Farletuzumab (a monoclonal antibody against folate receptor alpha) in relapsed platinum-sensitive ovarian cancer.
Gynecol Oncol
; 129(3): 452-8, 2013 Jun.
Article
en En
| MEDLINE
| ID: mdl-23474348
ABSTRACT
OBJECTIVE:
Farletuzumab is a humanized monoclonal antibody to folate receptor-α, which is over-expressed in most epithelial ovarian cancers but largely absent on normal tissue. We evaluated clinical activity of farletuzumab, alone and combined with chemotherapy, in women with first-relapse, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancers.METHODS:
Fifty-four eligible subjects received open-label farletuzumab weekly, single agent or combined with carboplatin (AUC5-6) and taxane (paclitaxel 175 mg/m(2) or docetaxel 75 mg/m(2)), every 21 days for 6 cycles, followed by farletuzumab maintenance until progression. Twenty-eight subjects with asymptomatic CA125 relapse received single-agent farletuzumab and could receive platinum/taxane chemotherapy plus farletuzumab after single-agent progression. Twenty-six subjects with symptomatic relapse entered the combination arm directly; 21 subjects entered after single agent. Primary endpoints included normalized CA125 and Overall Response Rate (ORR). Duration of each subject's second progression-free interval (PFI2) was compared with her own first response interval (PFI1).RESULTS:
Farletuzumab was well-tolerated as single agent, without additive toxicity when administered with chemotherapy. Of 47 subjects who received farletuzumab with chemotherapy, 38 (80.9%) normalized CA125. In 9/42 (21%) evaluable subjects, PFI2 was≥PFI1, better than the historical rate (3%). There was a high response rate among subjects with PFI1 <12 months (75%), comparable to that in subjects with PFI1 ≥12 months (84%). Complete or partial ORR was 75% with combination therapy.CONCLUSION:
Based on this study, farletuzumab with carboplatin and taxane may enhance the response rate and duration of response in platinum-sensitive ovarian cancer patients with first relapse after remission of 6-18 months.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Neoplasias Ováricas
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Protocolos de Quimioterapia Combinada Antineoplásica
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Neoplasias Glandulares y Epiteliales
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Anticuerpos Monoclonales Humanizados
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Etiology_studies
Límite:
Female
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Humans
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Middle aged
Idioma:
En
Revista:
Gynecol Oncol
Año:
2013
Tipo del documento:
Article
País de afiliación:
Estados Unidos