| Abstract | BACKGROUND: We conducted a multicenter randomized phase II trial to evaluate two schedules of single-agent docetaxel in the first-line treatment of elderly and performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC). METHODS: Patients 70 years of age and older with a PS 0-1 or patients of any age and PS 2 were randomly assigned to docetaxel 75 mg/m2 on day 1 every 3 weeks or 30 mg/m2 on days 1, 8, and 15 every 28 days. The primary end point was frequency of grade 3/4 toxicities. Health-related quality of life, response, and survival were secondary end points. RESULTS: Fifty-five patients were randomized to received docetaxel every 3 weeks and 56 to receive docetaxel weekly. Hematologic toxicity, primarily grade 3/4 neutropenia, was significantly lower in the weekly schedule (0% versus 44%; p < 0.001). Health-related quality of life was similar between the two arms. Efficacy parameters were not significantly different, with a trend toward better survival in the weekly schedule group (6.7 versus 3.5 months). Patients with PS 0-1 had a significantly longer survival compared with PS 2 patients (7.8 versus 2.9 months; p < 0.001). A subset analysis of 30 octogenarian patients revealed similar outcomes as in 70- to 79-year-old patients. CONCLUSION: Weekly docetaxel is associated with less neutropenia and a trend toward improved survival in elderly or PS 2 patients. PS rather than age is the primary determinant of outcome in this population. Octogenarians benefited from weekly docetaxel. Future studies should separate elderly patients from PS 2 patients. |
| Authors | Rogerio Lilenbaum, Mark Rubin, Joyce Samuel, Laszlo Boros, Tarek Chidiac, Leonard Seigel, Afshin Dowlati, Patricia Graham, Jennifer Beaumont, Hongyan Du
(Affiliation: Mount Sinai Cancer Center, Miami Beach, FL 33140, USA. rlilenbaum at aptiumoncology.com)
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| Journal | Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
(J Thorac Oncol)
Vol. 2
Issue 4
Pg. 306-11
(Apr 2007)
ISSN: 1556-1380 United States |
| PMID | 17409802
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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| Chemical References |
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| Topics |
- Age Factors
- Aged
- Aged, 80 and over
- Carcinoma, Non-Small-Cell Lung
(drug therapy, mortality, pathology)
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- Infusions, Intravenous
- Linear Models
- Lung Neoplasms
(drug therapy, mortality, pathology)
- Male
- Maximum Tolerated Dose
- Neoplasm Staging
- Neutropenia
(chemically induced, epidemiology)
- Probability
- Proportional Hazards Models
- Risk Factors
- Survival Analysis
- Taxoids
(administration & dosage, adverse effects)
- Treatment Outcome
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