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Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

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Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. / González-Martín, Antonio; Pothuri, Bhavana; Vergote, Ignace; DePont Christensen, René; Graybill, Whitney; Mirza, Mansoor R; McCormick, Colleen; Lorusso, Domenica; Hoskins, Paul; Freyer, Gilles; Baumann, Klaus; Jardon, Kris; Redondo, Andrés; Moore, Richard G; Vulsteke, Christof; O'Cearbhaill, Roisin E; Lund, Bente; Backes, Floor; Barretina-Ginesta, Pilar; Haggerty, Ashley F; Rubio-Pérez, Maria J; Shahin, Mark S; Mangili, Giorgia; Bradley, William H; Bruchim, Ilan; Sun, Kaiming; Malinowska, Izabela A; Li, Yong; Gupta, Divya; Monk, Bradley J; PRIMA/ENGOT-OV26/GOG-3012 Investigators.

In: NEW ENGL J MED, Vol. 381, No. 25, 19.12.2019, p. 2391-2402.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

González-Martín, A, Pothuri, B, Vergote, I, DePont Christensen, R, Graybill, W, Mirza, MR, McCormick, C, Lorusso, D, Hoskins, P, Freyer, G, Baumann, K, Jardon, K, Redondo, A, Moore, RG, Vulsteke, C, O'Cearbhaill, RE, Lund, B, Backes, F, Barretina-Ginesta, P, Haggerty, AF, Rubio-Pérez, MJ, Shahin, MS, Mangili, G, Bradley, WH, Bruchim, I, Sun, K, Malinowska, IA, Li, Y, Gupta, D, Monk, BJ & PRIMA/ENGOT-OV26/GOG-3012 Investigators 2019, 'Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer', NEW ENGL J MED, vol. 381, no. 25, pp. 2391-2402. https://doi.org/10.1056/NEJMoa1910962

APA

González-Martín, A., Pothuri, B., Vergote, I., DePont Christensen, R., Graybill, W., Mirza, M. R., McCormick, C., Lorusso, D., Hoskins, P., Freyer, G., Baumann, K., Jardon, K., Redondo, A., Moore, R. G., Vulsteke, C., O'Cearbhaill, R. E., Lund, B., Backes, F., Barretina-Ginesta, P., ... PRIMA/ENGOT-OV26/GOG-3012 Investigators (2019). Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. NEW ENGL J MED, 381(25), 2391-2402. https://doi.org/10.1056/NEJMoa1910962

Vancouver

González-Martín A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR et al. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. NEW ENGL J MED. 2019 Dec 19;381(25):2391-2402. https://doi.org/10.1056/NEJMoa1910962

Bibtex

@article{8428f557e4c444cd9ab9f46e6fb231fa,
title = "Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer",
abstract = "BACKGROUND: Niraparib, an inhibitor of poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence of BRCA mutations. The efficacy of niraparib in patients with newly diagnosed advanced ovarian cancer after a response to first-line platinum-based chemotherapy is unknown.METHODS: In this randomized, double-blind, phase 3 trial, we randomly assigned patients with newly diagnosed advanced ovarian cancer in a 2:1 ratio to receive niraparib or placebo once daily after a response to platinum-based chemotherapy. The primary end point was progression-free survival in patients who had tumors with homologous-recombination deficiency and in those in the overall population, as determined on hierarchical testing. A prespecified interim analysis for overall survival was conducted at the time of the primary analysis of progression-free survival.RESULTS: Of the 733 patients who underwent randomization, 373 (50.9%) had tumors with homologous-recombination deficiency. Among the patients in this category, the median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months vs. 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70; 95% CI, 0.44 to 1.11). The most common adverse events of grade 3 or higher were anemia (in 31.0% of the patients), thrombocytopenia (in 28.7%), and neutropenia (in 12.8%). No treatment-related deaths occurred.CONCLUSIONS: Among patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency. (Funded by GlaxoSmithKline; PRIMA/ENGOT-OV26/GOG-3012 ClinicalTrials.gov number, NCT02655016.).",
keywords = "Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Agents/therapeutic use, Combined Modality Therapy, Double-Blind Method, Female, Humans, Indazoles/adverse effects, Maintenance Chemotherapy, Middle Aged, Nausea/chemically induced, Ovarian Neoplasms/drug therapy, Piperidines/adverse effects, Poly(ADP-ribose) Polymerase Inhibitors/adverse effects, Progression-Free Survival, Quality of Life, Survival Analysis",
author = "Antonio Gonz{\'a}lez-Mart{\'i}n and Bhavana Pothuri and Ignace Vergote and {DePont Christensen}, Ren{\'e} and Whitney Graybill and Mirza, {Mansoor R} and Colleen McCormick and Domenica Lorusso and Paul Hoskins and Gilles Freyer and Klaus Baumann and Kris Jardon and Andr{\'e}s Redondo and Moore, {Richard G} and Christof Vulsteke and O'Cearbhaill, {Roisin E} and Bente Lund and Floor Backes and Pilar Barretina-Ginesta and Haggerty, {Ashley F} and Rubio-P{\'e}rez, {Maria J} and Shahin, {Mark S} and Giorgia Mangili and Bradley, {William H} and Ilan Bruchim and Kaiming Sun and Malinowska, {Izabela A} and Yong Li and Divya Gupta and Monk, {Bradley J} and {PRIMA/ENGOT-OV26/GOG-3012 Investigators}",
note = "Copyright {\textcopyright} 2019 Massachusetts Medical Society.",
year = "2019",
month = dec,
day = "19",
doi = "10.1056/NEJMoa1910962",
language = "English",
volume = "381",
pages = "2391--2402",
journal = "NEW ENGL J MED",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "25",

