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

Robert L. Coleman(The University of Texas MD Anderson Cancer Center), Gini F. Fleming(University of Chicago), Mark F. Brady(Roswell Park Comprehensive Cancer Center), Elizabeth M. Swisher(Seattle Cancer Care Alliance), Karina Dahl Steffensen(University of Southern Denmark), Michael Friedländer(UNSW Sydney), Aikou Okamoto(Jikei University School of Medicine), Kathleen N. Moore(University of Oklahoma Health Sciences Center), Noa Ben-Baruch(Kaplan Medical Center), Theresa L. Werner(Huntsman Cancer Institute), Noelle Cloven(Texas Oncology), Ana Oaknin(Hebron University), Paul DiSilvestro(Women & Infants Hospital of Rhode Island), Mark A. Morgan(Penn Center for AIDS Research), Joo‐Hyun Nam(Ulsan College), Charles A. Leath(University of Alabama at Birmingham), Shibani Nicum(Oxford University Hospitals NHS Trust), Andrea R. Hagemann(Washington University in St. Louis), Ramey D. Littell(Kaiser Permanente), David Cella(Robert H. Lurie Comprehensive Cancer Center of Northwestern University), Sally Baron‐Hay(Northern Cancer Institute), Jesús García-Donás(HM Hospitales), Mika Mizuno(Aichi Cancer Center), Katherine M. Bell‐McGuinn(Memorial Sloan Kettering Cancer Center), Danielle Sullivan(AbbVie (United States)), Bruce Allen Bach(AbbVie (United States)), Sudipta Bhattacharya(AbbVie (United States)), Christine K. Ratajczak(AbbVie (United States)), Peter Ansell(AbbVie (United States)), Minh H. Dinh(AbbVie (United States)), Carol Aghajanian(Memorial Sloan Kettering Cancer Center), Michael A. Bookman(Kaiser Permanente)
New England Journal of Medicine
September 28, 2019
Cited by 922Open Access
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Abstract

BACKGROUND: Data are limited regarding the use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors, such as veliparib, in combination with chemotherapy followed by maintenance as initial treatment in patients with high-grade serous ovarian carcinoma. METHODS: -mutation cohort), and the intention-to-treat population. RESULTS: -mutation cohort, the median progression-free survival was 34.7 months in the veliparib-throughout group and 22.0 months in the control group (hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.28 to 0.68; P<0.001); in the HRD cohort, it was 31.9 months and 20.5 months, respectively (hazard ratio, 0.57; 95 CI, 0.43 to 0.76; P<0.001); and in the intention-to-treat population, it was 23.5 months and 17.3 months (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). Veliparib led to a higher incidence of anemia and thrombocytopenia when combined with chemotherapy as well as of nausea and fatigue overall. CONCLUSIONS: Across all trial populations, 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. (Funded by AbbVie; VELIA/GOG-3005 ClinicalTrials.gov number, NCT02470585.).


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