Randomized phase II study of nintedanib in metastatic castration-resistant prostate cancer postdocetaxel.
Anticancer Drugs
; 25(9): 1081-8, 2014 Oct.
Article
en En
| MEDLINE
| ID: mdl-24849708
ABSTRACT
This open-label, phase II trial assessed the efficacy and safety of two doses of nintedanib, a triple angiokinase inhibitor targeting vascular endothelial growth factor, fibroblast growth factor, and platelet-derived growth factor signaling, in patients with metastatic castration-resistant prostate cancer (mCRPC) following progression on docetaxel-based regimens. Patients were randomized to nintedanib 150 mg (arm A, n=40) or 250 mg (arm B, n=41) twice daily for 6 months unless disease progression or adverse events (AEs) led to discontinuation. The primary endpoint was the prostate-specific antigen (PSA) response rate (confirmed PSA decline of ≥20% from baseline). Eighty-one patients were enrolled. The PSA response rate was 0% (0/32) in arm A versus 11.1% (4/36) in arm B (P=0.12); 5.6% of patients (2/36) in arm B showed a PSA reduction of at least 50%. In arm B, the rate of PSA increase was significantly decelerated on treatment versus before treatment (P=0.002). The median progression-free survival was 73.5 and 76.0 days for arm A and arm B, respectively (P=0.3). AEs included gastrointestinal disorders, asthenia, hypertension, and reversible elevated transaminases. The incidence of drug-related serious AEs (no drug-related deaths) was 20.0% (arm A) and 24.4% (arm B). The primary endpoint was not met. Nintedanib (250 mg) showed only modest activity with manageable AEs in patients with mCRPC post-docetaxel.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Adenocarcinoma
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Neoplasias de la Próstata Resistentes a la Castración
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Indoles
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Antineoplásicos
Tipo de estudio:
Clinical_trials
Límite:
Aged
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Aged80
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2014
Tipo del documento:
Article