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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
- Source :
- Journal of Thoracic Oncology, Journal of Thoracic Oncology, 2021, 16 (9), pp.1547-1558. ⟨10.1016/j.jtho.2021.02.009⟩, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, instname, Journal of Thoracic Oncology, 16(9), 1547-1558. ELSEVIER SCIENCE INC, Blackhall, F, Jao, K, Greillier, L, Cho, B C, Penkov, K, Reguart, N, Majem, M, Nackaerts, K, Syrigos, K, Hansen, K, Schuette, W, Cetnar, J, Cappuzzo, F, Okamoto, I, Erman, M, Langer, S W, Kato, T, Groen, H, Sun, Z, Luo, Y, Tanwani, P, Caffrey, L, Komarnitsky, P & Reinmuth, N 2021, ' Efficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC : Results From the Phase 3 TAHOE Study ', Journal of Thoracic Oncology, vol. 16, no. 9, pp. 1547-1558 . https://doi.org/10.1016/j.jtho.2021.02.009
- Publication Year :
- 2021
- Publisher :
- HAL CCSD, 2021.
-
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. ispartof: JOURNAL OF THORACIC ONCOLOGY vol:16 issue:9 pages:1547-1558 ispartof: location:United States status: published
- Subjects :
- 0301 basic medicine
Pulmonary and Respiratory Medicine
Oncology
medicine.medical_specialty
medicine.medical_treatment
CELL LUNG-CANCER
Population
Peripheral edema
Phases of clinical research
[SDV.CAN]Life Sciences [q-bio]/Cancer
Delta-like protein 3
Rovalpituzumab tesirine
[SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract
03 medical and health sciences
0302 clinical medicine
Internal medicine
medicine
DRUG
education
ComputingMilieux_MISCELLANEOUS
Chemotherapy
education.field_of_study
Small cell lung cancer
business.industry
Hazard ratio
Confidence interval
030104 developmental biology
030220 oncology & carcinogenesis
Topotecan
medicine.symptom
business
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 15560864 and 15561380
- Database :
- OpenAIRE
- Journal :
- Journal of Thoracic Oncology, Journal of Thoracic Oncology, 2021, 16 (9), pp.1547-1558. ⟨10.1016/j.jtho.2021.02.009⟩, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, instname, Journal of Thoracic Oncology, 16(9), 1547-1558. ELSEVIER SCIENCE INC, Blackhall, F, Jao, K, Greillier, L, Cho, B C, Penkov, K, Reguart, N, Majem, M, Nackaerts, K, Syrigos, K, Hansen, K, Schuette, W, Cetnar, J, Cappuzzo, F, Okamoto, I, Erman, M, Langer, S W, Kato, T, Groen, H, Sun, Z, Luo, Y, Tanwani, P, Caffrey, L, Komarnitsky, P & Reinmuth, N 2021, ' Efficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC : Results From the Phase 3 TAHOE Study ', Journal of Thoracic Oncology, vol. 16, no. 9, pp. 1547-1558 . https://doi.org/10.1016/j.jtho.2021.02.009
- Accession number :
- edsair.doi.dedup.....c3e048ee78da505d668e2db8c63cc573