VELIA Study
Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer
Disease site
Ovary
Pubmed link
Publication month/year
September 2019
Study question
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
Clinical trial
Interventions compared
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)
Control arm
The control group (in which patients received chemotherapy plus placebo followed by placebo maintenance)
Primary outcome
Progression-free survival
Secondary outcome
Overall survival
Inclusion criteria
- At least 18 years old
- High grade serous epithelial ovarian, fallopian tube, or primary peritoneal carcinoma stage III or IV
Results
| Placebo | Veliparib through out group | |
|---|---|---|
|
Randomised (n) |
375 |
382 |
|
Received treatmen |
371 |
377 |
|
median progression-free survival-BRCA mutation cohort (months) |
22 |
34.7 |
|
Median progression-free survival – cohort (months) |
20.5 |
31.9 |
HRD: Homologous-recombination deficiency
Other results
- 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.
Conclusions
- 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.