The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
FDA Drug Approval Summary: Erlotinib (Tarceva®) Tablets
Abstract
On November 18, 2004, erlotinib (Tarceva®; OSI Pharmaceuticals, Inc., Melville, NY, http://www.osip.com, and Genentech, Inc., South San Francisco, CA, http://www.gene.com) received regular approval as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Survival of erlotinib-treated patients was superior to that of placebo-treated patients. The median survival duration of erlotinib-treated patients was 6.67 months, compared with 4.70 months for placebo-treated patients. Exploratory univariate analyses showed a larger survival prolongation in two subsets of patients: those who never smoked and those with epidermal growth factor receptor (EGFR)-positive tumors. Patients who never smoked and were EGFR-positive had a large erlotinib survival benefit. Erlotinib was also superior to placebo for progression-free survival and a response rate of 8.9% versus 0.9%. Skin rash and diarrhea were the most common erlotinib adverse events. Severe rash occurred in 8%, and severe diarrhea occurred in 6% of erlotinib-treated patients. In the first-line treatment of NSCLC, two large, controlled, randomized trials showed no benefit from adding erlotinib to doublet, platinum-based chemotherapy. Therefore, erlotinib is not indicated for use in this setting.
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Lynch, T. J., Bell, D. W., Sordella, R., Gurubhagavatula, S., Okimoto, R. A., Brannigan, B. W., Harris, P. L., Haserlat, S. M., Supko, J. G., Haluska, F. G., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa040938 · Cited by 11,486
EGFR Mutations in Lung Cancer: Correlation with Clinical Response to Gefitinib Therapy
Paez, J. G., Jänne, P. A., Lee, J. C., Tracy, S., Greulich, H., Gabriel, S., Herman, P., Kaye, F. J., Lindeman, N., Boggon, T. J., et al. (2004) · Science · doi:10.1126/science.1099314 · Cited by 9,368
Herbst, R. S., Prager, D., Hermann, R., Fehrenbacher, L., Johnson, B. E., Sandler, A., Kris, M. G., Tran, H. T., Klein, P., Li, X., et al. (2005) · Journal of Clinical Oncology · doi:10.1200/jco.2005.02.840 · Cited by 1,490 · cited 1×
“evidence of erlotinib benefit in tumor response rates, time to progression, or overall survival when compared with placebo-treated patients [4, 5 ].”
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Self-citationNitrogen Containing Heterocycles as Anticancer Agents: A Medicinal Chemistry Perspective
Kumar, A., Singh, A. K., Singh, H., Vijayan, V., Kumar, D., Naik, J., Thareja, S., Yadav, J. P., Pathak, P., Grishina, M., et al. (2023) · Pharmaceuticals · doi:10.3390/ph16020299 · Cited by 363
Gonzales, A. J., Hook, K. E., Althaus, I. W., Ellis, P. A., Trachet, E., Delaney, A. M., Harvey, P. J., Ellis, T. A., Amato, D. M., Nelson, J. M., et al. (2008) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-07-2232 · Cited by 226
Metadata
- Authors
- Cohen, M. H., Johnson, J. R., Chen, Y.-F., Sridhara, R., & Pazdur, R.
- Venue
- The Oncologist
- Publisher
- Oxford University Press (OUP)
- Published
- 2005-08-01
- Volume
- 10
- Issue
- 7
- Pages
- 461-466
- ISSN
- 1083-7159 (ISSN-L)
- 1549-490X
- OpenAlex
- W2109678955
- Cited by
- 445
- References
- 3
- FWCI
- 11.35
- Type
- journal article
- Language
- en
- Open access
- closed
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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