Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin–paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002)
Open accessAbstract
Background NEJ002 study, comparing gefitinib with carboplatin (CBDCA) and paclitaxel (PTX; Taxol) as the first-line treatment for advanced non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation, previously reported superiority of gefitinib over CBDCA/PTX on progression-free survival (PFS). Subsequent analysis was carried out mainly regarding overall survival (OS).Materials and methods For all 228 patients in NEJ002, survival data were updated in December, 2010. Detailed information regarding subsequent chemotherapy after the protocol treatment was also assessed retrospectively and the impact of some key drugs on OS was evaluated.Results The median survival time (MST) was 27.7 months for the gefitinib group, and was 26.6 months for the CBDCA/PTX group (HR, 0.887; P=0.483). The OS of patients who received platinum throughout their treatment (n=186) was not statistically different from that of patients who never received platinum (n=40). The MST of patients treated with gefitinib, platinum, and pemetrexed (PEM) or docetaxel (DOC, Taxotere; n=76) was around 3 years.Conclusions No significant difference in OS was observed between gefitinib and CBDCA/PTX in the NEJ002 study, probably due to a high crossover use of gefitinib in the CBDCA/PTX group. Considering the many benefits and the risk of missing an opportunity to use the most effective agent for EGFR-mutated NSCLC, the first-line gefitinib is strongly recommended.
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Several studies have consistently shown that EGFR TKIs (gefitinib, erlotinib, afatinib) produce higher response rates, longer PFS and improved quality of life compared with platinum-based doublet chemotherapy in PS 0-2 patients whose tumours have an activating EGFR mutation.
“Several studies have consistently demonstrated that the EGFR TKIs (gefitinib, erlotinib and afatinib) produce higher RRs, longer PFS and improve QoL compared with standard platinum-based doublet chemotherapy in patients with good PS (PS 0-2), whose tumour harbours an activating (sensitising) EGFR mutation [105-112].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [107]
Another phase III study of gefitinib versus carboplatin plus paclitaxel in patients with EGFR-sensitizing mutations found an improvement in PFS but not OS, presumably due to crossover to chemotherapy in the gefitinib arm.
“Similarly, another phase III study of gefitinib versus carboplatin plus paclitaxel in patients with EGFR-sensitizing mutations also found an improvement in PFS but not OS, again presumably secondarily to crossover to chemotherapy in the gefitinib arm.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [21]
Neither the IPASS study nor the other phase III study reported survival of patients who did or did not experience an initial response to gefitinib.
“Neither study reported the survival of patients who did or did not experience an initial response to gefitinib.20,21”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [21]
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Self-citation
- Authors
- Inoue, A., Kobayashi, K., Maemondo, M., Sugawara, S., Oizumi, S., Isobe, H., Gemma, A., Harada, M., Yoshizawa, H., Kinoshita, I., Fujita, Y., Okinaga, S., Hirano, H., Yoshimori, K., Harada, T., Saijo, Y., Hagiwara, K., Morita, S., & Nukiwa, T.
- Affiliations
- Tohoku University Hospital (JP)
- Saitama International Medical Center (JP)
- Miyagi Prefectural Hospital Organization (JP)
- Sendai Kousei Hospital (JP)
- Hokkaido University (JP)
- KKR Sapporo Medical Center (JP)
- Nippon Medical School (JP)
- Sapporo National Hospital (JP)
- Niigata University Medical and Dental Hospital (JP)
- National Hospital Organization Asahikawa Medical Center (JP)
- Iwate Prefectural Central Hospital (JP)
- Japan Anti Tuberculosis Association (JP)
- Hirosaki University (JP)
- Saitama Medical University (JP)
- Yokohama City University Medical Center (JP)
- Corresponding author
- Inoue, A.
- ORCID
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2013-01
- Volume
- 24
- Issue
- 1
- Pages
- 54-59
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2149733252
- Cited by
- 540
- References
- 5
- Citations by year
- 2026: 7 · 2025: 15 · 2024: 18 · 2023: 30 · 2022: 27 · 2021: 55 · 2020: 46 · 2019: 43 · 2018: 51 · 2017: 53 · 2016: 44 · 2015: 67 · 2014: 38 · 2013: 42 · 2012: 3
- FWCI
- 38.66
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Japan Society for Promotion of Science and Japanese Foundation
- Multidisciplinary Treatment of Cancer
- Tokyo Cooperative Oncology Group
- 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 › Lung Cancer Research Studies
- Keywords
- gefitinib, carboplatin, paclitaxel, non-small cell lung cancer, EGFR mutation, first-line therapy, overall survival, progression-free survival, pemetrexed, docetaxel, platinum-based chemotherapy
- MeSH terms
- Gefitinib, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Mutation, Quinazolines, Survival Analysis, Carboplatin, Paclitaxel, ErbB Receptors
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