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AboutTALZENNA MoATalzenna MoAgBRCA testingIdentifying patientsGuidelinesStudy designStudy designBaseline characteristicsEfficacy & SafetyTALZENNA efficacyPrimary endpoint & subgroup analysisSecondary endpoints: ORRSecondary endpoint: OSExploratory endpoints: DoR & TTRTALZENNA safetySafety and tolerabillityAdverse eventsHaematologic/Nonhaematologic AEsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptomsDosingDosingDose recommendation and special populationsDose modifications/managementPatient ProfilesSupport & ResourcesSupport & ResourcesMaterialsVideosElevateElevatePersonalising Breast Cancer TreatmentUnderstanding and Optimising PARP Inhibitors for mBCPARP Inhibitors in mBC: the role of Real World Evidence
Patient-reported outcomes (PROs) were assessed using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires1

PROs were included as exploratory endpoints in an open-label study; analyses were prespecified and adjustments for multiplicity were not made. No efficacy conclusions can be made from these data2

EORTC QLQ-C30 and EORTC QLQ-BR23 have established reference values in the metastatic setting, showing their validity and reliability for quality of life (QoL) assessment in patients with LA/mBC3

EORTC QLQ-C30 is a general cancer-related PRO instrument1,3,4

Assesses PROs in the following scales validated individually, not collectively:

  • Global health status/quality of life (GHS/QoL) 
  • Functional status across 5 scales: physical, role, emotional, cognitive, and social functioning 
  • Symptom severity across 8 scales: fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea
EORTC QLQ-BR23 is a breast cancer-specific PRO instrument1,3​​​​​​​

Assesses PROs in the following scales validated individually, not collectively:

  • Functional status across 4 scales: body image, sexual functioning, sexual enjoyment, and future perspective
  • Symptom severity across 4 scales: side effects, breast symptoms, arm symptoms, and upset by hair loss
Scoring1,3

GHS/QoL is evaluated using two 7-point Likert scales with responses from "very poor" to "excellent." A 4-point Likert scale with responses from "not at all" to "very much" is used to evaluate functional and symptom scales.

AE=adverse event; EORTC=European Organisation for Research and Treatment of Cancer; LA/mBC=locally advanced/metastatic breast cancer; PFS=progression-free survival; QLQ-BR23=Quality of Life Questionnaire–Breast Cancer Module; QLQ-C30=Quality of Life Questionnaire–Core 30. Explore more GHS/QoL
References:Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation (supplementary appendix). N Engl J Med. 2018;379(8):753-763.Fayers PM, Aaronson NK, Bjordal K, et al; on behalf of the EORTC Quality of Life Group. The EORTC QLC-C30 Scoring Manual. 3rd ed. Brussels, Belgium: European Organisation for Research and Treatment of Cancer; 2001.Ettl J, Quek RGW, Lee KH, et al. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018;29:1939-1947.TALZENNA Summary of Product Characteristics. 
​​​​​​​ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of full SmPC for how to report adverse reactions.

Legal Category: S1A 
Further information is available upon request

PP-TAL-IRL-0061 April 2023
Patient-reported outcomes with TALZENNA Significantly longer PFS

Superior to chemotherapy in delaying disease progression5​​​​​​​

See the data 
Manageable safety profile 

AEs were manageable with a low discontinuation rate5

Review Safety
TALZENNA Summary of Product Characteristics Product CharacteristicsLoading

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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