Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial
Abstract
BACKGROUND: Vinorelbine prolongs survival and improves quality of life in elderly patients with advanced non-small-cell lung cancer (NSCLC). Some studies have also suggested that gemcitabine is well tolerated and effective in such patients. We compared the effectiveness and toxicity of the combination of vinorelbine plus gemcitabine with those of each drug given alone in an open-label, randomized phase III trial in elderly patients with advanced NSCLC. METHODS: Patients aged 70 years and older, enrolled between December 1997 and November 2000, were randomly assigned to receive intravenous vinorelbine (30 mg/m(2) of body surface area), gemcitabine (1200 mg/m(2)), or vinorelbine (25 mg/m(2)) plus gemcitabine (1000 mg/m(2)). All treatments were delivered on days 1 and 8 every 3 weeks for a maximum of six cycles. The primary endpoint was survival. Survival curves were drawn using the Kaplan-Meier method and analyzed by the Mantel-Haenszel test. Secondary endpoints were quality of life and toxicity. RESULTS: Of 698 patients available for intention-to-treat analysis, 233 were assigned to receive vinorelbine, 233 to gemcitabine, and 232 to vinorelbine plus gemcitabine. Compared with each single drug, the combination treatment did not improve survival. The hazard ratio of death for patients receiving the combination treatment was 1.17 (95% confidence interval [CI] = 0.95 to 1.44) that of patients receiving vinorelbine and 1.06 (95% CI = 0.86 to 1.29) that of patients receiving gemcitabine. Although quality of life was similar across the three treatment arms, the combination treatment was more toxic than the two drugs given singly. CONCLUSION: The combination of vinorelbine plus gemcitabine is not more effective than single-agent vinorelbine or gemcitabine in the 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 [69]
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Self-citation
- Authors
- Gridelli, C., Perrone, F., Gallo, C., Cigolari, S., Rossi, A., Piantedosi, F., Barbera, S., Ferrau, F., Piazza, E., Rosetti, F., Clerici, M., Bertetto, O., Robbiati, S. F., Frontini, L., Sacco, C., Castiglione, F., Favaretto, A., Novello, S., Migliorino, M. R., Gasparini, G., Galetta, D., Iaffaioli, R. V., & Gebbia, V.
- Affiliations
- Azienda Ospedaliera S.Giuseppe Moscati (IT)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- Istituto Oncologico Veneto (IT)
- Corresponding author
- Gridelli, C.
- ORCID
- Venue
- JNCI Journal of the National Cancer Institute
- Publisher
- Oxford University Press (OUP)
- Published
- 2003-03-05
- Volume
- 95
- Issue
- 5
- Pages
- 362-372
- ISSN
- 0027-8874 (ISSN-L)
- 1460-2105
- OpenAlex
- W2137009016
- Cited by
- 781
- References
- 41
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 4 · 2023: 9 · 2022: 7 · 2021: 12 · 2020: 28 · 2019: 18 · 2018: 34 · 2017: 28 · 2016: 28 · 2015: 41 · 2014: 32 · 2013: 34 · 2012: 57
- FWCI
- 50.06
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JNCI Journal of the National Cancer Institute (publishedVersion)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- advanced non-small cell lung cancer, elderly patients, vinorelbine, gemcitabine, combination chemotherapy, single-agent chemotherapy, survival, treatment toxicity, quality of life
- MeSH terms
- Vinorelbine, Gemcitabine, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Deoxycytidine, Female, Humans, Italy, Lung Neoplasms, Male, Neoplasm Staging, Quality of Life, Surveys and Questionnaires, Vinblastine, Survival Analysis, Treatment Outcome
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