A Randomized Phase II Trial of Two Schedules of Docetaxel in Elderly or Poor Performance Status Patients with Advanced Non-small Cell Lung Cancer
Autor: | Joyce Samuel, Rogerio Lilenbaum, Tarek Chidiac, Jennifer L. Beaumont, Patricia Graham, Laszlo Boros, Leonard Seigel, Hongyan Du, Afshin Dowlati, Mark A. Rubin |
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Rok vydání: | 2007 |
Předmět: |
Male
Oncology Pulmonary and Respiratory Medicine medicine.medical_specialty Lung Neoplasms Neutropenia Maximum Tolerated Dose Population Docetaxel Drug Administration Schedule Elderly Quality of life Risk Factors Carcinoma Non-Small-Cell Lung Internal medicine medicine Clinical endpoint Humans Infusions Intravenous education Lung cancer Aged Neoplasm Staging Probability Proportional Hazards Models Aged 80 and over education.field_of_study Dose-Response Relationship Drug Performance status business.industry Age Factors medicine.disease Survival Analysis Treatment Outcome Linear Models Female Taxoids Non small cell Advanced non-small cell lung cancer business Follow-Up Studies medicine.drug |
Zdroj: | Journal of Thoracic Oncology. 2(4):306-311 |
ISSN: | 1556-0864 |
DOI: | 10.1097/01.jto.0000263713.38826.8e |
Popis: | 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. |
Databáze: | OpenAIRE |
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