Utilization of Poly(ADP-Ribose) Polymerase Inhibitors in Ovarian Cancer: A Retrospective Cohort Study of US Healthcare Claims Data

Arend, Rebecca C.; O’Malley, David M.; Banerjee, Susana; McLaurin, Kimmie; Davidson, Richard; Long, Gráinne H.

doi:10.1007/s12325-021-01959-5

Cited by 13 publications

(7 citation statements)

References 40 publications

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“…A subsequent post hoc analysis reported that patients with a weight of less than 77 kg or a baseline platelet count of less than 150,000/mm 3 benefited from a reduced starting dose of 200 mg once daily (Berek et al, 2018) in the ENGOT-OV16/NOVA study. In a retrospective cohort study of US health care claims data, fewer patients receiving niraparib (69.3%) than olaparib (89.4%) or rucaparib (93.2%) started treatment at the highest indicated dose (Arend et al, 2021). The above results suggest that modified niraparib doses were implemented in clinical practice to mitigate the risk of severe hematologic toxicity.…”

Section: Hematologic Toxicitymentioning

confidence: 96%

Adverse Event Profiles of PARP Inhibitors: Analysis of Spontaneous Reports Submitted to FAERS

Tian¹,

Chen²,

Gai

et al. 2022

Front. Pharmacol.

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Background: Several poly ADP ribose polymerase inhibitors (PARPis) are currently approved for the treatment of a variety of cancers. The safety profile of PARPis has not yet been systemically analyzed in the real world. We conducted this pharmacovigilance analysis using the US FDA’s Adverse Event Reporting System (FAERS) database to explore the difference in adverse events (AEs) among PARPis.Methods: FAERS data (December 2014 to October 2021) were searched for reports of all FDA-approved PARPis across all indications. We used the standardized MedDRA query (SMQ) generalized search AEs on the preferred term (PT) level based on case reports. After filtering duplicate reports, disproportionality analysis was used to detect safety signals by calculating reporting odds ratios (ROR). Reports were considered statistically significant if the 95% confidence interval did not contain the null value.Results: Within the standardized MedDRA queries, significant safety signals were found, including those for olaparib [blood premalignant disorders (ROR = 17.06)], rucaparib [taste and smell disorders (ROR = 9.17)], niraparib [hematopoietic throbocytopenia (ROR = 28.2)], and talazoparib [hematopoietic erythropenia (ROR = 9.38)]. For AEs on the PT level, we found several significant signals, including platelet count decreased with niraparib (ROR = 52.78); red blood cell count decreased with niraparib (ROR = 70.47) and rucaparib (ROR = 15.09); myelodysplastic syndrome with olaparib (ROR = 35.47); acute myeloid leukaemia with olaparib (ROR = 25.14); blood pressure fluctuation with niraparib (ROR = 20.54); lymphangioleiomyomatosis with niraparib (ROR = 471.20); photosensitivity reaction with niraparib (ROR = 21.77) and rucaparib (ROR = 18.92); renal impairment with rucaparib (ROR = 33.32); and interstitial lung disease with Olaparib (ROR = 11.31). All the detected safety signals were confirmed using signals of disproportionality reporting methods.Conclusion: PARPis differed in their safety profile reports. The analysis of the FAERS database revealed significant safety signals that matched previously published case reports, including serious gastrointestinal, blood and lymphatic system, cardiovascular and respiratory complications, which require individualized drug administration according to patients’ conditions.

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Section: Hematologic Toxicitymentioning

confidence: 96%

Adverse Event Profiles of PARP Inhibitors: Analysis of Spontaneous Reports Submitted to FAERS

Tian¹,

Chen²,

Gai

et al. 2022

Front. Pharmacol.

