Patient-Reported Outcomes With TALZENNA

PRO Assessments

pro-assessments_1
  • 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 data3
  • EORTC QLQ-C30 and EORTC QLQ-BR23 each have established reference values in the metastatic setting, showing their validity and reliability for the assessment of QoL in patients with mBC4 
pro-assessments_2_1

 

 

Prespecified exploratory endpoint: PROs
GHS/QoL

A significant overall improvement in GHS/QoL was observed in patients receiving TALZENNA vs chemotherapy2,5*†

Estimated Overall Mean Change From Baseline in GHS/QoL

ghs_qol_0
 

 Adapted from Litton et al. 2018,2 and Ettl et al. 2018.5

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 data.3

PROs were evaluated using the EORTC QLQ-C30 and the EORTC QLQ-BR23 questionnaires for general cancer-related and breast cancer-specific outcomes, respectively. 
*Conducted in the PRO-evaluable population, defined as those in the ITT population with a baseline assessment and at least 1 postbaseline assessment before the end of the study.
Capecitabine, eribulin, gemcitabine, or vinorelbine.
Results from longitudinal repeated measures analyses (mixed-effects model).

Patients taking TALZENNA experienced a significant delay in the time to definitive clinically meaningful deterioration§ in GHS/QoL vs chemotherapy3,5 ||

Time to Clinically Meaningful Deterioration of GHS/QoL

ghs_qol2_0

NR=not reported.  
Adapted from Litton et al. Suppl Appendix 2018,3 and Ettl et al. 2018.5

§Defined as the time from randomization to the first observation with a ≥10-point decrease and no subsequent observations with a <10-point decrease from baseline.
||Results analyzed with the use of a stratified log-rank test, summarized with the use of Kaplan-Meier methods.2

 

 

Breast Symptoms

TALZENNA is the only PARP inhibitor to investigate and report breast cancer-specific PROs and symptoms 

Significant improvement in breast symptoms2,3,5,6¶

Estimated Overall Mean Change From Baseline in Breast Symptoms#

breast-symptoms

Adapted from Litton et al. 2018,2 and Ettl et al. 2018.5

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 data.3

PROs were evaluated using the EORTC QLQ-C30 and the EORTC QLQ-BR23 questionnaires for general cancer-related and breast cancer-specific outcomes, respectively. 
Conducted in the PRO-evaluable population, defined as those in the ITT population with a baseline assessment and at least 1 postbaseline assessment before the end of the study.
#Results from longitudinal repeated measures analyses (mixed-effects model).

 

Patients taking TALZENNA experienced a significant delay in the time to definitive clinically meaningful deterioration in patient-reported breast symptoms vs chemotherapy (medians not reached)3,5,7**††

Time to Clinically Meaningful Deterioration in Breast Symptoms

breast-symptoms2

Adapted from Litton et al. Suppl Appendix. 2018,3 and data on file.7
**Defined as the time from randomization to the first observation with a ≥10-point increase and no subsequent observations with a <10-point increase from baseline.
††Results analyzed with the use of a stratified log-rank test, summarized with the use of Kaplan-Meier methods.2

 

BRCA=breast cancer susceptibility gene; CI=confidence interval; EORTC=European Organization for Research and Treatment of Cancer; HER2-=human epidermal growth factor receptor 2 negative; HR=hazard ratio; ITT=intent-to-treat; mBC=metastatic breast cancer; PARP=poly (ADP-ribose) polymerase; QLQ-BR23=Quality of Life Questionnaire–Breast Cancer Module; QLQ-C30=Quality of Life Questionnaire–Core 30.

 

REFERENCES
  1. TALZENNA Summary of Product Characteristics.
  2. 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.
  3. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. doi:10.1056/NEJMoa1802905; supplementary appendix:1-22.
  4. 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.
  5. 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.
  6. Robson M, Im S-A, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377(6):523-533.
  7. Data on file. Pfizer Inc., New York, NY.
  8. Hurvitz SA, Gonçalvez A, Rugo HS, et al. Talazoparib, an oral poly(ADP-ribose) polymerase inhibitor for patients with locally advanced/metastatic breast cancer and a germline BRCA mutation: detailed safety analyses from the randomized, multinational, phase 3 EMBRACA trial. Poster presented at: 36th Annual Miami Breast Cancer Conference; March 7-10, 2019; Miami, FL Poster 761.
 

▼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.