The DOI matches its Crossref record; 11 of the 11 references it cites were found in a registry or an index.
Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study
Open accessAbstract
BACKGROUND: In the global FLAURA study, first-line osimertinib, a third-generation irreversible tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR), significantly improved progression-free survival (PFS) and overall survival (OS) versus comparator EGFR TKIs in patients with EGFR mutation-positive (EGFRm) advanced non-small-cell lung cancer (NSCLC). OBJECTIVE: The FLAURA China study assessed first-line osimertinib in Chinese patients with EGFRm advanced NSCLC (NCT02296125). METHODS: FLAURA China was a double-blind, randomized, phase III study. Adults from mainland China with previously untreated EGFRm (Exon 19 deletion or L858R) advanced NSCLC were enrolled in the global study or a China-only study under the same protocol; 136 patients were randomized to osimertinib (80 mg once daily [od]; n = 71) or comparator EGFR TKI (gefitinib or erlotinib; all sites selected gefitinib 250 mg od; n = 65). Patients were randomized and allocated to treatment groups by a central computer system. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was investigator-assessed PFS; OS was a secondary endpoint. RESULTS: All 136 randomized patients were analyzed. Osimertinib extended median PFS by 8.0 months versus comparator EGFR TKI (17.8 vs. 9.8 months; hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.37-0.85). Median OS was 33.1 months in the osimertinib group versus 25.7 months in the comparator group (HR 0.85; 95% CI 0.56-1.29). At 3 years, 20% of patients on osimertinib and 8% on the comparator remained on randomized treatment. Grade 3 or higher adverse events (AEs) were reported in 54 and 28% of patients in the osimertinib and comparator groups, respectively, driven by increased local reporting of laboratory- and disease-related AEs. No new safety signals were identified. CONCLUSIONS: First-line osimertinib treatment resulted in a clinically meaningful PFS and OS benefit versus comparator EGFR TKI in Chinese patients with EGFRm advanced NSCLC. Safety data were consistent with the known safety profile of osimertinib. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02296125, registered 20 November 2014.
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Cites
Osimertinib in Untreated EGFR -Mutated Advanced Non–Small-Cell Lung Cancer
Soria, J.-C., Ohe, Y., Vansteenkiste, J., Reungwetwattana, T., Chewaskulyong, B., Lee, K. H., Dechaphunkul, A., Imamura, F., Nogami, N., Kurata, T., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1713137 · Cited by 5,508
Self-citationOsimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer
Mok, T. S., Wu, Y.-L., Ahn, M.-J., Garassino, M. C., Kim, H. R., Ramalingam, S. S., Shepherd, F. A., He, Y., Akamatsu, H., Theelen, W. S. M. E., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1612674 · Cited by 3,379
Self-citationOverall Survival with Osimertinib in Untreated, EGFR -Mutated Advanced NSCLC
Ramalingam, S. S., Vansteenkiste, J., Planchard, D., Cho, B. C., Gray, J. E., Ohe, Y., Zhou, C., Reungwetwattana, T., Cheng, Y., Chewaskulyong, B., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1913662 · Cited by 2,914
Self-citationCross, D. A. E., Ashton, S. E., Ghiorghiu, S., Eberlein, C., Nebhan, C. A., Spitzler, P. J., Orme, J. P., Finlay, M. R. V., Ward, R. A., Mellor, M. J., et al. (2014) · Cancer Discovery · doi:10.1158/2159-8290.cd-14-0337 · Cited by 2,246
Wu, Y.-L., Zhou, C., Hu, C.-P., Feng, J., Lu, S., Huang, Y., Li, W., Hou, M., Shi, J. H., Lee, K. Y., et al. (2014) · The Lancet Oncology · doi:10.1016/s1470-2045(13)70604-1 · Cited by 1,978
Self-citationYang, J. C.-H., Wu, Y.-L., Schuler, M., Sebastian, M., Popat, S., Yamamoto, N., Zhou, C., Hu, C.-P., O'Byrne, K., Feng, J., et al. (2015) · The Lancet Oncology · doi:10.1016/s1470-2045(14)71173-8 · Cited by 1,574 · cited 1×
“Most of these trials, which compared EGFR TKI with chemotherapy or head to head with another EGFR TKI, have not demonstrated statistically significant differences in OS [7, 9, 16, 17, 21].”
BackgroundWu, Y.-L., Cheng, Y., Zhou, X., Lee, K. H., Nakagawa, K., Niho, S., Tsuji, F., Linke, R., Rosell, R., Corral, J., et al. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30608-3 · Cited by 1,216
Self-citationMiller, V. A., Hirsh, V., Cadranel, J., Chen, Y.-M., Park, K., Kim, S.-W., Zhou, C., Su, W.-C., Wang, M., Sun, Y., et al. (2012) · The Lancet Oncology · doi:10.1016/s1470-2045(12)70087-6 · Cited by 961
Wu, Y.-L., Ahn, M.-J., Garassino, M. C., Han, J.-Y., Katakami, N., Kim, H. R., Hodge, R., Kaur, P., Brown, A. P., Ghiorghiu, D., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2018.77.9363 · Cited by 517
Zhou, C., Wu, Y. L., Chen, G., Feng, J., Liu, X.-Q., Wang, C., Zhang, S., Wang, J., Zhou, S., Ren, S., et al. (2015) · Annals of Oncology · doi:10.1093/annonc/mdv276 · Cited by 464
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Cited by
Non‐small cell lung cancer in China
Chen, P., Liu, Y., Wen, Y., & Zhou, C. (2022) · Cancer Communications · doi:10.1002/cac2.12359 · Cited by 656
Advances and future directions in ROS1 fusion-positive lung cancer
Boulanger, M. C., Schneider, J. L., & Lin, J. J. (2024) · The Oncologist · doi:10.1093/oncolo/oyae205 · Cited by 38
Xiong, A., Ren, S., Liu, H., Miao, L., Wang, L., Chen, J., Li, W., Li, R., Wang, X., Lu, Z., et al. (2022) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2022.06.013 · Cited by 20
Self-citationShi, Y., Zhou, J., Zhao, Y., Zhu, B., Zhang, L., Li, X., Fang, J., Shi, J., Zhuang, Z., Yang, S., et al. (2023) · BMC Medicine · doi:10.1186/s12916-022-02692-8 · Cited by 13
Metadata
- Authors
- Cheng, Y., He, Y., Li, W., Zhang, H.-L., Zhou, Q., Wang, B., Liu, C., Walding, A., Saggese, M., Huang, X., Fan, M., Wang, J., & Ramalingam, S. S.
- Venue
- Targeted Oncology
- Published
- 2021-02-05
- Volume
- 16
- Issue
- 2
- Pages
- 165-176
- ISSN
- 1776-2596 (ISSN-L)
- 1776-260X
- OpenAlex
- W3128870202
- Cited by
- 170
- References
- 11
- FWCI
- 14.75
- Type
- journal article
- Language
- en
- Open access
- hybrid
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