Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904)
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PURPOSE: Docetaxel has shown activity in elderly patients with advanced non-small-cell lung cancer (NSCLC). This randomized phase III trial evaluated the efficacy and safety of docetaxel versus vinorelbine (the current standard treatment) in elderly patients. PATIENTS AND METHODS: Chemotherapy-naïve patients age 70 years or older with stage IIIB/IV NSCLC and performance status 2 or lower were eligible. Patients randomly received docetaxel 60 mg/m2 (day 1) or vinorelbine 25 mg/m2 (days 1 and 8) every 21 days for four cycles. The primary end point was overall survival. Overall disease-related symptom improvement was assessed using an eight-item questionnaire. RESULTS: In total, 182 patients were enrolled. Median age was 76 years (range, 70 years to 86 years). There was no statistical difference in median overall survival with docetaxel versus vinorelbine (14.3 months v 9.9 months; hazard ratio, 0.780; 95% CI, 0.561 to 1.085; P = .138). There was a significant difference in median progression-free survival (5.5 months v 3.1 months; P < .001). Response rates were also significantly improved with docetaxel versus vinorelbine (22.7% v 9.9%; P = .019). The most common grade 3 to 4 toxicities were neutropenia (82.9% for docetaxel; 69.2% for vinorelbine; P = .031) and leukopenia (58.0% for docetaxel; 51.7% for vinorelbine). Other toxicities were mild and generally well tolerated. Docetaxel improved overall disease-related symptoms over vinorelbine (odds ratio, 1.86; 95% CI, 1.09 to 3.20). CONCLUSION: Docetaxel improved progression-free survival, response rate, and disease-related symptoms versus vinorelbine. Overall survival was not statistically significantly improved at this time. Docetaxel monotherapy may be considered as an option in the standard treatment of elderly patients with advanced NSCLC.
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Several phase III trials established single-agent therapy (docetaxel, vinorelbine, or gemcitabine) as the standard of care for first-line therapy for advanced NSCLC patients aged ≥70.
“Several phase III trials established single-agent therapy (docetaxel, vinorelbine or gemcitabine) as the standard of care for first-line therapy for advanced NSCLC patients aged ≥70 [69,71].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [71]
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“3 months) should be reexamined by another confirmatory study [13].”
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“Single-agent chemotherapy is considered to be the standard care for elderly patients who have a good performance status (PS) based on several phase III trials (1, 2).”
BackgroundMethodInfluentialCaring for the Older Population With Advanced Lung Cancer
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“A taxane is an accepted single agent standard in elderly patients with advanced NSCLC [15,16].”
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“Therefore, DTX has been recommended in Japan’s guidelines for treatment of lung cancer in the elderly [14].”
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“In elderly patients who are less fit, single agent therapy (vinorelbine, gemcitabine or taxane) is an option [6-8].”
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“2015; Herbst 2016; Reck 2016), and was favorable in comparison with earlier reports on cytotoxic drugs among elderly patients (Gridelli 2003; Kudoh 2006).”
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Treatment Toxicity in Elderly Patients With Advanced Non–Small Cell Lung Cancer
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“trial comparing vinorelbine to docetaxel did not report significant differences in OS, but higher incidence of grade 3–4 neutropenia with docetaxel [19].”
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Management of Lung Cancer in the Elderly
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“The trial had a slow accrual rate because of the reluctance of investigators to prescribe chemotherapy in patients with a PS of 2, and a further slowdown of accrual occurred after 2006 when Kudoh et al reported their randomized trial in elderly patients.(7) Because of these reasons, the data monitoring committee decid…”
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“This finding was of particular relevance given the concern for poor tolerability of combination regimens in the elderly demographic.(19)”
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ResultChemotherapy in elderly patients with advanced non-small cell lung cancer
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“Docetaxel is an effective drug for the treatment of patients with several cancers, including non-small cell lung cancer (23, 24).”
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- Authors
- Kudoh, S., Takeda, K., Nakagawa, K., Takada, M., Katakami, N., Matsui, K., Shinkai, T., Sawa, T., Goto, I., Semba, H., Seto, T., Ando, M., Satoh, T., Yoshimura, N., Negoro, S., & Fukuoka, M.
- Affiliations
- Osaka Prefectural Medical Center (JP)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2006-08-01
- Volume
- 24
- Issue
- 22
- Pages
- 3657-3663
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2151522757
- Cited by
- 360
- References
- 25
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 4 · 2023: 8 · 2022: 7 · 2021: 16 · 2020: 24 · 2019: 16 · 2018: 21 · 2017: 15 · 2016: 25 · 2015: 23 · 2014: 18 · 2013: 20 · 2012: 37
- FWCI
- 19.45
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- 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
- docetaxel, vinorelbine, non-small cell lung cancer, elderly patients, chemotherapy-naive patients, overall survival, progression-free survival, response rate, neutropenia, leukopenia, chemotherapy toxicity, disease-related symptoms, first-line chemotherapy, taxanes, vinca alkaloids, advanced non-small cell lung cancer
- MeSH terms
- Docetaxel, Vinorelbine, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Antineoplastic Agents, Phytogenic, Carcinoma, Non-Small-Cell Lung, Drug Administration Schedule, Female, Humans, Japan, Lung Neoplasms, Male, Prospective Studies, Quality of Life, Vinblastine, Odds Ratio, Survival Analysis, Treatment Outcome, Disease-Free Survival, Taxoids
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