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Efficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC: Results From the Phase 3 TAHOE Study

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dc.contributor.author조병철-
dc.date.accessioned2021-10-21T00:17:06Z-
dc.date.available2021-10-21T00:17:06Z-
dc.date.issued2021-09-
dc.identifier.issn1556-0864-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/185456-
dc.description.abstractIntroduction: 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.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherElsevier-
dc.relation.isPartOfJOURNAL OF THORACIC ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdult-
dc.subject.MESHAntibodies, Monoclonal, Humanized-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / therapeutic use-
dc.subject.MESHBenzodiazepinones-
dc.subject.MESHHumans-
dc.subject.MESHImmunoconjugates* / therapeutic use-
dc.subject.MESHIntracellular Signaling Peptides and Proteins-
dc.subject.MESHLung Neoplasms* / drug therapy-
dc.subject.MESHMembrane Proteins-
dc.subject.MESHMiddle Aged-
dc.subject.MESHSmall Cell Lung Carcinoma* / drug therapy-
dc.subject.MESHTopotecan / therapeutic use-
dc.titleEfficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC: Results From the Phase 3 TAHOE Study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorFiona Blackhall-
dc.contributor.googleauthorKevin Jao-
dc.contributor.googleauthorLaurent Greillier-
dc.contributor.googleauthorByoung Chul Cho-
dc.contributor.googleauthorKonstantin Penkov-
dc.contributor.googleauthorNoemi Reguart-
dc.contributor.googleauthorMargarita Majem-
dc.contributor.googleauthorKristiaan Nackaerts-
dc.contributor.googleauthorKonstantinos Syrigos-
dc.contributor.googleauthorKarin Hansen-
dc.contributor.googleauthorWolfgang Schuette-
dc.contributor.googleauthorJeremy Cetnar-
dc.contributor.googleauthorFederico Cappuzzo-
dc.contributor.googleauthorIsamu Okamoto-
dc.contributor.googleauthorMustafa Erman-
dc.contributor.googleauthorSeppo W Langer-
dc.contributor.googleauthorTerufumi Kato-
dc.contributor.googleauthorHarry Groen-
dc.contributor.googleauthorZhaowen Sun-
dc.contributor.googleauthorYan Luo-
dc.contributor.googleauthorPoonam Tanwani-
dc.contributor.googleauthorLaura Caffrey-
dc.contributor.googleauthorPhilip Komarnitsky-
dc.contributor.googleauthorNiels Reinmuth-
dc.identifier.doi10.1016/j.jtho.2021.02.009-
dc.contributor.localIdA03822-
dc.relation.journalcodeJ01909-
dc.identifier.eissn1556-1380-
dc.identifier.pmid33607312-
dc.subject.keywordDelta-like protein 3-
dc.subject.keywordRovalpituzumab tesirine-
dc.subject.keywordSmall cell lung cancer-
dc.subject.keywordTopotecan-
dc.contributor.alternativeNameCho, Byoung Chul-
dc.contributor.affiliatedAuthor조병철-
dc.citation.volume16-
dc.citation.number9-
dc.citation.startPage1547-
dc.citation.endPage1558-
dc.identifier.bibliographicCitationJOURNAL OF THORACIC ONCOLOGY, Vol.16(9) : 1547-1558, 2021-09-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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