A phase III randomised controlled trial of erlotinib vs gefitinib in advanced non-small cell lung cancer with EGFR mutations
Open accessAbstract
BACKGROUND: A phase III trial was conducted to compare the safety and efficacy of erlotinib with that of gefitinib in advanced non-small cell lung cancer harbouring epidermal growth factor receptor mutations in exon 19 or 21. METHODS: Eligible patients were randomised to receive erlotinib (150 mg per day) or gefitinib (250 mg per day) orally until disease progression or unacceptable toxicity. We aimed to determine whether erlotinib is superior to gefitinib in efficacy. The primary end point was progression-free survival. RESULTS: A total of 256 patients were randomised to receive erlotinib (N=128) or gefitinib (N=128). Median progression-free survival was not better with erlotinib than with gefitinib (13.0 vs 10.4 months, 95% confidence interval (CI) 0.62-1.05, P=0.108). The corresponding response rates and median overall survival were 56.3% vs 52.3% (P=0.530) and 22.9 vs 20.1 months (95% CI 0.63-1.13, P=0.250), respectively. There were no significant differences in grade 3/4 toxicities between the two arms (P=0.172). CONCLUSIONS: The primary end point was not met. Erlotinib was not significantly superior to gefitinib in terms of efficacy in advanced non-small cell lung cancer with epidermal growth factor receptor mutations in exon 19 or 21, and the two treatments had similar toxicities.
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In head-to-head trials, there were no significant differences between gefitinib and erlotinib in PFS, ORR, or OS in any line of treatment.
“there were no significant differences between the two first-generation agents with regard to duration of progression-free survival (PFS), objective response rate (ORR), or overall survival (OS) in any line of treatment.”
From Afatinib for the treatment of <i>EGFR</i> mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [36]
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Cites
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Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
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Self-citationSequist, L. V., Yang, J. C.-H., Yamamoto, N., O'Byrne, K., Hirsh, V., Mok, T., Geater, S. L., Orlov, S., Tsai, C.-M., Boyer, M., et al. (2013) · Journal of Clinical Oncology · doi:10.1200/jco.2012.44.2806 · Cited by 3,228 · see citing works
Self-citationWu, 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 · see citing works
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× · see citing works
“Recently, an analysis of OS data from two randomised phase III trials suggested that EGFR del19-positive disease might be distinct from L858R-positive disease and that these subgroups should be analysed separately in future trials (Sequist et al, 2013; Wu et al, 2014; Yang et al, 2015).”
BackgroundSelf-citationPark, K., Tan, E.-H., O'Byrne, K., Zhang, L., Boyer, M., Mok, T., Hirsh, V., Yang, J. C.-H., Lee, K. H., Lu, S., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30033-x · Cited by 1,183 · cited 1× · see citing works
“Recently, in the LUX LUNG 7 trial, first-line afatinib (an irreversible ErbB family blocker) significantly improved PFS vs gefitinib in EGFR-mutant patients (HR 0.73, 95% CI 0.57–0.95, P¼ 0.0165; Park et al, 2016).”
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- Authors
- Yang, J. J., Zhou, Q., Yan, H. H., Zhang, X. C., Chen, H. J., Tu, H. Y., Wang, Z., Xu, C. R., Su, J., Wang, B. C., Jiang, B. Y., Bai, X. Y., Zhong, W. Z., Yang, X. N., & Wu, Y. L.
- Affiliations
- Guangdong General Hospital (CN)
- Corresponding author
- Wu, Y L
- Venue
- British Journal of Cancer
- Published
- 2017-01-19
- Volume
- 116
- Issue
- 5
- Pages
- 568-574
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- PMC
- PMC5344291
- OpenAlex
- W2575565717
- Cited by
- 175
- References
- 7
- Citations by year
- 2026: 2 · 2025: 12 · 2024: 6 · 2023: 11 · 2022: 18 · 2021: 31 · 2020: 31 · 2019: 30 · 2018: 26 · 2017: 6 · 2016: 2
- FWCI
- 21.04
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- British Journal of Cancer (publishedVersion, cc-by-nc-sa)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion, cc-by-nc-sa)
- PubMed (publishedVersion)
- Funders
- National Health and Family Planning Commission of the People's Republic of China (201402031)
- Guangzhou Municipal Science and Technology Bureau (2014Y2-00545)
- NIH Clinical Center
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Keywords
- erlotinib, gefitinib, advanced non-small cell lung cancer, EGFR mutation, exon 19 deletion, exon 21 mutation, EGFR tyrosine kinase inhibitors, progression-free survival, overall survival, drug toxicity comparison
- MeSH terms
- Erlotinib Hydrochloride, Gefitinib, Administration, Oral, Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Quinazolines, Survival Analysis, Treatment Outcome, ErbB Receptors
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