ICON7
Trial question
What is the role of bevacizumab added to platinum-based chemotherapy in women with newly diagnosed ovarian cancer?
Study design
Multi-center
Open label
RCT
Population
1528 female patients.
Inclusion criteria: adult women with newly diagnosed ovarian cancer that was either high-risk early-stage disease or more advanced disease.
Key exclusion criteria: other tumor types; previous systemic therapy; planned surgery; uncontrolled hypertension.
Interventions
N=764 bevacizumab (intravenous bevacizumab 7.5 mg/kg body weight every 3 weeks plus intravenous carboplatin and paclitaxel 175 mg/m² of body surface area).
N=764 standard chemotherapy (six 3-weekly cycles of intravenous carboplatin and paclitaxel 175 mg/m² of body surface area).
Primary outcome
Mean overall survival in all patients
45.5 months
44.6 months
45.5 months
34.1 months
22.8 months
11.4 months
0.0 months
Bevacizumab
Standard
chemotherapy
No significant
difference ↔
No significant difference in mean overall survival in all patients (45.5 months vs. 44.6 months; HR 0.99, 99% CI 0.85 to 1.14).
Secondary outcomes
No significant difference in mean progression-free survival in all patients (29.2 months vs. 27.7 months; HR 0.93, 95% CI 0.83 to 1.05).
Significant increase in mean overall survival in high-risk patients (39.3 months vs. 34.5 months; HR 1.28, 95% CI 1.03 to 1.59).
Significant increase in mean progression-free survival in high-risk patients (20 months vs. 15.9 months; HR 1.37, 95% CI 1.14 to 1.64).
Conclusion
In adult women with newly diagnosed ovarian cancer that was either high-risk early-stage disease or more advanced disease, bevacizumab was not superior to standard chemotherapy with respect to mean overall survival in all patients.
Reference
Amit M Oza, Adrian D Cook, Jacobus Pfisterer et al. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial. Lancet Oncol. 2015 Aug;16(8):928-36.
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