Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer
Efficacy of Veliparib added to first-line induction chemotherapy with carboplatin and paclitaxel and continued as maintenance monotherapy in patients with previously untreated stage III or IV high-grade serous ovarian carcinoma.
Type of study
Veliparib vs placebo (for chemotherapy and maintenance )
Experimental arm (Intervention)
- The Veliparib combination-only group (in which patients received chemotherapy plus Veliparib followed by placebo maintenance)
- Veliparib-throughout group (in which patients received chemotherapy plus Veliparib followed by Veliparib maintenance)
The control group (in which patients received chemotherapy plus placebo followed by placebo maintenance)
- At least 18 years old
- High grade serous epithelial ovarian, fallopian tube, or primary peritoneal carcinoma stage III or IV
|Control arm (Placebo)||Intervention arm (Veliparib-through-out group)|
|Received treatment (n)||371||377|
|Median progression-free survival-BRCA mutation cohort||22.0 months||34.7 months|
|Median progression-free survival – Homologous-recombination deficiency (HRD) cohort||20.5 months||31.9 months|
- BRCA mutation cohort-(hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.28 to 0.68; P<0.001)
- HRD cohort-(hazard ratio, 0.57; 95 CI, 0.43 to 0.76; P<0.001)
- Veliparib led to a higher incidence of anaemia and thrombocytopenia when combined with chemotherapy as well as of nausea and fatigue overall. QoL was not significantly affected by the side effects.
- A regimen of carboplatin, paclitaxel, and Veliparib induction therapy followed by Veliparib maintenance therapy led to significantly longer progression-free survival than carboplatin plus paclitaxel induction therapy alone.
- The independent value of adding Veliparib during induction therapy without Veliparib maintenance was less clear.