Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.
N Engl J Med
; 379(26): 2495-2505, 2018 12 27.
Article
en En
| MEDLINE
| ID: mdl-30345884
ABSTRACT
BACKGROUND:
Most women with newly diagnosed advanced ovarian cancer have a relapse within 3 years after standard treatment with surgery and platinum-based chemotherapy. The benefit of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor olaparib in relapsed disease has been well established, but the benefit of olaparib as maintenance therapy in newly diagnosed disease is uncertain.METHODS:
We conducted an international, randomized, double-blind, phase 3 trial to evaluate the efficacy of olaparib as maintenance therapy in patients with newly diagnosed advanced (International Federation of Gynecology and Obstetrics stage III or IV) high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer (or a combination thereof) with a mutation in BRCA1, BRCA2, or both ( BRCA1/2) who had a complete or partial clinical response after platinum-based chemotherapy. The patients were randomly assigned, in a 21 ratio, to receive olaparib tablets (300 mg twice daily) or placebo. The primary end point was progression-free survival.RESULTS:
Of the 391 patients who underwent randomization, 260 were assigned to receive olaparib and 131 to receive placebo. A total of 388 patients had a centrally confirmed germline BRCA1/2 mutation, and 2 patients had a centrally confirmed somatic BRCA1/2 mutation. After a median follow-up of 41 months, the risk of disease progression or death was 70% lower with olaparib than with placebo (Kaplan-Meier estimate of the rate of freedom from disease progression and from death at 3 years, 60% vs. 27%; hazard ratio for disease progression or death, 0.30; 95% confidence interval, 0.23 to 0.41; P<0.001). Adverse events were consistent with the known toxic effects of olaparib.CONCLUSIONS:
The use of maintenance therapy with olaparib provided a substantial benefit with regard to progression-free survival among women with newly diagnosed advanced ovarian cancer and a BRCA1/2 mutation, with a 70% lower risk of disease progression or death with olaparib than with placebo. (Funded by AstraZeneca and Merck; SOLO1 ClinicalTrials.gov number, NCT01844986 .).
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
6_ODS3_enfermedades_notrasmisibles
Problema de salud:
6_digestive_diseases
/
6_endocrine_disorders
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6_ovary_cancer
Asunto principal:
Neoplasias Ováricas
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Ftalazinas
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Piperazinas
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Carcinoma Endometrioide
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Inhibidores de Poli(ADP-Ribosa) Polimerasas
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
Límite:
Adult
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
N Engl J Med
Año:
2018
Tipo del documento:
Article