دورية أكاديمية
Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer
| العنوان: | Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer |
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| المؤلفون: | Coleman, Robert L, Fleming, Gini F, Brady, Mark F, Swisher, Elizabeth M, Steffensen, Karina D, Friedlander, Michael, Okamoto, Aikou, Moore, Kathleen N, Efrat Ben-Baruch, Noa, Werner, Theresa L, Cloven, Noelle G, Oaknin, Ana, DiSilvestro, Paul A, Morgan, Mark A, Nam, Joo-Hyun, Leath, Charles A, Nicum, Shibani, Hagemann, Andrea R, Littell, Ramey D, Cella, David, Baron-Hay, Sally, Garcia-Donas, Jesus, Mizuno, Mika, Bell-McGuinn, Katherine, Sullivan, Danielle M, Bach, Bruce A, Bhattacharya, Sudipta, Ratajczak, Christine K, Ansell, Peter J, Dinh, Minh H, Aghajanian, Carol, Bookman, Michael A |
| المصدر: | Coleman , R L , Fleming , G F , Brady , M F , Swisher , E M , Steffensen , K D , Friedlander , M , Okamoto , A , Moore , K N , Efrat Ben-Baruch , N , Werner , T L , Cloven , N G , Oaknin , A , DiSilvestro , P A , Morgan , M A , Nam , J-H , Leath , C A , Nicum , S , Hagemann , A R , Littell , R D , Cella , D , Baron-Hay , S , Garcia-Donas .... |
| سنة النشر: | 2019 |
| المجموعة: | University of Southern Denmark: Research Output / Syddansk Universitet |
| مصطلحات موضوعية: | Administration, Oral, Adult, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Benzimidazoles/adverse effects, Carboplatin/administration & dosage, Combined Modality Therapy, Cystadenocarcinoma, Serous/drug therapy, Double-Blind Method, Female, Genes, BRCA1, BRCA2, Humans, Intention to Treat Analysis, Maintenance Chemotherapy, Middle Aged, Mutation, Ovarian Neoplasms/drug therapy, Paclitaxel/administration & dosage, Poly(ADP-ribose) Polymerase Inhibitors/adverse effects, Progression-Free Survival, Quality of Life |
| الوصف: | 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: In an international, phase 3, placebo-controlled trial, we assessed the 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. Patients were randomly assigned in a 1:1:1 ratio to receive chemotherapy plus placebo followed by placebo maintenance (control), chemotherapy plus veliparib followed by placebo maintenance (veliparib combination only), or chemotherapy plus veliparib followed by veliparib maintenance (veliparib throughout). Cytoreductive surgery could be performed before initiation or after 3 cycles of trial treatment. Combination chemotherapy was 6 cycles, and maintenance therapy was 30 additional cycles. The primary end point was investigator-assessed progression-free survival in the veliparib-throughout group as compared with the control group, analyzed sequentially in the BRCA-mutation cohort, the cohort with homologous-recombination deficiency (HRD) (which included the BRCA-mutation cohort), and the intention-to-treat population. RESULTS: A total of 1140 patients underwent randomization. In the BRCA-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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://portal.findresearcher.sdu.dk/da/publications/acae948f-8625-4820-bb82-dcae1f3993b0Test |
| DOI: | 10.1056/NEJMoa1909707 |
| الإتاحة: | https://doi.org/10.1056/NEJMoa1909707Test https://portal.findresearcher.sdu.dk/da/publications/acae948f-8625-4820-bb82-dcae1f3993b0Test https://findresearcher.sdu.dk/ws/files/161318291/nejmoa1909707.pdfTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.D4FBA125 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1056/NEJMoa1909707 |
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