A prospective evaluation of tolerability of niraparib dosing based upon baseline body weight (wt) and platelet (blplt) count: Blinded pooled interim safety data from the PRIMA Study

González, A.D.; Mirza, Mansoor Raza; Vergote, Ignace; Li, Y.; Hazard, Sebastien; Clark, Romnee; Graybill, Whitney; Pothuri, Bhavana; Monk, Bradley J.

doi:10.1093/annonc/mdy285.150

Cited by 12 publications

(28 citation statements)

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“…A total of 471 patients received a fixed starting dose of niraparib/placebo (300 mg), and 159 patients were treated with an individualized dose of niraparib/placebo according to weight and platelet count (200 mg for bodyweight <77 kg and platelet count <150,000 μL). AEs grade ≥3 were lower in the individualized dosing group (pooled niraparib/placebo) as compared with the group that received a fixed starting dose of 300 mg of niraparib/placebo [ 71 ].…”

Section: Efficacy and Safety Of Niraparibmentioning

confidence: 99%

Differences in PARP Inhibitors for the Treatment of Ovarian Cancer: Mechanisms of Action, Pharmacology, Safety, and Efficacy

Valabrega

Scotto

Tuninetti

et al. 2021

IJMS

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Poly(ADP-ribose) polymerases (PARP) are proteins responsible for DNA damage detection and signal transduction. PARP inhibitors (PARPi) are able to interact with the binding site for PARP cofactor (NAD+) and trapping PARP on the DNA. In this way, they inhibit single-strand DNA damage repair. These drugs have been approved in recent years for the treatment of ovarian cancer. Although they share some similarities, from the point of view of the chemical structure and pharmacodynamic, pharmacokinetic properties, these drugs also have some substantial differences. These differences may underlie the different safety profiles and activity of PARPi.

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Section: Efficacy and Safety Of Niraparibmentioning

confidence: 99%

Differences in PARP Inhibitors for the Treatment of Ovarian Cancer: Mechanisms of Action, Pharmacology, Safety, and Efficacy

Valabrega

Scotto

Tuninetti

et al. 2021

IJMS

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“…Of the 12 RCTs identified, 6 trials evaluated maintenance therapies initiated after 1L chemotherapy, including niraparib (PRIMA [ 16 , 40 , 41 , 42 , 43 ]), olaparib (SOLO-1 [ 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 ]), abagovomab (MIMOSA [ 57 , 58 ]), pazopanib (AGO-OVAR16 [ 59 , 60 , 61 , 62 , 63 , 64 , 65 ] and NCT01227928 [ 66 , 67 ]), and olaparib added to bevacizumab after 1L chemotherapy (PAOLA-1 [ 19 , 34 ]). The remaining RCTs evaluated bevacizumab (ICON-7 [ 68 , 69 ] and GOG-0218 [ 70 , 71 ]), nintedanib (CHIVA/GINECO [ 37 ] and AGO-OVAR12 [ 72 ]), trebananib (TRINOVA-3 [ 73 ]), or veliparib (VELIA/GOG-3005 [ 74 , 75 ]) as maintenance therapies initiated with 1L chemotherapy and continuing into a maintenance phase.…”

Section: Resultsmentioning

confidence: 99%

“…Upon review, all 12 RCTs were excluded from this feasibility assessment due to heterogeneity in either the study design, patient population, and/or outcomes compared with PRIMA [ 16 , 40 , 41 , 42 , 43 ] ( Table 2 ).…”

Section: Resultsmentioning

confidence: 99%

“…Therapies that were evaluated as maintenance therapies initiated alongside 1L chemotherapy, followed by a maintenance phase, cannot be compared with PRIMA [ 16 , 40 , 41 , 42 , 43 ], in which niraparib was initiated following 1L chemotherapy. For therapies initiated with 1L chemotherapy, it is not possible to elucidate the contribution of the agent to the maintenance phase from that in the 1L chemotherapy phase.…”

