Effects of Vinorelbine on Quality of Life and Survival of Elderly Patients With Advanced Non-Small-Cell Lung Cancer
Open Access
- 6 January 1999
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in JNCI Journal of the National Cancer Institute
- Vol. 91 (1), 66-72
- https://doi.org/10.1093/jnci/91.1.66
Abstract
BACKGROUND: Vinorelbine, a semisynthetic vinca alkaloid, represents a well-tolerated treatment for elderly patients with advanced non-small-cell lung cancer (NSCLC). We explored the quality of life (QoL) of such patients in a multicenter randomized trial that compared vinorelbine treatment with supportive care alone. METHODS: Eligible patients were 70 years of age or older, had stage IV or IIIB NSCLC that was ineligible for radiotherapy, and had a performance status of 0-2 (a status of fully active to a status of capable of all self-care but unable to work). Vinorelbine was given intravenously on days 1 and 8 of a 21-day treatment cycle, for a total of six cycles. QoL was evaluated with European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-LC13, and the QoL data were analyzed by fitting a linear mixed model for each QoL scale. Survival curves were plotted and were compared with the Mantel-Haenszel test. Relative hazards of death and 95% confidence intervals (CIs) were estimated by the Cox model. RESULTS: Investigators, blinded to the results, stopped the trial early because of a low enrollment rate. (From April 1996 to November 1997, 191 of the 350 targeted patients were randomly assigned.) Data from 161 patients have been analyzed. Vinorelbine-treated patients scored better than control patients on QoL functioning scales, and they reported fewer lung cancer-related symptoms but reported worse toxicity-related symptoms. There was a statistically significant (two-sided P = .03) survival advantage for patients receiving vinorelbine; median survival increased from 21 to 28 weeks in the vinorelbine-treated group. The relative hazard of death for vinorelbine-treated patients was 0.65 (95% CI = 0.45-0.93). CONCLUSION: Vinorelbine improves survival of elderly patients with advanced NSCLC and possibly improves overall QoL.Keywords
This publication has 16 references indexed in Scilit:
- Comparison of several model-based methods for analysing incomplete quality of life data in cancer clinical trialsStatistics in Medicine, 1998
- Using the general linear mixed model to analyse unbalanced repeated measures and longitudinal dataStatistics in Medicine, 1997
- Prospective Evaluation of the Feasibility of Cisplatin‐based Chemotherapy for Elderly Lung Cancer Patients with Normal Organ FunctionsJapanese Journal of Cancer Research, 1995
- Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trialsBMJ, 1995
- Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients.Journal of Clinical Oncology, 1994
- Cancer in the Elderly: Meeting the Challenge of an Aging PopulationJNCI Journal of the National Cancer Institute, 1993
- The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in OncologyJNCI Journal of the National Cancer Institute, 1993
- Discrete sequential boundaries for clinical trialsBiometrika, 1983
- Reporting results of cancer treatmentCancer, 1981
- Nonparametric Estimation from Incomplete ObservationsJournal of the American Statistical Association, 1958