Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer

Disease site

Ovary

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
Control arm (Placebo) Intervention arm (Veliparib-through-out group)
Randomised (n) 375 382
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
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.
Reviewer name