The DOI matches its Crossref record; 19 of the 19 references it cites were found in a registry or an index.
Gefitinib Alone Versus Gefitinib Plus Chemotherapy for Non–Small-Cell Lung Cancer With Mutated Epidermal Growth Factor Receptor: NEJ009 Study
Abstract
PURPOSE: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor combined with cytotoxic chemotherapy is highly effective for the treatment of advanced non–small-cell lung cancer (NSCLC) with EGFR mutations; however, little is known about the efficacy and safety of this combination compared with that of standard therapy with EGFR- tyrosine kinase inhibitors alone. METHODS: We randomly assigned 345 patients with newly diagnosed metastatic NSCLC with EGFR mutations to gefitinib combined with carboplatin plus pemetrexed or gefitinib alone. Progression-free survival (PFS), PFS2, and overall survival (OS) were sequentially analyzed as primary end points according to a hierarchical sequential testing method. Secondary end points were objective response rate (ORR), safety, and quality of life. RESULTS: The combination group demonstrated a better ORR and PFS than the gefitinib group (ORR, 84% v 67% [ P < .001]; PFS, 20.9 v 11.9 months; hazard ratio for death or disease progression, 0.490 [ P < .001]), although PFS2 was not significantly different (20.9 v 18.0 months; P = .092). Median OS in the combination group was also significantly longer than in the gefitinib group (50.9 v 38.8 months; hazard ratio for death, 0.722; P = .021). The rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities, in the combination group was higher than in the gefitinib group (65.3% v 31.0%); there were no differences in quality of life. One treatment-related death was observed in the combination group. CONCLUSION: Compared with gefitinib alone, gefitinib combined with carboplatin plus pemetrexed improved PFS in patients with untreated advanced NSCLC with EGFR mutations with an acceptable toxicity profile, although its OS benefit requires further validation.
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Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., Filiberti, A., Flechtner, H., Fleishman, S. B., Haes, J. C. J. M. D., et al. (1993) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/85.5.365 · Cited by 16,005
Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
Mok, T. S., Wu, Y.-L., Thongprasert, S., Yang, C.-H., Chu, D.-T., Saijo, N., Sunpaweravong, P., Han, B., Margono, B., Ichinose, Y., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0810699 · Cited by 8,261
Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer
Gandhi, L., Rodríguez-Abreu, D., Gadgeel, S., Esteban, E., Felip, E., De Angelis, F., Domine, M., Clingan, P., Hochmair, M. J., Powell, S. F., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1801005 · Cited by 6,607
Gefitinib or Chemotherapy for Non–Small-Cell Lung Cancer with Mutated EGFR
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Self-citationOsimertinib 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
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Self-citationZhou, C., Wu, Y.-L., Chen, G., Feng, J., Liu, X.-Q., Wang, C., Zhang, S., Wang, J., Zhou, S., Ren, S., et al. (2011) · The Lancet Oncology · doi:10.1016/s1470-2045(11)70184-x · Cited by 4,081
Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer
Paz-Ares, L., Luft, A., Vicente, D., Tafreshi, A., Gümüş, M., Mazières, J., Hermes, B., Çay Şenler, F., Csőszi, T., Fülöp, A., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1810865 · Cited by 3,617
Self-citationOsimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer
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Lung cancer immunotherapy: progress, pitfalls, and promises
Lahiri, A., Maji, A., Potdar, P. D., Singh, N., Parikh, P., Bisht, B., Mukherjee, A., & Paul, M. K. (2023) · Molecular Cancer · doi:10.1186/s12943-023-01740-y · Cited by 1,102
Smart nanoparticles for cancer therapy
Sun, L., Liu, H., Ye, Y., Lei, Y., Islam, R., Tan, S., Tong, R., Miao, Y.-B., & Cai, L. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-023-01642-x · Cited by 1,073
Hendriks, L. E., Kerr, K. M., Menis, J., Mok, T. S., Nestle, U., Passaro, A., Peters, S., Planchard, D., Smit, E. F., Solomon, B. J., et al. (2023) · Annals of Oncology · doi:10.1016/j.annonc.2022.12.009 · Cited by 853
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Metadata
- Authors
- Hosomi, Y., Morita, S., Sugawara, S., Kato, T., Fukuhara, T., Gemma, A., Takahashi, K., Fujita, Y., Harada, T., Minato, K., Takamura, K., Hagiwara, K., Kobayashi, K., Nukiwa, T., Inoue, A., & for the North-East Japan Study Group
- Venue
- Journal of Clinical Oncology
- Published
- 2020-01-10
- Volume
- 38
- Issue
- 2
- Pages
- 115-123
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2987053327
- Cited by
- 481
- References
- 19
- FWCI
- 41.35
- Type
- journal article
- Language
- en
- Open access
- closed
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- Hosomi, Y., Morita, S., Sugawara, S., Kato, T., Fukuhara, T., Gemma, A., Takahashi, K., Fujita, Y., Harada, T., Minato, K., Takamura, K., Hagiwara, K., Kobayashi, K., Nukiwa, T., Inoue, A., & for the North-East Japan Study Group. (2020). Gefitinib Alone Versus Gefitinib Plus Chemotherapy for Non–Small-Cell Lung Cancer With Mutated Epidermal Growth Factor Receptor: NEJ009 Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.19.01488
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