A phase II study of feasibility and toxicity of bevacizumab in combination with temozolomide in patients with recurrent glioblastoma
Clin. transl. oncol. (Print)
; 17(9): 743-750, sept. 2015. tab, ilus
Article
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| IBECS
| ID: ibc-140333
Biblioteca responsable:
ES1.1
Ubicación: BNCS
ABSTRACT
Purpose. The aim of this prospective and multicentric phase II study was to evaluate the efficacy and safety of temozolomide (TMZ) and bevacizumab (BV) in patients (pts) with recurrent glioblastoma (GB), previously treated with chemoradiotherapy and at least three cycles of adjuvant TMZ. Patients and methods. Patients with GB at first relapse received BV 10 mg/kg day every 2 weeks and TMZ 150 mg/m2 days 17 and 1521, every 28 days. Patients underwent brain magnetic resonance imaging every 8 weeks. Results. Thirty-two evaluable pts were recruited in 8 sites. Fourteen pts (44 %) had gross total resection. O6-methylguanine-DNA methyltransferase (MGMT) promoter was methylated in 12 pts, unmethylated in 6 pts, and missing in 14 pts. The estimated 6-month progression free survival (PFS) rate was 21.9 % (95 % CI 9.340.0 %). The median PFS and overall survival (OS) were 4.2 months (95 % CI 3.65.4 months) and 7.3 months (95 % CI 5.88.8 months), respectively. No significant association with MGMT status was found in terms of OS or PFS. Six of 32 pts (19 %; 95 % CI 7.236.4) were long-term survivors, with a median PFS and OS (50 % events) of 9.5 months (95 % CI 7.923.6) and 15.4 (95 % CI 8.9NA), respectively no differences in baseline characteristics were identified in comparison with total population. No unexpected toxicities or treatment-related deaths were observed. Conclusions. This regimen showed to be feasible and well tolerated in pts with recurrent GB pretreated with TMZ. Further investigation is warranted to identify subpopulations that are more likely to benefit from addition of BV to GB therapy (AU)
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Colección:
06-national
/
ES
Base de datos:
IBECS
Asunto principal:
ADN-Citosina Metilasas
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Glioblastoma
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Anticuerpos Monoclonales Humanizados
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Quimioradioterapia
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Antineoplásicos
Tipo de estudio:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Female
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Humans
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Male
Idioma:
En
Revista:
Clin. transl. oncol. (Print)
Año:
2015
Tipo del documento:
Article