Abstract | BACKGROUND: In phase II trials, paclitaxel has been shown to have antitumor activity in patients with advanced non-small-cell lung cancer (NSCLC). However, the survival and quality-of-life (QOL) benefits of paclitaxel used as a single agent compared with supportive care alone have not been assessed in a randomized clinical trial. METHODS: RESULTS: Pretreatment characteristics were evenly distributed between the two arms. Survival was statistically significantly better in the paclitaxel plus supportive care arm than in the supportive care alone arm (two-sided P =.037) (median survival = 6.8 months versus 4.8 months). Cox multivariate analysis showed paclitaxel plus supportive care to be statistically significantly associated with improved survival (two-sided P =.048). QOL was similar for both treatment arms, except for the functional activity score of the Rotterdam Symptom Checklist, where QOL data statistically significantly favored the paclitaxel plus supportive care arm (two-sided P =.043). CONCLUSION: The addition of paclitaxel to best supportive care significantly improved survival and time to disease progression compared with best supportive care in patients with advanced NSCLC and may improve some aspects of QOL.
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Authors | M Ranson, N Davidson, M Nicolson, S Falk, J Carmichael, P Lopez, H Anderson, N Gustafson, A Jeynes, G Gallant, T Washington, N Thatcher |
Journal | Journal of the National Cancer Institute
(J Natl Cancer Inst)
Vol. 92
Issue 13
Pg. 1074-80
(Jul 05 2000)
ISSN: 0027-8874 [Print] United States |
PMID | 10880550
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Phytogenic
- Paclitaxel
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Phytogenic
(adverse effects, therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, pathology, therapy)
- Disease Progression
- Female
- Humans
- Lung Neoplasms
(drug therapy, pathology, therapy)
- Male
- Middle Aged
- Neoplasm Staging
- Paclitaxel
(adverse effects, therapeutic use)
- Proportional Hazards Models
- Quality of Life
- Survival Analysis
- Treatment Outcome
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