Results of a phase II multicenter trial of weekly docetaxel and gemcitabine as first-line therapy for patients with advanced non-small cell lung cancer.
Lung Cancer
; 47(1): 121-7, 2005 Jan.
Article
em En
| MEDLINE
| ID: mdl-15603862
ABSTRACT
PURPOSE:
Standard treatment for advanced non-small cell lung cancer (NSCLC) consists of platinum based combination chemotherapy but efficacy is limited and treatment can be toxic. This trial evaluated a weekly regimen of docetaxel and gemcitabine for advanced NSCLC. The primary endpoint was objective response rate. Other endpoints were 1-year survival, median survival, median duration of response, median disease-free progression, safety, and quality of life. PATIENTS ANDMETHODS:
Fifty patients with advanced NSCLC were treated. Patients received docetaxel (1 per week, 36 mg/m(2)) weeks 1-6 and gemcitabine (1 per week, 900 mg/m(2)) weeks 1, 2, 4, and 5. Each 8-week cycle was repeated for a total of three cycles. Patients completed quality of life surveys (FACT-L) before each cycle.RESULTS:
The median age was 68.5 years; 74% were >60 years old. In the intent-to-treat (ITT) analysis of response, 10 patients had a partial response (20%) and five patients had stable disease (10%). The 1-year survival was 32%; median survival for all patients was 6.9 months (range, <1-26.2) and the median progression-free survival was 5.1 months (range, <1-25.5). Toxicities (> grade 3) included neutropenia, thrombocytopenia, GI disorders (nausea, vomiting, dehydration, diarrhea, stomach pain), and asthenia; 10 patients experienced hematological toxicities that were > grade 3. Quality of life decreased during the study.CONCLUSIONS:
This study demonstrated that the nonplatinum doublet (docetaxel + gemcitabine) given on a weekly schedule for advanced NSCLC had efficacy similar to that reported with other regimens and was well tolerated. Therefore, this non-platinum based regimen appears promising and warrants further evaluation.
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Coleções:
01-internacional
Contexto em Saúde:
3_ND
Base de dados:
MEDLINE
Assunto principal:
Protocolos de Quimioterapia Combinada Antineoplásica
/
Carcinoma Pulmonar de Células não Pequenas
/
Desoxicitidina
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Neoplasias Pulmonares
Tipo de estudo:
Clinical_trials
Aspecto:
Patient_preference
Limite:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Lung Cancer
Ano de publicação:
2005
Tipo de documento:
Article