Progression-free survival by investigator versus blinded independent central review in newly diagnosed patients with high-grade serous ovarian cancer: Analysis of the VELIA/GOG-3005 trial.
Gynecol Oncol
; 162(2): 375-381, 2021 08.
Article
em En
| MEDLINE
| ID: mdl-34112513
ABSTRACT
OBJECTIVE:
In the phase 3 VELIA/GOG-3005 trial, veliparib added to carboplatin-paclitaxel and continued as maintenance improved progression-free survival (PFS) compared to carboplatin-paclitaxel alone in patients with newly diagnosed ovarian carcinoma. Primary analysis of PFS was by investigator (INV) assessment, with a supplemental analysis of PFS by blinded independent central review (BICR).METHODS:
Patients received veliparib or placebo with carboplatin-paclitaxel (6â¯cycles) and as maintenance (30 additional cycles). The primary analysis compared PFS in the veliparib-throughout arm to the carboplatin-paclitaxel only arm in the BRCA mutation (BRCAm), homologous recombination deficiency (HRD), and intention-to-treat (ITT) populations. Exploratory analyses of PFS in BRCA wildtype (BRCAwt), homologous recombination proficient (HRP), and HRDâ¯+â¯BRCAwt populations were also performed. PFS per BICR and overall concordance rates between INV and BICR assessments were analyzed.RESULTS:
Hazard ratios for PFS by INV and BICR were consistent in each of the primary analysis and exploratory populations. In the ITT population, median PFS per INV was 23.5â¯months in the veliparib-throughout arm versus 17.3â¯months in the control arm (hazard ratio [HR] 0.683, 95% confidence interval [CI] 0.562-0.831; Pâ¯<â¯0.001). Median PFS by BICR was 29.3â¯months versus 19.2â¯months (HR 0.687, 95% CI 0.504-0.806). In the ITT population, the overall concordance rates between INV and BICR were 78% and 75% for the veliparib-throughout and control arms, respectively.CONCLUSIONS:
Hazard ratios for PFS per BICR and per INV were consistent, with no suggestion of investigator bias. These findings support the reliability of PFS by INV in ovarian cancer trials.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Ovarianas
/
Benzimidazóis
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Protocolos de Quimioterapia Combinada Antineoplásica
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Carcinoma Epitelial do Ovário
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Female
/
Humans
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article