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“…79 The IQVIA Institute for Human Data Science estimates global spending on oncology drugs will reach $269 billion by 2025. 80 Specifi cally, in the United States, IQVIA highlights MM because annual spending has increased 20% or more since 2017. This increase refl ects the arrival of new treatment options to the market with novel mechanisms of action, improved diagnosis rates, and longer treatment durations.…”

Section: Managed Care Considerations Economic Burden Of Multiple Myelomamentioning

confidence: 99%

“…This increase refl ects the arrival of new treatment options to the market with novel mechanisms of action, improved diagnosis rates, and longer treatment durations. 80 The National Cancer Institute's Physician Data Query cancer information summary about fi nancial toxicity and cancer treatment states, "fi nancial toxicity and fi nancial distress are used to describe how out-of-pocket costs can cause fi nancial problems for a patient." 81 Patients who have MM are at a higher risk of fi nancial toxicity, as they are likely to develop advanced-stage cancer, recurrent cancer, and cancer with a poor prognosis.…”

Section: Managed Care Considerations Economic Burden Of Multiple Myelomamentioning

confidence: 99%

“…82,83 Lastly, patients need access to treatment centers to reduce travel and/ or relocation burden. 80 Administering treatment in the outpatient setting may alleviate some of the patients' geographic concerns. 82…”

Section: Phase-based Cost Modelingmentioning

confidence: 99%

“…79 One retrospective observational study characterizing the real-world usage of PARP inhibitors in women with ovarian cancer identified that adherence rates, defined by a medication possession ratio of 80% or more, were 80%, 63%, and 39% with olaparib, rucaparib, and niraparib, respectively. 80 Pharmacists are key healthcare practitioners who can provide patients with cancer with individualized attention to manage and mitigate acute toxicities while encouraging patients to remain focused on the goals of treatment. Interventions including intensive monitoring and serial follow-up to check in with patients can improve adherence.…”

Section: Pharmacists' Impactmentioning

confidence: 99%

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Addressing cancer health disparities in a multilateral collaboration in an independent community cancer clinic: translating words into action

2022

Am J Manag Care

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WARNINGS AND PRECAUTIONSOcular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the rst 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).Visual Acuity Changes: A clinically signi cant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the rst dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the rst infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with di culty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS.Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the rst thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding...

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PARP Inhibitors in Ovarian Cancer: A Review

et al. 2023

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Poly(ADP-ribose) polymerase (PARP) inhibitors (PARPis) have transformed the ovarian cancer (OC) treatment landscape. This narrative review provides a comprehensive overview of data for the PARPis olaparib, niraparib, and rucaparib in patients with OC and discusses their role in disease management, with a focus on the use of PARPis as maintenance therapy in the United States (US). Olaparib was the first PARPi to be approved as first-line maintenance monotherapy in the US, with maintenance niraparib subsequently approved in the first-line setting. Data also support the efficacy of rucaparib as first-line maintenance monotherapy. PARPi maintenance combination therapy (olaparib plus bevacizumab) also provides benefit in patients with newly diagnosed advanced OC whose tumors tested positive for homologous recombination deficiency (HRD). Biomarker testing is critical in the newly diagnosed setting to identify patients most likely to benefit from PARPi maintenance therapy and guide treatment decisions. Clinical trial data support the use of PARPis (olaparib, niraparib, rucaparib) as second-line or later maintenance therapy in patients with platinum-sensitive relapsed OC. Although distinct differences in tolerability profile were observed between PARPis, they were generally well tolerated, with the majority of adverse events managed by dose modification. PARPis had no detrimental effect on patients' health-related quality of life. Real-world data support the use of PARPis in OC, although some differences between PARPis are apparent. Data from trials investigating novel combination strategies, such as PARPis plus immune checkpoint inhibitors, are awaited with interest; the optimal sequencing of novel therapies in OC remains to be established.

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Utilization of Poly(ADP-Ribose) Polymerase Inhibitors in Ovarian Cancer: A Retrospective Cohort Study of US Healthcare Claims Data

Cited by 13 publications

References 40 publications

Adverse Event Profiles of PARP Inhibitors: Analysis of Spontaneous Reports Submitted to FAERS

Adverse Event Profiles of PARP Inhibitors: Analysis of Spontaneous Reports Submitted to FAERS

Addressing cancer health disparities in a multilateral collaboration in an independent community cancer clinic: translating words into action

PARP Inhibitors in Ovarian Cancer: A Review

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