The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Efficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC: Results From the Phase 3 TAHOE Study
Open accessAbstract
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/m 2 ) 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.
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Paz-Ares, L., Dvorkin, M., Chen, Y., Reinmuth, N., Hotta, K., Trukhin, D., Statsenko, G., Hochmair, M. J., Özgüroğlu, M., Ji, J. H., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(19)32222-6 · Cited by 2,298
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Thomas, A., Teicher, B. A., & Hassan, R. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30030-4 · Cited by 606
Delta-like protein 3 expression and therapeutic targeting in neuroendocrine prostate cancer
Puca, L., Gavyert, K., Sailer, V., Conteduca, V., Dardenne, E., Sigouros, M., Isse, K., Kearney, M., Vosoughi, A., Fernandez, L., et al. (2019) · Science Translational Medicine · doi:10.1126/scitranslmed.aav0891 · Cited by 214
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Notch signaling pathway: architecture, disease, and therapeutics
Zhou, B., Lin, W., Long, Y., Yang, Y., Zhang, H., Wu, K., & Chu, Q. (2022) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-022-00934-y · Cited by 1,114
Notch signaling pathway in cancer: from mechanistic insights to targeted therapies
Shi, Q., Xue, C., Zeng, Y., Yuan, X., Chu, Q., Jiang, S., Wang, J., Zhang, Y., Zhu, D., & Li, L. (2024) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-024-01828-x · Cited by 401
Megyesfalvi, Z., Gay, C. M., Popper, H., Pirker, R., Ostoros, G., Heeke, S., Lang, C., Hoetzenecker, K., Schwendenwein, A., Boettiger, K., et al. (2023) · CA: A Cancer Journal for Clinicians · doi:10.3322/caac.21785 · Cited by 369
Paz-Ares, L., Champiat, S., Lai, W. V., Izumi, H., Govindan, R., Boyer, M., Hummel, H.-D., Borghaei, H., Johnson, M. L., Steeghs, N., et al. (2023) · Journal of Clinical Oncology · doi:10.1200/jco.22.02823 · Cited by 336
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Metadata
- Authors
- 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.
- Venue
- Journal of Thoracic Oncology
- Publisher
- Elsevier BV
- Published
- 2021-09
- Volume
- 16
- Issue
- 9
- Pages
- 1547-1558
- ISSN
- 1556-0864 (ISSN-L)
- OpenAlex
- W3132559292
- Cited by
- 279
- References
- 3
- FWCI
- 13.94
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- 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., . . . 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. https://doi.org/10.1016/j.jtho.2021.02.009
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