Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial

Josep M Del Campo, Ursula A Matulonis, Susanne Malander, Diane Provencher, Sven Mahner, Philippe Follana, Justin Waters, Jonathan S Berek, Kathrine Woie, Amit M Oza, Ulrich Canzler, Marta Gil-Martin, Anne Lesoin, Bradley J Monk, Bente Lund, Lucy Gilbert, Robert M Wenham, Benedict Benigno, Sujata Arora, Sebastien J Hazard & 1 andre Mansoor R Mirza

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

PURPOSE: In the ENGOT-OV16/NOVA trial ( ClinicalTrials.gov identifier: NCT01847274 ), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy.

PATIENTS AND METHODS: A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (gBRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed gBRCAmut (non-gBRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to gBRCAmut status and response to their last platinum-based therapy. Ovarian cancer-specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy-Ovarian Symptom Index.

RESULTS: Progression-free survival was improved in patients treated with niraparib compared with placebo in both the gBRCAmut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non-gBRCAmut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.

CONCLUSION: Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.

OriginalsprogEngelsk
TidsskriftJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Antal sider10
ISSN0732-183X
DOI
StatusE-pub ahead of print - 7 jun. 2019

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Platinum
Ovarian Neoplasms
Drug Therapy
Germ-Line Mutation
Therapeutics
Disease-Free Survival
Placebos
Mutation
niraparib
Quality of Life
Safety
Incidence

Citer dette

Del Campo, Josep M ; Matulonis, Ursula A ; Malander, Susanne ; Provencher, Diane ; Mahner, Sven ; Follana, Philippe ; Waters, Justin ; Berek, Jonathan S ; Woie, Kathrine ; Oza, Amit M ; Canzler, Ulrich ; Gil-Martin, Marta ; Lesoin, Anne ; Monk, Bradley J ; Lund, Bente ; Gilbert, Lucy ; Wenham, Robert M ; Benigno, Benedict ; Arora, Sujata ; Hazard, Sebastien J ; Mirza, Mansoor R. / Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial. I: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2019.
@article{abd4aeff9ab04c13af46d377710bf522,
title = "Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial",
abstract = "PURPOSE: In the ENGOT-OV16/NOVA trial ( ClinicalTrials.gov identifier: NCT01847274 ), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy.PATIENTS AND METHODS: A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (gBRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed gBRCAmut (non-gBRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to gBRCAmut status and response to their last platinum-based therapy. Ovarian cancer-specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy-Ovarian Symptom Index.RESULTS: Progression-free survival was improved in patients treated with niraparib compared with placebo in both the gBRCAmut cohort (PR: hazard ratio [HR], 0.24; 95{\%} CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95{\%} CI, 0.160 to 0.546; P < .0001) and the non-gBRCAmut cohort (PR: HR, 0.35; 95{\%} CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95{\%} CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.CONCLUSION: Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.",
author = "{Del Campo}, {Josep M} and Matulonis, {Ursula A} and Susanne Malander and Diane Provencher and Sven Mahner and Philippe Follana and Justin Waters and Berek, {Jonathan S} and Kathrine Woie and Oza, {Amit M} and Ulrich Canzler and Marta Gil-Martin and Anne Lesoin and Monk, {Bradley J} and Bente Lund and Lucy Gilbert and Wenham, {Robert M} and Benedict Benigno and Sujata Arora and Hazard, {Sebastien J} and Mirza, {Mansoor R}",
year = "2019",
month = "6",
day = "7",
doi = "10.1200/JCO.18.02238",
language = "English",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",

}

Del Campo, JM, Matulonis, UA, Malander, S, Provencher, D, Mahner, S, Follana, P, Waters, J, Berek, JS, Woie, K, Oza, AM, Canzler, U, Gil-Martin, M, Lesoin, A, Monk, BJ, Lund, B, Gilbert, L, Wenham, RM, Benigno, B, Arora, S, Hazard, SJ & Mirza, MR 2019, 'Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial' Journal of clinical oncology : official journal of the American Society of Clinical Oncology. https://doi.org/10.1200/JCO.18.02238

Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial. / Del Campo, Josep M; Matulonis, Ursula A; Malander, Susanne; Provencher, Diane; Mahner, Sven; Follana, Philippe; Waters, Justin; Berek, Jonathan S; Woie, Kathrine; Oza, Amit M; Canzler, Ulrich; Gil-Martin, Marta; Lesoin, Anne; Monk, Bradley J; Lund, Bente; Gilbert, Lucy; Wenham, Robert M; Benigno, Benedict; Arora, Sujata; Hazard, Sebastien J; Mirza, Mansoor R.

I: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 07.06.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial

AU - Del Campo, Josep M

AU - Matulonis, Ursula A

AU - Malander, Susanne

AU - Provencher, Diane

AU - Mahner, Sven

AU - Follana, Philippe

AU - Waters, Justin

AU - Berek, Jonathan S

AU - Woie, Kathrine

AU - Oza, Amit M

AU - Canzler, Ulrich

AU - Gil-Martin, Marta

AU - Lesoin, Anne

AU - Monk, Bradley J

AU - Lund, Bente

AU - Gilbert, Lucy

AU - Wenham, Robert M

AU - Benigno, Benedict

AU - Arora, Sujata

AU - Hazard, Sebastien J

AU - Mirza, Mansoor R

PY - 2019/6/7

Y1 - 2019/6/7

N2 - PURPOSE: In the ENGOT-OV16/NOVA trial ( ClinicalTrials.gov identifier: NCT01847274 ), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy.PATIENTS AND METHODS: A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (gBRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed gBRCAmut (non-gBRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to gBRCAmut status and response to their last platinum-based therapy. Ovarian cancer-specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy-Ovarian Symptom Index.RESULTS: Progression-free survival was improved in patients treated with niraparib compared with placebo in both the gBRCAmut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non-gBRCAmut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.CONCLUSION: Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.

AB - PURPOSE: In the ENGOT-OV16/NOVA trial ( ClinicalTrials.gov identifier: NCT01847274 ), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy.PATIENTS AND METHODS: A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (gBRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed gBRCAmut (non-gBRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to gBRCAmut status and response to their last platinum-based therapy. Ovarian cancer-specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy-Ovarian Symptom Index.RESULTS: Progression-free survival was improved in patients treated with niraparib compared with placebo in both the gBRCAmut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non-gBRCAmut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.CONCLUSION: Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.

U2 - 10.1200/JCO.18.02238

DO - 10.1200/JCO.18.02238

M3 - Journal article

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

ER -