Phase III Study, V-15-32, of Gefitinib Versus Docetaxel in Previously Treated Japanese Patients With Non–Small-Cell Lung Cancer
Open accessAbstract
Purpose: This phase III study (V-15-32) compared gefitinib (250 mg/d) with docetaxel (60 mg/m 2) in patients (N = 489) with advanced/metastatic non–small-cell lung cancer (NSCLC) who had failed one or two chemotherapy regimens. Methods: The primary objective was to compare overall survival to demonstrate noninferiority for gefitinib relative to docetaxel. An unadjusted Cox regression model was used for the primary analysis. Results: Noninferiority in overall survival was not achieved (hazard ratio [HR], 1.12; 95.24% CI, 0.89 to 1.40) according to the predefined criterion (upper CI limit for HR ≤ 1.25); however, no significant difference in overall survival (P = .330) was apparent between treatments. Poststudy, 36% of gefitinib-treated patients received subsequent docetaxel, and 53% of docetaxel-treated patients received subsequent gefitinib. Gefitinib significantly improved objective response rate and quality of life versus docetaxel; progression-free survival, disease control rates, and symptom improvement were similar for the two treatments. Grades 3 to 4 adverse events occurred in 40.6% (gefitinib) and 81.6% (docetaxel) of patients. Incidence of interstitial lung disease was 5.7% (gefitinib) and 2.9% (docetaxel). Four deaths occurred due to adverse events in the gefitinib arm (three deaths as a result of interstitial lung disease, judged to be treatment related; one as a result of pneumonia, not treatment related), and none occurred in the docetaxel arm. Conclusion: Noninferiority in overall survival between gefitinib and docetaxel was not demonstrated according to predefined criteria; however, there was no statistically significant difference in overall survival. Secondary end points showed similar or superior efficacy for gefitinib compared with docetaxel. Gefitinib remains an effective treatment option for previously treated Japanese patients with NSCLC.
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Some second-line studies included patients who had received more than two previous regimens.
“Some of the second-line studies included patients who had received > two previous regimens.15,23,47,48,51,65”
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 [23]
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- Authors
- Maruyama, R., Nishiwaki, Y., Tamura, T., Yamamoto, N., Tsuboi, M., Nakagawa, K., Shinkai, T., Negoro, S., Imamura, F., Eguchi, K., Takeda, K., Inoue, A., Tomii, K., Harada, M., Masuda, N., Jiang, H., Itoh, Y., Ichinose, Y., Saijo, N., & Fukuoka, M.
- Affiliations
- Tokai University (JP)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2008-09-10
- Volume
- 26
- Issue
- 26
- Pages
- 4244-4252
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2153942353
- Cited by
- 367
- References
- 19
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 4 · 2023: 4 · 2022: 3 · 2021: 5 · 2020: 8 · 2019: 11 · 2018: 14 · 2017: 24 · 2016: 28 · 2015: 34 · 2014: 32 · 2013: 39 · 2012: 29
- FWCI
- 39.17
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bristol-Myers Squibb
- Eli Lilly and Company
- AstraZeneca
- Sanofi
- American Society of Clinical Oncology
- Chugai Pharmaceutical
- 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, docetaxel, non-small cell lung cancer, metastatic lung cancer, previously treated patients, EGFR tyrosine kinase inhibitors, non-inferiority, overall survival, interstitial lung disease, adverse events, Japanese patients
- MeSH terms
- Docetaxel, Gefitinib, Aged, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Quinazolines, Proportional Hazards Models, Survival Analysis, Taxoids
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