}

RIS

TY - JOUR

T1 - Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

AU - González-Martín, Antonio

AU - Pothuri, Bhavana

AU - Vergote, Ignace

AU - DePont Christensen, René

AU - Graybill, Whitney

AU - Mirza, Mansoor R

AU - McCormick, Colleen

AU - Lorusso, Domenica

AU - Hoskins, Paul

AU - Freyer, Gilles

AU - Baumann, Klaus

AU - Jardon, Kris

AU - Redondo, Andrés

AU - Moore, Richard G

AU - Vulsteke, Christof

AU - O'Cearbhaill, Roisin E

AU - Lund, Bente

AU - Backes, Floor

AU - Barretina-Ginesta, Pilar

AU - Haggerty, Ashley F

AU - Rubio-Pérez, Maria J

AU - Shahin, Mark S

AU - Mangili, Giorgia

AU - Bradley, William H

AU - Bruchim, Ilan

AU - Sun, Kaiming

AU - Malinowska, Izabela A

AU - Li, Yong

AU - Gupta, Divya

AU - Monk, Bradley J

AU - PRIMA/ENGOT-OV26/GOG-3012 Investigators

N1 - Copyright © 2019 Massachusetts Medical Society.

PY - 2019/12/19

Y1 - 2019/12/19

N2 - BACKGROUND: Niraparib, an inhibitor of poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence of BRCA mutations. The efficacy of niraparib in patients with newly diagnosed advanced ovarian cancer after a response to first-line platinum-based chemotherapy is unknown.METHODS: In this randomized, double-blind, phase 3 trial, we randomly assigned patients with newly diagnosed advanced ovarian cancer in a 2:1 ratio to receive niraparib or placebo once daily after a response to platinum-based chemotherapy. The primary end point was progression-free survival in patients who had tumors with homologous-recombination deficiency and in those in the overall population, as determined on hierarchical testing. A prespecified interim analysis for overall survival was conducted at the time of the primary analysis of progression-free survival.RESULTS: Of the 733 patients who underwent randomization, 373 (50.9%) had tumors with homologous-recombination deficiency. Among the patients in this category, the median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months vs. 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70; 95% CI, 0.44 to 1.11). The most common adverse events of grade 3 or higher were anemia (in 31.0% of the patients), thrombocytopenia (in 28.7%), and neutropenia (in 12.8%). No treatment-related deaths occurred.CONCLUSIONS: Among patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency. (Funded by GlaxoSmithKline; PRIMA/ENGOT-OV26/GOG-3012 ClinicalTrials.gov number, NCT02655016.).

AB - BACKGROUND: Niraparib, an inhibitor of poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence of BRCA mutations. The efficacy of niraparib in patients with newly diagnosed advanced ovarian cancer after a response to first-line platinum-based chemotherapy is unknown.METHODS: In this randomized, double-blind, phase 3 trial, we randomly assigned patients with newly diagnosed advanced ovarian cancer in a 2:1 ratio to receive niraparib or placebo once daily after a response to platinum-based chemotherapy. The primary end point was progression-free survival in patients who had tumors with homologous-recombination deficiency and in those in the overall population, as determined on hierarchical testing. A prespecified interim analysis for overall survival was conducted at the time of the primary analysis of progression-free survival.RESULTS: Of the 733 patients who underwent randomization, 373 (50.9%) had tumors with homologous-recombination deficiency. Among the patients in this category, the median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months vs. 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70; 95% CI, 0.44 to 1.11). The most common adverse events of grade 3 or higher were anemia (in 31.0% of the patients), thrombocytopenia (in 28.7%), and neutropenia (in 12.8%). No treatment-related deaths occurred.CONCLUSIONS: Among patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency. (Funded by GlaxoSmithKline; PRIMA/ENGOT-OV26/GOG-3012 ClinicalTrials.gov number, NCT02655016.).

KW - Administration, Oral

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Agents/therapeutic use

KW - Combined Modality Therapy

KW - Double-Blind Method

KW - Female

KW - Humans

KW - Indazoles/adverse effects

KW - Maintenance Chemotherapy

KW - Middle Aged

KW - Nausea/chemically induced

KW - Ovarian Neoplasms/drug therapy

KW - Piperidines/adverse effects

KW - Poly(ADP-ribose) Polymerase Inhibitors/adverse effects

KW - Progression-Free Survival

KW - Quality of Life

KW - Survival Analysis

U2 - 10.1056/NEJMoa1910962

DO - 10.1056/NEJMoa1910962

M3 - SCORING: Journal article

C2 - 31562799

VL - 381

SP - 2391

EP - 2402

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 25

ER -