Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-Analysis
Background: Patients with epithelial ovarian cancer (EOC), treated with niraparib maintenance, present with haematological and gastrointestinal toxicities. Limited data exist on niraparib safety assessment. Objective: To evaluate niraparib safety profile, as maintenance therapy, in women with platin...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-01-01
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| Series: | Current Oncology |
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| Online Access: | https://www.mdpi.com/1718-7729/29/1/29 |
| _version_ | 1797494837497298944 |
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| author | Antonia Pagkali Ioannis Mamais Adamantios Michalinos Aris P. Agouridis |
| author_facet | Antonia Pagkali Ioannis Mamais Adamantios Michalinos Aris P. Agouridis |
| author_sort | Antonia Pagkali |
| collection | DOAJ |
| description | Background: Patients with epithelial ovarian cancer (EOC), treated with niraparib maintenance, present with haematological and gastrointestinal toxicities. Limited data exist on niraparib safety assessment. Objective: To evaluate niraparib safety profile, as maintenance therapy, in women with platinum-sensitive EOC. Methods: PubMed and Cochrane searches were carried out up to April 2021 for randomised controlled trials (RCTs) evaluating niraparib versus placebo in EOC patients with a response to platinum-based chemotherapy. Regarding the meta-analysis, for dichotomous data, the pooled risk ratio (RR) was calculated. Results: A total of 1539 patients from three RCTs revealed that niraparib-treated patients are associated with a significantly higher risk of any grade of nausea (RR, 2.15; 95% CI, 1.86 to 2.48), fatigue (RR, 1.26; 95% CI, 1.05 to 1.52, <i>p</i> < 0.00001), anemia (RR, 6.86; 95% CI, 2.54 to 18.52, <i>p</i> = 0.0001), thrombocytopenia (RR, 7.02; 95% CI, 1.68 to 29.38, <i>p</i> < 0.00001), vomiting (RR, 2.51; 95% CI, 1.50 to 4.19, <i>p</i> = 0.0005), neutropenia (RR, 2.96; 95% CI, 1.13 to 7.73, <i>p</i> < 0.00001), headache (RR, 2.08; 95% CI, 1.57 to 2.74, <i>p</i> < 0.00001), constipation (RR, 2.10; 95% CI, 1.72 to 2.57, <i>p</i> < 0.00001) and insomnia (RR, 2.48; 95% CI, 1.52 to 2.89, <i>p</i> = 0.0003) when compared with placebo. For grade 3 or 4 adverse effects, significantly higher risk was only noted for fatigue (RR,6.25; 95% CI, 1.70 to 23.05, <i>p</i> = 0.006), anemia (RR, 16.23; 95% CI, 4.86 to 54.17, <i>p</i> < 0.00001), thrombocytopenia (RR, 35.12; 95% CI, 12.23 to 100.82, <i>p</i> < 0.00001) and neutropenia episodes (RR, 6.35; 95% CI, 2.08 to 19.39, <i>p</i> = 0.001) for those taking niraparib. Notably, incidents of adverse effects and discontinuation rates were substantially lower among patients treated with an individualised niraparib dose than those treated with the standard one. Efficacy was not reduced, and no treatment-related deaths occurred during the included trials. Conclusion: Niraparib is considered an effective and well-tolerated choice, with an improved safety profile, for the maintenance treatment of EOC patients. |
| first_indexed | 2024-03-10T01:40:02Z |
| format | Article |
| id | doaj.art-17b009ad475a44979812aa775b3ad115 |
| institution | Directory Open Access Journal |
| issn | 1198-0052 1718-7729 |
| language | English |
| last_indexed | 2024-03-10T01:40:02Z |
