530P PRIMA/ENGOT-OV26/GOG-3012 study: Updated long-term PFS and safety

Martin, Andrew; Pothuri, Bhavana; Vergote, I.; Graybill, W.; Mirza, Mansoor Raza; Mccormick, C.; Lorusso, D.; Backes, Floor J.; Baumann, Klaus; Sánchez, A. Redondo; Moore, R. G.; Vulsteke, Christof; O’Cearbhaill, R.E.; Malinowska, Izabela; Shtessel, L.; Compton, Natalie; Monk, B.J.

doi:10.1016/j.annonc.2022.07.658

Cited by 13 publications

(13 citation statements)

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“…45 Long-term progression-free survival (ad hoc analyses) reported from the updated PRIMA trial cut-off date (data cut-off November 2021) demonstrated a sustained and durable progression-free survival benefit in the overall population and across biomarker subgroups after a median follow-up of 3.5 years. 46 Long-term niraparib monotherapy was also associated with a low rate of treatment Review discontinuation due to adverse events and the benefit of an individualized starting dose was reinforced with patients generally having a lower incidence of treatment-emergent adverse events. 46 Using PARP inhibitors can increase the chemotherapy-free interval for patients with epithelial ovarian cancer, with the potential to delay or avoid chemotherapy-associated toxicity.…”

Section: Discussionmentioning

confidence: 99%

“…46 Long-term niraparib monotherapy was also associated with a low rate of treatment Review discontinuation due to adverse events and the benefit of an individualized starting dose was reinforced with patients generally having a lower incidence of treatment-emergent adverse events. 46 Using PARP inhibitors can increase the chemotherapy-free interval for patients with epithelial ovarian cancer, with the potential to delay or avoid chemotherapy-associated toxicity.…”

Section: Discussionmentioning

confidence: 99%

“…Additionally, a recent ad hoc interim analysis from the NORA trial of niraparib maintenance treatment using an individualized starting dose for patients with platinum-sensitive recurrent ovarian cancer (data cut-off September 2022) reported a potentially favorable trend in overall survival, irrespective of germline BRCA status 45. Long-term progression-free survival (ad hoc analyses) reported from the updated PRIMA trial cut-off date (data cut-off November 2021) demonstrated a sustained and durable progression-free survival benefit in the overall population and across biomarker sub-groups after a median follow-up of 3.5 years 46. Long-term niraparib monotherapy was also associated with a low rate of treatment discontinuation due to adverse events and the benefit of an individualized starting dose was reinforced with patients generally having a lower incidence of treatment-emergent adverse events 46.…”

Section: Discussionmentioning

confidence: 99%

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Safety and management of niraparib monotherapy in ovarian cancer clinical trials

Monk

González-Martín

Buckley

et al. 2023

International Journal of Gynecological Cancer

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Niraparib is a poly (ADP-ribose) polymerase inhibitor that has shown a significant improvement in progression-free survival irrespective of biomarker status in patients with advanced epithelial ovarian cancer. This review focuses on the adverse events associated with niraparib and their management to maintain efficacy of niraparib treatment and improve quality of life for patients. In five trials assessing efficacy of niraparib in patients with advanced epithelial ovarian cancer (PRIMA, NOVA, NORA, QUADRA, and PRIME), treatment-emergent adverse events of any grade were reported in nearly all patients (≥99%) receiving niraparib; the events were grade ≥3 in 51–74% of patients. Across all lines of therapy, treatment-emergent adverse events led to dose interruptions in 62–80% of patients receiving niraparib and dose reductions in 47–71%. Hematologic events were most frequently reported, including thrombocytopenia, anemia, and neutropenia. Common non-hematologic events included gastrointestinal events, which were generally low grade (<5% were grade ≥3). Clinical strategies to manage these and other events, such as fatigue and insomnia, cognitive behavioral therapy and pharmacologic agents, are summarized. Once-daily niraparib dosing may be advantageous for some patients for many reasons, including night-time dosing which may help alleviate gastrointestinal symptoms. An individualized starting dose (determined by baseline body weight and platelet count) of niraparib demonstrated an improved safety profile while maintaining efficacy. Patients receiving the niraparib individualized starting dose had fewer grade ≥3 adverse events, dose interruptions, and dose reductions than patients receiving a fixed starting dose. The safety profile of niraparib across five pivotal studies in advanced epithelial ovarian cancer was consistent across multiple lines of treatment, including as maintenance therapy in first-line and recurrent settings and as treatment in heavily pre-treated patients. Long-term safety data from the NOVA trial confirmed that, with appropriate and early dose modifications, niraparib is well tolerated.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Safety and management of niraparib monotherapy in ovarian cancer clinical trials

