Pancytopenia Related to PARP Inhibitors (PancytoRIB)

Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)

Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious adverse events such as pancytopenia. Today, data about pancytopenia are scarce.

The objective was to investigate reports of pancytopenia adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: PARP inhibitor

Detailed Description

Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of pancytopenia related to PARPi.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Basse Normandie
    • Caen, Basse Normandie, France, 14000
      • Alexandre Joachim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients treated with PARPi and experiencing pancytopenia.

Description

Inclusion Criteria:

• case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
• patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none) and pamiparib (none).

Exclusion Criteria: chronology not compatible between the PARPi and adverse event.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancytopenia reports related to PARPi.	Identification of the pancytopenia adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.	From inception to Feb, 2021

Secondary Outcome Measures

Outcome Measure	Time Frame
Description of the latency period since first PARPi exposure.	From inception to Feb, 2021
Description of the fatality rate.	From inception to Feb, 2021
Description of patients who experienced co-reported adverse events	From inception to Feb, 2021

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2021
• Primary Completion (Actual): February 27, 2021
• Study Completion (Actual): March 24, 2021

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Pancytopenia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Olaparib; Veliparib; Niraparib; Rucaparib; Poly(ADP-ribose) Polymerase Inhibitors; Talazoparib
• Other Study ID Numbers: Pharmaco 20200210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No