| publishDate | 2022-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj.art-17b009ad475a44979812aa775b3ad1152023-11-23T13:26:05ZengMDPI AGCurrent Oncology1198-00521718-77292022-01-0129132133610.3390/curroncol29010029Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-AnalysisAntonia Pagkali0Ioannis Mamais1Adamantios Michalinos2Aris P. Agouridis3School of Medicine, European University Cyprus, Nicosia 2404, CyprusDepartment of Health Sciences School of Sciences, European University Cyprus, Nicosia 2404, CyprusSchool of Medicine, European University Cyprus, Nicosia 2404, CyprusSchool of Medicine, European University Cyprus, Nicosia 2404, CyprusBackground: Patients with epithelial ovarian cancer (EOC), treated with niraparib maintenance, present with haematological and gastrointestinal toxicities. Limited data exist on niraparib safety assessment. Objective: To evaluate niraparib safety profile, as maintenance therapy, in women with platinum-sensitive EOC. Methods: PubMed and Cochrane searches were carried out up to April 2021 for randomised controlled trials (RCTs) evaluating niraparib versus placebo in EOC patients with a response to platinum-based chemotherapy. Regarding the meta-analysis, for dichotomous data, the pooled risk ratio (RR) was calculated. Results: A total of 1539 patients from three RCTs revealed that niraparib-treated patients are associated with a significantly higher risk of any grade of nausea (RR, 2.15; 95% CI, 1.86 to 2.48), fatigue (RR, 1.26; 95% CI, 1.05 to 1.52, <i>p</i> < 0.00001), anemia (RR, 6.86; 95% CI, 2.54 to 18.52, <i>p</i> = 0.0001), thrombocytopenia (RR, 7.02; 95% CI, 1.68 to 29.38, <i>p</i> < 0.00001), vomiting (RR, 2.51; 95% CI, 1.50 to 4.19, <i>p</i> = 0.0005), neutropenia (RR, 2.96; 95% CI, 1.13 to 7.73, <i>p</i> < 0.00001), headache (RR, 2.08; 95% CI, 1.57 to 2.74, <i>p</i> < 0.00001), constipation (RR, 2.10; 95% CI, 1.72 to 2.57, <i>p</i> < 0.00001) and insomnia (RR, 2.48; 95% CI, 1.52 to 2.89, <i>p</i> = 0.0003) when compared with placebo. For grade 3 or 4 adverse effects, significantly higher risk was only noted for fatigue (RR,6.25; 95% CI, 1.70 to 23.05, <i>p</i> = 0.006), anemia (RR, 16.23; 95% CI, 4.86 to 54.17, <i>p</i> < 0.00001), thrombocytopenia (RR, 35.12; 95% CI, 12.23 to 100.82, <i>p</i> < 0.00001) and neutropenia episodes (RR, 6.35; 95% CI, 2.08 to 19.39, <i>p</i> = 0.001) for those taking niraparib. Notably, incidents of adverse effects and discontinuation rates were substantially lower among patients treated with an individualised niraparib dose than those treated with the standard one. Efficacy was not reduced, and no treatment-related deaths occurred during the included trials. Conclusion: Niraparib is considered an effective and well-tolerated choice, with an improved safety profile, for the maintenance treatment of EOC patients.https://www.mdpi.com/1718-7729/29/1/29niraparibmaintenance therapysafety profilemeta-analysisovarian cancerrandomised controlled trials |
| spellingShingle | Antonia Pagkali Ioannis Mamais Adamantios Michalinos Aris P. Agouridis Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-Analysis Current Oncology niraparib maintenance therapy safety profile meta-analysis ovarian cancer randomised controlled trials |
| title | Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-Analysis |
| title_full | Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-Analysis |
| title_fullStr | Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-Analysis |
| title_full_unstemmed | Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-Analysis |
| title_short | Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-Analysis |
| title_sort | safety profile of niraparib as maintenance therapy for ovarian cancer a systematic review and meta analysis |
| topic | niraparib maintenance therapy safety profile meta-analysis ovarian cancer randomised controlled trials |
| url | https://www.mdpi.com/1718-7729/29/1/29 |
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