Monk

González-Martín

Buckley

et al. 2023

International Journal of Gynecological Cancer

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“…7 Moreover, the updated progression-free survival data from the PRIMA trial confirmed the clinical benefit of PARPi also in homologous recombination-proficient patients, although the magnitude of this benefit was less prominent and further effort is required to improve the outcomes in this cohort. 8 Figure 1 illustrates an algorithm with the currently approved first-line maintenance options in advanced epithelial ovarian cancer. The BRCA/homologous recombination deficiency mutational status is the main driver for choosing the most appropriate strategy.…”

Section: What Is the State Of The Art Of First-line Poly (Adp-ribose)...mentioning

confidence: 99%

“…Before the advent of PARPi, 70% of patients with advanced ovarian cancer relapsed within 3 years from the initial diagnosis and the 5-year overall survival was extremely poor (5–20%) with a median time to progression of 10–20 months 5. The updated long-term data from the SOLO1,6 PAOLA1,7 and PRIMA8 trials showed unprecedented survival rates in ovarian cancer, reinforcing the role of PARPi as a practice-changing treatment (Table 1). In the updated analysis of the SOLO1 trial after 7 years of follow-up—although the data were still immature—nearly 70% of patients treated with olaparib were alive and half of them did not receive any subsequent treatment 6.…”

Section: What Is the State Of The Art Of First-line Poly (Adp-ribose)...mentioning

confidence: 99%

Poly (ADP-ribose) polymerase inhibitors (PARPi) in ovarian cancer: lessons learned and future directions

Caruso

Tomao

Parma

et al. 2023

International Journal of Gynecological Cancer

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Poly (ADP-ribose) polymerase inhibitors (PARPi) represent a new standard of care in the upfront treatment of advanced epithelial ovarian cancer to the point that the vast majority of patients now receive a PARPi, alone or in combination with the anti-angiogenic bevacizumab, as part of their first-line maintenance therapy. The clinical benefit of PARPi is well established; however, much has changed since their introduction and several relevant questions have been raised and remain unresolved in the post-PARPi era. The decision-making process regarding the most appropriate first-line maintenance therapy could be challenging in clinical practice, especially in the homologous recombination-proficient setting, and several other factors need to be considered apart from the mutational status. Concerns regarding post-PARPi progression treatment have emerged, highlighting an unmet need to define a valid algorithm strategy. PARPi may not only compromise the response to further platinum due to cross-resistance mechanisms but the impact on subsequent non-platinum chemotherapy and surgery also remains unclear. Definitive results on the role of PARPi rechallenge are awaited, especially in the case of oligoprogression managed with locoregional treatment. Moreover, the updated overall survival data from the recurrent setting warrant caution in using PARPi as single agents for unselected patients. Several PARPi combination regimens are emerging for overcoming PARPi resistance and may become our new therapeutic armamentarium. This review discusses a set of clinically relevant issues in the PARPi era and provides a glimpse of future challenges and opportunities in ovarian cancer treatment.

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Cost-Effectiveness Analysis of Biomarker Testing to Guide First-Line PARP Inhibitor Maintenance for Patients with Advanced Ovarian Cancer After Response to First-Line Platinum Chemotherapy in the USA

Elsea¹,

Muston

Fan

et al. 2023

Targ Oncol

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530P PRIMA/ENGOT-OV26/GOG-3012 study: Updated long-term PFS and safety

Cited by 13 publications

References 0 publications

Safety and management of niraparib monotherapy in ovarian cancer clinical trials

Safety and management of niraparib monotherapy in ovarian cancer clinical trials

Poly (ADP-ribose) polymerase inhibitors (PARPi) in ovarian cancer: lessons learned and future directions

Cost-Effectiveness Analysis of Biomarker Testing to Guide First-Line PARP Inhibitor Maintenance for Patients with Advanced Ovarian Cancer After Response to First-Line Platinum Chemotherapy in the USA

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