Section: Resultsmentioning

confidence: 99%

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Feasibility Study of a Network Meta-Analysis and Unanchored Population-Adjusted Indirect Treatment Comparison of Niraparib, Olaparib, and Bevacizumab as Maintenance Therapies in Patients with Newly Diagnosed Advanced Ovarian Cancer

Lorusso

Guy²,

Samyshkin

et al. 2022

Cancers

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Selecting a first-line (1L) maintenance option for ovarian cancer is challenging given the variety of therapies, differing trials, and the lack of head-to-head data for angiogenesis and poly(ADP-ribose) polymerase (PARP) inhibitors. Thus, indirect treatment comparisons (ITCs) can aid treatment decision making. This study assessed the feasibility of two ITCs, a network meta-analysis (NMA) and a population-adjusted ITC (PAIC), comparing the efficacy of the PARP inhibitor niraparib in the PRIMA trial (NCT02655016) with other 1L maintenance treatments. A systematic literature review was conducted to identify trials using the Cochrane Handbook for Systematic Reviews of Interventions to assess differences in trial design, population characteristics, treatment arms, and outcome measures. All 12 trials identified were excluded from the NMA due to the absence of a common comparator and differences in survival measures and/or inclusion criteria. The PAIC comparing PRIMA and PAOLA-1 trials was also not feasible due to differences in inclusion criteria, survival measures, and the previous receipt of chemotherapy/bevacizumab. Neither ITC met recommended guidelines for analysis; the results of such comparisons would not be considered appropriate evidence when selecting 1L maintenance options in ovarian cancer. ITCs in this setting should be performed cautiously, as many factors can preclude objective trial comparisons.

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“…Most predictive factors for dose reduction were baseline body weight and baseline platelet counts, and patients with a baseline body weight of <77 kg and/or baseline platelets of <150,000/µL could benefit from a starting dose of 200 mg/day. This recommendation was prospectively analyzed and confirmed in a phase III randomized trial (PRIMA) [27]. Moore et al [28] presented the data from a post hoc analysis of the phase II QUADRA (NCT02354586) trial, which reported the use of niraparib in patients with PSR OC who have homologous recombination deficiency (HRD).…”

Section: Ovarian Cancermentioning

confidence: 99%

Major clinical research advances in gynecologic cancer in 2018

et al. 2019

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In this review, we summarized 14 major clinical advances in gynecology which occurred in 2008. For cervical cancer, clinical impact of HPV vaccine, prognostic value of imaging during radiotherapy, and oncologic/obstetric outcomes of fertility-sparing surgery were chosen. For uterine cancer, optimal method of adjuvant radiotherapy in intermediaterisk patients, extent of lymph node dissection, outcome of robot-assisted staging surgery, new standard chemotherapy regimen for leiomyosarcoma were selected. For ovarian cancer, recent changes in adjuvant therapy, feasibility of neoadjuvant chemotherapy, prediction of optimal secondary cytoreduction, studies on new biomarkers, advances in screening and treatment of women with BRCA mutations were included. For other cancers, the safety of sentinel lymph node dissection in vulvar cancer and chemotherapy regimens for low-risk gestational trophoblastic tumors were reviewed.

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A prospective evaluation of tolerability of niraparib dosing based upon baseline body weight (wt) and platelet (blplt) count: Blinded pooled interim safety data from the PRIMA Study

Cited by 12 publications

References 0 publications

Differences in PARP Inhibitors for the Treatment of Ovarian Cancer: Mechanisms of Action, Pharmacology, Safety, and Efficacy

Differences in PARP Inhibitors for the Treatment of Ovarian Cancer: Mechanisms of Action, Pharmacology, Safety, and Efficacy

Feasibility Study of a Network Meta-Analysis and Unanchored Population-Adjusted Indirect Treatment Comparison of Niraparib, Olaparib, and Bevacizumab as Maintenance Therapies in Patients with Newly Diagnosed Advanced Ovarian Cancer

Major clinical research advances in gynecologic cancer in 2018

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