoconjugates* / therapeutic use | - |
dc.subject.MESH | Intracellular Signaling Peptides and Proteins | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Membrane Proteins | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Small Cell Lung Carcinoma* / drug therapy | - |
dc.subject.MESH | Topotecan / therapeutic use | - |
dc.title | Efficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC: Results From the Phase 3 TAHOE Study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Fiona Blackhall | - |
dc.contributor.googleauthor | Kevin Jao | - |
dc.contributor.googleauthor | Laurent Greillier | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Konstantin Penkov | - |
dc.contributor.googleauthor | Noemi Reguart | - |
dc.contributor.googleauthor | Margarita Majem | - |
dc.contributor.googleauthor | Kristiaan Nackaerts | - |
dc.contributor.googleauthor | Konstantinos Syrigos | - |
dc.contributor.googleauthor | Karin Hansen | - |
dc.contributor.googleauthor | Wolfgang Schuette | - |
dc.contributor.googleauthor | Jeremy Cetnar | - |
dc.contributor.googleauthor | Federico Cappuzzo | - |
dc.contributor.googleauthor | Isamu Okamoto | - |
dc.contributor.googleauthor | Mustafa Erman | - |
dc.contributor.googleauthor | Seppo W Langer | - |
dc.contributor.googleauthor | Terufumi Kato | - |
dc.contributor.googleauthor | Harry Groen | - |
dc.contributor.googleauthor | Zhaowen Sun | - |
dc.contributor.googleauthor | Yan Luo | - |
dc.contributor.googleauthor | Poonam Tanwani | - |
dc.contributor.googleauthor | Laura Caffrey | - |
dc.contributor.googleauthor | Philip Komarnitsky | - |
dc.contributor.googleauthor | Niels Reinmuth | - |
dc.identifier.doi | 10.1016/j.jtho.2021.02.009 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J01909 | - |
dc.identifier.eissn | 1556-1380 | - |
dc.identifier.pmid | 33607312 | - |
dc.subject.keyword | Delta-like protein 3 | - |
dc.subject.keyword | Rovalpituzumab tesirine | - |
dc.subject.keyword | Small cell lung cancer | - |
dc.subject.keyword | Topotecan | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 16 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | 1547 | - |
dc.citation.endPage | 1558 | - |
dc.identifier.bibliographicCitation | JOURNAL OF THORACIC ONCOLOGY, Vol.16(9) : 1547-1558, 2021-09 | - |
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