Bevacizumab plus fosbretabulin in recurrent ovarian cancer: Overall survival and exploratory analyses of a randomized phase II NRG oncology/gynecologic oncology group study.
Gynecol Oncol
; 159(1): 79-87, 2020 10.
Article
em En
| MEDLINE
| ID: mdl-32723679
ABSTRACT
OBJECTIVE:
To explore the relationship between tumor size and response to combined anti-vascular targeted therapy using the anti-angiogenesis inhibitor, bevacizumab, and the tubulin-binding vascular disrupting agent, fosbretabulin.METHODS:
An exploratory, post-hoc analysis of the randomized phase II trial, Gynecologic Oncology Group-0186I, was performed. One hundred and seven patients with recurrent ovarian carcinoma, treated with up to 3 prior regimens, were randomized to bevacizumab 15â¯mg/kg body weight with or without intravenous fosbretabulin 60â¯mg/m2 body surface area every 21 days until progression or unacceptable toxicity. The primary analysis favored the combination (HR 0.69; 95% CI, 0.47-1.00; pâ¯=â¯.049) [Monk BJ, et al. J Clin Oncol 2016;342279-86]. The Cox proportional hazards model was used to estimate the treatment effect in various subpopulations.RESULTS:
With extended follow-up, the median PFS for bevacizumab plus fosbretabulin was 7.6⯠months as compared to 4.8⯠months with bevacizumab alone (HR 0.74; 90% CI, 0.54-1.02). Overall survival was similar in the experimental and control arms (25.2 vs 24.4 mos, respectively, HR 0.85; 90% CI, 0.59-1.22; pâ¯=â¯.461). Eighty-one patients had measurable disease and median tumor size was 5.7 â¯cm. In the ≤5.7 â¯cm subgroup, the HR for progression or death was 0.77 (90% CI 0.45-1.31). Patients with tumors >5.7⯠cm (nâ¯=â¯40) had a HR for progression or death of 0.55; 90% CI, 0.32-0.96; pâ¯=â¯.075).CONCLUSIONS:
Although no significant survival benefit was observed, the trend showing a reduced HR for progression or death with increasing tumor size when fosbretabulin is added to bevacizumab compared to bevacizumab alone warrants further study.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Temas:
Geral
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Tipos_de_cancer
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Outros_tipos
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Ovarianas
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Estilbenos
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Protocolos de Quimioterapia Combinada Antineoplásica
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Bevacizumab
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Recidiva Local de Neoplasia
Tipo de estudo:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adult
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Gynecol Oncol
Ano de publicação:
2020
Tipo de documento:
Article