Patient reported outcomes of a randomized, placebo-controlled trial of bevacizumab in the front-line treatment of ovarian cancer: a Gynecologic Oncology Group Study.
Gynecol Oncol
; 128(3): 573-8, 2013 Mar.
Article
en En
| MEDLINE
| ID: mdl-23219660
ABSTRACT
PURPOSE:
To analyze quality of life (QOL) in a randomized, placebo-controlled phase III trial concluding that the addition of concurrent and maintenance bevacizumab (Arm 3) to carboplatin and paclitaxel prolongs progression-free survival in front-line treatment of advanced ovarian cancer compared to chemotherapy alone (Arm 1) or chemotherapy with bevacizumab in cycles 2-6 only (Arm 2). PATIENTS ANDMETHODS:
The Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) was used to assess QOL before cycles 1, 4, 7, 13, and 21; and 6months after completing study therapy. Differences in QOL scores were assessed using a linear mixed model, adjusting for baseline score, and age. The significance level was set at 0.0167 to account for multiple comparisons.RESULTS:
1693 patients were queried. Arm 2 (p<0.001) and Arm 3 (p<0.001) reported lower QOL scores than those in Arm 1. The treatment differences were observed mainly at cycle 4, when the patients receiving bevacizumab (Arm 2 and Arm 3) reported 2.72 points (98.3% CI 0.88-4.57; effect size=0.18) and 2.96 points (98.3% CI 1.13-4.78; effect size=0.20) lower QOL respectively, than those in Arm 1. The difference in QOL scores between Arm 1 and Arm 3 remained statistically significant up to cycle 7. The percentage of patients who reported abdominal discomfort dropped over time, without significant differences among study arms.CONCLUSION:
The small QOL difference observed during chemotherapy did not persist during maintenance bevacizumab.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Neoplasias Ováricas
/
Protocolos de Quimioterapia Combinada Antineoplásica
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Female
/
Humans
Idioma:
En
Revista:
Gynecol Oncol
Año:
2013
Tipo del documento:
Article
País de afiliación:
Estados Unidos