Phase II study of sunitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer.
Lung Cancer
; 74(3): 474-80, 2011 Dec.
Article
en En
| MEDLINE
| ID: mdl-21680048
ABSTRACT
This open-label, phase II study evaluated the antitumor activity and safety of sunitinib monotherapy as maintenance treatment following first-line chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Following treatment with standard doublet chemotherapy (paclitaxel and carboplatin), patients received oral sunitinib (starting dose 50mg/day) in 6-week cycles (Schedule 4/2 4 weeks on treatment, 2 weeks off treatment) until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint was probability of survival at 1 year ≥55%. Of 84 patients who received first-line chemotherapy, 66 (79%) received sunitinib maintenance therapy (median sunitinib cycles started 2 [range 1-20]). Probability of survival at 1 year was 40.5% (95% confidence interval [CI] 29.8, 51.0). Median overall survival was 10.4 months (95% CI 8.0, 12.2). The objective response rate was 27.4% (95% CI 18.2, 38.2). The most frequently reported all-causality adverse events of any grade during sunitinib maintenance therapy were fatigue/asthenia (55%), diarrhea (36%), and nausea (32%). These data suggest that maintenance therapy may have value in NSCLC, although the primary endpoint of the study was not met.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Pirroles
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Protocolos de Quimioterapia Combinada Antineoplásica
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Carcinoma de Pulmón de Células no Pequeñas
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Quimioterapia de Mantención
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Indoles
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Neoplasias Pulmonares
Tipo de estudio:
Observational_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Lung Cancer
Asunto de la revista:
NEOPLASIAS
Año:
2011
Tipo del documento:
Article
País de afiliación:
Francia