A multicenter phase II study of the combination of irinotecan and gemcitabine in previously treated patients with small-cell lung cancer.
Oncology
; 66(3): 192-6, 2004.
Article
em En
| MEDLINE
| ID: mdl-15218309
ABSTRACT
OBJECTIVE:
To evaluate efficacy and toxicity of the combination of irinotecan and gemcitabine in pretreated patients having small-cell lung cancer. PATIENTS ANDMETHODS:
Thirty-one patients (median age 60 years, performance status 0-1 in 87% and 2 in 13% of the patients) with limited or extensive-stage disease, refractory or relapsing after at least one prior chemotherapy regimen, received gemcitabine 1,000 mg/m(2) on days 1 and 8 and irinotecan 300 mg/m(2) on day 8, every 21 days. Sixteen (52%) patients had sensitive and 15 (48%) refractory disease. Fifteen patients (48%) had received > or =2 prior regimens.RESULTS:
All patients were evaluable for toxicity and 26 for response analysis. A median of three (range 1-6) cycles per patient was administered. Three partial responses were documented for an overall response rate of 10% (95% CI 0.73-20.09), and disease stabilization was obtained in 7 patients (22%; intention-to-treat analysis). Two of the responders had refractory, and 1 had sensitive disease. The median time to progression was 4.5 months, the median duration of responses was 2.5 months, and the median survival time was 6 months. Grade 3-4 (WHO) neutropenia was observed in 9 patients (29%), grade 3-4 thrombocytopenia in 4 (13%), and grade 3-4 diahrrea in 3 patients (10%). Three patients experienced febrile neutropenia. No toxic deaths occurred.CONCLUSIONS:
The combination showed modest activity in this patient group with a poor prognosis. Thus we believe it merits further investigation in the treatment of patients with small-cell lung cancer who have failed one prior chemotherapy regimen.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Camptotecina
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Protocolos de Quimioterapia Combinada Antineoplásica
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Carcinoma de Células Pequenas
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Desoxicitidina
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Neoplasias Pulmonares
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2004
Tipo de documento:
Article