Many patients aged 70 and older who are diagnosed with NSCLC are often not offered cytotoxic chemotherapy because of concerns about the ability of patients to tolerate the treatment. The drugs vinorelbine and gemcitabine have each been shown to be effective and tolerable in elderly patients with advanced NSCLC. In preliminary studies in adult patients with advanced NSCLC, the combination of vinorelbine and gemcitabine resulted in a modest response rate and mild toxicity.
In the Multicenter Italian Lung Cancer in the Elderly Study (MILES) Phase III Randomized Trial, Cesare Gridelli, M.D., of the S.G. Moscati Hospital, Avellino, and the Istituto Nazionale dei Tumori of Naples, and his colleagues, randomly assigned 698 patients aged 70 and older to receive either vinorelbine, gemcitabine, or a combination of the two drugs.
Compared with vinorelbine and gemcitabine alone, the combination therapy did not improve overall and progression-free survival. In fact, the combination of vinorelbine plus gemcitabine resulted in more side effects, including low white blood cell counts and vomiting, than either of the drugs alone.
The authors say these results do not rule out the possibility that other regimens of combined chemotherapy could be more effective than single-agent chemotherapy in the treatment of elderly patients with advanced NSCLC and suggest that different chemotherapy combinations, particularly cisplatin-based combinations, be explored.
In an accompanying editorial, Paul A. Bunn Jr., M.D., of the University of Colorado Cancer Center in Denver, and Rogerio Lilenbaum, M.D., of the Mt. Sinai Cancer Center in Miami Beach, Fla., point out that these results contrast with those of a previous study that found a statistically significant survival advantage for patients receiving the two drugs in combination.
Taken together, the results indicate that elderly patients with advanced NSCLC can benefit from both single-agent therapy and from some combinations and that both single agents and some combinations can be delivered safely, they say.
"The issue of whether some combinations (e.g., paclitaxel plus carboplatin) are preferred over single agents cannot be definitely determined from the studies to date," the editorialists write. "It is hoped that less toxic targeted therapies given sequentially or in combination will provide further advances in the future."
Contact: Dr. Cesare Gridelli, 39-0825-203573 (office), 39-335-381624 (mobile), cgridelli@libero.it
Editorial: Jenny Bertrand, University of Colorado Cancer Center, 720-848-0426; fax: 720-848-0353, jenny.bertrand@uchsc.edu
Gridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, et al. 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. J Natl Cancer Inst 2003;95:362–72.
Editorial: Bunn PA Jr, Lilenbaum R. Chemotherapy for elderly patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 2003;95:341–3.
Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage.
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JNCI Journal of the National Cancer Institute