Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial.
J Clin Oncol
; 37(32): 2968-2973, 2019 11 10.
Article
en En
| MEDLINE
| ID: mdl-31173551
ABSTRACT
PURPOSE:
In the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier NCT01847274), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy. PATIENTS ANDMETHODS:
A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (gBRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed gBRCAmut (non-gBRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to gBRCAmut status and response to their last platinum-based therapy. Ovarian cancer-specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy-Ovarian Symptom Index.RESULTS:
Progression-free survival was improved in patients treated with niraparib compared with placebo in both the gBRCAmut cohort (PR hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non-gBRCAmut cohort (PR HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.CONCLUSION:
Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Neoplasias Ováricas
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Piperidinas
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Protocolos de Quimioterapia Combinada Antineoplásica
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Inhibidores de Poli(ADP-Ribosa) Polimerasas
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Indazoles
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Recurrencia Local de Neoplasia
Tipo de estudio:
Clinical_trials
Aspecto:
Patient_preference
Límite:
Adult
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Aged
/
Aged80
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
J Clin Oncol
Año:
2019
Tipo del documento:
Article
País de afiliación:
España
Pais de publicación:
EEUU
/
ESTADOS UNIDOS
/
ESTADOS UNIDOS DA AMERICA
/
EUA
/
UNITED STATES
/
UNITED STATES OF AMERICA
/
US
/
USA